Evaluating Baricitinib With Corticosteroids Compared to Corticosteroids Alone for Treating Polymyalgia Rheumatica in Adults Aged 50 and Older

What this Trial Is About

Polymyalgia rheumatica PMR is an inflammatory disease affecting older adults, diagnosed using established criteria. The disease activity is monitored using the PMR Activity Score PMR-AS, which assesses symptoms like morning stiffness, limb movement, pain, physician assessment, and C-reactive protein levels. Treatment commonly involves long-term low-dose glucocorticoids GCs, but these can cause side effects and relapses occur in about 30% of patients during dose reduction. There is uncertainty about the optimal duration and dosage of GCs, and new alternatives are being explored to improve treatment safety and effectiveness. This study evaluates baricitinib, an oral JAK inhibitor available in 2 mg and 4 mg doses, as a potential treatment for early PMR. Participants will be randomly assigned to receive baricitinib 4 mg, baricitinib 2 mg, or placebo, all combined with corticosteroids at the start. The treatment lasts 12 weeks initially then, based on disease activity measured by PMR-AS, participants may continue their assigned treatment for another 12 weeks or adjust corticosteroid doses. The goal is to see if baricitinib can reduce glucocorticoid use while maintaining low disease activity. Participants will be involved in regular assessments of their PMR symptoms using the PMR-AS score over 24 weeks. Researchers will track disease activity, medication doses, and safety throughout the study. The study aims to confirm whether a 6-month treatment with baricitinib is effective and safe as an alternative or complement to corticosteroids. The total participation duration includes baseline and follow-up visits to monitor progress and collect data on treatment impact.

Justification And Evaluation of Baricitinib Plus Corticosteroids Versus corticosteroiDs Alone in pOlymyalgia RhEumatica