Baricitinib cuts need for oral steroids in polymyalgia rheumatica

In the treatment of patients with polymyalgia rheumatica, the Janus kinase 1/2 inhibitor baricitinib helps reduce the need to take oral glucocorticoids to have low disease activity while having no new safety signals, according to data from the randomized, double-blind BACHELOR trial.

BACHELOR included 34 patients who had recently received a diagnosis of polymyalgia rheumatica, a C-reactive protein polymyalgia rheumatica activity score (CRP PMR-AS) of more than 17. These patients were randomly assigned to receive either 4-mg baricitinib or placebo, with oral glucocorticoids given as a rescue medication in the event of high disease activity. Treatment was administered orally for 12 weeks, followed by 2-mg baricitinib (n=18) or placebo (n=16) for another 12 weeks. Subdeltoid glucocorticoid injections at week 1 and week 4 were permitted.

The primary endpoint was a CRP PMR-AS of ≤10 at week 12 without oral glucocorticoid use from week 1 to week 12, analysed in the intention-to-treat population. All patients were followed up for 36 weeks.

Of the randomized patients, one in the placebo group withdrew before receiving the first infusion and was excluded in the analyses. At week 12, 78 percent of baricitinib-treated patients achieved the primary endpoint as opposed to only 13 percent of those who received placebo (relative risk, 5.8, 95 percent confidence interval [CI], 3.2–10.6; p<0.0001).

In terms of safety, the most common adverse events were musculoskeletal and connective tissue disorders, reported in 72 percent and 25 percent of patients in the baricitinib and placebo groups, respectively. None of the patients in either treatment group died or experienced major adverse cardiovascular events.