Sarilumab allows steroid taper ‘more frequently’ vs methotrexate in polymyalgia rheumatica
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WASHINGTON — Patients with polymyalgia rheumatica were more likely to discontinue steroids after treatment with sarilumab than methotrexate, according to data presented at ACR Convergence 2024.
“We have clinical trial data in PMR showing the efficacy of sarilumab but limited real world evidence demonstrating the effectiveness of sarilumab against active comparator treatments like methotrexate,” Jeffrey Curtis, MD, MS, MPH, of the University of Alabama at Birmingham division of clinical immunology and rheumatology, told Healio. “That evidence gap motivated this analysis.”
To compare glucocorticoid discontinuation rates between sarilumab (Kevzara, Sanofi Regeneron) and methotrexate in patients with PMR, Curtis and colleagues analyzed augmented commercial claims data from Komodo HealthMap. The primary endpoint was the proportion of patients treated with sarilumab vs. methotrexate to achieve glucocorticoid discontinuation at 6 months.
The researchers first assessed a group of 235 patients aged 50 years or older with at least two PMR diagnoses, who had been treated with sarilumab as a second- or third-line therapy following FDA approval. Of this group, 107 had at least 6 months of follow-up and had a mean starting prednisone dose of 8.4 mg/day (standard deviation, 5.6). Results showed that 47.7% of these patients were able to discontinue glucocorticoids within 6 months. By 10 months, 71.4% were able to discontinue glucocorticoids.
Meanwhile, the researchers gathered a comparator cohort of 210 patients who had been treated with methotrexate plus glucocorticoids. Comparators were to be matched 1:1 to sarilumab users based on age, sex, race/ethnicity, insurance type, baseline GC use and dose, time since first PMR diagnosis, and comorbidities.
After restricting their final analysis to patients with at least 6 months of follow-up with full coverage — 68 patients total — the researchers deemed the sarilumab and methotrexate cohorts to be balanced and similar in characteristics.
In that final analysis, 59% of patients using sarilumab were able to discontinue glucocorticoids within 6 months, compared with 35% for methotrexate, according to the researchers. Moreover, patients treated with sarilumab required 122 days on treatment with glucocorticoids (interquartile range, 61-195), while those on methotrexate required 227 days (IQR, 131-287) on steroids. Sarilumab was also associated with a numerically lower cumulative dose of glucocorticoids than methotrexate — 679 mg (IQR, 440-1,005) vs. 867 mg (IQR, 523-1,248).
“We observed that PMR patients receiving sarilumab were more likely to be able to discontinue glucocorticoids — a mainstay of treatment for PMR — more frequently and quickly, and to use a lower steroid dose, compared to patients receiving methotrexate,” Curtis said. “Given the toxicities of long-term glucocorticoids, especially in the older patients that are the typical demographic affected by PMR, having an effective steroid sparing agent like sarilumab enables us to minimize steroid-related toxicities such as infections, osteoporosis and fracture.”
According to Curtis, this study should allow rheumatologists to offer evidence-based options to their patients with PMR.
“The main take home is that, for patients with PMR, we now have an FDA-approved, evidence-based therapy that has shown efficacy not only in a clinical trial, but effectiveness in real-world settings, such as this study,” he said. “If providers treating PMR are having difficulty tapering people off steroids without concomitant immunomodulatory therapy, sarilumab appears more effective than our older treatment options like methotrexate to enable that to happen.”
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Curtis J. Abstract #1700. Presented at: ACR Convergence 2024; Nov. 14-19, 2024; Washington, D.C.
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