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

ROBUST JOINT SYMPTOM RELIEF

ACR20 ACHIEVED AT WEEK 24

IN KEEPsAKE 1 AND KEEPsAKE 2, THE PRIMARY ENDPOINT WAS ACR20 RESPONSE AT WEEK 24 (NRI-C).1

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

KEEPsAKE 2:
SKYRIZI 51% (n=224), PLACEBO 27% (n=219)

NON-RANKED SECONDARY ENDPOINTS WERE ACR50/70 RESPONSE AT WEEK 24 (NRI-C).1

KEEPsAKE 1:
ACR50 - SKYRIZI 33% (n=483), PLACEBO 11% (n=481)
ACR70 - SKYRIZI 15% (n=483), PLACEBO 5% (n=481)

KEEPsAKE 2:
ACR50 - SKYRIZI 26% (n=224), PLACEBO 9% (n=219)
ACR70 - SKYRIZI 12% (n=224), PLACEBO 6% (n=219)

DATA LIMITATIONS:

Data labeled as a primary 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 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

ACR50 RESPONSE RATES SUSTAINED AT ~3 YEARS2,4,5

KEEPsAKE 1: csDMARD-IR

ALL DATA IS AS OBSERVED

33% of patients achieved ACR50 after 3 doses of SKYRIZI 150mg, compared to 48% of patients achieving ACR50 after 5 doses of SKYRIZI 150mg, and 52% of patients achieving ACR50 after 13 doses of SKYRIZI 150mg. 12% of patients receiving placebo achieved ACR50.

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.

ACR50=improvement of at least 50% in tender joint count, swollen joint count, and at least 3 other core criteria; csDMARD-IR=intolerance or inadequate response to conventional synthetic disease-modifying antirheumatic drug(s); NRI=nonresponder imputation; OLE=open-label extension; RCT=randomized controlled trial.

ACR70 RESPONSE RATES SUSTAINED AT ~3 YEARS2,4,5

KEEPsAKE 1: csDMARD-IR

ALL DATA IS AS OBSERVED

15% of patients achieved ACR70 after 3 doses of SKYRIZI 150mg, compared to 29% of patients achieving ACR70 after 5 doses of SKYRIZI 150mg, and 35% of patients achieving ACR70 after 13 doses of SKYRIZI 150mg. 5% of patients receiving placebo achieved ACR70.

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.

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.

ACR70=improvement of at least 70% in tender joint count, swollen joint count, and at least 3 other core criteria; csDMARD-IR=intolerance or inadequate response to conventional synthetic disease-modifying antirheumatic drug(s); NRI=nonresponder imputation; OLE=open-label extension; RCT=randomized controlled trial.

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 conclude with a discussion of SKYRIZI's safety profile across 2 indications.

COMPLETE RESOLUTION OF ENTHESITIS & DACTYLITIS6*

ENTHESITIS RESOLUTION (LEI=0) ACHIEVED AT WEEK 24 (SKYRIZI 48%, n=444; PLACEBO 35%, n=448; P<0.001)6†

DACTYLITIS RESOLUTION (LDI=0) ACHIEVED AT WEEK 24 (SKYRIZI 68%, n=188; PLACEBO 51%, n=204; P<0.001)6†

Pooled KEEPsAKE 1 and KEEPsAKE 2 data (NRI-C) (ranked secondary endpoints).

INTEGRATED RESULTS FROM KEEPsAKE 1: csDMARD-IR AND KEEPsAKE 2: MIXED POPULATION (~50% csDMARD-IR, ~50% bio-IR) LEI AND LDI OVER TIME1,4,5*

ALL DATA IS AS OBSERVED

For patients with baseline presence of enthesitis (LEI>0)

Dactylitis (LDI score=0).

For patients with baseline presence of dactylitis (LDI>0)

WEEK 24 RCT (AO)

HALF

of patients experienced

RESOLUTION OF
ENTHESITIS

52% (n=426) vs 42% with placebo (n=416)

7 IN 10

patients experienced

RESOLUTION OF
DACTYLITIS

74% (n=181) vs 60% with placebo (n=192)

WEEK 148 OLE (AO)

77%

of patients had a
similar response rate
(n=342)

97%

of patients had a
similar response rate
(n=151)

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.

*Resolution defined as Leeds Enthesitis Index (LEI)=0 and Leeds Dactylitis Index (LDI)=0. These measures were only evaluated in patients with involvement at baseline.

SKYRIZI VS OTEZLA® (apremilast)

In adult patients with moderate Ps7

WELL-STUDIED SAFETY PROFILE

Across PsA & Ps1