Although a continuous 5-mg dose of glucocorticoids yielded stronger DAS28-ESR outcomes among patients with rheumatoid arthritis receiving tocilizumab, approximately two-thirds of patients were able to taper off glucocorticoids while maintaining low disease activity, according to data presented at the EULAR Annual Congress.
“On the basis of our results, we believe that all patients achieving low disease activity or remission with tocilizumab should be offered glucocorticoid tapering,” Gerd Rüdiger Burmester, MD, of the Free University and Humboldt University of Berlin, said in a press release.
The study included 259 patients, with 131 participants in the taper group and 125 in the continuous 5-mg dose group. Eligible participants were also receiving tocilizumab (Actemra, Genentech) with or without DMARDS.
Study protocols called for glucocorticoid or prednisone-equivalent dose of 5 mg to 15 mg per day for 24 weeks or less. Patients were required to be at low disease activity at enrollment.
The tapering schedule was from 4 mg per day with 1-mg reduction every 4 weeks to 0 mg per day at weeks 16 to 24. The researchers reported on 24-week results for 114 patients in the taper group and 112 in the continuous group. Mean change in DAS28-ESR at week 24 served as the primary endpoint. DAS28-ESR of 3.2 or less at week 24, plus no flares during the study period and a lack of adrenal insufficiency necessitating replacement therapy were the main secondary endpoints.
P < .001).
This trend of improved DAS28-ESR held in a number of subgroups, such as patients treated with tocilizumab monotherapy (difference = 0.5; 95% CI, 0.1-1); those treated with tocilizumab plus DMARDS (difference = 0.7; 95% CI, 0.4-1); patients with baseline DAS28 less than 2 (difference = 0.6; 95% CI, 0.2-1); and those with a baseline DAS28 score of 2 or higher (difference = 0.6; 95% CI, 0.2-1).
Treatment success occurred in 65% of participants in the taper arm and 77% of those in the continuous therapy arm (RR = 0.83; P = .021). Flares occurred in 26% of patients in the taper arm and 11% of those in the continuous arm. There was one discontinuation in the continuous therapy arm.
Safety data showed a 3% rate of serious adverse events among tapered patients, compared with 5% for continuously treated patients. Symptomatic adrenal insufficiency was not reported in either arm. Patients who experienced a flare underwent rescue therapy of 5 mg of glucocorticoids for 2 weeks before continuing blinded treatment.
“The 0.6 DAS28-ESR unit between-arm difference should be interpreted in the context of approximately two-thirds of tapered patients experiencing treatment success and no tapered patients discontinuing due to lack of flare control,” the researchers concluded. “The results suggest that all patients achieving [low disease activity] or remission with [tocilizumab] and receiving long-term low-dose [glucocorticoids] should be considered for [glucocorticoid] tapering, ideally targeting discontinuation” – by Rob Volansky
Burmester GR, et al. OP0030. Presented at: EULAR Annual Congress; June 12-15, 2019; Madrid.
Disclosure: Burmester reports consulting for and being on the speakers’ bureau of Roche and Sanofi-Genzyme.