medwireNews: Tocilizumab improves glucocorticoid-free remission rates, time to first relapse, and cumulative glucocorticoid dose versus placebo in people with polymyalgia rheumatica (PMR), show phase 2/3 study data presented at the ACR Convergence 2021 virtual meeting.
The multicenter PMR-SPARE trial included 36 patients with new-onset PMR who were randomly assigned to receive subcutaneous tocilizumab 162 mg/week (n=19) or matching placebo (n=17) for 16 weeks. Participants were either glucocorticoid-naïve at baseline or had received no more than 2 weeks of glucocorticoid therapy. They were all given oral prednisone at a starting dose of 20 mg, which was rapidly tapered to nil over 11 weeks.
Michael Bonelli, from the Medical University of Vienna in Austria, reported that the odds of achieving the primary endpoint of glucocorticoid-free clinical remission at week 16 was a significant 12.9 times higher with tocilizumab than with placebo. Specifically, the glucocorticoid-free remission rates were 63.2% and 11.8% in the tocilizumab and placebo groups, respectively.
Furthermore, mean time to first clinical relapse was significantly longer with tocilizumab than with placebo (130 vs 82 days) and the median cumulative glucocorticoid dose was significantly lower (727 vs 935 mg).
Significant differences in favor of tocilizumab were also achieved for a number of other secondary outcomes including glucocorticoid-free remission at weeks 12 and 24 (both 57.9 vs 17.6%).
Adverse event (AE) rates were similar between the two groups overall, while serious AEs were reported by 5% and 29% of participants given tocilizumab and placebo, respectively.
Infections were the most common AEs, occurring in 63% of people who received tocilizumab and 35% of those who received placebo, but Bonelli noted that there were no serious infections in either group.
The presenter concluded that “in new onset polymyalgia rheumatica patients undergoing rapid glucocorticoid tapering, tocilizumab was superior to placebo in regards to glucocorticoid-free remission, time to first relapse, as well as cumulative glucocorticoid dose.”
He therefore suggests that “tocilizumab might be considered as a glucocorticoid sparing agent in patients with new onset polymyalgia rheumatica.”
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