The mean time to first relapse in days (± standard deviation [SD]) for patients who received tocilizumab was 130±13 days compared with patients who received placebo, 82 ± 11 days (P=0.007). At week 16, the median cumulative prednisone dose (interquartile range) was 727 mg (range: 721–842 mg) for patients treated with tocilizumab and 935 mg (861–1244 mg) for patients who received placebo (P=0.003). At week 24, the glucocorticoid-free remission rates were similar to those at week 16: 57.9% for patients treated with tocilizumab compared with 17.6% of patients on placebo.
Statistical significance was reached for many secondary outcomes, including cumulative prednisone dose at week 24. The cumulative prednisone dose was 781 mg (range: 721–972 mg) for patients treated with tocilizumab and 1,290 mg (1,106–1,809 mg) for patients who received placebo (P=0.001).
Five patients in the placebo group had a serious adverse event, and one serious adverse event occurred in a patient who received tocilizumab. The specifics of these adverse events were not reported.
This study showed that tocilizumab was superior to placebo for sustained glucocorticoid-free remission, time to relapse and cumulative glucocorticoid dose. These results show that tocilizumab may be a viable agent for these patients, improving efficacy and safety in managing PMR.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
References
- Bonelli M, Radner H, Smolen J, et al. Tocilizumab in patients with new onset polymyalgia rheumatica (PMR-SPARE)—A phase 2/3 randomized controlled trial [abstract: 0507]. Arthritis Rheumatol. 2021 Oct;73(suppl 10).
- Polymyalgia rheumatica. Mayo Clinic. 2021
- Diseases and conditions: Polymyalgia rheumatica. American College of Rheumatology. 2019 Mar.
- Aletaha D. A study to evaluate the efficacy of tocilizumab as a remission-induction and glucocorticoid-sparing regimen in subjects with new-onset polymyalgia rheumatica (PMR-SPARE). ClinicalTrials.gov. 2021 Jan 22.