5F-05 - Effectiveness of Sarilumab vs. Methotrexate as a Glucocorticoid-sparing agent in Patients with Polymyalgia Rheumatica

Background: Methotrexate and sarilumab (the only FDA approved therapy for PMR) are recommended for glucocorticoid (GC)-dependent patients, but no direct comparison exists.

Objectives: To compare effectiveness of sarilumab vs methotrexate as a GC-sparing agent in second line treatment of PMR.

Methods: A retrospective comparative cohort study from Komodo HealthMap commercial medical and prescription claims evaluated effectiveness of sarilumab vs methotrexate in second-line treated patients with PMR ≥50 years, with ≥1 inpatient/2 outpatient PMR diagnoses, on GC, initiating (index date) sarilumab (02/28/2023-07/24/2024) or methotrexate (07/01/2021-07/24/2024), ≥12-month coverage pre-index (baseline) and ≥60 days follow-up. Key exclusion criteria included prior immunomodulatory treatment, seropositive RA or other rheumatic disease during baseline. Patients were exact matched on age, index GC and baseline GC dose categories, and prior GCA; PS matched (SMD>0.1)- demographics, insurance, baseline GC duration, cumulative GC prior to index, time from diagnosis, healthcare utilization and comorbidities. Primary outcomes were time-to-GC discontinuation up to 1 year in all patients (adjusted hazard ratio [aHR] estimated with Cox proportional hazards models) and percent GC discontinuation at fixed intervals. Secondary outcomes were cumulative GC dose and days-to-GC discontinuation at fixed intervals. Fixed interval endpoints were assessed in matched pairs with follow-up available at each specified interval using chi square test.

Results: Of 174 patients on sarilumab, 156 were matched to methotrexate of which 83, 55, and 35 matched pairs had ≥6, ≥8, and ≥10 months of follow-up respectively. Patient characteristics were similar; mean age 67 years, mean disease duration >14 months.

Sarilumab vs. methotrexate initiators (N=156 pairs) were more likely to discontinue GC (aHR: 1.76 [95% CI: 1.24–2.50]) with fewer days-to-median survival (129 vs 188; p= 0.0081). In matched pairs with ≥6, ≥8, and ≥10 months follow-up, more sarilumab vs. methotrexate patients (61% vs. 43%, p=0.02; 73% vs. 51%, p=0.02; 83% vs. 57%, p=0.02 respectively) discontinued GC with fewer median days-to-GC discontinuation (133 vs 205, p=0.002; 130 vs 227, p=0.002; 128 vs 283, p=0.004 respectively). At 8- and 10-months cumulative GC use was lower for sarilumab vs. methotrexate (median 725 vs 1250 mg, p=0.004; 838 vs 1516 mg, p=0.03 respectively).

Conclusions: Sarilumab was more effective than methotrexate as a GC-sparing agent for PMR.

Original presentation at RWCS 2025.