A variety of patient-reported quality of life and function measures, including the Short Form-36 Mental Component and Physical Component Scores, the Functional Assessment of Chronic Illness, the EuroQol-5 Dimension (EQ-5D) and the Health Assessment Questionnaire-Disability Index (HAQ-DI), favored sarilumab in a statistically significant manner, as did some of the physician assessments like the PMR-Activity Scale (PMR-AS).
Adverse events were as expected with sarilumab, and the frequency of serious adverse events was similar in both arms. In the sarilumab arm, 15% of patients had neutropenia, and another 15% had arthralgias. The comparator arm had more effects related to glucocorticoids, such as insomnia (16%). Dr. Spiera also pointed out that no patients in the sarilumab group had diverticulitis that required medical intervention from gastrointestinal perforation; this was a potential concern given the older patient age group and this rare potential adverse effect of IL-6 inhibitors.
When asked when he might use sarilumab in clinical practice, Dr. Spiera noted that for a patient not flaring on very low glucocorticoid doses, it might not be needed. “But that’s not the group of patients that’s our challenge,” he added. “I think I’d be interested in giving it to any patient who has previously flared or any patient at very high risk of glucocorticoid side effects.”
Ruth Jessen Hickman, MD, a graduate of the Indiana University School of Medicine, is a medical and science writer in Bloomington, Ind.
References
- Spiera R, Unizony S, Warrington K, et al. Sarilumab in patients with relapsing polymyalgia rheumatica: A phase 3, multicenter, randomized, double blind, placebo controlled trial (SAPHYR) [abstract]. Arthritis Rheumatol. 2022 Nov;74(suppl 9).
- Spiera R, Unizony S, Warrington K, et al. Resolution of PMR signs and symptoms in patients treated with sarilumab: A phase 3, multicenter, randomized, blind, placebo controlled trial (SAPHYR) in relapsing PMR. Arthritis Rheumatol. 2022 Nov;74 (suppl 9).
- Lally L, Forbess L, Hatzis C, et al. Brief report: A prospective open-label phase IIa trial of tocilizumab in the treatment of polymyalgia rheumatica. Arthritis Rheumatol. 2016 Oct;68(10):2550–2554.
- Bonelli M, Radner H, Kerschbaumer A, et al. Tocilizumab in patients with new onset polymyalgia rheumatica (PMR-SPARE): A phase 2/3 randomised controlled trial. Ann Rheum Dis. 2022 Jun;81(6):838–844.
- 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.
