AB0379 BARICITINIB IN POLYMYALGIA RHEUMATICA AND GIANT CELL ARTERITIS: REPORT OF SIX CASES
Authors: D. Camellino, C. Dejaco, A. Giusti, F. Martini, R. Cosso, G. Girasole, G. Bianchi
Journal: Annals of the Rheumatic Diseases (2021)

Background: Glucocorticoids (GC) are the cornerstone of the treatment of polymyalgia rheumatica (PMR) and giant cell arteritis (GCA), but they are associated with several adverse events (AEs). Moreover, a considerable proportion of patients relapse during GC tapering. Objectives: To describe the efficacy and safety of the JAK-inhibitor baricitinib (BARI) in a group of patients with PMR and/or GCA. Methods: Case series of patients with PMR and/or GCA with a refractory disease course, despite several lines of therapy, including methotrexate (MTX) and tocilizumab (TCZ), started treatment with BARI. All patients underwent periodic, standardised clinical and laboratory examinations, and also FDG-PET/CT. PMR-activity score (AS) was calculated at each visit except in patients with isolated large vessel vasculitis (LVV) or GCA. Results: A total of six patients (five females and one male, median age 64 years, range 50-83) were treated with BARI. Two of them had isolated PMR (patients #1 and #6), two had PMR with associated LVV (patients #2 and #5), and one (patient #3) had cranial-GCA. Demographic and clinical characteristics are provided in Table 1. At the time of starting BARI, patients were taking a median prednisone dose of 8.75 mg/day (range 0-25), and the 4 patients with PMR±LVV had a median PMR-activity score (PMR-AS) of 23.3 (indicating high disease activity), which decreased to 1.58 after 6 months of treatment with BARI. Two of them could stop GC and continued BARI monotherapy (in one case, BARI was tapered down to 2 mg/day after 12 months). After starting BARI, patient #3 (GCA) could gradually taper prednisone from 25 mg/day to 10 mg/day in six months, without reporting fever or headache. After one year of treatment, she feels well while taking prednisone 7.5 mg/day. Patient #4 (LVV) remained clinically stable during the treatment with BARI, but a follow-up FDG-PET/CT showed LVV, and we decided to stop BARI and restart TCZ. After 4 months of treatment with BARI, patient #5 suffered from pneumonia, while she was also taking prednisone 15 mg/day. BARI was therefore stopped. No other AEs attributable to BARI were detected. Conclusion: BARI appears as an appealing option for treating patients with PMR and/or GCA. Although these preliminary results should be confirmed by a RCT, BARI lowered rapidly disease activity and exerted a significant steroid-sparing effect, allowing GC withdrawal in 2 out of 6 patients. Table 1. Demographic and clinical characteristics of patients. Patient # Sex Age Diagnosis Previous treatment Disease duration (months ) PMR-AS 1 F 66 PMR MTX, HCQ, SSZ 25.5 40.5 2 F 78 PMR+LVV TCZ, MTX 41.8 28.8 3 F 61 GCA CYC, MMF, TCZ 119.8 N/A 4 F 60 LVV TCZ 16.4 N/A 5 F 83 PMR+LVV MTX, TCZ 24.4 15.2 6 M 50 PMR MTX 24.6 17.8 CYC: cyclophosphamide, GCA: giant cell arteritis, HCQ: hydroxychloroquine, LVV: large vessel vasculitis, MMF: mycophenolate mofetil, MTX: methotrexate, N/A: not applicable, PMR: polymyalgia rheumatica, PMR-AS: PMR-activity score, SSZ: sulfasalazine, TCZ: tocilizumab. Disclosure of Interests: Dario Camellino Speakers bureau: Medac, Eli Lilly, Paid instructor for: Mylan, Consultant of: Accord, Celgene, Novartis, Sanofi, Christian Dejaco Speakers bureau: Eli Lilly (&lt;10.000€), Andrea Giusti Speakers bureau: UCB, Amgen, Kyowa Kirin, Abiogen Pharma, and Eli Lilly, Consultant of: EffRx, Abiogen Pharma, FRANCO MARTINI: None declared, Renzo Cosso: None declared, Giuseppe Girasole: None declared, Gerolamo Bianchi Speakers bureau: Amgen, MSD, Novartis, Pfizer, Roche, Sanofi, Genzyme, and Servier, Consultant of: Abbvie, Abiogen Pharma, BMS, Celgene, Eli Lilly, GSK, Janssen-Cilag, Medac