Clinical Implications
“The current practice is to treat patients with corticosteroids and try to taper the dose over nine to 12 months, treating flares when they occur by increasing the dose of corticosteroids. Often, patients are ultimately treated with two years of corticosteroids, and some observational studies [have reported] as long as six years of corticosteroid exposure. Although rheumatologists are vigilant regarding corticosteroid-related side effects and are good at monitoring and addressing those, this prolonged exposure nevertheless comes at a price in terms of side effects and impaired quality of life,” explains Dr. Spiera. “We now have an effective therapy specifically approved for treating patients who flare in the context of a corticosteroid taper. Previously these patients were offered methotrexate, with limited efficacy.
“I suspect that new-onset PMR patients will now be treated as before with corticosteroids, but with a planned taper over a shorter period (perhaps six months or less), recognizing that should a flare occur, there is an effective intervention that would be appropriate in most patients.
“It should be noted that this study did not address whether sarilumab should be used in new-onset PMR and indeed the FDA indication is for patients for whom corticosteroids were inadequate or who could not tolerate a corticosteroid taper,” continues Dr. Spiera. “What role, if any, sarilumab has in the treatment of new-onset PMR remains to be determined.”
Katie Robinson is a medical writer based in New York.
Disclosure
Sanofi and Regeneron Pharmaceuticals sponsored the trial and took part in its design, along with the collection and analysis of the data.
References
- Spiera RF, Unizony S, Warrington KJ, et al. Sarilumab for relapse of polymyalgia rheumatica during glucocorticoid taper. N Engl J Med. 2023 Oct 5;389(14):1263–1272.
- Highlights of prescribing information: Kevzara (sarilumab) injection for subcutaneous use. U.S. Food & Drug Administration. 2023 Feb 28.
- News release: Kevzara (sarilumab) approved by FDA as first and only biologic indicated for patients with polymyalgia rheumatica. Regeneron. 2023 Feb 28. https://investor.regeneron.com/news-releases/news-release-details/kevzarar-sarilumab-approved-fda-first-and-only-biologic.
- Jiemy WF, Zhang A, Boots AMH, et al. Expression of interleukin-6 in synovial tissue of patients with polymyalgia rheumatica. Ann Rheum Dis. Mar 2023;82(3):440–442.
- Devauchelle-Pensec V, Carvajal-Alegria G, Dernis E, et al. Effect of tocilizumab on disease activity in patients with active polymyalgia rheumatica receiving glucocorticoid therapy: A randomized clinical trial. JAMA. 2022 Sep 20;328(11):1053–1062.
