Spondyloarthritis & psoriatic arthritis

Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 2 study

Rheumatology (Oxford)Published Randomised controlled trial

Authors' conclusion

Risankizumab was well tolerated and improved symptoms of PsA in Bio-IR/csDMARD-IR patients, with a consistent long-term safety profile from weeks 24 to 52.

Study context

Population
Patients with active PsA and previous inadequate response/intolerance to one or two biologics (Bio-IR) or ≥1 csDMARD (csDMARD-IR)
Participants
224 vs 220
Comparison
Risankizumab 150 mg SC vs placebo
  • Risankizumabn = 224
  • Placebon = 220reference
Primary endpoint
ACR20
Follow-up
Week 24
Methodological detailsphase 3, ongoing, placebo-controlled, follow-up analysis to week 52
  • Phase 3
  • Ongoing
  • Placebo-controlled
  • Follow-up analysis to week 52

Primary result

As reported in the abstract

P < 0.001

Further findings

ACR20 · week 52

  • ACR20: Placebo group switched to risankizumab at week 24

Other efficacy measures

Similar trends were observed

Deaths · through week 52

No deaths reported

Safety

Serious treatment-emergent adverse events (TEAEs) and TEAEs leading to discontinuation · through week 52

Rates remained stable

Original publication

Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 2 study. Rheumatology (Oxford). Published 25 October 2022. doi:10.1093/rheumatology/keac605

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