Date: Monday, November 8, 2021
Session Type: Poster Session C
Session Time: 8:30AM-10:30AM
Background/Purpose: Corticosteroids remain the cornerstone of polymyalgia rheumatica treatment, but their use has several disadvantages such as long treatment duration and glucocorticoid-related adverse events.1,2 Data on evidence based effective glucocorticoid-sparing agents are negative or absent.2
Because B-cells may be involved in the pathogenesis of polymyalgia rheumatica, we evaluated the efficacy of rituximab in polymyalgia rheumatica.
Methods: In a 21-week double-blind placebo controlled exploratory study, 47 polymyalgia rheumatica patients (recently diagnosed n=38 / relapsing on prednisolone ≥7.5mg/day n=9) fulfilling the 2012 EULAR/ACR criteria, were randomized 1:1 to intravenous rituximab 1 x 1000 mg (n=23) or placebo (n=24), with a 17-week long glucocorticoid co-treatment. Primary outcome was glucocorticoid-free remission at week 21. Secondary outcomes were glucocorticoid ≤5mg/day and adverse events. Several post-hoc analyses were done for robustness of results.
Results: Glucocorticoid-free remission was achieved in 48% (rituximab) versus 21% (placebo), one-sided 95%-CI 4% to 100%; p=0.049, and glucocorticoid ≤5mg/day in 100% versus 54% (one sided 95%-CI 20% to 100%; p=0.005). Post-hoc analysis showed efficacy mainly in recently diagnosed patients: glucocorticoid-free remission in 58% versus 21% (one-sided 95%-CI 10% to 100%; p=0.02); glucocorticoid ≤5mg/day in 100% versus 47% (one-sided 95%-CI 29 to 100%; p< 0.001). No significant differences were observed regarding other outcomes (table 1), except for less morning stiffness after rituximab.
Conclusion: Rituximab is superior to placebo in combination with 17-week glucocorticoid-treatment to achieve glucocorticoid free remission in polymyalgia rheumatica. The largest effect was seen in recently diagnosed polymyalgia rheumatica patients (funding: Sint Maartenskliniek; Dutch trial number NL7414).
To cite this abstract in AMA style:Marsman D, den Broeder N, van den Hoogen F, den Broeder A, van der Maas A. Rituximab Is Superior to Placebo in Polymyalgia Rheumatica Patients: A Double Blind Randomized Controlled Proof of Principle Trial [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 10). https://acrabstracts.org/abstract/rituximab-is-superior-to-placebo-in-polymyalgia-rheumatica-patients-a-double-blind-randomized-controlled-proof-of-principle-trial/. Accessed June 25, 2022.
« Back to ACR Convergence 2021
ACR Meeting Abstracts - https://acrabstracts.org/abstract/rituximab-is-superior-to-placebo-in-polymyalgia-rheumatica-patients-a-double-blind-randomized-controlled-proof-of-principle-trial/