TOPLINE

Patients with steroid-refractory polymyalgia rheumatica (PMR) initiating interleukin 6 receptor inhibitor (IL-6Ri) therapy were more likely to discontinue glucocorticoids and achieve minimal glucocorticoid use by year 1 compared with those receiving conventional synthetic immunomodulatory (csIM) therapy or methotrexate alone. IL-6Ri therapy demonstrated a safety profile consistent with previous studies.

METHODOLOGY

• Researchers conducted a retrospective cohort study involving patients with steroid-refractory PMR identified from the Medicare Chronic Conditions Warehouse.
• A total of 415 matched treatment pairs with PMR were included after propensity score matching: 187 pairs in the csIM-naive cohort (cohort 1) and 228 pairs in the csIM-experienced cohort (cohort 2); in each pair, patients received either IL-6Ri therapy (tocilizumab or sarilumab) or csIM therapy (methotrexate, leflunomide, or azathioprine) added to glucocorticoids.
• The 2 primary effectiveness outcomes were complete discontinuation of oral glucocorticoid therapy and a composite outcome of minimal glucocorticoid use, defined as a prednisone-equivalent dose of ≤2 mg/day or full discontinuation.
• Safety outcomes included adverse events (AEs) of special interest such as hospitalized infections, gastrointestinal perforation, major adverse cardiovascular events (MACE), malignancies, and drug-induced liver injury.

TAKEAWAY

• By year 1, IL-6Ri initiators were more likely to discontinue glucocorticoids vs csIM initiators (hazard ratio [HR], 1.28; P = .031); vs methotrexate specifically, IL-6Ri showed a similar but nonsignificant trend toward greater discontinuation (P = .11).
• IL-6Ri initiators were more likely to achieve minimal glucocorticoid use vs csIM initiators (HR, 1.28; P = .025) and vs methotrexate initiators (HR, 1.41; P = .022).
• Over the course of a year, patients on IL-6Ri had their glucocorticoid dose lowered by a greater amount than those on csIM, and this pattern was statistically significant (P for trend = .016).
• Incidence rates for most AEs of special interest — including MACE, malignancies, gastrointestinal perforation, and drug-induced liver injury — were comparable between IL-6Ri and csIM groups over 2 years. However, hospitalized infections were significantly higher in the IL-6Ri group during year 1 but became similar in both groups by year 2.

IN PRACTICE

"In this real world study, IL-6Ri therapy was more effective than csIM therapy (overall and MTX [methotrexate] specifically) in discontinuing or minimising GC [glucocorticoid] use at year 1 in csIM-naive and csIM-experienced patients with PMR, with safety being consistent with results of previous studies," wrote the authors of the study.

SOURCE

The study was led by Anisha Bharadwaj Dua, Northwestern University Feinberg School of Medicine in Chicago. It was published online on August 3 in RMD Open.

LIMITATIONS

The study included patients with a history of seronegative rheumatoid arthritis. All IL-6Ri use may have been off-label during the study period, suggesting IL-6Ri-treated patients likely had more severe disease. The data primarily represent a Medicare-age population (≥ 65 years), potentially underrepresenting younger patients with PMR.

DISCLOSURES

This work was supported by grants from Regeneron Pharmaceuticals and Sanofi. Several authors are employees of Sanofi and may hold stock and/or stock options in the company. Multiple authors reported financial relationships with Sanofi and other pharmaceutical companies, including consulting fees, research or grant support, speakers bureau participation, and honoraria.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.