SAFETY PROFILE ESTABLISHED IN Ps AND PsA1

~7 YEARS OF CONSISTENT SAFETY DATA IN Ps2*

SERIOUS ADVERSE EVENT (SAE) RATES IN Ps STUDIES2,3

AT WEEK 16

9.9

EVENTS PER 100 PYs

SKYRIZI

(n=1,306, PYs=402)

17.4

EVENTS PER 100 PYs

PLACEBO

(n=300, PYs=92)

~7 YEARS EXPOSURE*†

7.6

EVENTS PER 100 PYs

SKYRIZI

(n=3,197, PYs=9,983)

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

PsA SAFETY PROFILE IS GENERALLY

CONSISTENT

WITH THAT OBSERVED IN PATIENTS WITH Ps1

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

SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients.1

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

No routine lab monitoring required during treatment.1

Warnings and precautions include HYPERSENSITIVITY, infections, tuberculosis, and immunizations.

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

*Long-term data include all administered doses ranging from 18 mg to 180 mg of SKYRIZI in 3,197 patients. The FDA-approved dose is 150 mg at Week 0, Week 4, and every 12 weeks thereafter.1,2

Long-term safety was evaluated in an all-SKYRIZI data set comprising 17 Phase 1-3 studies in patients with moderate to severe plaque psoriasis encompassing 5 trials using integrated data evaluated at Week 16 (including UltIMMa-1, UltIMMa-2, IMMhance, and IMMvent), and 12 additional trials including LIMMitless.

STUDY DESIGN:

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

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.

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). 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 204 weeks in adult patients with active psoriatic arthritis.1,10,11

ADVERSE EVENTS OF INTEREST FROM
POOLED TRIAL DATA

Ps (WEEK 16)8,12-14

ACROSS 4 PIVOTAL TRIALS

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

Safety up to ~7 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 ~7 years of exposure.1,2

PsA (WEEK 24)14,18,19

ACROSS 2 PIVOTAL TRIALS

PsA at week 24 in SKYRIZI® vs. placebo.

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 DESIGN:

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

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 204 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

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

ADVERSE EVENTS OF INTEREST
IN Ps THROUGH 52 WEEKS1,15,16

POOLED DATA FROM 2 PIVOTAL TRIALS AT WEEK 521,15,16

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

Safety up to ~7 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 ~7 years of exposure.1,2

STUDY DESIGN:

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

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

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

Patient with Skyrizi Complete

ADVERSE EVENTS OF INTEREST IN Ps AND PsA FOLLOWING LONG-TERM EXPOSURE2

Up to ~7 years of exposure in Ps
ACROSS 17 TRIALS2,14,19,20

Adverse Events of Interest of Treatments Up To ~6 Years of Exposure

RESULTS PRESENTED INCLUDE VARYING LENGTHS OF TREATMENT EXPOSURE AND ALL EXPLORED DOSING
REGIMENS FOR SKYRIZI, INCLUDING THE APPROVED 150 MG/DOSE.1,2

Long-term safety was evaluated in an all-SKYRIZI data set comprising 17 Phase 1-3 studies in patients with moderate to severe plaque psoriasis encompassing 5 trials using integrated data evaluated at Week 16 (including UltIMMa-1, UltIMMa-2, IMMhance, and IMMvent), and 12 additional trials including LIMMitless.3

STUDY DESIGN:

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). Patients who completed UltIMMa-1 or -2, IMMvent, or IMMhance were eligible to participate.7-9

Long-term safety from a 17-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.3

Long-term data include all administered doses ranging from 18 mg to 180 mg of SKYRIZI in 3,197 patients. The FDA-approved dose is 150 mg at Week 0, Week 4, and every 12 weeks thereafter.1,2

Up to ~1.5 years of exposure in PsA
ACROSS 4 TRIALS2,14,19,20

Adverse Events of Interest of Treatments Up To ~6 Years of Exposure

RESULTS PRESENTED INCLUDE VARYING LENGTHS OF TREATMENT EXPOSURE AND ALL EXPLORED DOSING
REGIMENS FOR SKYRIZI, INCLUDING THE APPROVED 150 MG/DOSE.2

Data are integrated from 4 completed or ongoing Phase 2-3 clinical trials in PsA (M16-244, M16-002, KEEPsAKE-1, and KEEPsAKE-2). Median treatment duration was 1.0 year (range: 84 days to 2.0 years).2

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 an additional 204 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

  1. aIncludes data from UltIMMa-1, UltIMMa-2, IMMhance, and IMMvent studies.
  2. bIncludes data from UltIMMa-1, UltIMMa-2, and Phase 2 study 1311.2.
  3. 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).
  4. dIncludes data from IMMvent study.
  5. eIncludes data from UltIMMa-1, UltIMMa-2, and IMMhance studies.
  6. fIncludes data from UltIMMa-1 and UltIMMa-2 studies.

 

MACE=Major Adverse Cardiac Events; NMSC=Non-melanoma Skin Cancer; TB=Tuberculosis; PYs=Patient-years; IBD=Inflammatory Bowel Disease.


See SkyriziResults in Ps

after 1 dose16

4 doses per year

3-month dosing after 2 initiation doses at
Weeks 0 and 4 (150 mg/dose)1