Data presented at the ACR Convergence 2024 in Washington indicates that sarilumab is more effective than methotrexate in enabling patients with polymyalgia rheumatica (PMR) to discontinue steroid use. The study, analyzing real-world data, highlights sarilumab's potential as a steroid-sparing agent, reducing the risk of long-term glucocorticoid toxicities.
Study Design and Results
The study, led by Jeffrey Curtis, MD, MS, MPH, from the University of Alabama at Birmingham, utilized augmented commercial claims data from Komodo HealthMap to compare glucocorticoid discontinuation rates between sarilumab (Kevzara, Sanofi Regeneron) and methotrexate in PMR patients. The primary endpoint was the proportion of patients achieving glucocorticoid discontinuation at 6 months.
The researchers initially assessed 235 patients aged 50 years or older with at least two PMR diagnoses, treated with sarilumab as a second- or third-line therapy after FDA approval. Of these, 107 had at least 6 months of follow-up, with a mean starting prednisone dose of 8.4 mg/day. Results showed that 47.7% of these patients discontinued glucocorticoids within 6 months, and 71.4% by 10 months.
A comparator cohort of 210 patients treated with methotrexate plus glucocorticoids was also analyzed. After restricting the final analysis to patients with at least 6 months of follow-up with full coverage (68 patients total), the sarilumab and methotrexate cohorts were deemed balanced and similar in characteristics.
The final analysis revealed that 59% of patients using sarilumab discontinued glucocorticoids within 6 months, compared to 35% for methotrexate. Furthermore, patients treated with sarilumab required 122 days on glucocorticoids (interquartile range, 61-195), while those on methotrexate required 227 days (IQR, 131-287). Sarilumab was also associated with a numerically lower cumulative dose of glucocorticoids: 679 mg (IQR, 440-1,005) vs. 867 mg (IQR, 523-1,248).
Clinical Implications
"We observed that PMR patients receiving sarilumab were more likely to be able to discontinue glucocorticoids more frequently and quickly, and to use a lower steroid dose, compared to patients receiving methotrexate," said Dr. Curtis. "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."
Expert Commentary
Dr. Curtis emphasized the significance of these findings for rheumatologists, stating, "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. 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."
