SAFETY PROFILE ESTABLISHED IN Ps AND PsA¹

PROVEN SAFETY DATA^1,2

Safety data evaluated in an all-SKYRIZI data set with up to 9 years of exposure across 23 Phase 1-4 studies in adults and up to 1 year of exposure in pediatric patients (6+) with moderate to severe Ps.*

*Representing different pools of patients with varying lengths of exposure.

labeled warnings or precautions for malignancy, IBD, depression, or candidiasis¹

labeled boxed warning

routine lab monitoring required during treatment¹

Initially evaluate for TB and instruct patients to report signs and symptoms of infection.

labeled liver testing for Ps or PsA¹

labeled drug interactions^1†

Safety Considerations: SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reactions to risankizumab-rzaa or any of its excipients. Warnings and precautions include hypersensitivity, infections, TB, and immunizations.¹

The safety profile in adult patients with PsA and pediatric patients with Ps is generally CONSISTENT with that observed in adult patients with Ps.¹

See safety data for Ps Week 16 and PsA Week 24.

^†Based on CYP450 studies, no clinically significant changes in the exposure of caffeine (CYP1A2 substrate), warfarin (CYP2C9 substrate), omeprazole (CYP2C19 substrate), metoprolol (CYP2D6 substrate), or midazolam (CYP3A substrate) were observed when used concomitantly with risankizumab-rzaa in subjects with plaque psoriasis (risankizumab-rzaa 150 mg administered subcutaneously at Weeks 0, 4, 8, and 12).

STUDY DESIGNS:

UltIMMa-1 (N=506) and UltIMMa-2 (N=491) were replicate Phase 3, randomized, double-blind, placebo- and active-controlled studies to evaluate the efficacy and safety of SKYRIZI (150 mg) vs placebo over 16 weeks and ustekinumab (45 mg or 90 mg, based on screening weight) over 52 weeks in adult patients with moderate to severe plaque psoriasis.^1,4

ACTIVE COMPARATOR

IMMhance was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the impact of treatment withdrawal and re-treatment of SKYRIZI compared to placebo in adult patients with moderate to severe plaque psoriasis.^1,5

IMMvent was a Phase 3, randomized, double-blind, double-dummy, active-controlled study to evaluate the efficacy and safety of SKYRIZI compared to HUMIRA® (adalimumab) in adult patients with moderate to severe plaque psoriasis over 44 weeks.⁶

LIMMitless is an ongoing, single-arm, multicenter, open-label extension of Phase 2 and 3 studies evaluating the long-term efficacy and safety of SKYRIZI (150 mg). Adult patients who completed UltIMMa-1 or -2, IMMvent, or IMMhance were eligible to participate.^7-9

KEEPsAKE-1 (N=964) and KEEPsAKE-2 (N=443) were 2 randomized, double-blind, placebo-controlled studies to evaluate the efficacy and safety of SKYRIZI (150 mg) vs placebo over 24 weeks with a long-term extension for up to an additional 316 weeks in adult patients with active psoriatic arthritis.^1,10,11

IMMpactful was a 52-week, Phase 4, multicenter, randomized, open-label, efficacy assessor-blinded study of SKYRIZI compared to SOTYKTU® (deucravacitinib) for the treatment of bio-naive adults with moderate plaque psoriasis who are candidates for systemic therapy.¹²

UnlIMMited Study-S was a Phase 4, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of SKYRIZI (150 mg) vs placebo over 16 weeks in adult patients with moderate to severe scalp psoriasis.¹³

UnlIMMited Study-G was a Phase 4, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of SKYRIZI (150 mg) vs placebo over 16 weeks in adult patients with moderate to severe genital psoriasis.¹³

Ps (WEEK 16) Ps (WEEK 16)

PsA (WEEK 24) PsA (WEEK 24)

Ps (WEEK 16)^8,14-16

ACROSS 4 PIVOTAL TRIALS

Ps at week 16 across SKYRIZI®, STELARA®, HUMIRA®, and the placebo.

SAFETY UP TO ~9 YEARS OF EXPOSURE:

With SKYRIZI, rates of adverse events (AEs) at Week 52 were similar to those observed at Week 16. Overall long-term AE rates remained consistent up to ~9 years of exposure.²

PsA (WEEK 24)^20-22

ACROSS 2 PIVOTAL TRIALS

Any adverse event of interest from pooled trial data at week 24 for SKYRIZI® vs placebo in PsA.

In PsA pivotal 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).¹

Most common adverse reactions (≥1%) associated with SKYRIZI include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.¹

STUDY DESIGNS:

KEEPsAKE-1 (N=964) and KEEPsAKE-2 (N=443) were 2 randomized, double-blind, placebo-controlled studies to evaluate the efficacy and safety of SKYRIZI (150 mg) vs placebo over 24 weeks with a long-term extension for up to 316 weeks in adult patients with active psoriatic arthritis. In KEEPsAKE-1, the study population had an inadequate response or intolerance to at least 1 conventional synthetic disease modifying antirheumatic drug (csDMARD), while in KEEPsAKE-2 patients had an inadequate response or intolerance to at least 1 biologic therapy OR to at least 1 csDMARD.^1,10,11

PsA SAFETY PROFILE IS GENERALLY

CONSISTENT

WITH THAT OBSERVED IN PATIENTS WITH Ps¹

WARNINGS AND PRECAUTIONS INCLUDE HYPERSENSITIVITY, INFECTIONS, TUBERCULOSIS, AND IMMUNIZATIONS.

NO LABELED WARNINGS OR PRECAUTIONS ON MALIGNANCY, IBD, DEPRESSION, OR CANDIDIASIS.¹

INITIALLY EVALUATE FOR TUBERCULOSIS AND INSTRUCT PATIENTS TO REPORT SIGNS AND SYMPTOMS OF INFECTION.

NO ROUTINE LAB MONITORING REQUIRED DURING TREATMENT.¹

NO LABELED LIVER TESTING REQUIRED FOR INITIATION OR DURING TREATMENT FOR Ps OR PsA.¹

Click to see HUMIRA® (adalimumab) Indication and Important Safety Information, including
BOXED WARNING for Serious Infections and Malignancy. See Full Prescribing Information.

POOLED DATA FROM 2 PIVOTAL TRIALS AT WEEK 52^16-18

Adverse events of interest in Ps in SKYRIZI® vs. STELARA® at 52 weeks.

SAFETY UP TO ~9 YEARS OF EXPOSURE:

With SKYRIZI, rates of adverse events (AEs) at Week 52 were similar to those observed at Week 16. Overall long-term AE rates remained consistent up to ~9 years of exposure.²

STUDY DESIGN:

VIEW MORE ABOUT IMMprint SAFETY DATA

SKYRIZI IS CONTRAINDICATED IN PATIENTS WITH A HISTORY OF SERIOUS HYPERSENSITIVITY REACTION TO RISANKIZUMAB-RZAA OR ANY OF THE EXCIPIENTS.¹

WARNINGS AND PRECAUTIONS INCLUDE HYPERSENSITIVITY, INFECTIONS, TUBERCULOSIS, AND IMMUNIZATIONS.

NO LABELED WARNINGS OR PRECAUTIONS ON MALIGNANCY, IBD, DEPRESSION, OR CANDIDIASIS..¹

INITIALLY EVALUATE FOR TUBERCULOSIS AND INSTRUCT PATIENTS TO REPORT SIGNS AND SYMPTOMS OF INFECTION.

NO ROUTINE LAB MONITORING REQUIRED DURING TREATMENT.¹

NO LABELED LIVER TESTING REQUIRED FOR INITIATION OR DURING TREATMENT FOR Ps OR PsA.¹

ACTIVE COMPARATOR

The ustekinumab used as a biologic active control in UltIMMa-1 and UltIMMa-2 was sourced from the European Union. Comparability between non–US-approved ustekinumab and US-approved ustekinumab has not been established. See Full Prescribing Information for US-approved ustekinumab, which reflects different rates of adverse events from those observed for EU-approved ustekinumab in the UltIMMa trials.

Safety analyses were performed using a safety analysis set (all patients who received ≥1 dose of study drug). No safety data for adalimumab or placebo were obtained beyond Week 16.

WARNINGS AND PRECAUTIONS INCLUDE HYPERSENSITIVITY, INFECTIONS, TUBERCULOSIS, AND IMMUNIZATIONS.

NO LABELED WARNINGS OR PRECAUTIONS ON MALIGNANCY, IBD, DEPRESSION, OR CANDIDIASIS.¹

INITIALLY EVALUATE FOR TUBERCULOSIS AND INSTRUCT PATIENTS TO REPORT SIGNS AND SYMPTOMS OF INFECTION.

NO ROUTINE LAB MONITORING REQUIRED DURING TREATMENT.¹

Ps (~9-YEAR DATA) Ps (~9-YEAR DATA)

PsA (6-YEAR DATA) PsA (6-YEAR DATA)

UP TO ~9 YEARS OF EXPOSURE IN Ps
ACROSS 23 TRIALS^2,3,16,19

ADVERSE EVENTS OF INTEREST IN Ps AND PsA FOLLOWING LONG-TERM EXPOSURE UP TO ~9 YEARS OF EXPOSURE IN Ps ACROSS 20 TRIALS.

Long-term results presented include varying lengths of treatment exposure and all explored dosing
regimens for SKYRIZI, including the approved 150 mg dose.

^‡Data are integrated from 23 Phase 1-4 clinical trials in Ps. Mean treatment duration was 3.2 years (9 days-9.1 years).²

STUDY DESIGN:

LIMMitless was a single-arm, multicenter, open-label extension of Phase 2 and 3 studies evaluating the long-term efficacy and safety of SKYRIZI (150 mg). Patients who completed UltIMMa-1 or -2, IMMvent, or IMMhance were eligible to participate.^7-9

Long-term safety from a 23-study pool, includes Phase 1 through open-label extension data, representing different pools of patients with varying lengths of treatment exposure. The long-term all-SKYRIZI psoriasis analysis set assessed safety of patients with psoriasis who received ≥1 dose of all explored doses of SKYRIZI through the end of exposure.²

Long-term data include all administered doses ranging from 18 mg to 180 mg of SKYRIZI in 3,658 patients. The FDA-approved dose is 150 mg at Week 0, Week 4, and every 12 weeks thereafter.^1,2

UP TO 6 YEARS OF EXPOSURE IN PsA
ACROSS 4 TRIALS^{16, 20, 23-25}

ADVERSE EVENTS OF INTEREST IN Ps AND PsA FOLLOWING LONG-TERM EXPOSURE UP TO 4 YEARS OF EXPOSURE IN PsA ACROSS 4 TRIALS.

LONG-TERM RESULTS PRESENTED INCLUDE VARYING LENGTHS OF TREATMENT EXPOSURE AND ALL EXPLORED DOSING
REGIMENS FOR SKYRIZI, INCLUDING THE APPROVED 150 MG DOSE.

^‡Data are integrated from 5 Phase 2-3 clinical trials in PsA. Median treatment duration was 3.6 years (56 days - 6.0 years).²⁴

STUDY DESIGN:

KEEPsAKE-1 (N=964) and KEEPsAKE-2 (N=443) were 2 randomized, double-blind, placebo-controlled studies that evaluated the efficacy and safety of SKYRIZI 150 mg vs placebo over 24 weeks with a long-term extension for up to 316 weeks. Both studies enrolled adult patients with active psoriatic arthritis. In KEEPsAKE-1, the study population had an inadequate response or intolerance to at least 1 csDMARD, while in KEEPsAKE-2 patients had an inadequate response or intolerance to at least 1 biologic therapy OR to at least 1 csDMARD.^1,10,11

Long-term data include all administered doses ranging from 18 mg to 180 mg of SKYRIZI in 3,658 patients. The FDA-approved dose is 150 mg at Week 0, Week 4, and every 12 weeks thereafter.^1,2

^aIncludes data from UltIMMa-1, UltIMMa-2, IMMhance, and IMMvent studies.¹⁵
^bIncludes data from UltIMMa-1, UltIMMa-2, and Phase 2 study 1311.2.¹⁵
^cSKYRIZI (150 mg), adalimumab, and placebo were only evaluated in Phase 3 trials; the ustekinumab group includes Phase 3 patients (N=199) in addition to Phase 2 patients (n=40).¹⁵
^dIncludes data from IMMvent study.⁸
^eIncludes data from UltIMMa-1, UltIMMa-2, and IMMhance studies.⁸

csDMARD=conventional synthetic disease-modifying antirheumatic Drug; NMSC=non-melanoma skin cancer; TB=tuberculosis; PYs=patient-years; IBD=inflammatory bowel disease.

csDMARD=Conventional Synthetic Disease-Modifying Antirheumatic Drug;
NMSC=non-melanoma skin cancer;
TB=tuberculosis;
PYs=patient-years;
IBD=inflammatory bowel disease