BACHELOR Trial - Baricitinib in Early Polymyalgia Rheumatica Save
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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I read this one time today and maybe I missed a lot but I have concerns....
If I am reading this right
GCs were optional ( you 'could" offer to IM injections and you could give GC for 'flair" [ uncertain what this means when all patients had active PMR at enrolment and all pts had active PMR ? and 1/2 were given placebo
I would not enroll if I had active PMR and I lack equipoise ( unless I missed something) to offer my patients such
Lastly - I think the PMR GC response is important diagnostically both when it works and especially when it doesn't
What can be said for Bari response??
Please rebut these comments perhaps my morning read missed the boat
LC - this was an odd trial that I published here because JAKi are just starting to be studied in both PMR and GCA. I agree with you this is a head scratcher, because:
- of the 39 enrolled only 34 were treated
- Yes, it looks like steroids were optional in this study where they state, "oral glucocorticoids as rescue treatment in the event of high disease activity" and that "Subdeltoid glucocorticoid injections at week 1 and week 4 were permitted" (not required)
- It looks like they were testing the concept of treating "early PMR" without steroids and with baricitinib. Success was disease control (but not remission) at week 12 without oral glucocorticoids.
I dont think this is a better way to treat PMR, I do think this says JAK inhibitors may be effective and should be studied
JC
Disclosures
The author has no conflicts of interest to disclose related to this subject
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