Vasculitis & polymyalgia rheumatica
Baricitinib in early polymyalgia rheumatica (BACHELOR): a randomised, double-blind, placebo-controlled, parallel-group trial
Primary result · CRP PMR-AS ≤10 without oral GCResult — go to the resultRelative risk 5.8 95% CI 3.2–10.6Authors' 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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