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
Nothing less than the opportunity for
ROBUST joint symptom relief1
ACR20 WAS ACHIEVED AT WEEK 24 (PRIMARY ENDPOINT)1
SIGNIFICANTLY HIGHER ACR20 RESPONSE RATES VS PLACEBO1-3
- SKYRIZI 150 mg (n=483)
- PLACEBO (n=481)
*Multiplicity-controlled P≤0.001 SKYRIZI vs placebo comparison. All other comparisons were not adjusted for multiplicity; therefore, statistical significance has not been established.
Analysis conducted using NRI-C method through Week 24; NRI method used from Week 24 through Week 52.
OLE LIMITATIONS:
In an OLE, there is a potential for enrichment of the long-term data in 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.1,2,4
NRI=non-responder imputation; NRI-C=non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.
ACR20 RESPONSE OBSERVED IN OVER HALF OF PATIENTS1-3
- SKYRIZI 150 mg (n=224)
- PLACEBO (n=219)
*Multiplicity-controlled P≤0.001 SKYRIZI vs placebo comparison. All other comparisons were not adjusted for multiplicity; therefore, statistical significance has not been established.
Analysis conducted using NRI-C method through Week 24; NRI method used from Week 24 through Week 52.
OLE LIMITATIONS:
In an OLE, there is a potential for enrichment of the long-term data in 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 subjects 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.1,2,4
NRI=non-responder imputation; NRI-C=non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.
SEE HOW SKYRIZI PERFORMED IN PsA CLINICAL TRIALS
EFFICACY & SAFETY RESULTS WITH SKYRIZI
Dr. Schwartzman and Dr. Khattri review the clinical efficacy endpoints from the PsA trials, including ACR20/50/70, ACR components such as patient-reported pain, and enthesitis and dactylitis, then follow with a discussion of SKYRIZI's safety profile across 2 indications.
ACR50 RESPONSE OBSERVED AT WEEK 24 AND AT 1 YEAR1,4,7
- SKYRIZI 150 mg (n=483)
- PLACEBO (n=481)
†Nominal P≤0.001 SKYRIZI vs placebo comparison. Analyses were not controlled for multiplicity; therefore, statistical significance has not been established.
Analysis conducted using NRI-C method through Week 24; NRI method used from Week 24 through Week 52.
OLE LIMITATIONS:
In an OLE, there is a potential for enrichment of the long-term data in 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.1,2,4
NRI=non-responder imputation; NRI-C=non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.
ACR50 RESPONSE OBSERVED AT WEEK 24 AND AT 1 YEAR1,4,7
- SKYRIZI 150 mg (n=224)
- PLACEBO (n=219)
†Nominal P≤0.001 SKYRIZI vs placebo comparison. Analyses were not controlled for multiplicity; therefore, statistical significance has not been established.
Analysis conducted using NRI-C method through Week 24; NRI method used from Week 24 through Week 52.
OLE LIMITATIONS:
In an OLE, there is a potential for enrichment of the long-term data in 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 subjects 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.1,2,4
NRI=non-responder imputation; NRI-C=non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.
ACR70 RESPONSE OBSERVED AT WEEK 24 AND AT 1 YEAR1,4,7
- SKYRIZI 150 mg (n=483)
- PLACEBO (n=481)
‡Nominal P≤0.001 SKYRIZI vs placebo comparison. Analyses were not controlled for multiplicity; therefore, statistical significance has not been established.
Analysis conducted using NRI-C method through Week 24; NRI method used from Week 24 through Week 52.
OLE LIMITATIONS:
In an OLE, there is a potential for enrichment of the long-term data in 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.1,2,4
NRI=non-responder imputation; NRI-C=non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.
ACR70 RESPONSE OBSERVED AT WEEK 24 AND AT 1 YEAR1,4,7
- SKYRIZI 150 mg (n=224)
- PLACEBO (n=219)
‡Nominal P≤0.001 SKYRIZI vs placebo comparison. Analyses were not controlled for multiplicity; therefore, statistical significance has not been established.
§Nominal P≤0.05 SKYRIZI vs placebo comparison. Analyses were not controlled for multiplicity; therefore, statistical significance has not been established.
Analysis conducted using NRI-C method through Week 24; NRI method used from Week 24 through Week 52.
OLE LIMITATIONS:
In an OLE, there is a potential for enrichment of the long-term data in 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 subjects 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.1,2,4
NRI=non-responder imputation; NRI-C=non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.
