Baricitinib offers steroid-free remission in polymyalgia rheumatica

Current targeted treatment options for polymyalgia rheumatica (PMR) are limited, raising the question of whether an oral Janus kinase (JAK) inhibitor could be effective in this indication. Phase 3 data suggest that baricitinib may represent such an option.

“Knowing all the adverse effects of glucocorticosteroids (GCs), we have a medical need for a GC-free remission in PMR,” said Prof. Helga Lechner-Radner (Medical University Vienna, Austria) [1]. Oral JAK inhibitors may offer a novel therapeutic option, especially in early PMR. To investigate this, a phase 3 trial enrolled 46 patients with very early disease, defined as symptom duration of 3 weeks or less, from centres in Austria, Italy, and Czechia. Patients were randomised 1:1 to receive baricitinib or placebo, while all underwent GC taper, with glucocorticoids reduced to 0 over the first 11 weeks but permitted to be continued or restarted if needed for symptom control.

The study consisted of 3 phases. The first lasted 16 weeks, with GC-free remission at week 16 as the primary endpoint. At week 16, patients in the placebo group crossed over to baricitinib for an additional 12 weeks, while patients originally assigned to baricitinib continued treatment. At week 28, all patients were re-randomised to continue baricitinib 4 mg, step down to 2 mg, or discontinue treatment, with a final assessment at week 44.

GC-free remission at week 16 was achieved by 65% of patients receiving baricitinib compared with 17% receiving placebo (P<0.01). As Prof. Lechner-Radner noted, a highly statistically significant separation between the groups was already evident by week 12. Following the crossover, the former placebo group also reached a GC-free remission rate of 65%. Relapse-free survival curves separated as early as week 9, favouring baricitinib, which was also associated with a lower cumulative GC dose and greater improvements in patient-reported pain and global assessment.

During the withdrawal phase, symptoms recurred in patients who discontinued baricitinib, suggesting that treatment benefits were not sustained after withdrawal. Among patients who continued baricitinib, only 7% lost GC-free remission, although this numerical difference did not reach statistical significance.

These findings suggest that baricitinib may provide an effective oral alternative to biologic therapy in PMR. However, the loss of benefit after treatment discontinuation indicates that continued treatment may be required to maintain disease control.

Lechner-Radner H, et al. Baricitinib for remission induction and glucocorticoid sparing in new-onset polymyalgia rheumatica (JAK-Spare) – a Phase III randomized controlled trial. LB0005, EULAR 2026, 3–6 June, London, United Kingdom.