Spondyloarthritis & psoriatic arthritis

Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 1 study

Rheumatology (Oxford)Published Randomised controlled trial

Authors' 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.

Study context

Population
Patients with active PsA and previous inadequate response/intolerance to ≥1 csDMARD (csDMARD-IR)
Participants
483 vs 481
Comparison
Risankizumab 150 mg SC vs placebo at weeks 0, 4 and 16; then open-label risankizumab 150 mg every 12 weeks from week 24 through week 208
  • Risankizumabn = 483
  • Placebon = 481reference
Methodological detailsphase 3, global, double-blind, placebo-controlled (24-week period 1), open-label extension (period 2), ongoing
  • Phase 3
  • Global
  • Double-blind
  • Placebo-controlled (24-week period 1)
  • Open-label extension (period 2)
  • Ongoing

Primary result

As reported in the abstract

ACR20 · week 24

P < 0.001

Further findings

ACR20 · week 52

  • ACR criteria (ACR20): Placebo patients received risankizumab from week 24

Other efficacy measures

Similar result trends were observed

Original publication

Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 1 study. Rheumatology (Oxford). Published 25 October 2022. doi:10.1093/rheumatology/keac607

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