التفاصيل البيبلوغرافية
| العنوان: |
Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 1 study. |
| المؤلفون: |
Kristensen, Lars Erik, Keiserman, Mauro, Papp, Kim, McCasland, Leslie, White, Douglas, Lu, Wenjing, Soliman, Ahmed M, Eldred, Ann, Barcomb, Lisa, Behrens, Frank |
| المصدر: |
Rheumatology; Jun2023, Vol. 62 Issue 6, p2113-2121, 9p |
| مصطلحات موضوعية: |
THERAPEUTIC use of monoclonal antibodies, PSORIATIC arthritis, DRUG efficacy, TREATMENT effectiveness, RANDOMIZED controlled trials, RESEARCH funding, QUESTIONNAIRES, STATISTICAL sampling, PATIENT safety |
| مستخلص: |
Objective PsA is a chronic disease with heterogeneous clinical manifestations requiring treatment options with long-term efficacy and safety. In this follow-up analysis, the 52-week efficacy and safety of risankizumab 150 mg in patients with active PsA who had previous inadequate response/intolerance to one or more conventional synthetic DMARDs (csDMARD-IR) were evaluated. Methods KEEPsAKE 1 is an ongoing, global, phase 3 study with a 24-week, double-blind, placebo-controlled period (period 1) and an open-label extension period (period 2). In period 1, eligible patients were randomized 1:1 to receive subcutaneous risankizumab 150 mg or placebo at weeks 0, 4 and 16. At week 24 (period 2), all continuing patients received open-label risankizumab 150 mg every 12 weeks through week 208. Results At week 24, 57.3% of risankizumab-treated patients (n = 483) achieved ≥20% improvement in ACR criteria (ACR20) vs 33.5% of placebo-treated patients (n = 481; P < 0.001). At week 52, 70.0% of patients who were randomized to receive continuous risankizumab therapy and 63.0% of patients who were randomized to receive placebo in period 1 and then receive risankizumab at week 24 achieved ACR20. Similar result trends were observed for other efficacy measures. Risankizumab was well tolerated through 52 weeks of treatment with a consistent safety profile from week 24 through week 52. Conclusion In patients with active PsA who were csDMARD-IR, continuous risankizumab treatment demonstrated robust long-term efficacy and was well tolerated through 52 weeks of treatment. Trial registration ClinicalTrials.gov, http://clinicaltrials.gov , KEEPsAKE1, NCT03675308. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
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