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

IN PATIENTS WITH PsA

 MINIMAL DISEASE ACTIVITY
RESPONSE RATES OBSERVED

IN KEEPsAKE 1 AND KEEPsAKE 2, THE PRIMARY ENDPOINT WAS ACR20 RESPONSE AT WEEK 24.1

KEEPsAKE 1:
SKYRIZI 57% (n=483), PLACEBO 34% (n=481)

KEEPsAKE 2:
SKYRIZI 51% (n=224), PLACEBO 27% (n=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 292 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

VIEW STUDY DESIGN AND BASELINE CHARACTERISTICS

SIGNIFICANT IMPROVEMENT IN DISEASE CONTROL AT WEEK 24 (AFTER 3 DOSES)4

MDA ACHIEVED AT WEEK 24 (SKYRIZI: 25%, N=483; PLACEBO: 10%, N=481), NRI-C4*

*KEEPsAKE 1 patients achieving MDA at Week 24 was a ranked secondary endpoint P<0.001.

MDA is achieved when meeting 5 of 7 criteria5:

  • Tender joint count ≤1
  • Swollen joint count ≤1
  • PASI ≤1 or BSA-Psoriasis ≤3%
  • Pain (VAS ≤15 mm)
  • PtGA (VAS ≤20 mm)
  • HAQ-DI ≤0.5
  • Tender entheseal points ≤1
MDA CRITERIA

MDA RESPONSE ACHIEVED AT ~4 YEARS1,6,7

KEEPsAKE 1: csDMARD-IR

ALL DATA IS AS OBSERVED

25% of patients achieved MDA response after 3 doses of SKYRIZI 150 mgs, compared to 41% of patients achieving MDA response after 5 doses of SKYRIZI 150 mgs, and 51% of patients achieved MDA response after 17 doses of SKYRIZI 150 mgs. 10% of patients receiving placebo achieved MDA response.

In an As Observed (AO) analysis, patients with missing data at a specific time are not included, which may enrich the population and increase the response rates.

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.

KEEPsAKE 2: MDA DATA
STUDY DESIGN AND BASELINE CHARACTERISTICS

BSA=body surface area; csDMARD-IR=intolerance or inadequate response to conventional synthetic disease-modifying antirheumatic drug(s); HAQ-DI=Health Assessment Questionnaire Disability Index; MDA=minimal disease activity; NRI=nonresponder imputation; OLE=open-label extension; PASI=Psoriasis Area and Severity Index; PtGA=Patient Global Assessment; RCT=randomized controlled trial; VAS=visual analog scale.

WELL-STUDIED SAFETY PROFILE

across 4 pivotal trials in PsA & Ps1

Review safety