ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 0858

Baricitinib in Early Polymyalgia Rheumatica (BACHELOR Study)

Alain SARAUX1, Guillermo CARVAJAL ALEGRIA2, Emmanuelle Dernis3, christian roux4, Christophe Richez5, Alice TISON6, Baptiste Quere7, Sandrine Jousse-Joulin8, Dewi Guellec7, Thierry Marhadou9, Patrice Kervarrec7, Divi Cornec10, Catherine Le Henaff7, Sandra Lesven7, nowak emmanuel7, Aghiles Souki7 and Valerie Devauchelle11, 1CHU Brest, Brest, France, 2CHRU de Tours, Tours, France, 3CH LE MANS, LE MANS, Pays de la Loire, France, 4rheumatology department, university Cote d'Azur, nice, France, 5Université de Bordeaux, Bordeaux, France, 6CHU de la Cavale Blanche, Brest, France, Brest, France, 7Centre Hospitalier Regional Universitaire (CHU) de Brest, Brest, France, 8cavale blanche hospital, brest, France, 9CHU Cavale Blanche, Brest, France, 10University of Brest, Brest, France, 11UBO, Brest, France

Meeting: ACR Convergence 2024

Keywords: , , , ,

Session Information

Date: Saturday, November 16, 2024

Title: Abstracts: Miscellaneous Rheumatic & Inflammatory Diseases I

Session Type: Abstract Session

Session Time: 3:00PM-4:30PM

Background/Purpose: Moderate glucocorticoids (GCs) improve nearly all cases of polymyalgia rheumatica (PMR) but related adverse events are common in senior patients.  The purpose of this randomized placebo-controlled trial in early PMR was to evaluate whether baricitinib (JAK 1/2 inhibitor) allows to reach disease control without GCs in recent-onset PMR. Moderate glucocorticoids (GCs) improve nearly all cases of polymyalgia rheumatica (PMR) but related adverse events are common in senior patients. The purpose of this randomized placebo-controlled trial in early PMR was to evaluate whether baricitinib (JAK 1/2 inhibitor) allows to reach disease control without GCs in recent-onset PMR.

Methods: We conducted a double-blind randomized (1:1) placebo-controlled parallel-group trial between December 1, 2020, and August 30, 2023. Thirty-four patients with recent (< 6 months) naïve to GCs PMR with C Reactive PMR activity score (CRP PMR-AS) >17 received oral baricitinib 4 mg or matching placebo, with oral GCs rescue in cases of high disease activity for 12 weeks, and then baricitinib 2 mg or matching placebo, until week 24. Subdeltoid GC injection at W0 and W4 as permitted. The primary endpoint was the CRP PMR-AS≤10 without oral GCs rescue from W0 to week 12.

Results: We randomized 34 patients (18 baricitinib and 16 placebo) (Figure 1). The primary endpoint was reached at week 12 by 14/18 (77.8%) and 2/16 (13.3%) of patients in the baricitinib and placebo groups, respectively (RR (95% CI): 5.8 (3.2; 10.6); crude p value=0.0004; adjusted p value< 0.0001) (Figure 2). Among secondary outcomes assessed at week 12 erythrocyte sedimentation rate (ESR) PMR-AS, ESR and visual analogic score pain were significantly lower in the placebo group than in the baricitinib group (p=0.02, 0.02 and 0.03 respectively) but patients of the placebo group received more GCs and patients of the baricitinib group had a higher MCS SF36 and EQ5D (p=0.005 and 0.043, respectively). There was no flare until week 36. There was no death, no major adverse cardiovascular events or safety signal.

Conclusion: This study suggests that baricitinib alone 4 mg 12 weeks and then 2 mg 12 weeks allows sustained low disease activity 36 weeks in early PMR patients without safety signal.

Supporting image 1

Figure 1 (Flowchart)

Supporting image 2

Figure 2 (Results)

Disclosures: A. SARAUX: Abbvie, BMS, Galapagos, Lilly, Novartis, Nordic, Pfizer, Roche-Chugai, Sanofi, UCB, 6, Abbvie, Bms, Lilly, Novartis, 5; G. CARVAJAL ALEGRIA: Abbvie, Chugai, Lilly, Novartis, 6; E. Dernis: AbbVie/Abbott, 2, Amgen, 2, Boehringer-Ingelheim, 2, Celgene, 2, Eli Lilly, 2, Galapagos, 2, Gilead, 2, Janssen, 2, Merck/MSD, 2, Nordic Pharma, 2, Novartis, 2, Pfizer, 2, Roche, 2, roche-chugaï, 2, Sandoz, 2, Sanofi, 2, UCB, 2; c. roux: None; C. Richez: Abbvie, Astra Zeneca, BMS, GSK, Lilly, Novartis, Pfizer, UCB, 6, Lilly and Biogen, 5; A. TISON: Galapagos, BMS, 6; B. Quere: None; S. Jousse-Joulin: None; D. Guellec: Lilly, Janssen-Cilag, Glaxosmithkline, 6; T. Marhadou: Abbvie, Amgen, Chugaï, Lilly, Mylan, Novartis, Pfizer, 6; P. Kervarrec: None; D. Cornec: None; C. Le Henaff: None; S. Lesven: None; n. emmanuel: None; A. Souki: None; V. Devauchelle: AbbVie, 2, BMS, 2, 5, Chugai, 5, Galapagos, 2, Janssen, 2, Lilly, 2, 5, Novartis, 2, Pfizer, 2.

To cite this abstract in AMA style:

SARAUX A, CARVAJAL ALEGRIA G, Dernis E, roux c, Richez C, TISON A, Quere B, Jousse-Joulin S, Guellec D, Marhadou T, Kervarrec P, Cornec D, Le Henaff C, Lesven S, emmanuel n, Souki A, Devauchelle V. Baricitinib in Early Polymyalgia Rheumatica (BACHELOR Study) [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/baricitinib-in-early-polymyalgia-rheumatica-bachelor-study/. Accessed .

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