BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica

Phase 2 Completed 34 enrolled University Hospital, Brest Eli Lilly and Company · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

Patients with recent PMR(6 months or less) with a PMR-AS \>17 and no oral or parenteral GCs during the past 2 weeks (at least) will be included. Treatment with oral baricitinib 4mg or placebo during 12 weeks and then, if PMR-AS≤10, they will receive baricitinib 2 mg for 12 weeks and then will stop treatment. No rescue is allowed before week 4 (visit 3) but patients may receive up to 2 intra-articular or soft tissue injections of GCs until week 4 according to investigator's opinion. From week 4 to week 12, steroids will be proposed as a rescue for both arms at investigators' discretion and according to PMR-AS.

Timeline

Start: 2020-12-01
Primary completion: 2023-08-30
Completion: 2023-08-30

Outcome

Met primary endpoint

paper The primary endpoint was reached at week 12 by 14 (78%) of 18 participants in the baricitinib group and two (13%) of 15 PMID 39818228 ↗

paper crude p=0·0004; adjusted p<0·0001 PMID 39818228 ↗

Publications

Saraux A, Carvajal Alegria G, Dernis E, Roux C, Richez C, Tison A, Quere B, Jousse-Joulin S, Guellec D, Marhadour T, Kervarrec P, Cornec D, Le Henaff C, Lesven S, Nowak E, Souki A, Devauchelle-Pensec V. Baricitinib in early polymyalgia rheumatica (BACHELOR): a randomised, double-blind, placebo-controlled, parallel-group trial. Lancet Rheumatol. 2025 Apr;7(4):e233-e242. doi: 10.1016/S2665-9913(24)00270-4. Epub 2025 Jan 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Baricitinib	Small molecule	2 mg	Oral