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

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Nothing less than the opportunity for

BETTER DISEASE CONTROL2,3

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

SIGNIFICANT IMPROVEMENT IN DISEASE CONTROL AT WEEK 242,3

MDA is achieved when meeting 5 of 7 criteria4:

  • Tender joint count ≤1
  • Swollen joint count ≤1
  • PASI ≤1 or BSA-psoriasis ≤3%
  • Patient assessment of pain VAS ≤15 mm
  • Patient global assessment of disease activity VAS ≤20 mm
  • HAQ-DI ≤0.5
  • Tender entheseal points ≤1

MINIMAL DISEASE ACTIVITY (MDA) RESPONSE OBSERVED AT WEEK 24 AND AT 1 YEAR2,5,6

  • SKYRIZI 150 mg (n=483)
  • PLACEBO (n=481)
38% of SKYRIZI® patients observed minimal disease activity at one year.

*P≤0.001 for SKYRIZI vs placebo. 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 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-C=non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.

MDA is achieved when meeting 5 of 7 criteria4:

  • Tender joint count ≤1
  • Swollen joint count ≤1
  • PASI ≤1 or BSA-psoriasis ≤3%
  • Patient assessment of pain VAS ≤15 mm
  • Patient global assessment of disease activity VAS ≤20 mm
  • HAQ-DI ≤0.5
  • Tender entheseal points ≤1

MINIMAL DISEASE ACTIVITY (MDA) RESPONSE OBSERVED AT WEEK 24 AND AT 1 YEAR3,7,8

  • SKYRIZI 150 mg (n=224)
  • PLACEBO (n=219)
Minimal disease activity (MDA) response observed at week 24 and at 1 year.

*P≤0.001 for SKYRIZI vs placebo. 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 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-C=non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.

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