| Autor: |
Merola JF; Department of Dermatology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA., Armstrong A; Division of Dermatology, University of California Los Angeles Health, Los Angeles, CA, USA., Khattri S; Department of Dermatology, Mt. Sinai Health System, New York, NY, USA., Paek SY; Division of Dermatology, Baylor University Medical Center, Texas A&M College of Medicine, Dallas, TX, USA., Padilla B; AbbVie Inc, North Chicago, IL, USA., Yue C; AbbVie Inc, North Chicago, IL, USA., Photowala H; AbbVie Inc, North Chicago, IL, USA., Kaplan B; AbbVie Inc, North Chicago, IL, USA., Kristensen LE; The Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark. |
| Abstrakt: |
In the KEEPsAKE 1 (NCT03675308) and KEEPsAKE 2 (NCT03671148) phase 3 trials, risankizumab demonstrated greater efficacy compared with placebo in patients with active psoriatic arthritis (PsA). This post hoc integrated analysis evaluated achieving the following efficacy outcomes at weeks 24 and 52 by baseline demographics and clinical characteristics: ≥20%/50%/70% improvement in American College of Rheumatology response criteria (ACR20/50/70), ≥90% improvement in Psoriasis Area and Severity Index, minimal disease activity status, Low Disease Activity status (Disease Activity in Psoriatic Arthritis), and minimal clinically important difference in pain. Baseline demographics and clinical characteristics were similar between risankizumab ( n = 707) and placebo ( n = 700) groups. Numerically higher ACR20 response rates at week 24 (primary endpoint) were observed among the risankizumab (46.3%-60.1%) vs. placebo (15.5%-36.2%) cohorts, regardless of subgroups. At week 52, consistent proportions of patients randomized to risankizumab achieved ACR20 (48.6%-75.8%) while those initially randomized to placebo and switched to risankizumab experienced an improvement from week 24 (43.7%-63.9%), regardless of subgroups. Similar trends were observed for other efficacy measures assessing rigorous skin response criteria, composite measures of overall disease activity, and PsA-related symptoms. Risankizumab treatment was efficacious among patients with varying demographic and psoriatic disease characteristics through 52 weeks. |
