In Ps clinical trials
SKYRIZI superiority data vs 3 agents in different biologic classes
SEE THE RESULTSThe 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
PASI 90 AND PASI 100
RESPONSES OBSERVED IN
PATIENTS WITH PsA2,3
IN KEEPsAKE 1 AND KEEPsAKE 2, THE PRIMARY ENDPOINT WAS ACR20 RESPONSE AT WEEK 24.1
KEEPsAKE 1:
SKYRIZI 57% (n=277/483), PLACEBO 34% (n=161/481)
KEEPsAKE 2:
SKYRIZI 51% (n=115/224), PLACEBO 27% (n=58/219)
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.1-3
DURABLE PASI 90 RESPONSE RATES OBSERVED AT WEEK 24 AND AT YEAR 12,4
- SKYRIZI 150 mg (n=273)
- PLACEBO (n=272)
*Multiplicity-controlled P≤0.001 versus placebo. All other comparisons were not adjusted for multiplicity; therefore, statistical significance has not been established.
Among patients with ≥3% body surface area affected by active plaque psoriasis at baseline.
Analysis conducted using NRI-C method through Week 24; NRI method used from Week 24 through Week 52.
OLE LIMITATIONS:
In an open-label extension, there is a potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.
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.1-3
NRI=non-responder imputation; NRI-C=non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19; PASI=Psoriasis Area Severity Index.
DURABLE PASI 90 RESPONSE RATES OBSERVED AT WEEK 24 AND AT 1 YEAR3,7
- SKYRIZI 150 mg (n=123)
- PLACEBO (n=119)
*P≤0.001 versus placebo. All other comparisons were not adjusted for multiplicity; therefore, statistical significance has not been established.
Among patients with ≥3% body surface area affected by active plaque psoriasis at baseline.
Analysis conducted using NRI-C method through Week 24; NRI method used from Week 24 through Week 52.
OLE LIMITATIONS:
In an open-label extension, there is a potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.
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.1-3
NRI=non-responder imputation; NRI-C=non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19; PASI=Psoriasis Area Severity Index.
†As of 10/2021. New patients defined as bio-naïve; switch patients defined as bio-experienced switching biologics. Source: Integrated Symphony Health (PatientSource) and IQVIA (NSP) through proprietary method on diagnosis classification.
PASI 100 RESPONSE OBSERVED AT WEEK 24 AND AT 1 YEAR6
- SKYRIZI 150 mg (n=273)
- PLACEBO (n=272)
NRI-C method used through Week 24; after Week 24, values presented are as observed.
Among patients with ≥3% body surface area affected by active plaque psoriasis at baseline.
DATA LIMITATIONS:
PASI 100 data for all comparisons were not adjusted for multiplicity; therefore statistical significance has not been established.
OLE LIMITATIONS:
In an open-label extension, there is a potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.
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.1-3
NRI=non-responder imputation; NRI-C=non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19; PASI=Psoriasis Area Severity Index.
PASI 100 RESPONSE OBSERVED AT WEEK 24 AND AT 1 YEAR8
- SKYRIZI 150 mg (n=123)
- PLACEBO (n=119)
NRI-C method used through Week 24; after Week 24, values presented are as observed.
Among patients with ≥3% body surface area affected by active plaque psoriasis at baseline.
DATA LIMITATIONS:
PASI 100 data for all comparisons were not adjusted for multiplicity; therefore statistical significance has not been established.
OLE LIMITATIONS:
In an open-label extension, there is a potential for enrichment of the long-term data in the remaining patient populations since patients who are unable to tolerate or do not respond to the drug often drop out.
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.1-3
NRI=non-responder imputation; NRI-C=non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19; PASI=Psoriasis Area Severity Index.
MINIMAL DISEASE ACTIVITY (MDA) RESPONSE
Improvement in multiple symptoms of PsA4,7
