NORTH CHICAGO, Ill., Nov. 5, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the presentation of integrated data from two Phase 3 clinical trials, KEEPsAKE 1 and KEEPsAKE 2, evaluating the efficacy and safety of risankizumab (SKYRIZI®) in adult patients with active psoriatic arthritis (PsA). The data showed that 24-weeks of treatment with risankizumab resulted in greater improvements in PsA signs and symptoms compared with placebo with no new safety signals.1 These results will be featured in an American College of Rheumatology (ACR) Convergence 2021 plenary session on Saturday, Nov. 6, from 9:45-10 a.m. CT (Abstract #0453).
"Psoriatic arthritis is a chronic, progressive and debilitating disease. These results support the potential of risankizumab to help improve joint and skin symptoms for people living with this disease and assist more people in their pursuit of reaching their treatment goals," said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie.
Patients receiving risankizumab achieved higher rates of ACR20 (55.5%) than patients receiving placebo (31.3%) at week 24.1 Additionally, patients receiving risankizumab showed greater improvements in the key clinical and patient-reported outcome endpoints compared to patients receiving placebo.1
Efficacy at Week 241*** | |||
Risankizumab 150 mg (N=707) | Placebo (N=700) | ||
ACR20, % | 55.5 | 31.3 | |
HAQ-DIa, change from baseline | -0.27 | -0.08 | |
PASI 90b, % | 53.2 | 10.0 | |
MDA, % | 25.2 | 10.6 | |
Resolution of enthesitisc, % | 48.4 | 34.8 | |
Resolution of dactylitisd, % | 68.1 | 51.0 |
ACR20, ≥ 20 improvement in American College of Rheumatology score; HAQ-DI, Health Assessment Questionnaire-Disability Index; PASI 90, ≥90% reduction in Psoriasis Area Severity Index; MDA, minimal disease activity; PBO, placebo; RZB, risankizumab. |
*** P-value
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