ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1391

Rituximab Is Superior to Placebo in Polymyalgia Rheumatica Patients: A Double Blind Randomized Controlled Proof of Principle Trial

Diane Marsman1, Nathan den Broeder2, Frank van den Hoogen3, Alfons den Broeder1 and Aatke van der Maas4, 1Sint Maartenskliniek, Nijmegen, Gelderland, Netherlands, 2Radboud University Medical Centre, Nijmegen, Gelderland, Netherlands, 3Sint Maartenskliniek, Ubbergen, Gelderland, Netherlands, 4St Maartenskliniek, Nijmegen, Gelderland, Netherlands

Meeting: ACR Convergence 2021

Keywords: , , , ,

Session Information

Date: Monday, November 8, 2021

Title: Vasculitis – Non-ANCA-Associated & Related Disorders Poster I: Giant Cell Arteritis & Polymyalgia Rheumatica (1391–1419)

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).

Table 1. Outcomes at week 21*

Figure 1. Mean Polymyalgia Rheumatica Activity Score at each visit.

Disclosures: D. Marsman, None; N. den Broeder, None; F. van den Hoogen, None; A. den Broeder, Amgen, 12, Expert witness fee adalimumab biosimilar litigation, Galapagos, 12, Congress invitation, Sanofi, 12, Congress invitation, Abbvie, 12, Editorial work education, Novartis, 12, Editorial work education, Abbvie, 5, Pfizer, 5, Lilly, 5, Novartis, 5, Sanofi, 5; A. van der Maas, None.

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 9). https://acrabstracts.org/abstract/rituximab-is-superior-to-placebo-in-polymyalgia-rheumatica-patients-a-double-blind-randomized-controlled-proof-of-principle-trial/. Accessed .

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