Risankizumab (SKYRIZI?) Phase 3 Results Demonstrate Improvements in Disease Activity Across Joint and Skin Symptoms Among Psoriatic Arthritis Patients
KEEPsAKE-1 and KEEPsAKE-2 Results at Week 24*,1 |
||||
KEEPsAKE-1 |
KEEPsAKE-2 |
|||
Risankizumab |
Placebo (n=481) |
Risankizumab |
Placebo (n=219) |
|
ACR20a |
57% |
34% |
51% |
27% |
ACR50a,f |
33% |
11% |
26% |
9% |
ACR70a,f |
15% |
5% |
12% |
6% |
PASI 90b |
52% |
10% |
55% |
10% |
HAQ-DIc |
-0.31 |
-0.11 |
-0.22 |
-0.05 |
MDAd |
25% |
10% |
26% |
11% |
PsA-mTSSe,? |
0.23 |
0.32 |
N/A |
N/A |
*?In both studies, ACR20 at week 24 was the primary endpoint, and PASI 90, HAQ-DI and MDA at week 24 were ranked secondary endpoints. ACR20, PASI 90, HAQ-DI and MDA achieved p-values of <0.001. Not all ranked secondary endpoints are shown. |
a?ACR20/50/70 is defined as at least a 20 percent/50 percent/70 percent reduction from baseline in the number of both tender and swollen joint counts and equivalent improvement in three or more of the five American College of Rheumatology core set measures: patient assessments of pain, patient global assessment of disease activity, physical function, physician global assessment of disease activity and acute phase reactant. |
b?PASI 90 is defined as achievement of at least a 90 percent reduction in Psoriasis Area Severity Index. It was assessed in patients with a body surface area (BSA) =3 percent at baseline. |
c?HAQ-DI is defined as change in baseline in the Health Assessment Questionnaire Disability Index, which is a patient-reported questionnaire including categories of dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. It asks patients about the amount of difficulty they experience in these activities as well as the use of aids and/or devices. |
d?MDA is defined as the fulfillment of 5 of 7 outcome measures: TJC =1; SJC =1; PASI =1 or BSA-Ps =3 percent; Patient's Assessment of Pain Numerical Rating Scale (NRS) =1.5; PtGA-Disease Activity NRS =2.0; HAQ-DI score =0.5; and LEI (Leeds Enthesitis Index) =1. |
e?PsA-mTSS is defined as a change in modified total Sharp score (mTSS) from baseline. |
f?ACR50 and ACR70 at week 24 were secondary endpoints and achieved nominal p-values of <0.05. These endpoints were not controlled for multiplicity. |
??PsA-mTSS at week 24 was a ranked secondary endpoint that did not reach statistical significance (p=0.496). It was not evaluated in KEEPsAKE-2. |
- AbbVie. Data on File: ABVRRTI71470.
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Contact(s)
Global Media Jenina Nu?ez +1 (708) 603-5755 jenina.nunez@abbvie.com or U.S. Media Brittany Seagraves +1 (224) 229-2144 brittany.seagraves@abbvie.com or Investors Liz Shea 1 (847) 935-2211
liz.shea@abbvie.com