AB0379 BARICITINIB IN POLYMYALGIA RHEUMATICA AND GIANT CELL ARTERITIS: REPORT OF SIX CASES

Abstract

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 (<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