Vasculitis & polymyalgia rheumatica

Results of a 1-year randomised double-blind placebo-controlled trial with methotrexate 25 mg/week in recently diagnosed polymyalgia rheumatica

Ann Rheum DisPublished Randomised controlled trial

Primary result · GC-free remissionResult — go to the resultRisk difference 34% 1-sided 95% CI 14%

Authors' conclusion

This small but high-quality RCT demonstrated that methotrexate 25 mg/wk significantly increases the likelihood of achieving GC-free remission at 52 weeks in newly diagnosed PMR.

Study context

Population
Patients with recently diagnosed PMR (2012 EULAR/ACR criteria) and <8 weeks of glucocorticoid (GC) use58 analysed
Participants
64 patients
Comparison
MTX 25 mg/wk vs placebo, alongside a 24-week GC-tapering protocol
Primary endpoint
GC-free remission (PMR-AS <10 and no GC use)
Follow-up
Week 52
Methodological detailsdouble-blind, placebo-controlled, 52-week
  • Double-blind
  • Placebo-controlled
  • 52-week

Primary result

GC-free remission · 52 weeks

Risk difference

34%

1-sided 95% CI 14%

1-sided P = .0042

By group

Methotrexatevs Placebo
risk difference 34% (1-sided 95% CI 14%); 1-sided P = .0042

As reported in the abstract

Original publication

Results of a 1-year randomised double-blind placebo-controlled trial with methotrexate 25 mg/week in recently diagnosed polymyalgia rheumatica. Ann Rheum Dis. Published 21 December 2025. doi:10.1016/j.ard.2025.11.025

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