REVISTA-MSP FEBRERO 2025

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EDICIÓN FEBRERO 2025

REMISIÓN ENDOSCÓPICA EN ENFERMEDAD DE CROHN Y COLITIS ULCEROSA DEFINICIÓN, EVALUACIÓN Y DESAFÍOS

María Eugenia Ríos Enríquez, MD Diplomate, Board of Internal Medicine Diplomate, Board of Gastrointestinal Disease Facultad Escuela de Medicina de Ponce Facultad Residencia de Medicina Interna del Hospital de la Concepción en San Germán

INNOVACIÓN EN INTERVENCIONES ARTERIALES PARA PACIENTES EN PUERTO RICO CATÉTER R2P

EXPLORANDO LA CONEXIÓN LA ENFERMEDAD DE ALZHEIMER, DEMENCIA Y EL MICROBIOMA INTESTINAL

LA ELECTROFISIOLOGÍA Y SU TECNOLOGÍA PARA CURAR ARRITMIA CARDIACA

Revista Puertorriqueña de Medicina y Salud Pública

A PCV for the prevention of IPD and pneumococcal pneumonia in adults

BRILLIANTLY DESIGNED FOR YOUR ADULT PATIENTS. 1-3 , a Only CAPVAXIVE is specifically designed for adults and covers the serotypes responsible on a national level for ~84% of adult IPD in the US—exceeding PCV20, which includes the serotypes that cause ~52%. 2,3,10,11 THE CDC RECOMMENDS CAPVAXIVE FOR 4,12,13 : Adults 50+: • Vaccine-naïve or vaccination history is unknown (lowered from 65+) Adults 19-49: • With certain chronic medical conditions or other risk factors † who are vaccine-naïve or vaccination history is unknown Previously Vaccinated Adults For Adults 19+: • Previously vaccinated with PCV13 only or PPSV23 only, ≥1 year prior at any age • Previously vaccinated but have not completed a recommended series b For Adults 65+: • As a supplemental dose for those previously vaccinated with PCV13 and PPSV23* * Routine if PCV13 was administered at any age and PPSV23 was administered before age 65 with the last pneumococcal vaccine being at least 5 years prior. Shared clinical decision-making if PCV13 was administered at any age and PPSV23 was administered at or after the age of 65 and the last pneumococcal vaccine was at least 5 years prior. 4 † Diabetes, renal disorders, chronic heart disease, chronic liver disease, chronic lung disease including asthma, smoking, alcoholism. 12

THAT’S BRILLIANT DESIGN A PCV specifically designed for adults and covers the serotypes responsible for most IPD cases 1-3,a

Encourage your appropriate adult patients to stay proactive with CAPVAXIVE. 14

VS by PCV20 1-3,a These values are based on CDC epidemiologic data and do not reflect the efficacy of the respective vaccines. 3 There are currently no studies comparing the efficacy of CAPVAXIVE and PCV20. a Based on CDC ABC surveillance data from the years 2018–2022, representing ~35 million persons and 10 states across the US. Regional variations may exist. 2-9 ~84% of US IPD cases in adults aged 50+ ~52% CAPVAXIVE was specifically designed for adults and helps protect against the serotypes that are responsible on a national level for a

Scan the QR code or go to capvaxivehcp.com to uncover more about the brilliant design behind CAPVAXIVE.

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a Based on CDC ABC surveillance data from the years 2018–2022, representing ~35 million persons and 10 states across the US. Regional variations may exist. 2-9 b Patients are eligible to receive CAPVAXIVE if they only received PCV13 or PPSV23 ≥1 year ago or if last dose of PPSV23 was completed ≥5 years ago where PCV13 and PPSV23 were both received. 4,12 Select Safety Information (continued) The most commonly reported (>10%) solicited adverse reactions in individuals 18 through 49 years of age who received CAPVAXIVE were: injection-site pain (73.1%), fatigue (36.0%), headache (27.5%), myalgia (16.4%), injection-site erythema (13.8%), and injection-site swelling (13.3%). The most commonly reported (>10%) solicited adverse reactions in individuals 50 years of age and older who received CAPVAXIVE were: injection-site pain (41.2%), fatigue (19.7%), and headache (11.0%). Vaccination with CAPVAXIVE may not protect all vaccine recipients. Please read the adjacent Brief Summary of the Prescribing Information. ABC, Active Bacterial Core; CDC, Centers for Disease Control and Prevention; IPD, invasive pneumococcal disease; PCV, pneumococcal conjugate vaccine; PCV13, 13-valent pneumococcal conjugate vaccine; PCV20, 20-valent pneumococcal conjugate vaccine; PPSV23, 23-valent pneumococcal polysaccharide vaccine; US, United States. References: 1. ABCs bact facts interactive data dashboard. SPN serotypes 1998-2022. Centers for Disease Control and Prevention. May 22, 2024. Accessed October 31, 2024. https://www.cdc.gov/ abcs/bact-facts/data-dashboard.html 2. Data available on request from Merck& Co., Inc., WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package US-PVV-00504. 3. 1998- 2022 serotype data for invasive pneumococcal disease cases by age group from Active Bacterial Core surveillance, ages 18-49, 50-64, 65 plus, year is between 2018 and 2022. Centers for Disease Control and Prevention. Last updated July 22, 2024. Accessed October 31, 2024. https://data.cdc.gov/Public-Health-Surveillance/1998-2022-Serotype-Data-for-Invasive-Pneumococcal-/qvzb-qs6p/ data 4. Kobayashi M, Leidner AJ, Gierke R, et al. Use of 21-valent pneumococcal conjugate vaccine among U.S. adults: recommendations of the Advisory Committee on Immunization Practices – United States, 2024. MMWR Morb Mortal Wkly Rep . 2024;73(36):793-798. doi:10.15585/mmwr.mm7336a3 5. Active Bacterial Core surveillance (ABCs) report, Emerging Infections Program network, Streptococcus pneumoniae , 2018. Centers for Disease Control and Prevention. Updated May 22, 2020. Accessed October 31, 2024. https://stacks.cdc.gov/view/cdc/140450 6. Active Bacterial Core surveillance (ABCs) report, Emerging Infections Program network, Streptococcus pneumoniae , 2019. Centers for Disease Control and Prevention. Updated June 16, 2021. Accessed October 31, 2024. https://www.cdc.gov/abcs/downloads/SPN_Surveillance_Report_2019.pdf 7. Active Bacterial Core surveillance (ABCs) report, Emerging Infections Program network, Streptococcus pneumoniae , 2020. Centers for Disease Control and Prevention. Updated September 20, 2022. Accessed October 31, 2024. https://www.cdc.gov/abcs/downloads/SPN_Surveillance_Report_2020.pdf 8. Active Bacterial Core surveillance (ABCs) report, Emerging Infections Program network, Streptococcus pneumoniae , 2021. Centers for Disease Control and Prevention. Updated June 2, 2023. Accessed October 31, 2024. https://www.cdc.gov/abcs/downloads/SPN_Surveillance_Report_2021.pdf 9. Active Bacterial Core surveillance (ABCs) report, Emerging Infections Program network, Streptococcus pneumoniae , 2022. Centers for Disease Control and Prevention. Updated July 5, 2024. Accessed November 1, 2024. https://www.cdc.gov/abcs/downloads/SPN_Surveillance_Report_2022.pdf 10. Prevnar 20. Prescribing Information. Pfizer Inc; 2023. 11. Prevnar 13. Prescribing Information. Pfizer Inc; 2023. 12. Kobayashi M. Summary of work group interpretation of EtR and policy options: PCV use in adults aged ≥50 years. Slide deck presented at: Advisory Committee on Immunization Practices Meeting; October 23, 2024; Atlanta, GA. Accessed October 31, 2024. https://www.cdc.gov/acip/downloads/slides-2024- 10-23-24/04-Kobayashi-Pneumococcal-508.pdf 13. ACIP recommendations. Centers for Disease Control and Prevention. Last reviewed June 28, 2024. Accessed October 31, 2024. https://www.cdc. gov/vaccines/acip/recommendations.html 14. Immunizations for respiratory viruses prevention. Centers for Disease Control and Prevention. Last reviewed March 1, 2024. Accessed October 31, 2024. https://www.cdc.gov/respiratory-viruses/prevention/immunizations.html

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Indications and Usage CAPVAXIVE™ is indicated for:

Revista Puertorriqueña de Medicina y Salud Pública The indication for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Select Safety Information Do not administer CAPVAXIVE to individuals with a history of a severe allergic reaction (eg, anaphylaxis) to any component of CAPVAXIVE or to diphtheria toxoid. Individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to CAPVAXIVE. (Select Safety Information continues on the next page) • active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in individuals 18 years of age and older. • active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in individuals 18 years of age and older.

Smallest Trim size: 15” x 10.5”

In Study 2 (NCT05464420), individuals 18 through 49 years of age who had not previously received a pneumococcal vaccine were enrolled and randomized to receive a single dose of CAPVAXIVE or PNEUMOVAX 23. The percentage of individuals 18 through 49 years of age with solicited adverse reactions that occurred within 5 days postvaccination of CAPVAXIVE or PNEUMOVAX 23 is shown in Table 2. Brief Summary of the Prescribing Information for CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) ( continued )

Table 3: Individuals with Solicited Local and Systemic Adverse Reactions Within 5 Days Postvaccination in Individuals 50 Years of Age and Older with Prior Pneumococcal Vaccination – Study 3 Individuals 50 Years of Age and Older Who Previously Received Pneumococcal Vaccines Study 3 (NCT05420961) enrolled individuals 50 years of age and older who had previously received a pneumococcal vaccine at least 1 year prior to enrollment. Participants were enrolled into 1 of 3 cohorts based on their pneumococcal vaccination history (cohort 1: PNEUMOVAX 23, cohort 2: Prevnar 13, or cohort 3: PNEUMOVAX 23 followed by or preceded by Prevnar 13, PNEUMOVAX 23 preceded by VAXNEUVANCE, or VAXNEUVANCE alone). Participants in cohort 1 were randomized to receive CAPVAXIVE or VAXNEUVANCE, participants in cohort 2 were randomized to receive CAPVAXIVE or PNEUMOVAX 23, and participants in cohort 3 received CAPVAXIVE. The percentage of individuals with solicited adverse reactions that occurred within 5 days postvaccination of CAPVAXIVE or active comparator is shown in Table 3.

Brief Summary of Prescribing Information for CAPVAXIVE DOSAGE AND ADMINISTRATION For intramuscular use. Dosage Administer a single 0.5 mL dose. Administration CAPVAXIVE is a colorless, clear to opalescent solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if particulate matter or discoloration is observed. Administer intramuscularly. DOSAGE FORMS AND STRENGTHS CAPVAXIVE is an injection. A single dose is 0.5 mL. CONTRAINDICATIONS Do not administer CAPVAXIVE to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of CAPVAXIVE or to diphtheria toxoid. WARNINGS AND PRECAUTIONS Management of Allergic Reactions Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of CAPVAXIVE. Altered Immunocompetence Individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to CAPVAXIVE. ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. The most commonly reported (>10%) solicited adverse reactions in individuals 18 through 49 years of age who received CAPVAXIVE were: injection-site pain (73.1%), fatigue (36.0%), headache (27.5%), myalgia (16.4%), injection-site erythema (13.8%), and injection-site swelling (13.3%). The most commonly reported (>10%) solicited adverse reactions in individuals 50 years of age and older who received CAPVAXIVE were: injection-site pain (41.2%), fatigue (19.7%), and headache (11.0%). Safety Assessment in Clinical Studies The safety of CAPVAXIVE was assessed in four clinical studies (Studies 1-4) conducted across the Americas, Europe, and Asia Pacific, which included individuals ranging in age from 18 to 97 years. Across all 4 studies, 4,556 individuals received CAPVAXIVE and 2,021 individuals received an active comparator vaccine. Safety was monitored using an electronic Vaccination Report Card for 30 days postvaccination. Injection-site adverse reactions, systemic adverse reactions, and body temperature were solicited Day 1 through Day 5 postvaccination. Unsolicited adverse events were reported Day 1 through Day 30 postvaccination. Serious adverse events (SAEs) were reported through 6 months postvaccination in all studies. Demographics of Individuals in Clinical Studies Across all studies, the mean age of the individuals who were randomized and vaccinated was 53.5 years, and 57.2% were female. The racial distribution was as follows: 76.0% were White, 10.2% were Black or African American, 9.9% were Asian, and 0.5% were American Indian or Alaska Native; 20.6% were of Hispanic or Latino ethnicity. Approximately 34% of vaccinated individuals had one or more prespecified chronic medical conditions known to increase the risk of pneumococcal disease (i.e., diabetes, renal disorders, chronic heart disease, chronic liver disease, chronic lung disease including asthma, smoking, alcoholism). Pneumococcal Vaccine-Naïve Individuals 18 Years of Age and Older In a double-blind study, Study 1 (NCT05425732), individuals 18 years of age and older who had not previously received a pneumococcal vaccine were enrolled and randomized to receive a single dose of CAPVAXIVE or Prevnar 20. The percentage of individuals 18 through 49 years of age and 50 years of age and older who reported solicited adverse reactions that occurred within 5 days postvaccination of CAPVAXIVE or Prevnar 20 is shown in Table 1. Solicited adverse reactions following administration of CAPVAXIVE lasted a median of 2 days with 81.3% of reactions lasting ≤3 days for individuals 18 through 49 years of age and a median of 1 day with 86.5% of reactions lasting ≤3 days for individuals 50 years of age and older.

Table 1: Individuals With Solicited Local and Systemic Adverse Reactions Within 5 Days Postvaccination in Pneumococcal Vaccine-Naïve Individuals 18 through 49 Years of Age and 50 Years of Age and Older – Study 1

Table 2: Individuals with Solicited Local and Systemic Adverse Reactions Within 5 Days Postvaccination in Pneumococcal Vaccine-Naïve Individuals 18 through 49 Years of Age – Study 2 CAPVAXIVE n (%) PNEUMOVAX 23 n (%) Individuals in population* 1,616 541 Local adverse reactions † Severity

18 through 49 Years of Age 50 Years of Age and older CAPVAXIVE n (%) Prevnar 20 n (%) CAPVAXIVE n (%) Prevnar 20 n (%)

Cohort 1*

Cohort 2 †

Cohort 3 ‡

CAPVAXIVE n (%)

VAXNEUVANCE n (%)

CAPVAXIVE n (%)

PNEUMOVAX 23 n (%)

CAPVAXIVE n (%)

Individuals in population*

200

100

1177

1175

Individuals in population §

230

117

174

105

Local adverse reactions †

Severity

Local adverse reactions ¶

Severity

Any

1,184 (73.3)

328 (60.6)

Any

143 (71.5)

74 (74.0)

464 (39.4)

607 (51.7)

Mild

759 (47.0)

234 (43.3)

Any

82 (35.7)

51 (43.6)

72 (41.4)

40 (47.1)

46 (43.8)

Mild

95 (47.5)

49 (49.0)

361 (30.7)

504 (42.9)

Pain

Moderate

395 (24.4)

86 (15.9)

Mild

65 (28.3)

43 (36.8)

52 (29.9)

30 (35.3)

37 (35.2)

Moderate

46 (23.0)

25 (25.0)

102 (8.7)

Pain

Severe

30 (1.9)

8 (1.5)

Moderate

16 (7.0)

8 (6.8)

20 (11.5)

10 (11.8)

9 (8.6)

Severe

2 (1.0)

1 (0.1)

Any

219 (13.6)

41 (7.6)

Severe

1 (0.4)

74 (6.3) ‡

Any

31 (15.5)

13 (13.0)

64 (5.4) ‡

Mild (≤5.0 cm)

143 (8.8)

30 (5.5)

Any

17 (7.4)

9 (7.7)

13 (7.5)

8 (9.4)

8 (7.6)

Mild (≤5.0 cm)

23 (11.5)

10 (10.0)

51 (4.3)

59 (5.0)

Moderate (>5.0 to ≤10.0 cm) Severe (>10.0 cm)

Erythema

Mild (≤5.0 cm)

10 (4.3)

6 (5.1)

5 (2.9)

2 (2.4)

4 (3.8)

Erythema

57 (3.5)

8 (1.5)

Moderate (>5.0 to ≤10.0 cm)

7 (3.5)

3 (3.0)

10 (0.8)

12 (1.0)

Erythema

Moderate (>5.0 to ≤10.0 cm)

5 (2.2)

2 (1.7)

6 (3.4)

6 (7.1)

3 (2.9)

19 (1.2)

3 (0.6)

Severe (>10.0 cm)

1 (0.5)

2 (0.2)

Severe (>10.0 cm)

2 (0.9)

1 (0.9)

2 (1.1)

0 (0.0)

1 (1.0)

Any

213 (13.2)

41 (7.6)

Any

28 (14.0)

14 (14.0)

71 (6.0)

98 (8.3)

Any

19 (8.3)

10 (8.5)

8 (4.6)

14 (16.5)

11 (10.5)

Mild (≤5.0 cm)

148 (9.2)

29 (5.4)

Mild (≤5.0 cm)

20 (10.0)

9 (9.0)

53 (4.5)

79 (6.7)

Mild (≤5.0 cm)

15 (6.5)

9 (7.7)

6 (3.4)

7 (8.2)

6 (5.7)

Swelling

Moderate (>5.0 to ≤10.0 cm) Severe (>10.0 cm)

Swelling

Moderate (>5.0 to ≤10.0 cm)

55 (3.4)

10 (1.8)

7 (3.5)

5 (5.0)

15 (1.3)

17 (1.4)

Swelling

Moderate (>5.0 to ≤10.0 cm)

4 (1.7)

1 (0.9)

2 (1.1)

7 (8.2)

4 (3.8)

Severe (>10.0 cm)

1 (0.5)

3 (0.3)

2 (0.2)

10 (0.6)

2 (0.4)

Severe (>10.0 cm)

1 (1.0)

Systemic adverse reactions †

Severity

Systemic adverse reactions †

Systemic adverse reactions ¶

Severity

Any

81 (40.5)

34 (34.0)

237 (20.1)

230 (19.6)

Any

573 (35.5)

184 (34.0)

Any

33 (14.3)

20 (17.1)

33 (19.0)

11 (12.9)

23 (21.9)

Mild

50 (25.0)

21 (21.0)

167 (14.2)

153 (13.0)

Mild

338 (20.9)

119 (22.0)

Fatigue

Mild

25 (10.9)

11 (9.4)

24 (13.8)

6 (7.1)

19 (18.1)

Moderate

29 (14.5)

11 (11.0)

70 (5.9)

72 (6.1)

Moderate

201 (12.4)

60 (11.1)

Fatigue

Moderate

8 (3.5)

9 (7.7)

8 (4.6)

5 (5.9)

4 (3.8)

Severe

2 (1.0)

2 (2.0)

5 (0.4)

Severe

34 (2.1)

5 (0.9)

Severe

1 (0.6)

Any

59 (29.5)

24 (24.0)

135 (11.5)

152 (12.9)

Any

440 (27.2)

116 (21.4)

Any

16 (7.0)

11 (9.4)

18 (10.3)

10 (11.8)

9 (8.6)

Mild

275 (17.0)

70 (12.9)

Mild

44 (22.0)

17 (17.0)

102 (8.7)

106 (9.0)

Headache

Mild

10 (4.3)

9 (7.7)

10 (5.7)

7 (8.2)

9 (8.6)

Moderate

151 (9.3)

43 (7.9)

Moderate

14 (7.0)

7 (7.0)

33 (2.8)

45 (3.8)

Headache

Moderate

5 (2.2)

2 (1.7)

8 (4.6)

3 (3.5)

Severe

14 (0.9)

3 (0.6)

Severe

1 (0.5)

1 (0.1)

Severe

1 (0.4)

Any

264 (16.3)

47 (8.7)

Any

33 (16.5)

14 (14.0)

70 (5.9)

79 (6.7)

Any

17 (7.4)

3 (2.6)

17 (9.8)

8 (9.4)

9 (8.6)

Mild

146 (9.0)

33 (6.1)

Mild

15 (7.5)

9 (9.0)

40 (3.4)

42 (3.6)

Myalgia

Mild

9 (3.9)

2 (1.7)

7 (4.0)

4 (4.7)

7 (6.7)

Myalgia

Moderate

103 (6.4)

12 (2.2)

Myalgia

Moderate

15 (7.5)

4 (4.0)

30 (2.5)

36 (3.1)

Moderate

8 (3.5)

1 (0.9)

9 (5.2)

4 (4.7)

2 (1.9)

Severe

15 (0.9)

2 (0.4)

Severe

3 (1.5)

1 (1.0)

1 (0.1)

Severe

1 (0.6)

≥38.0°C (100.4°F)

48 (3.0)

12 (2.2)

≥38.0°C (100.4°F)

7 (3.5)

1 (1.0)

15 (1.3)

≥38.0°C (100.4°F)

4 (1.7)

3 (2.6)

5 (2.9)

1 (1.2)

≥38.0°C (100.4°F) to <38.5°C (101.3°F) ≥38.5°C (101.3°F) to <39.0°C (102.2°F)

3 (1.5)

7 (0.6)

≥38.0°C (100.4°F) to <38.5°C (101.3°F) ≥38.5°C (101.3°F) to <39.0°C (102.2°F)

31 (1.9)

4 (0.7)

Pyrexia §

2 (0.9)

1 (0.6)

2 (1.0)

6 (0.5)

5 (0.4)

Pyrexia ‡

Pyrexia #

≥39.0°C (102.2°F)

2 (1.0)

1 (1.0)

2 (0.2)

3 (0.3)

11 (0.7)

2 (0.4)

2 (0.9)

2 (1.7)

2 (1.1)

1 (1.2)

*Every individual is counted a single time for each applicable row and column. † Injection-site erythema, injection-site pain, injection-site swelling, fatigue, headache, and myalgia were solicited from Day 1 through Day 5 postvaccination. ‡ Includes one individual with an event of missing/unknown intensity. § Pyrexia was defined as temperature ≥38.0°C (100.4°F) solicited from Day 1 through Day 5 postvaccination. Percentages are based on the number of individuals with temperature data: 18 through 49 years of age: CAPVAXIVE, n=199, Prevnar 20, n=100. 50 years of age and older: CAPVAXIVE, n=1169, Prevnar 20, n=1170. Mild: does not interfere with activity; Moderate: interferes with activity; Severe: prevents daily activity.

≥39.0°C (102.2°F)

6 (0.4)

6 (1.1)

≥39.0°C (102.2°F)

1 (0.9)

2 (1.1)

*Every individual is counted a single time for each applicable row and column. † Injection-site erythema, injection-site pain, injection-site swelling, fatigue, headache, and myalgia were solicited from Day 1 through Day 5 postvaccination. ‡ Pyrexia was defined as temperature ≥38.0°C (100.4°F) solicited from Day 1 through Day 5 postvaccination. Percentages are based on the number of individuals with temperature data: CAPVAXIVE, n=1,606; PNEUMOVAX 23, n=541. Mild: does not interfere with activity; Moderate: interferes with activity; Severe: prevents daily activity

*Cohort 1 prior vaccination with PNEUMOVAX 23 † Cohort 2 prior vaccination with Prevnar 13 ‡ Cohort 3 prior vaccination with Prevnar 13+PNEUMOVAX 23 (n=45), or VAXNEUVANCE+PNEUMOVAX 23 (n=5), or PNEUMOVAX 23+Prevnar 13 (n=54), or VAXNEUVANCE (n=1) or Prevnar 20 (n=0) § Every individual is counted a single time for each applicable row and for each column. ¶ Injection-site erythema, injection-site pain, injection-site swelling, fatigue, headache, and myalgia were solicited from Day 1 through Day 5 postvaccination. # Pyrexia was defined as temperature ≥38.0°C (100.4°F) solicited from Day 1 through Day 5 postvaccination. Mild: does not interfere with activity; Moderate: interferes with activity; Severe: prevents daily activity

Revista Puertorriqueña de Medicina y Salud Pública

Smallest Trim size: 7.5” x 10.5” Largest Trim size: 8.125” x 10.875”

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Brief Summary of the Prescribing Information for CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) ( continued )

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Safety With Concomitant Influenza Vaccine Administration In Study 4 (NCT05526716), individuals 50 years of age and older with or without a history of prior pneumococcal vaccination were enrolled and randomized to receive either CAPVAXIVE and quadrivalent influenza vaccine [Fluzone Quadrivalent, (QIV)] concomitantly followed by placebo 30 days later (concomitant group), or QIV and placebo concomitantly followed by CAPVAXIVE 30 days later (sequential group). In Study 4, the rates and severity of solicited systemic adverse reactions and solicited local adverse reactions at the CAPVAXIVE injection site were similar when CAPVAXIVE was administered with or without inactivated QIV. Serious Adverse Events Across studies 1-4, the proportion of individuals reporting 1 or more SAEs within 1-month postvaccination was 0.3% in individuals vaccinated with CAPVAXIVE (n=14) and 0.3% in individuals vaccinated with an active comparator (n=7). The proportion of individuals reporting 1 or more SAEs within 6 months postvaccination was 1.4% in individuals vaccinated with CAPVAXIVE (n=56) and 2.0% in individuals vaccinated with an active comparator (n=40). There were no notable patterns or imbalances between vaccine groups for SAEs. Two individuals who received CAPVAXIVE had SAEs considered related to vaccination. One individual experienced an acute allergic reaction of bronchospasm (Grade 3, required medical intervention) which occurred within 30 minutes postvaccination; one individual experienced injection-site cellulitis (Grade 4, required hospitalization) on Day 6 postvaccination. USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. There are no adequate and well-controlled studies of CAPVAXIVE in pregnant individuals. Data on CAPVAXIVE administered to pregnant individuals are insufficient to inform vaccine-associated risks in pregnancy. A developmental toxicity study has been performed in female rats administered 0.25 mL of a conjugated polysaccharide vaccine formulation on four occasions: twice prior to mating, once during gestation, and once during lactation. This study revealed no adverse effects on fetal or preweaning development. Data Animal Data In a developmental toxicity study, female rats were administered 0.25 mL of a conjugated polysaccharide vaccine formulation containing the same conjugated polysaccharides as in CAPVAXIVE. Animals received 42 mcg polysaccharide per dose (a full human dose of CAPVAXIVE contains 84 mcg polysaccharide/dose) by intramuscular injection on four occasions: 28 and 7 days prior to mating, on gestation day 6, and on lactation day 7. There were no embryofetal deaths or fetal malformations, and no adverse effects on female fertility and preweaning development were observed.

Lactation Risk Summary

Human data are not available to assess the impact of CAPVAXIVE on milk production, its presence in breast milk, or its effects on the breastfed child. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CAPVAXIVE and any potential adverse effects on the breastfed child from CAPVAXIVE or from the underlying maternal condition. For preventive vaccines, the underlying condition is susceptibility to disease prevented by the vaccine. Pediatric Use The safety and effectiveness of CAPVAXIVE in individuals younger than 18 years of age have not been established. Geriatric Use Across studies 1-4, of the 4,556 individuals who received CAPVAXIVE, 1,487 individuals (32.6%) were 65 years of age and older, and 339 individuals (7.4%) were 75 years of age and older. In Study 1, of the 1,379 individuals who received CAPVAXIVE, 590 individuals (42.8%) were 65 years of age and older, and 126 individuals (9.1%) were 75 years of age and older. No clinically meaningful differences in safety of CAPVAXIVE were observed between these individuals and individuals less than 65 years of age. The opsonophagocytic activity (OPA) responses in individuals 65 years of age and older were generally lower than those observed in individuals less than 65 years of age. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility CAPVAXIVE has not been evaluated for carcinogenic or mutagenic potential or for Advise the patient to read the FDA-approved patient labeling (Patient Information). • Inform the patient of the benefits and risks associated with vaccination with CAPVAXIVE. • Inform the patient that vaccination with CAPVAXIVE may not protect all vaccine recipients. • Instruct the patient to report any adverse reactions to their healthcare provider or to the vaccine manufacturer or the U.S. Department of Health and Human Services through the Vaccine Adverse Event Reporting System (VAERS), 1-800-822-7967, or report online at www.vaers.hhs.gov. impairment of male fertility in animals. PATIENT COUNSELING INFORMATION The trademarks depicted herein are owned by their respective companies. For more detailed information, please read the Prescribing Information.

uspi-v116-i-2406r000 Revised: 06/2024

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CONTENIDO

ADELANTOS INVESTIGATIVOS EN CÁNCER DE PRÓSTATA EN PUERTO RICO

LA CORRELACIÓN ENTRE LA ENFERMEDAD DE ALZHEIMER Y LA CONTAMINACIÓN AMBIENTAL 24

38 CATÉTER R2P: INNOVACIÓN EN INTERVENCIONES ARTERIALES PARA PACIENTES EN PUERTO RICO

46 EFICACIA DE LOS TRATAMIENTOS EN LA REMISIÓN DEL PICOR EN LA DERMATITIS ATÓPICA: UNA REVISIÓN DE LITERATURA

EDITOR FUNDADOR Juan Carlos Orengo Valverde, MD, MPH, PhD EDITOR Oscar Soto Raíces, MD PRINCIPAL OFICIAL EJECUTIVO Pedro Carlos Lugo Hernández III, P.A.C. PRESIDENTA Y FUNDADORA Glorybelle Hernández Figueroa, MBA VICEPRESIDENTA Y FUNDADORA Laila Paloma Lugo, MBA ADMINISTRACIÓN Marta Ivelisse Vélez Ramos, MBA, CONTABILIDAD Pamela Placeres, CPA, Tatiana Figueroa, MARKETING Y SERVICIOS 360 Darlene Rodríguez, Yasmin Morell, RELACIONES CON LA COMUNIDAD Y ALIANZAS ESPECIALES Cyd Marie Llaurador, ARTISTA GRÁFICO Camila Bitar REALIZADORES AUDIOVSUAL Diego Benavides, Juan José Amaya, DIRECTORA DE NOTICIAS Camila Sánchez, FOTOS Revista Medicina y Salud Pública DIRECCIÓN GENERAL / FUNDADOR Carlos Alexis Lugo Marrero DISTRIBUCIÓN OFICINAS Y TORRES MÉDICAS Editorial Mundo ENVÍO DE REVISTAS Y DISTRIBUCIÓN A GRUPOS MÉDICOS Servicio de correo postal/Comunicación Inteligente Para ventas y otros servicios pueden comunicarse al 787.848.3333, msp@editorialmundo.com o www.medicinaysaludpublica.com Revista Puertorriqueña de Medicina y Salud Pública ISSN 1937-8521 COMITÉ EDITORIAL CIENTÍFICO COMITÉ EDITORIAL Olga Rodríguez, MD - Decana Escuela de Medicina de Ponce (Puerto Rico), Vivian Green, LND, MS, PhD, Sub editora y fundadora (Puerto Rico), José Cordero, MD, MPH - Exdecano Escuela Graduada Salud Pública Recinto de Ciencias Médicas UPR (Puerto Rico), Simón Carlo, MD (Puerto Rico), Bárbara Rosado, MD (Puerto Rico), Idhaliz Flores PhD (Puerto Rico), Jesús Cruz-Correa, MD, FACOG (Puerto Rico), Rafael Bredy, MD, LicMTo, MBE, MS (Puerto Rico), David Caseida, MD, FACOG, (Puerto Rico), José Capriles, MD, MHSA (Puerto Rico) Joaquín Laboy, MD, FACOG (Puerto Rico), Luis Adrian Rivera Pomales, MD, PEMBA, MPH, CMQ (Puerto Rico), Juan Fernández, MS, PhD (Puerto Rico), Nuria Sebate, MD (Puerto Rico), Pedro Amador, MD, MPH (Puerto Rico), Nydia Cappas, PsyD (Puerto Rico), Luis Franco, MD (Puerto Rico), Federico Montealegre, DVM, PhD, Msc (Puerto Rico), Nydia Ortiz, PsyD (Puerto Rico), José Pons, PhD, FPPR (Puerto Rico), Esdrás Vélez, JD, MPH (Puerto Rico), Diego Zavala, MSc, PhD, (Puerto Rico), Ana Torres-Martín, MD (Puerto Rico), Julio Cádiz, MD, MPH (Puerto Rico), Rafael Gómez-Cuevas (Colombia), José Javier Orengo, PhD(c) (España), Cesar A. Del Rey, MD (Panamá), Pedro Serrano, MD, PhD (España), Luis Serra-Majem, MD, PhD (España), José Ramón Calvo, MD, PhD (España).

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EDITORIAL INNOVACIÓN MÉDICA UN COMPROMISO CON LA CIENCIA Y EL PACIENTE

El avance de la medicina nos ofrece nuevas opor- tunidades para mejorar el diagnóstico y tratamiento de diversas enfermedades. La detección tempra- na, junto con el desarrollo de terapias innovadoras, ha permitido transformar la forma en que enfrenta- mos patologías complejas, brindando a los pacientes mejores expectativas y calidad de vida. Sin embargo, estos progresos solo son efectivos cuando se com- binan con un enfoque integral y multidisciplinario. La investigación continúa revelando el impacto de la inteligencia artificial, los biomarcadores y la medicina personalizada en la optimización de tratamientos. Es- tos avances no solo mejoran la precisión en el diagnós- tico, sino que también permiten intervenciones más dirigidas y con menos efectos secundarios. La colabo- ración entre especialistas es clave para garantizar que estas innovaciones lleguen a quienes más las necesitan. En esta edición de la Revista Medicina y Sa- lud Pública (MSP), reunimos el conocimien- to de expertos que han dedicado su labor a impulsar la ciencia y la práctica clínica. Sus aporta- ciones son fundamentales para actualizar el ejerci- cio médico y reforzar el acceso equitativo a la salud. Agradecemos a cada profesional que ha compar- tido su experiencia en estas páginas, contribu- yendo a la educación médica y a la divulgación científica. Confiamos en que este contenido les proporcionará herramientas valiosas para su ejer- cicio clínico y para el bienestar de los pacientes. ¡Disfruten esta nueva edición de MSP!

Dr. Oscar Soto Raices

Principal Oficial Médico Soto-Raices Mindful Rehumatix & Medical Research Group. Presidente Fundación Enfermedades Reumáticas de Puerto Rico (FER).

"LA DETECCIÓN TEMPRANA, JUNTO CON EL DESARROLLO DE TERAPIAS INNOVADORAS, HA PERMITIDO TRANSFORMAR LA FORMA EN QUE ENFRENTAMOS PATOLOGÍAS COMPLEJAS, BRINDANDO A LOS PACIENTES MEJORES EXPECTATIVAS Y CALIDAD DE VIDA"

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MSP ARTÍCULO / ORIGINAL

Remisión Endoscópica en Enfermedad de Crohn y Colitis Ulcerosa: Definición, evaluación y desafíos

María Eugenia Ríos Enríquez MD Gastroenterología

Facultad de la Escuela de Medicina de Ponce Facultad de la Residencia de Medicina Interna del Hospital de la Concepción en San Germán.

Resumen La remisión endoscópica es un objetivo terapéutico fundamental en el manejo de la enfermedad de Crohn y la colitis ulcerosa. Representa la resolución de las lesiones inflamatorias observadas en la mucosa intestinal mediante endoscopia. A diferencia de la remisión clínica, que se basa en la ausencia de síntomas, la remisión endoscópica implica la curación visual del tejido, lo que conlleva beneficios a largo plazo en la reducción de complicaciones. En este artículo se revisan los criterios de evaluación, los marcadores utilizados, los desafíos diagnósticos y los tratamientos disponibles para alcanzar la remisión endoscópica.

Abstract Endoscopic remission is a fundamental therapeutic goal in the management of Crohn's disease and ulcerative colitis. It represents the resolution of inflammatory lesions seen in the intestinal mucosa by endoscopy. In contrast to clinical remission, which is based on the absence of symptoms, endoscopic remission implies visual healing of the tissue, leading to long-term benefits in the reduction of complications. This article reviews the evaluation criteria, markers used, diagnostic challenges and treatments available to achieve endoscopic remission.

Palabras clave: Remisión endoscópica, enfermedad de Crohn, colitis ulcerosa, inflamación intestinal, tratamiento biológico Keywords: Endoscopic remission, Crohn's disease, ulcerative colitis, intestinal inflammation, biologic therapy.

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MSP ARTÍCULO / ORIGINAL

Inhibidores de interleuquinas y linfocitos: Nuevas opciones terapéuticas dirigidas a dianas es- pecíficas del sistema inmune. Corticosteroides: Aunque efectivos en el control rápido de la inflamación, su uso prolongado se evi - ta debido a efectos adversos graves como osteopo- rosis y trastornos metabólicos. Criterios de elegibilidad para nuevas terapias La selección del tratamiento depende de factores individuales del paciente, incluyendo la severidad de la enfermedad, comorbilidades y riesgo cardio- vascular. Los inhibidores de JAK, por ejemplo, han mostrado eficacia en pacientes jóvenes sin enfer - medades cardiovasculares preexistentes, mientras que los anti-TNF siguen siendo una opción princi- pal para muchos casos.

experiencia del especialista sigue siendo un factor clave.

Introducción

Las enfermedades inflamatorias intestinales, como la enfermedad de Crohn y la colitis ulcerosa, son patologías crónicas que afectan el tracto gastrointestinal. La remisión endoscópica es un concepto clave en el tratamiento de estas condiciones, ya que se asocia con mejores resultados a largo plazo, como la reducción de hospitalizaciones, cirugías y riesgo de neoplasias. Este artículo explora la importancia de la remisión endoscópica, su diferencia con la remisión clínica, los métodos de evaluación, los desafíos en su determinación y las opciones terapéuticas disponibles.

Tratamientos para alcanzar la remisión endoscópica

En las últimas décadas, los tratamientos para la en- fermedad inflamatoria intestinal han evolucionado considerablemente. Actualmente, las opciones in- cluyen: Terapias biológicas: Inhibidores del factor de ne - crosis tumoral (anti-TNF) como infliximab y ada - limumab. Moléculas pequeñas: Inhibidores de JAK, que actúan bloqueando la cascada inflamatoria.

Diferencias entre remisión clínica y remisión endoscópica

• Reducción del enrojecimiento y edema de la mucosa. Para cuantificar estos hallazgos, se utilizan escalas como el Mayo Score en colitis ulcerosa, donde una puntuación de cero indica remisión endoscópica. Además de la endoscopía, biomarcadores como la calprotectina fecal y la proteína C reactiva pueden complementar la evaluación y ayudar a predecir re- caídas antes de que los síntomas se presenten clíni- camente.

La remisión clínica se define por la ausencia de sín - tomas en el paciente, como diarrea, sangrado rectal y dolor abdominal. Sin embargo, esto no siempre refleja la curación del tejido intestinal. La remisión endoscópica, en cambio, se confirma mediante una endoscopía que muestra la restauración de la mu- cosa intestinal a un estado visualmente normal. Es posible que un paciente experimente mejoría sinto- mática sin que su mucosa haya cicatrizado comple- tamente, lo que aumenta el riesgo de complicacio- nes futuras. Marcadores de remisión endoscópica La evaluación endoscópica de la remisión se basa en varios criterios visuales, como: La evaluación endoscópica de la remisión se basa en varios criterios visuales, como:

Conclusión La remisión endoscópica es un indicador clave del control de la enfermedad de Crohn y la colitis ulcerosa, ya que se asocia con mejores resultados clínicos a largo plazo. Aunque el tratamiento ha avanzado significativamente, los desafíos en la evaluación endoscópica y la variabilidad en la respuesta terapéutica siguen presentes. La investigación continua en nuevas estrategias terapéuticas es esencial para mejorar la calidad de vida de los pacientes y optimizar los resultados del tratamiento

Desafíos en la evaluación de la remisión endoscópica

A pesar de los intentos de estandarización, la eva- luación endoscópica sigue siendo subjetiva. Dife- rentes gastroenterólogos pueden interpretar de ma- nera distinta la severidad de la inflamación, incluso con el uso de escalas. Adicionalmente, la calidad de la imagen endoscópica y la preparación del paciente pueden afectar la interpretación de los resultados. Los endoscopios de alta definición han mejorado la capacidad de detección de lesiones sutiles, pero la

• Patrón vascular normal. • Ausencia de ulceraciones y exudados.

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WHAT IS ONE THING THAT COULD MEAN EVERYTHING TO YOUR PATIENTS?

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IS EVERYTHING CONTROL

For adults with moderately to severely active ulcerative colitis (UC) 1

SKYRIZI provides the opportunity for endoscopic and symptom control. For your patients, that’s everything.

ENDOSCOPIC HEALING Endoscopic improvement,* endoscopic remission, † and histo-endoscopic mucosaI improvement (HEMI) ‡ at Week 52 1 The relationship between HEMI to disease progression and long-term outcomes was not evaluated. 1 DURABLE REMISSION Clinical remission § and steroid-free clinical remission || at Week 52 1 EARLY DISEASE CONTROL • Clinical response ¶ as early as Week 4 1 • Clinical remission § and endoscopic improvement* at Week 12 1

WELL-STUDIED SAFETY Safety profile established across 4 indications with up to ~9 years of clinical trial experience 1,2 EXCEPTIONAL ACCESS & SUPPORT Committed to exceptional access and support from AbbVie

SCAN TO SEE THE DATA WWW.SKYRIZIHCP.COM/UC

INDICATIONS 1 Plaque Psoriasis: SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Psoriatic Arthritis: SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults. Crohn’s Disease: SKYRIZI is indicated for the treatment of moderately to severely active Crohn’s disease in adults. Ulcerative Colitis: SKYRIZI is indicated for the treatment of moderately to severely active ulcerative colitis in adults. SAFETY CONSIDERATIONS 1 SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of its excipients. Serious hypersensitivity reactions, including anaphylaxis, have been reported with use of SKYRIZI. If a serious hypersensitivity reaction occurs, discontinue SKYRIZI and initiate appropriate therapy immediately. SKYRIZI may increase the risk of infection. Instruct patients to report signs or symptoms of clinically important infection during treatment. Should such an infection occur, discontinue SKYRIZI until infection resolves. Evaluate patients for tuberculosis infection prior to initiating treatment with SKYRIZI. Drug-induced liver injury was reported in a patient with Crohn’s disease during induction dosing of SKYRIZI. For the treatment of Crohn’s disease and ulcerative colitis, evaluate liver enzymes and bilirubin at baseline and during induction (12 weeks). Interrupt treatment with SKYRIZI if drug-induced liver injury is suspected, until this diagnosis is excluded. Avoid use of live vaccines in SKYRIZI patients.

STUDY DESIGN INSPIRE Induction (N=966) was a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of SKYRIZI 1200 mg IV, at Weeks 0, 4, and 8 vs placebo over 12 weeks in adult patients with moderate to severe UC. The primary endpoint was clinical remission § at Week 12. 1 COMMAND Maintenance (N=547) was a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of SKYRIZI 180 mg or 360 mg SC vs placebo up to 52 weeks in adult patients who were clinical responders to one of three SKYRIZI induction regimens consisting of 600 mg, 1200 mg or 1800 mg IV (the 600 mg and 1800 mg IV are not FDA-approved induction regimens) in the INSPIRE Phase 2b or Phase 3 studies. The primary endpoint was clinical remission at Week 52. COMMAND also included a prespecified subgroup analysis inclusive only of patients who responded to the FDA-approved induction dosing of SKYRIZI 1200 mg IV (N=271). 1

Please see additional Important Safety Information on the following spread. Please see adjacent pages for the Brief Summary of full Prescribing Information.

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DO NOT RE-SIZE US-SKZG-241093

SKYRIZI ® (sky-RIZZ-ee) (risankizumab-rzaa) injection, for subcutaneous or intravenous use 90 mg/mL single-dose prefilled syringe 150 mg/mL single-dose pen and prefilled syringe 600 mg/10 mL single-dose vial for intravenous infusion

PROFESSIONAL BRIEF SUMMARY CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION

IMPORTANT SAFETY INFORMATION Hypersensitivity Reactions IMPORTANT SAFETY INFORMATION Hypersensitivity Reactions IMPORTANT SAFETY INFORMATION Hypersensitivity Reactions

SKYRIZI ® (risankizumab-rzaa) is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients. Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of SKYRIZI. If a serious hypersensitivity reaction occurs, discontinue SKYRIZI and initiate appropriate therapy immediately. Infection SKYRIZI may increase the risk of infection. Do not initiate treatment with SKYRIZI in patients with a clinically important active infection until it resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing SKYRIZI. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, closely monitor and discontinue SKYRIZI until the infection resolves. Tuberculosis (TB) Prior to initiating treatment with SKYRIZI, evaluate for TB infection and consider treatment in patients with latent or active TB for whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SKYRIZI treatment. Do not administer SKYRIZI to patients with active TB. Hepatotoxicity in Treatment of Inflammatory Bowel Disease Drug-induced liver injury was reported in a patient with Crohn’s disease who was hospitalized for a rash during induction dosing of SKYRIZI. For the treatment of Crohn’s disease and ulcerative colitis, evaluate liver enzymes and bilirubin at baseline and during induction (12 weeks); monitor thereafter according to routine patient management. Consider an alternate treatment for patients with evidence of liver cirrhosis. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct your patient to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction. Administration of Vaccines Avoid use of live vaccines in patients treated with SKYRIZI. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating SKYRIZI, complete all age-appropriate vaccinations according to current immunization guidelines. Adverse Reactions Most common (≥1%) adverse reactions associated with SKYRIZI in plaque psoriasis and psoriatic arthritis include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections. In psoriatic arthritis phase 3 trials, the incidence of hepatic events was higher with SKYRIZI compared to placebo. Most common (>3%) adverse reactions associated with SKYRIZI in Crohn’s disease are upper respiratory infections, headache, and arthralgia in induction, and arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection in maintenance. Most common (≥3%) adverse reactions associated with SKYRIZI in ulcerative colitis are arthralgia in induction, and arthralgia, pyrexia, injection site reactions, and rash in maintenance. Most common (>3%) adverse reactions associated with SKYRIZI in Crohn’s disease are upper respiratory infections, headache, and arthralgia in induction, and arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection in maintenance. Most common (≥3%) adverse reactions associated with SKYRIZI in ulcerative colitis are arthralgia in induction, and arthralgia, pyrexia, injection site reactions, and rash in maintenance. Lipid Elevations: Increases from baseline and increases relative to placebo were observed at Week 4 and remained stable to Week 12 in patients treated with SKYRIZI in Crohn’s disease. Lipid elevations observed in patients with ulcerative colitis were similar to those in Crohn’s disease. Dosage Forms and Strengths: SKYRIZI (risankizumab-rzaa) is available in a 150 mg/mL prefilled syringe and pen, a 600 mg/10 mL single-dose vial for intravenous infusion, and a 180 mg/1.2 mL or 360 mg/2.4 mL single-dose prefilled cartridge with on-body injector. Please see adjacent pages for Brief Summary of full Prescribing Information. Dosage Forms and Strengths: SKYRIZI (risankizumab-rzaa) is available in a 150 mg/mL prefilled syringe and pen, a 600 mg/10 mL single-dose vial for intravenous infusion, and a 180 mg/1.2 mL or 360 mg/2.4 mL single-dose prefilled cartridge with on-body injector. Please see adjacent pages for Brief Summary of full Prescribing Information. *Endoscopic improvement in UC is defined as Mayo endoscopic subscore of 0 or 1 without friability. 1 Endoscopic results are based on a full colonoscopy or flexible sigmoidoscopy at the discretion of the investigator. † Endoscopic remission in UC is defined as Mayo endoscopic subscore of 0. Endoscopic results are based on a full colonoscopy or flexible sigmoidoscopy, at the discretion of the investigator. ‡ Histo-endoscopic mucosal improvement in UC is defined as Mayo endoscopy subscore of 0 or 1 without friability and Geboes score ≤3.1 (neutrophil infiltration in <5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue). Endoscopic results are based on a full colonoscopy or flexible sigmoidoscopy, at the discretion of the investigator, and histology results are based on a set of 2 biopsies. § Clinical remission in UC was defined as stool frequency subscore ≤1 and not greater than baseline, rectal bleeding subscore of 0, and endoscopic subscore ≤1 without friability. 1 || Steroid-free clinical remission in UC is defined as clinical remission per modified Mayo Score (rectal bleeding, stool frequency, endoscopic subscore) at Week 52 and corticosteroid-free for ≥90 days immediately preceding Week 52. 1 ¶ Clinical response at Week 4 in UC per partial Mayo Score is a composite of Mayo stool frequency and rectal bleeding subscores and was defined as a decrease in total score ≥30% and ≥1 point from baseline and a decrease in rectal bleeding subscore ≥1 or rectal bleeding subscore of 0 or 1. 1 IL-23i=interleukin-23 inhibitor; IV=intravenous; SC=subcutaneous. || References: 1. SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc. 2. Data on file, AbbVie Inc. ABVRRTI78474. *Endoscopic improvement in UC is defined as Mayo endoscopic subscore of 0 or 1 without friability. 1 Endoscopic results are based on a full colonoscopy or flexible sigmoidoscopy at the discretion of the investigator. † Endoscopic remission in UC is defined as Mayo endoscopic subscore of 0. Endoscopic results are based on a full colonoscopy or flexible sigmoidoscopy, at the discretion of the investigator. ‡ Histo-endoscopic mucosal improvement in UC is defined as Mayo endoscopy subscore of 0 or 1 without friability and Geboes score ≤3.1 (neutrophil infiltration in <5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue). Endoscopic results are based on a full colonoscopy or flexible sigmoidoscopy, at the discretion of the investigator, and histology results are based on a set of 2 biopsies. § Clinical remission in UC was defined as stool frequency subscore ≤1 and not greater than baseline, rectal bleeding subscore of 0, and endoscopic subscore ≤1 without friability. 1 || Steroid-free clinical remission in UC is defined as clinical remission per modified Mayo Score (rectal bleeding, stool frequency, endoscopic subscore) at Week 52 and corticosteroid-free for ≥90 days immediately preceding Week 52. 1 ¶ Clinical response at Week 4 in UC per partial Mayo Score is a composite of Mayo stool frequency and rectal bleeding subscores and was defined as a decrease in total score ≥30% and ≥1 point from baseline and a decrease in rectal bleeding subscore ≥1 or rectal bleeding subscore of 0 or 1. 1 IL-23i=interleukin-23 inhibitor; IV=intravenous; SC=subcutaneous. *Endoscopic improvement in UC is defined as Mayo endoscopic subscore of 0 or 1 without friability. 1 Endoscopic results are based on a full colonoscopy or flexible sigmoidoscopy at the discretion of the investigator. † Endoscopic remission in UC is defined as Mayo endoscopic subscore of 0. Endoscopic results are based on a full colonoscopy or flexible sigmoidoscopy, at the discretion of the investigator. ‡ Histo-endoscopic mucosal improvement in UC is defined as Mayo endoscopy subscore of 0 or 1 without friability and Geboes score ≤3.1 (neutrophil infiltration in <5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue). Endoscopic results are based on a full colonoscopy or flexible sigmoidoscopy, at the discretion of the investigator, and histology results are based on a set of 2 biopsies. § Clinical remission in UC was defined as stool frequency subscore ≤1 and not greater than baseline, rectal bleeding subscore of 0, and endoscopic subscore ≤1 without friability. 1 || Steroid-free clinical remission in UC is defined as clinical remission per modified Mayo Score (rectal bleeding, stool frequency, endoscopic subscore) at Week 52 and corticosteroid-free for ≥90 days immediately preceding Week 52. 1 ¶ Clinical response at Week 4 in UC per partial Mayo Score is a composite of Mayo stool frequency and rectal bleeding subscores and was defined as a decrease in total score ≥30% and ≥1 point from baseline and a decrease in rectal bleeding subscore ≥1 or rectal bleeding subscore of 0 or 1. 1 IL-23i=interleukin-23 inhibitor; IV=intravenous; SC=subcutaneous. SKYRIZI ® (risankizumab-rzaa) is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients. Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of SKYRIZI. If a serious hypersensitivity reaction occurs, discontinue SKYRIZI and initiate appropriate therapy immediately. Infection SKYRIZI may increase the risk of infection. Do not initiate treatment with SKYRIZI in patients with a clinically important active infection until it resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing SKYRIZI. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, closely monitor and discontinue SKYRIZI until the infection resolves. Tuberculosis (TB) Prior to initiating treatment with SKYRIZI, evaluate for TB infection and consider treatment in patients with latent or active TB for whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SKYRIZI treatment. Do not administer SKYRIZI to patients with active TB. Hepatotoxicity in Treatment of Inflammatory Bowel Disease Drug-induced liver injury was reported in a patient with Crohn’s disease who was hospitalized for a rash during induction dosing of SKYRIZI. For the treatment of Crohn’s disease and ulcerative colitis, evaluate liver enzymes and bilirubin at baseline and during induction (12 weeks); monitor thereafter according to routine patient management. Consider an alternate treatment for patients with evidence of liver cirrhosis. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct your patient to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction. Administration of Vaccines Avoid use of live vaccines in patients treated with SKYRIZI. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating SKYRIZI, complete all age-appropriate vaccinations according to current immunization guidelines. Adverse Reactions Most common (≥1%) adverse reactions associated with SKYRIZI in plaque psoriasis and psoriatic arthritis include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections. In psoriatic arthritis phase 3 trials, the incidence of hepatic events was higher with SKYRIZI compared to placebo. Drug-induced liver injury was reported in a patient with Crohn’s disease who was hospitalized for a rash during induction dosing of SKYRIZI. For the treatment of Crohn’s disease and ulcerative colitis, evaluate liver enzymes and bilirubin at baseline and during induction (12 weeks); monitor thereafter according to routine patient management. Consider an alternate treatment for patients with evidence of liver cirrhosis. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct your patient to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction. Administration of Vaccines Avoid use of live vaccines in patients treated with SKYRIZI. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating SKYRIZI, complete all age-appropriate vaccinations according to current immunization guidelines. Adverse Reactions Most common (≥1%) adverse reactions associated with SKYRIZI in plaque psoriasis and psoriatic arthritis include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections. In psoriatic arthritis phase 3 trials, the incidence of hepatic events was higher with SKYRIZI compared to placebo. Lipid Elevations: Increases from baseline and increases relative to placebo were observed at Week 4 and remained stable to Week 12 in patients treated with SKYRIZI in Crohn’s disease. Lipid elevations observed in patients with ulcerative colitis were similar to those in Crohn’s disease. Most common (>3%) adverse reactions associated with SKYRIZI in Crohn’s disease are upper respiratory infections, headache, and arthralgia in induction, and arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection in maintenance. Most common (≥3%) adverse reactions associated with SKYRIZI in ulcerative colitis are arthralgia in induction, and arthralgia, pyrexia, injection site reactions, and rash in maintenance. Lipid Elevations: Increases from baseline and increases relative to placebo were observed at Week 4 and remained stable to Week 12 in patients treated with SKYRIZI in Crohn’s disease. Lipid elevations observed in patients with ulcerative colitis were similar to those in Crohn’s disease. Dosage Forms and Strengths: SKYRIZI (risankizumab-rzaa) is available in a 150 mg/mL prefilled syringe and pen, a 600 mg/10 mL single-dose vial for intravenous infusion, and a 180 mg/1.2 mL or 360 mg/2.4 mL single-dose prefilled cartridge with on-body injector. Please see adjacent pages for Brief Summary of full Prescribing Information. SKYRIZI ® (risankizumab-rzaa) is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients. Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of SKYRIZI. If a serious hypersensitivity reaction occurs, discontinue SKYRIZI and initiate appropriate therapy immediately. Infection SKYRIZI may increase the risk of infection. Do not initiate treatment with SKYRIZI in patients with a clinically important active infection until it resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing SKYRIZI. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, closely monitor and discontinue SKYRIZI until the infection resolves. Tuberculosis (TB) Prior to initiating treatment with SKYRIZI, evaluate for TB infection and consider treatment in patients with latent or active TB for whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SKYRIZI treatment. Do not administer SKYRIZI to patients with active TB. Hepatotoxicity in Treatment of Inflammatory Bowel Disease

180 mg/1.2 mL single-dose prefilled cartridge with on-body injector 360 mg/2.4 mL single-dose prefilled cartridge with on-body injector

INDICATIONS AND USAGE Plaque Psoriasis SKYRIZI ® is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Psoriatic Arthritis SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults. Crohn’s Disease SKYRIZI is indicated for the treatment of moderately to severely active Crohn’s disease in adults. Ulcerative Colitis SKYRIZI is indicated for the treatment of moderately to severely active ulcerative colitis in adults. CONTRAINDICATIONS SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients [see Warnings and Precautions] . WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, have been reported with use of SKYRIZI. If a serious hypersensitivity reaction occurs, discontinue SKYRIZI and initiate appropriate therapy immediately [see Adverse Reactions]. Infections SKYRIZI may increase the risk of infections [see Adverse Reactions] . Treatment with SKYRIZI should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing SKYRIZI. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer SKYRIZI until the infection resolves. Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with SKYRIZI. Across the Phase 3 psoriasis clinical studies, of the 72 subjects with latent TB who were concurrently treated with SKYRIZI and appropriate TB prophylaxis during the studies, none developed active TB during the mean follow-up of 61 weeks on SKYRIZI. Two subjects taking isoniazid for treatment of latent TB discontinued treatment due to liver injury. Of the 31 subjects from the PsO-3 study with latent TB who did not receive prophylaxis during the study, none developed active TB during the mean follow-up of 55 weeks on SKYRIZI. Consider anti-TB therapy prior to initiating SKYRIZI in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SKYRIZI treatment. Do not administer SKYRIZI to patients with active TB. Hepatotoxicity in Treatment of Inflammatory Bowel Disease A serious adverse reaction of drug-induced liver injury in conjunction with a rash that required hospitalization was reported in a patient with Crohn’s disease (ALT 54x ULN, AST 30x ULN, and total bilirubin 2.2x ULN) following two 600 mg intravenous doses of SKYRIZI. The liver test abnormalities resolved following administration of steroids. SKYRIZI was subsequently discontinued. For the treatment of Crohn’s disease and ulcerative colitis, evaluate liver enzymes and bilirubin at baseline, and during induction at least up to 12 weeks of treatment. Monitor thereafter according to routine patient management. Consider other treatment options in patients with evidence of liver cirrhosis. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction. Administration of Vaccines Avoid use of live vaccines in patients treated with SKYRIZI. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating therapy with SKYRIZI, complete all age-appropriate vaccinations according to current immunization guidelines. No data are available on the response to live or inactive vaccines. ADVERSE REACTIONS The following adverse reactions are discussed in other sections of labeling: • Hypersensitivity Reactions [see Warnings and Precautions] • Infections [see Warnings and Precautions] • Tuberculosis [see Warnings and Precautions] • Hepatotoxicity in Treatment of Inflammatory Bowel Disease [see Warnings and Precautions] Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse drug reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Plaque Psoriasis A total of 2234 subjects were treated with SKYRIZI in clinical development trials in plaque psoriasis. Of these, 1208 subjects with psoriasis were exposed to SKYRIZI for at least one year. Data from placebo- and active-controlled trials were pooled to evaluate the safety of SKYRIZI for up to 16 weeks. In total, 1306 subjects were evaluated in the SKYRIZI 150 mg group.

Table 2. Adverse Drug Reactions Reported in > 3% of Subjects with Crohn’s Disease Treated with SKYRIZI in Placebo-Controlled 12-Week Induction Studies (CD-1, CD-2, and CD-4)

Table 1 summarizes the adverse drug reactions that occurred at a rate of at least 1% and at a higher rate in the SKYRIZI group than the placebo group during the 16-week controlled period of pooled clinical trials. Table 1. Adverse Drug Reactions Occurring in ≥ 1% of Subjects with Plaque Psoriasis on SKYRIZI through Week 16

SKYRIZI 600 mg Intravenous Infusion a N = 620 n (%)

Placebo N = 432 n (%)

Adverse Drug Reactions

SKYRIZI N = 1306 n (%) 170 (13.0)

Placebo N = 300 n (%) 29 (9.7)

Adverse Drug Reactions

Upper respiratory infections b

66 (10.6) 41 (6.6)

40 (9.3) 24 (5.6)

Upper respiratory infections a

Headache c Arthralgia

Headache b

46 (3.5) 33 (2.5) 19 (1.5) 15 (1.1)

6 (2.0) 3 (1.0) 3 (1.0)

31 (5.0) 19 (4.4) a SKYRIZI 600 mg as an intravenous infusion at Week 0, Week 4, and Week 8. b Includes: influenza like illness, nasopharyngitis, influenza, pharyngitis, upper respiratory tract infection, viral upper respiratory tract infection, COVID-19, nasal congestion, respiratory tract infection viral, viral pharyngitis, tonsillitis, upper respiratory tract inflammation c Includes: headache, tension headache Adverse reactions reported in >3% of subjects in the maintenance study and at a higher rate than placebo are shown in Table 3. Table 3. Adverse Reactions Reported in >3% of Subjects with Crohn’s Disease Treated with SKYRIZI a in Placebo-Controlled 52-Week Maintenance Study (CD-3)

Fatigue c

Injection site reactions d

Tinea infections e 1 (0.3) a Includes: respiratory tract infection (viral, bacterial or unspecified), sinusitis (including acute), rhinitis, nasopharyngitis, pharyngitis (including viral), tonsillitis b Includes: headache, tension headache, sinus headache, cervicogenic headache c Includes: fatigue, asthenia d Includes: injection site bruising, erythema, extravasation, hematoma, hemorrhage, infection, inflammation, irritation, pain, pruritus, reaction, swelling, warmth e Includes: tinea pedis, tinea cruris, body tinea, tinea versicolor, tinea manuum, tinea infection, onychomycosis Adverse drug reactions that occurred in < 1% but > 0.1% of subjects in the SKYRIZI group and at a higher rate than in the placebo group through Week 16 were folliculitis and urticaria. Specific Adverse Drug Reactions Infections In the first 16 weeks, infections occurred in 22.1% of the SKYRIZI group (90.8 events per 100 subject-years) compared with 14.7% of the placebo group (56.5 events per 100 subject-years) and did not lead to discontinuation of SKYRIZI. The rates of serious infections for the SKYRIZI group and the placebo group were ≤0.4%. Serious infections in the SKYRIZI group included cellulitis, osteomyelitis, sepsis, and herpes zoster. In Studies PsO-1 and PsO-2, through Week 52, the rate of infections (73.9 events per 100 subject-years) was similar to the rate observed during the first Through Week 52, no new adverse reactions were identified, and the rates of the adverse reactions were similar to those observed during the first 16 weeks of treatment. During this period, serious infections that led to study discontinuation included pneumonia. Psoriatic Arthritis 16 weeks of treatment. Safety Through Week 52 The overall safety profile observed in subjects with psoriatic arthritis treated with SKYRIZI is generally consistent with the safety profile in subjects with plaque psoriasis. Additionally, in the Phase 3 placebo-controlled trials the incidence of hepatic events was higher in the SKYRIZI group (5.4%, 16.7 events per 100 patient years) compared to the placebo group (3.9%, 12.6 events per 100 patient years). Of these, the most common events that were reported more frequently in both the placebo group and the SKYRIZI group were ALT increased (placebo: n=12 (1.7%); SKYRIZI: n=16 (2.3%)), AST increased (placebo: n=9 (1.3%); SKYRIZI: n=13 (1.8%)), and GGT increased (placebo: n=5 (0.7%); SKYRIZI: n=8 (1.1%)). There were no serious hepatic events reported. The incidence of hypersensitivity reactions was higher in the SKYRIZI group (n=16, 2.3%) compared to the placebo group (n=9, 1.3%). In the Phase 3 placebo-controlled trials, hypersensitivity reactions reported at a higher rate in the SKYRIZI group included rash (placebo: n=4 (0.6%); SKYRIZI: n=5 (0.7%), allergic rhinitis (placebo: n=1 (0.1%); SKYRIZI: n=2 (0.3%), and facial swelling (placebo: n=0 (0.0%); SKYRIZI n=1 (0.1%). One case of anaphylaxis was reported in a subject who received SKYRIZI in the Phase 2 clinical trial. Crohn’s Disease SKYRIZI was studied up to 12 weeks in subjects with moderately to severely active Crohn’s disease in two randomized, double-blind, placebo-controlled induction studies (CD-1, CD-2) and a randomized, double-blind, placebo- controlled, dose-finding study (CD-4; NCT02031276). Long-term safety up to 52 weeks was evaluated in subjects who responded to induction therapy in a randomized, double-blind, placebo-controlled maintenance study (CD-3). In the two induction studies (CD-1, CD-2) and the dose finding study (CD-4), 620 subjects received the SKYRIZI intravenous induction regimen at Weeks 0, 4 and 8. In the maintenance study (CD-3), 297 subjects who achieved clinical response, defined as a reduction in CDAI of at least 100 points from baseline after 12 weeks of induction treatment with intravenous SKYRIZI in studies CD-1 and CD-2, received a maintenance regimen of SKYRIZI either 180 mg or 360 mg subcutaneously at Week 12 and every 8 weeks thereafter for up to an additional 52 weeks. Adverse reactions reported in > 3% of subjects in induction studies and at a higher rate than placebo are shown in Table 2.

SKYRIZI 180 mg Subcutaneous Injection N = 155 n (%)

SKYRIZI 360 mg Subcutaneous Injection N = 142 n (%)

Placebo N = 143 n (%)

Adverse Drug Reactions

Arthralgia

13 (8.4) 9 (5.8) 7 (4.5) 7 (4.5) 4 (2.6) 3 (1.9) 1 (0.6) 1 (0.6)

13 (9.2) 12 (8.5)

12 (8.4) 6 (4.2) 4 (2.8) 6 (4.2) 4 (2.8) 3 (2.1) 2 (1.4)

Abdominal pain b

Injection site reactions c,d

8 (5.6) 7 (4.9) 7 (4.9) 6 (4.2) 5 (3.5) 5 (3.5)

Anemia Pyrexia

Back pain Arthropathy

Urinary tract infection 4 (2.8) a SKYRIZI 180 mg or 360 mg at Week 12 and every 8 weeks thereafter for up to an additional 52 weeks b Includes: abdominal pain, abdominal pain upper, abdominal pain lower c Includes: injection site rash, injection site erythema, injection site swelling, injection site urticaria, injection site warmth, injection site pain, injection site hypersensitivity, injection site reaction d Some subjects had multiple occurrences of injection site reactions. In this table, injection site reactions are counted only once per subject for the rate calculations. Specific Adverse Drug Reactions Infections In the maintenance study (CD-3) through Week 52, the rate of infections was 32.3% (50.2 events per 100 subject-years) in subjects who received SKYRIZI 180 mg and 36.6% (60.8 events per 100 subject-years) in subjects who received SKYRIZI 360 mg compared to 36.4% (60.3 events per 100 subject-years) in subjects who received placebo after SKYRIZI induction. The rate of serious infections was 2.6% (2.7 events per 100 subject-years) in subjects who received SKYRIZI 180 mg and 5.6% (7.4 events per 100 subject-years) in subjects who received SKYRIZI 360 mg compared to 2.1% (2.4 events per 100 subject-years) in subjects who received placebo after SKYRIZI induction. Lipid Elevations Elevations in lipid parameters (total cholesterol and low-density lipoprotein cholesterol [LDL-C]) were first assessed at 4 weeks following initiation of SKYRIZI in the induction trials (CD-1, CD-2). Increases from baseline and increases relative to placebo were observed at Week 4 and remained stable to Week 12. Following SKYRIZI induction, mean total cholesterol increased by 9.4 mg/dL from baseline to a mean absolute value of 175.1 mg/dL at Week 12. Similarly, mean LDL-C increased by 6.6 mg/dL from baseline to a mean absolute value of 92.6 mg/dL at Week 12. Mean LDL-C increased by 3.1 mg/dL from baseline to a mean absolute value of 99.0 mg/dL at Week 52 with SKYRIZI 180 mg maintenance treatment and by 2.3 mg/dL from baseline to a mean absolute value of 102.2 mg/dL at Week 52 with SKYRIZI 360 mg maintenance treatment (CD-3). Ulcerative Colitis SKYRIZI was studied up to 12 weeks in subjects with moderately to severely active ulcerative colitis in a randomized, double-blind, placebo-controlled induction study (UC-1) and a randomized, double-blind, placebo-controlled, dose-finding study (UC-3). Long-term safety up to 52 weeks was evaluated in subjects who responded to induction therapy in a randomized, double- blind, placebo-controlled maintenance study (UC-2) . In the induction studies (UC-1 and UC-3), 712 subjects received the SKYRIZI 1,200 mg intravenous induction regimen at Weeks 0, 4 and 8. In the maintenance study (UC-2), 347 subjects who achieved clinical response, defined as a decrease in mMS of ≥2 points and ≥30% from baseline and a decrease in RBS ≥1 from baseline or an absolute RBS ≤1, received a maintenance regimen of SKYRIZI either 180 mg or 360 mg subcutaneously at Week 12 and every 8 weeks thereafter for up to an additional 52 weeks. The adverse reaction reported in ≥3% subjects treated with SKYRIZI in the ulcerative colitis induction studies (UC-1 and UC-3) and at a higher rate than placebo was arthralgia (3% SKYRIZI vs 1% placebo).

© 2024 AbbVie. All rights reserved. SKYRIZI ® and its design are registered trademarks of AbbVie Biotechnology Ltd. US-SKZG-241093 November 2024 © 2024 AbbVie. All rights reserved. SKYRIZI ® and its design are registered trademarks of AbbVie Biotechnology Ltd. US-SKZG-241093 November 2024 © 2024 AbbVie. All rights reserved. SKYRIZI ® and its design are registered trademarks of AbbVie Biotechnology Ltd. US-SKZG-241093 November 2024

References: 1. SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc. 2. Data on file, AbbVie Inc. ABVRRTI78474. References: 1. SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc. 2. Data on file, AbbVie Inc. ABVRRTI78474.

20086179 R1 Skyrizi PB-7.625 x 10.5 (2 Pages).indd 1

21/06/2024 9:56 AM

Revista Puertorriqueña de Medicina y Salud Pública

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