medwireNews: Treatment with the interleukin (IL)-6 inhibitor tocilizumab over 96 weeks is associated with a reduction in glucocorticoid dose among patients with Takayasu arteritis, researchers report.
These findings are based on a follow-up analysis of the phase 3 TAKT trial, which included 36 patients who had experienced relapse within 12 weeks of study entry despite glucocorticoid treatment. The previously reported primary analysis demonstrated that time to relapse did not significantly differ among patients treated with tocilizumab 162 mg/week versus placebo over a median treatment duration of 19.00 and 12.86 weeks, respectively.
After completion of the placebo-controlled period, 28 participants went on to receive open-label tocilizumab for a total of 96 weeks, and glucocorticoid dose was tapered at the investigators’ discretion.
The current follow-up analysis, published in Rheumatology, demonstrated that the median glucocorticoid dose decreased from 0.223 mg/kg per day at the time of relapse before study entry to 0.131 mg/kg per day at week 48, and decreased further to 0.105 mg/kg per day at week 96.
In all, 18.8%, 25.8%, and 46.4% of participants achieved a glucocorticoid dose reduction to below 0.1 mg/kg per day at weeks 24, 48, and 96, respectively, and four patients had discontinued glucocorticoids completely by week 96, as did another three patients after this checkpoint.
These findings indicate “a clear steroid-sparing effect […] with tocilizumab treatment from week 24 through week 96 compared with the [glucocorticoid] dose at relapse before study entry,” say Yoshikazu Nakaoka (Osaka University Graduate School of Medicine, Japan) and study co-authors.
The researchers also conducted imaging evaluations, finding that 17.9% of patients experienced an improvement in their condition over 96 weeks, while 67.9% remained stable and 14.3% experienced worsening disease. In all, 18 relapses occurred in 14 patients during the open-label follow-up period, giving an event rate of 29.4 relapses per 100 patient–years.
Nakaoka and team report that the adverse events (AEs) observed in the long-term study were “consistent with the known safety profile” of the IL-6 inhibitor in patients with rheumatoid arthritis, “with no new signals observed.”
The most frequently reported AEs were infections and infestations, affecting 88.9% of participants. A quarter of participants experienced serious AEs, most commonly gastroenteritis and pneumonia, reported in 5.6% of patients each.
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