The IL-23 inhibitor from AbbVie indicated for the treatment of adults with
active psoriatic arthritis (PsA) and for moderate to severe plaque psoriasis (Ps)
in adults who are candidates for systemic therapy or phototherapy.1
WELL-STUDIED
SAFETY PROFILE1
ADVERSE EVENTS OF INTEREST THROUGH 52 WEEKS
CLICK TO VIEW ADDITIONAL Ps SAFETY DATA
SKYRIZI IS CONTRAINDICATED IN PATIENTS WITH A HISTORY OF SERIOUS HYPERSENSITIVITY REACTION TO RISANKIZUMAB-RZAA OR ANY OF THE EXCIPIENTS1
Warnings and precautions include hypersensitivity, infections, tuberculosis (TB), and immunizations
NO LABELED WARNINGS OR PRECAUTIONS ON MALIGNANCY, IBD, OR DEPRESSION1
Initially evaluate for tuberculosis (TB) and instruct patients to report signs and symptoms of infection
No routine lab monitoring required during treatment1
aIncludes data from KEEPsAKE 1 and KEEPsAKE 2 studies.
bIncludes data from UltIMMa-1, UltIMMa-2, IMMhance, and IMMvent studies.
cIncludes data from UltIMMa-1, UltIMMa-2, and IMMhance studies.
Most common adverse reactions (≥1%) associated with SKYRIZI include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.1
In PsA Phase 3 trials, the incidence of hepatic events for SKYRIZI was 5.4% (16.7 events per 100 PYs) compared to 3.9% (12.6 events per 100 PYs) with placebo.1
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, open-label 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.1,6,7
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.1,8
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.9
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.1,10
STELARA is a registered trademark of Johnson & Johnson. See US Prescribing Information for further information.
IBD=inflammatory bowel disease; MACE=major adverse cardiovascular event; NMSC=nonmelanoma skin cancer; Ps=psoriasis; PsA=psoriatic arthritis; TB=tuberculosis.
CLICK TO VIEW ADDITIONAL WEEK 52 AEs IN Ps
SKYRIZI IS CONTRAINDICATED IN PATIENTS WITH A HISTORY OF SERIOUS HYPERSENSITIVITY REACTION TO RISANKIZUMAB-RZAA OR ANY OF THE EXCIPIENTS1
Warnings and precautions include hypersensitivity, infections, tuberculosis (TB), and immunizations
NO LABELED WARNINGS OR PRECAUTIONS ON MALIGNANCY, IBD, OR DEPRESSION1
Initially evaluate for tuberculosis (TB) and instruct patients to report signs and symptoms of infection
No routine lab monitoring required during treatment1
In an integrated analysis of 2 clinical trials, Ps patients on SKYRIZI experienced any infection at a rate of 73.9 events per 100 PYs at Week 52 (N=598, PYs=618).1
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, open-label 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.1,6,7
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 52 weeks in adult patients with moderate to severe plaque psoriasis.1,8
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.9
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.1,10
Well-studied safety profile from 19 clinical trials (2 PsA, 17 Ps)1,11
SKYRIZI IS CONTRAINDICATED IN PATIENTS WITH A HISTORY OF SERIOUS HYPERSENSITIVITY REACTION TO RISANKIZUMAB-RZAA OR ANY OF THE EXCIPIENTS1
Warnings and precautions include hypersensitivity, infections, tuberculosis, and immunizations
NO LABELED WARNINGS OR PRECAUTIONS ON MALIGNANCY, IBD, OR DEPRESSION1
Initially evaluate for tuberculosis and instruct patients to report signs and symptoms of infection
No routine lab monitoring required during treatment1
*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.
†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:
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.1,6,7
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.1,8
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.9
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.1,10
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.5,12,13
ACR20/50/70 RESPONSE RATES
In patients with PsA at Week 24 and 1 year6,7
Primary endpoint ACR20 at 24 weeks
4 DOSES PER YEAR
4 doses per year after 2 initiation doses at Weeks 0 and 4 (150 mg/dose)1
