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BACHELOR Trial - Baricitinib in Early Polymyalgia Rheumatica

Lancet reports a French study demonstrating the efficacy of baricitinib in patients with polymyalgia rheumatica (PMR).
 
Glucocorticoids are the mainstay of therapy in PMR patients and may be problematic in older individuals. 
 
This was a multicenter, randomised, double-blind, placebo-controlled, parallel-group trial of active PMR patients, naive to glucocorticoids with a C-reactive protein polymyalgia rheumatica activity score (CRP PMR-AS) of more than 17. Patients were randomized (1:1) to receive either 4 mg baricitinib orally or placebo for 12 weeks, followed by 2 mg baricitinib or placebo for another 12 weeks. The primary outcome was a CRP PMR-AS of 10 or less at week 12 without oral glucocorticoid use from week 1 to week 12. Patients were followed up for 36 weeks. 
 
A total of 39 patients were enrolled and randomized. One placebo patient withdrew before the first treatment. 
 
The week 12 Efficacy (primary) endpoint was:
  • 78% baricitinib group 
  • 13% placebo group (relative risk 5.8, adjusted p<0·0001)
Adverse events (mostly musculoskeletal) were higher in baricitinib (72%) patients compared to 25% in the placebo group. There were no deaths and no major adverse cardiovascular events.
 
This small pilot study suggests that baricitinib is effective in early PMR. Further study is warranted. 

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Disclosures
The author has no conflicts of interest to disclose related to this subject
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