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04-02-2025 | Inflammatory Rheumatic Diseases | Editor's Choice | News

Baricitinib 'promising' for polymyalgia rheumatica, reducing glucocorticoids

Author: Sarah Pritchard

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medwireNews: Treatment with the Janus kinase (JAK) 1/2 inhibitor baricitinib for 12 weeks results in low disease activity for individuals with a recent diagnosis of polymyalgia rheumatica compared with placebo, and with a reduced need for oral glucocorticoids, report researchers.

Currently, for people with polymyalgia rheumatica, “[g]lucocorticoids, mainly prednisone or prednisolone, are the mainstay of treatment,” write Alain Saraux (Université de Bretagne Occidentale, Brest, France) and colleagues in The Lancet Rheumatology.  

They explain: “If an alternative to oral glucocorticoids in early polymyalgia rheumatica existed, patients might experience fewer adverse events, and short-term treatment might avoid difficult withdrawal.”

The team randomly assigned 34 adults (22 women) aged a mean of 69 years within 6 months of symptom onset to receive either oral baricitinib 4 mg for 12 weeks followed by 2 mg for a further 12 weeks (n=18), or an oral placebo (n=16) for the entire 24-week duration of the BACHELOR trial.

“Baricitinib is an oral selective inhibitor of JAK1 and JAK2 with a short half-life,” explain the researchers, adding that “[a]dministration of baricitinib results in the rapid, dose-dependent inhibition of IL-6-induced STAT3 phosphorylation.”

Saraux and co-investigators followed-up participants for 12 weeks’ post-treatment to assess their disease activity, measured by the C-reactive protein polymyalgia rheumatica activity score (CRP PMR-AS), which accounts for factors including pain, morning stiffness, and the ability to elevate the upper limbs. A CRP PMR-AS of 10 points or less out of a possible 100 points – where a score above 17 points represents high disease activity – in combination with no requirement for oral glucocorticoids, indicated no disease activity, explain Saraux et al.

The cohort had a mean CRP PMR-AS of 31.7 points at study entry and none were taking glucocorticoids, report the researchers. A total of 12 participants in the baricitinib group completed treatment as did four in the placebo group, with a respective three and six individuals from each group given rescue treatment with glucocorticoids.

By week 12 of follow-up, 78% of individuals in the baricitinib group and 13% in the placebo group had a CRP PMR-AS of 10 points or less with no need for glucocorticoids, so that baricitinib-treated participants were a significant 5.8 times more likely to achieve the primary endpoint than their placebo-treated counterparts.

At the same time point, patients given baracitinib had significantly poorer outcomes than controls on secondary endpoints, with a higher erythrocyte sedimentation rate (ERS), a higher ESR PMR-AS score, and a higher pain level on a visual analog scale.

However, by week 12 the baricitinib group were less likely than the placebo group to need one or more glucocorticoid injections (11 vs 33%) or oral glucocorticoids (6 vs 67%), and had a lower rate of synovitis or tenosynovitis signs (61 vs 75%).

In terms of adverse events, 72% and 25% of individuals in the baricitinib and placebo groups, respectively, experienced musculoskeletal and connective tissue disorders, while none developed giant cell arteritis, thromboembolic events, or died, observed Saraux et al.

“[T]his study showed that comparing a biologic with placebo in early polymyalgia rheumatica while delaying or avoiding initiation of oral glucocorticoids is possible,” the team concludes.

In an accompanying comment, Milena Bond and Christian Dejaco, both from the Teaching Hospital of the Paracelsius Medical University in Brunico, Italy, highlight that while the BACHELOR results “are promising,” they do not yet mark the “start of a glucocorticoids-free era for polymyalgia rheumatica.”

JAK inhibitors are not currently approved for treatment of the condition, and the findings need replication in phase 3 trials, they write, adding that longer studies investigating possible occurrences of major adverse events, such as cardiovascular disease or malignancy, late rheumatic flares, and giant cell arteritis are also needed.

“Tailoring treatments to individual patient profiles – considering disease severity, giant cell arteritis overlap, comorbidities, and risk factors for glucocorticoid dependence or adverse events – will be key to developing a personalised, effective, and safe treatment approach for patients with polymyalgia rheumatica,” conclude Bond and Dejaco.

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2025 Springer Healthcare Ltd, part of the Springer Nature Group

Lancet Rheumatol 2025; doi.org/10.1016/ S2665-9913(24)00270-4
Lancet Rheumatol 2025; doi.org/10.1016/ S2665-9913(24)00302-3

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