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

Learn more about AbbVie’s response to COVID-19

Nothing less than the opportunity for

ROBUST joint symptom relief1

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

COMPLETE RESOLUTION OF ENTHESITIS & DACTYLITIS

Resolution of swelling and tenderness in enthesitis or dactylitis associated with PsA2,4

INTEGRATED RESULTS FROM KEEPsAKE 1 AND KEEPsAKE 2

ENTHESITIS
(LEI score=0)

DACTYLITIS
(LDI score=0)

AT WEEK 24 (NRI-C)

RANKED SECONDARY ENDPOINTS

48%

(n=215/444)

vs 35% with placebo (n=156/448)
P≤0.001

68%

(n=128/188)

vs 51% with placebo (n=104/204)
P≤0.001

AT WEEK 52 IN OLE (NRI)

55%

(n=244/444)

76%

(n=143/188)

Baseline presence of enthesitis (LEI >0): SKYRIZI n=444; PLACEBO n=448.2,3

Baseline presence of dactylitis (LDI >0): SKYRIZI n=188; PLACEBO n=204.2,3

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.

DATA LIMITATIONS:

Data labeled as a ranked secondary endpoint were multiplicity controlled for comparisons. All other comparisons were not adjusted for multiplicity; therefore, statistical significance has not been established.

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

LEI=Leeds Enthesitis Index; LDI=Leeds Dactylitis Index; NRI=non-responder imputation; NRI-C=non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.

PASI 90 & PASI 100 RESPONSES

In patients with PsA2,3,5,6

WELL-STUDIED SAFETY PROFILE

Across indications1