Tocilizumab wins over Prednisone in Patients with Active Polymyalgia Rheumatica: JAMA
Tocilizumab usage in active polymyalgia rheumatica patients resulted in a polymyalgia rheumatica activity score computed using the C-reactive protein level (CRP PMR-AS) less than 10 in a significantly greater number of patients. Prednisone requirement has also reduced at week 24 as per a study that was published in the journal JAMA Network.
There are not so many treatments for patients with glucocorticoid-dependent polymyalgia rheumatica. IL-6 antagonists can reduce disease activity in patients with active glucocorticoid-dependent polymyalgia rheumatica. Hence researchers compared the efficacy of tocilizumab vs placebo in patients with glucocorticoid-dependent polymyalgia rheumatica from February 2017 to October 2019.
A double-blind, parallel-group, placebo-controlled randomized clinical trial was carried out on 101 patients with polymyalgia rheumatica at 17 hospitals in France. Patients with persistent disease activity having a CRP PMR-AS score >10 and prednisone dose greater than or equal to 10 mg per day were taken. They were randomly assigned to receive intravenous tocilizumab of 8 mg/kg or placebo every 4 weeks for 24 weeks, combined with predefined standardized tapering of oral prednisone. The primary efficacy endpoint was CRP PMR-AS less than 10 combined with either prednisone dose less than or equal to 5 mg per day or a decrease in prednisone dose greater than or equal to 10 mg from baseline at week 24. There were 11 secondary outcomes assessed at week 24 like the disease activity as measured by CRP PMR-AS and the proportion of patients no longer taking prednisone.
Key findings:
- Of the 101 randomized patients, there were 51 in the Tocilizumab group and 50 in the placebo group.
- The mean age was 67.2 years and 68 were women. Of the total 100 received at least 1 infusion and 100 completed the trial.
- The primary endpoint was achieved in 67.3% of patients in the tocilizumab group and 31.4% of patients in the placebo group.
- Of the 11 reported secondary endpoints at 24 weeks, 7 showed significant differences favoring tocilizumab, including mean CRP PMR-AS score and the percentage of patients no longer receiving prednisone.
- The most frequent adverse events were infections, experienced by 23 patients in the tocilizumab group and 20 in the placebo group.
Thus, the researchers concluded that active polymyalgia rheumatica patients on tocilizumab had a significantly greater percentage of patients with a CRP PMR-AS less than 10 with reduced prednisone requirements at week 24.
For further reading: 10.1001/jama.2022.15459
Devauchelle-Pensec V, Carvajal-Alegria G, Dernis E, et al. Effect of Tocilizumab on Disease Activity in Patients With Active Polymyalgia Rheumatica Receiving Glucocorticoid Therapy: A Randomized Clinical Trial. JAMA. 2022;328(11):1053-1062.
