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Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial.
Östör, Andrew; Van den Bosch, Filip; Papp, Kim; Asnal, Cecilia; Blanco, Ricardo; Aelion, Jacob; Alperovich, Gabriela; Lu, Wenjing; Wang, Zailong; Soliman, Ahmed M; Eldred, Ann; Barcomb, Lisa; Kivitz, Alan.
  • Östör A; Monash Medical School, Cabrini Hospital and Emertius Research, Melbourne, Victoria, Australia andrewostor@gmail.com.
  • Van den Bosch F; Department of Rheumatology, Ghent University, VIB Center for Inflammation Research, Gent, Belgium.
  • Papp K; Probity Medical Research-K Papp Clinical Research, Waterloo, Ontario, Canada.
  • Asnal C; DOM Centro de Reumatología, Buenos Aires, Argentina.
  • Blanco R; Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain.
  • Aelion J; Arthritis Clinic and West Tennessee Research Institute, Jackson, Tennessee, USA.
  • Alperovich G; AbbVie Inc, Madrid, Spain.
  • Lu W; AbbVie Inc, Madrid, Spain.
  • Wang Z; AbbVie Inc, Madrid, Spain.
  • Soliman AM; AbbVie Inc, Madrid, Spain.
  • Eldred A; AbbVie Inc, Madrid, Spain.
  • Barcomb L; AbbVie Inc, Madrid, Spain.
  • Kivitz A; AbbVie Inc, North Chicago, Illinois, USA.
Ann Rheum Dis ; 81(3): 351-358, 2022 03.
Article in English | MEDLINE | ID: covidwho-1685504
ABSTRACT

OBJECTIVES:

Risankizumab is an interleukin-23 inhibitor under study for the treatment of patients with psoriatic arthritis (PsA). The phase 3 KEEPsAKE 2 trial investigated the efficacy and safety of risankizumab versus placebo in patients with active PsA who had previous inadequate response or intolerance to ≤2 biological therapies (Bio-IR) and/or ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR). Results through week 24 are reported here.

METHODS:

Adults with PsA who were Bio-IR and/or csDMARD-IR were randomised to receive subcutaneously administered risankizumab 150 mg or placebo at weeks 0, 4 and 16 during a 24-week, double-blind treatment period. The primary endpoint was the proportion of patients who achieved ≥20% improvement in American College of Rheumatology score (ACR20) at week 24. Secondary endpoints assessed key domains of PsA and patient-reported outcomes.

RESULTS:

A total of 444 patients (median age 53 years, range 23-84 years) were randomised to risankizumab (n=224) or placebo (n=220); 206 patients (46.5%) were Bio-IR. At week 24, a significantly greater proportion of patients receiving risankizumab achieved the primary endpoint of ACR20 (51.3% vs 26.5%, p<0.001) and all secondary endpoints (p<0.05) compared with placebo. Serious adverse events were reported for 4.0% and 5.5% of risankizumab-treated and placebo-treated patients, respectively; serious infections were reported for 0.9% and 2.3%, respectively.

CONCLUSION:

Treatment with risankizumab resulted in significant improvements versus placebo in key disease outcomes and was well tolerated in patients with PsA who were Bio-IR and/or csDMARD-IR. TRIAL REGISTRATION NUMBER NCT03671148.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Arthritis, Psoriatic / Antirheumatic Agents / Antibodies, Monoclonal Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Limits: Adult / Aged / Female / Humans / Male / Middle aged / Young adult Language: English Journal: Ann Rheum Dis Year: 2022 Document Type: Article Affiliation country: Annrheumdis-2021-221048

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Arthritis, Psoriatic / Antirheumatic Agents / Antibodies, Monoclonal Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Limits: Adult / Aged / Female / Humans / Male / Middle aged / Young adult Language: English Journal: Ann Rheum Dis Year: 2022 Document Type: Article Affiliation country: Annrheumdis-2021-221048