Vasculitis & polymyalgia rheumatica

A Randomized, Double‐Blind, Placebo‐Controlled Trial of Abatacept for the Treatment of Relapsing, Nonsevere Granulomatosis With Polyangiitis

Arthritis RheumatolPublished Randomised controlled trial

An erratum to this article was published (Arthritis Rheumatol, Aug 2026 ↗)

Authors' conclusion

In patients with relapsing, nonsevere GPA, abatacept did not reduce the risk of relapse, severe worsening, or failure to achieve remission.

Study context

Population
Patients with relapsing, nonsevere granulomatosis with polyangiitis (GPA); those on MTX, AZA, mycophenolate or LEF continued at a stable doserandomized
Participants
65 patients
Comparison
Abatacept 125 mg SC weekly vs placebo, both with prednisone 30 mg/day tapered and discontinued at week 12
  • Abataceptn = 34
  • Placebon = 31reference
Primary endpoint
Rate of treatment failure: relapse, disease worsening, or failure to achieve BVAS/WG of 0 or 1 by 6 months
Follow-up
Six months
Methodological detailsdouble-blind, placebo-controlled, multicentre, Patients not in remission by month 6, or with nonsevere relapse or worsening, could receive open-label abatacept
  • Double-blind
  • Placebo-controlled
  • Multicentre
  • Patients not in remission by month 6, or with nonsevere relapse or worsening, could receive open-label abatacept

Primary result

As reported in the abstract

Treatment failure rate
  • No statistical difference in treatment failure rate between abatacept and placebo
  • Abatacept vs Placebo: P = 0.853

Secondary outcomes

Key secondary end points: time to full remission (BVAS/WG = 0), duration of GC-free remission, relapse severity, prevention of damage, patient-reported quality of life

No statistical difference between abatacept and placebo

Original publication

A Randomized, Double‐Blind, Placebo‐Controlled Trial of Abatacept for the Treatment of Relapsing, Nonsevere Granulomatosis With Polyangiitis. Arthritis Rheumatol. Published 15 August 2025. doi:10.1002/art.43272

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