Vasculitis & polymyalgia rheumatica

Baricitinib in early polymyalgia rheumatica (BACHELOR): a randomised, double-blind, placebo-controlled, parallel-group trial

Lancet RheumatolPublished Randomised controlled trial

Primary result · CRP PMR-AS ≤10 without oral GCResult — go to the resultRelative risk 5.8 95% CI 3.2–10.6

Authors' conclusion

This study suggests that, compared with placebo, individuals with polymyalgia rheumatica receiving 4 mg baricitinib are less likely to need oral glucocorticoids to have low disease activity at week 12 of treatment without any new safety signals.

Study context

Population
Participants with recent (<6 months) PMR naive to GC and a CRP PMR-AS of more than 17, six expert centres in Franceone placebo withdrew before treatment
Participants
34 participants
Comparison
Baricitinib 4 mg orally for 12 weeks, then 2 mg for another 12 weeks, vs placebo
  • Baricitinibn = 18
  • Placebon = 16reference
Primary endpoint
CRP PMR-AS of 10 or less at week 12 without oral GC use from week 1 to week 12
Follow-up
Week 12
Methodological detailsdouble-blind, placebo-controlled, parallel-group, multicentre (six expert centres), stratified by hospital, Participants followed up for 36 weeks
  • Double-blind
  • Placebo-controlled
  • Parallel-group
  • Multicentre (six expert centres)
  • Stratified by hospital
  • Participants followed up for 36 weeks

Primary result

CRP PMR-AS ≤10 without oral GC

Relative risk

5.8

95% CI 3.2–10.6

crude p=0.0004

Events by treatment group

Baricitinibvs Placebo
RR 5.8 (95% CI 3.2–10.6); crude p=0.0004

As reported in the abstract

Further findings

Deaths and MACE

None in either study group

Safety

Musculoskeletal and connective tissue disorders (most common adverse events)

Original publication

Baricitinib in early polymyalgia rheumatica (BACHELOR): a randomised, double-blind, placebo-controlled, parallel-group trial. Lancet Rheumatol. Published 13 January 2025. doi:10.1016/s2665-9913(24)00270-4

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