medwireNews: Rheumatoid arthritis (RA) patients who achieve low disease activity with tocilizumab and low-dose glucocorticoids should be considered for glucocorticoid tapering, suggests research presented at the EULAR 2019 congress in Madrid, Spain.
“Almost two-thirds of patients who tapered discontinued glucocorticoid without flare and maintained low disease activity,” reported Gerd Burmester (Charité-Universitätsmedizin Berlin, Germany).
The SEMIRA (Steroid EliMination In RA) randomized controlled trial involved 259 RA patients who had received tocilizumab, with or without conventional DMARDs, and glucocorticoids (prednisone-equivalent dose of 5─15 mg/day) for at least 24 weeks and achieved low disease activity, defined as a DAS28-ESR score of 3.2 or below.
These patients, who were receiving stable concomitant glucocorticoid therapy at a prednisone dose of 5 mg, were randomly assigned to have their glucocorticoid treatment tapered, from 4 mg/day with a 1 mg reduction every 4 weeks to 0 mg/day at weeks 16─24, or continue at the 5 mg dose. This was done while continuing subcutaneous tocilizumab at 162 mg/week and stable conventional DMARD doses.
The 131 patients who underwent tapering had a least squares mean increase in DAS28-ESR score of 0.538 from randomization to week 24, while the score decreased by 0.075 in the 128 patients who continued glucocorticoid therapy.
This gave a small, albeit significant, between-group difference for change of 0.613, said Burmester.
Nevertheless, he pointed out that despite this difference, the patients who tapered prednisone were still, on average, in low disease activity, and “many of them fulfilled at least DAS28-ESR remission criteria.”
Indeed, on the basis of treatment success, most (65%) of the patients who tapered glucocorticoid treatment were in remission or had low disease activity at week 24, had not experienced flares, and had no symptomatic adrenal insufficiency. This compared with 77% of patients who continued treatment.
Flares, defined as a DAS28-ESR score above 3.2 or a 0.6-point increase from randomization, occurred in both groups of patients, affecting 26% of those who tapered treatment and 11% of those who continued, but Burmester pointed out that most of these occurred toward the end of the 24 weeks and none were severe enough to necessitate discontinuation of the tapering strategy.
When the researchers looked at the change in DAS28-ESR over the time course of tapering, they found that there was an increase after the last 1 mg had been withdrawn.
“We don’t know if it is just this 1 mg or if this is a characteristic over time that would have occurred at the very end and this needs further study,” Burmester commented.
He suggested that “tocilizumab may have the potential to reduce the cumulative glucocorticoid burden for many patients,” adding that “safety was similar whether glucocorticoids were continued or tapered and […] there was not a single case of adrenal insufficiency” in the group of patients in the tapering scheme.
“This tapering scheme has the potential […] to inform clinical practice on how to act and aid in patient conversations,” he concluded.
By Lucy Piper
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