The IL-23 inhibitor from AbbVie for patients 6 years of age and older with active psoriatic arthritis (PsA) or with moderate to severe plaque psoriasis (Ps) who are candidates for systemic therapy or phototherapy.1
SUSTAINED JOINT SYMPTOM RELIEF
ACR20 achieved at Week 24 with response rates observed up to ~6 years1-7
SELECT BASELINE CHARACTERISTICS IN SKYRIZI CLINICAL TRIALS1-3
BIO-NAÏVE PATIENTS IN KEEPsAKE 1: SELECT BASELINE CHARACTERISTICS
KEEPsAKE 1 | SKYRIZI (n=483) AND PLACEBO (n=481) PATIENTS
Patients HAD
NO PRIOR USE
OF BIOLOGICS
~21
TENDER
JOINTS
AT BASELINE
(based on 68 joints),
mean
~12
SWOLLEN
JOINTS
AT BASELINE
(based on 66 joints),
mean
~61%
OF PATIENTS WITH
PREEXISTING
ENTHESITIS
(LEI>0), %
~31%
OF PATIENTS WITH
PREEXISTING
DACTYLITIS
(LDI>0), %
Age (years)
median (range)
SKYRIZI: 52 (20–85)
Placebo: 52 (22–79)
Sex
female, n (%)
SKYRIZI: 231 (48%)
Placebo: 247 (51%)
KEEPsAKE 2 | SKYRIZI (n=224)
AND PLACEBO (n=219) PATIENTS
PATIENTS WITH PREEXISTING
ENTHESITIS (LEI>0)
SKYRIZI:
66%
Placebo: 72%
PATIENTS WITH PREEXISTING
DACTYLITIS (LDI>0)
SKYRIZI:
18%
Placebo: 26%
IN KEEPsAKE 1 AND KEEPsAKE 2, THE PRIMARY ENDPOINT WAS ACR20 RESPONSE AT WEEK 24 (NRI‑C).1-3
KEEPsAKE 1
57% SKYRIZI (n=483)
34% PLACEBO (n=481)
KEEPsAKE 2
51% SKYRIZI (n=224)
27% PLACEBO (n=219)
NON-RANKED SECONDARY ENDPOINTS WERE ACR50/70 RESPONSE AT WEEK 24 (NRI‑C).1-3
KEEPsAKE 1
ACR50:
33% SKYRIZI (n=483)
11% PLACEBO (n=481)
ACR70: 15% SKYRIZI (n=483)
5% PLACEBO (n=481)
KEEPsAKE 2
ACR50:
26% SKYRIZI (n=224)
9% PLACEBO (n=219)
ACR70: 12% SKYRIZI (n=224)
6% PLACEBO (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.1,4,5
SUSTAINED RELIEF IN JOINTS WITH RESULTS UP TO ~6 YEARS
ACR20/50/70 RESPONSE RATES FOR csDMARD-IR PATIENTS SUSTAINED AT ~6 YEARS6,7
KEEPsAKE 1: csDMARD-IR | ALL DATA IS AS OBSERVED
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: An OLE may enrich long-term data, as patients intolerant or unresponsive to the drug drop out.
ACR20/50/70=improvement of at least 20%, 50%, or 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.
IMPROVEMENTS IN ACR COMPONENTS OF DISEASE ACTIVITY
AT WEEK 24 (MMRM) AND ~6 YEARS (AO)1,7
KEEPsAKE 1: csDMARD-IR
| SKYRIZI (n=483) | Placebo (n=481) | ||||
|---|---|---|---|---|---|
| Baseline | Mean Change at Week 24 (RCT) |
Mean Change at Week 304 (OLE) |
Baseline | Mean Change at Week 24 (RCT) |
|
| Number of Swollen Joints (0-66) |
12.1 | -8.7 | -11.1 (n=333) |
12.2 | -6.7 |
| Number of Tender Joints (0-68) |
20.8 | -12.0 | -17.5 (n=333) |
20.5 | -7.9 |
| Patient’s Assessment of Pain (0-100 VAS) |
57.1 | -21.4 | -28.9 (n=320) |
57.1 | -10.9 |
| Patient’s Global Assessment of Disease Activity (0-100 VAS) |
57.9 | -22.6 | -28.2 (n=320) |
57.4 | -11.1 |
| Physician’s Global Assessment of Disease Activity (0-100 VAS) |
61.3 | -34.8 | -51.2 (n=300) |
62.4 | -22.2 |
| HAQ-DI* (0-3 scale, where 0=no difficulty, 3=inability to perform) |
1.2 | -0.3 | -0.40 (n=320) |
1.2 | -0.1 |
| hs-CRP (mg/L) |
11.9 | -4.3 | -4.07 (n=310) |
11.3 | -0.2 |
DATA LIMITATION: Data labeled as a ranked secondary endpoint was multiplicity-controlled for comparisons. All other comparisons were not adjusted for multiplicity; therefore, statistical significance has not been established.
OLE LIMITATIONS: An OLE may enrich long-term data, as patients intolerant or unresponsive to the drug drop out.
AO ANALYSIS: Patients with missing data at a specific time are not included, which may enrich the population and increase the response rates.
*Week 24 ranked secondary endpoint.2
ACR=American College of Rheumatology; AO=as observed; csDMARD-IR=intolerance or inadequate response to conventional synthetic disease-modifying antirheumatic drug(s); HAQ-DI=health assessment questionnaire disability index; hs-CRP=high-sensitivity C-reactive protein; MMRM=mixed-effect model for repeated measures; OLE=open-label extension; RCT=randomized controlled trial; VAS=visual analog scale.
DO YOUR PsA PATIENTS HAVE SKIN INVOLVEMENT?
See the sustained PASI 90 and PASI 100 response rates out to ~6 years7
COMPLETE RESOLUTION OF ENTHESITIS & DACTYLITIS2,†
ENTHESITIS RESOLUTION (LEI=0) ACHIEVED AT WEEK 24 (SKYRIZI 48%, n=444; PLACEBO 35%, n=448; P<0.001)2,‡
DACTYLITIS RESOLUTION (LDI=0) ACHIEVED AT WEEK 24 (SKYRIZI 68%, n=188; PLACEBO 51%, n=204; P<0.001)2,‡
‡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 TIME6,8
ALL DATA IS AS OBSERVED
% of SKYRIZI patients who achieved
COMPLETE RESOLUTION OF ENTHESITIS
(LEI=0)
At Week 24 (RCT)
52% (n=426)
vs 42% with Placebo (n=416)
At Week 304 (OLE)
% of SKYRIZI patients who achieved
COMPLETE RESOLUTION OF DACTYLITIS
(LDI=0)
At Week 24 (RCT)
74% (n=181)
vs 60% with Placebo (n=192)
At Week 304 (OLE)
OLE LIMITATIONS: An OLE may enrich long-term data, as patients intolerant or unresponsive to the drug drop out.
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.
†Resolution defined as Leeds Enthesitis Index=0 and Leeds Dactylitis Index=0. These measures were only evaluated in patients with involvement at baseline.
SKYRIZI vs OTEZLA® (apremilast)
In adult patients with moderate Ps9
WELL-STUDIED SAFETY PROFILE
Across PsA & Ps1