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Clinical Trial
. 2022 Jun;81(6):838-844.
doi: 10.1136/annrheumdis-2021-221126. Epub 2022 Feb 24.

Tocilizumab in patients with new onset polymyalgia rheumatica (PMR-SPARE): a phase 2/3 randomised controlled trial

Michael Bonelli  1 , Helga Radner  1 , Andreas Kerschbaumer  1 , Daniel Mrak  1 , Martina Durechova  1 , Jutta Stieger  2 , Rusmir Husic  3 , Peter Mandl  1 , Josef S Smolen  1 , Christian Dejaco  3   4 , Daniel Aletaha  5
Affiliations
Clinical Trial

Tocilizumab in patients with new onset polymyalgia rheumatica (PMR-SPARE): a phase 2/3 randomised controlled trial

Michael Bonelli et al. Ann Rheum Dis. 2022 Jun.

Abstract

Background: Polymyalgia rheumatica is the second most common inflammatory rheumatic disease of people >50 years. Glucocorticoid therapy is highly effective, but many patients require treatment for several years. Effective glucocorticoid sparing agents are still needed.

Methods: In this double-blind, multi-centre phase 2/3 clinical trial, we randomly assigned 36 patients with new onset polymyalgia rheumatica from three centres to receive subcutaneous tocilizumab (162 mg per week) or placebo for 16 weeks (1:1 ratio). All patients received oral prednisone, tapered from 20 mg to 0 mg over 11 weeks.The primary endpoint was the proportion of patients in glucocorticoid-free remission at week 16; key secondary endpoints, including time to first relapse and cumulative glucocorticoid dose at weeks 16 and 24, were evaluated.

Results: From 20 November 2017 to 28 October 2019 39 patients were screened for eligibility; 19 patients received tocilizumab and 17 placebo. Glucocorticoid-free remission at week 16 was achieved in 12 out of 19 patients on tocilizumab (63.2%) and 2 out of 17 patients receiving placebo (11.8%, p=0.002), corresponding to an OR of 12.9 (95 % CI: 2.2 to 73.6) in favour of tocilizumab. Mean (±SD) time to first relapse was 130±13 and 82±11 days (p=0.007), respectively, and the median (IQR) cumulative glucocorticoid dose was 727 (721-842) mg and 935 (861-1244) mg (p=0.003), respectively. Serious adverse events were observed in five placebo patients and one tocilizumab patient.

Conclusion: In patients with new onset polymyalgia rheumatica undergoing rapid glucocorticoid tapering, tocilizumab was superior to placebo regarding sustained glucocorticoid-free remission, time to relapse and cumulative glucocorticoid dose.

Trial registration number: NCT03263715.

Keywords: antirheumatic agents; glucocorticoids; polymyalgia rheumatica.

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Conflict of interest statement

Competing interests: AK reports about contracts and personal fees from AbbVie, Bristol Myers Squibb, Celgene, Eli Lilly, Gilead, Merck Sharp and Dohme. RH reports about personal fees from MSD, AbbVie, Pfizer, Lilly, Bristol Myers Squibb, Celgene and Novartis. MB reports about personal fees from Eli Lilly. PM reports speaker fees from AbbVie, Janssen and Novartis and research grants from AbbVie, BMS, Novartis, Janssen, MSD and UCB. MB reports about personal fees from Eli Lilly. DA reports about financial support from Roche to perform this study for the Department of Rheumatology. DA received grants and consulting fees from AbbVie, Amgen, Lilly, Merck, Novartis, Pfizer, Roche and Sandoz. CD received grants, consulting and personal fees from Celgene, Roche, Sanofi, AbbVie, Janssen, Roche, Novartis and Pfizer. JS reports about grants, consulting and personal fees from AbbVie, AstraZeneca, Lilly, Novartis, Amgen, Astro, Bristol Myers Squibb, Celgene, Celltrion, Chugai, Gilead, ILTOO, Janssen, Merck Sharp & Dohme, Novartis-Sandoz, Pfizer, Roche, Samsung and UCB. All other authors declare no competing interests. DA and JS declare that they currently have active roles as editorial board members of the journal.

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