Spondyloarthritis & psoriatic arthritis

Upadacitinib in patients with psoriatic arthritis and inadequate response to biologics: 3-year results from the open-label extension of the randomised controlled phase 3 SELECT-PsA 2 study

Clin Exp RheumatolPublished Open-label extension of the SELECT-PsA 2 randomised controlled trial

Authors' conclusion

Efficacy of upadacitinib was maintained up to 152 weeks of treatment in this highly treatment-refractory population of patients with PsA. The long-term safety profile of upadacitinib 15 mg was consistent with its known safety profile across indications; no new safety signals were identified.

Study context

Population
Patients with PsA and inadequate response (IR) to biologic disease-modifying anti-rheumatic drugs (bDMARDs)entered open-label extension (OLE)
Participants
450 patients
Comparison
Upadacitinib 15 mg vs 30 mg QD
Primary endpoint
Long-term safety and efficacy
Follow-up
Up to 152 weeks
Methodological detailsblinded randomised period, placebo-controlled for 24 weeks, TNFi-IR subanalysis
  • Blinded randomised period
  • Placebo-controlled for 24 weeks
  • TNFi-IR subanalysis

Primary result

As reported in the abstract

Efficacy (ACR20/50/70, MDA, PASI 75/90/100) · week 152
  • Improvements observed at week 56 were maintained through week 152

Further findings

Efficacy in TNFi-IR subgroup

Similar to those reported in the overall population

Safety

Long-term safety · up to 152 weeks

Well tolerated; no cumulative adverse effects observed through 152 weeks

Original publication

Upadacitinib in patients with psoriatic arthritis and inadequate response to biologics: 3-year results from the open-label extension of the randomised controlled phase 3 SELECT-PsA 2 study. Clin Exp Rheumatol. Published 23 February 2023. doi:10.55563/clinexprheumatol/8l7bbk

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