medwireNews: Doubling the dose interval of subcutaneous tocilizumab after 24 weeks reduces the likelihood of maintaining remission without improving tolerability in patients with moderate-to severe rheumatoid arthritis (RA), study findings indicate.
In spite of this, nearly three-quarters of patients who extended their dose interval remained in remission 24 weeks later.
Raimon Sanmarti (Hospital Clinic of Barcelona, Spain) and co-investigators therefore suggest that the strategy “warrants further investigation in randomized controlled trials with longer follow-up periods and a comparison between a continuation strategy and a strategy that includes dose reduction and restarting of full doses in cases of relapse.”
The study included 179 patients who had achieved clinical remission (DAS28-ESR<2.6) at weeks 20 and 24 of treatment with weekly subcutaneous tocilizumab 162 mg as part of the TOZURA study. The majority (82%) also received a conventional synthetic DMARD, typically methotrexate.
At week 24, the patients were randomly assigned to continue with the same weekly regimen for a further 24 weeks (n=89) or switch to the same treatment dose but given every other week (n=90).
As reported in Arthritis & Rheumatology, 89.9% of patients who continued with weekly treatments retained their remission status at week 48, which was significantly higher than the 73.3% who remained in remission while receiving treatment every other week.
Time to relapse was longer with the weekly schedule, but not significantly so. There were also no significant differences between the two groups in other efficacy measures such as the CDAI, SDAI, and HAQ-DI but results for each of these favored weekly dosing.
Treatment-emergent adverse events (TEAEs) were reported by 56% of patients who received weekly treatment and by 70% of those who received treatment every other week, with the proportion requiring dose modification at 17% and 26%, respectively.
The most common TEAEs were infections, occurring in 28% of the weekly group and 30% of the bi-weekly group, while 47% and 37%, respectively, experienced neutropenia and 18% and 17% developed thrombocytopenia.
There was one AE of special interest recorded among the patients who received weekly treatment (a significant increase in alanine aminotransferase levels) and two (one herpes zoster and one varicella infection) among the patients who received bi-weekly treatments.
Sanmarti and team point out that the US FDA recommends that tocilizumab be given at an initial dose of 162 mg every 2 weeks, but say “there are several issues to resolve before this strategy may be considered a truly feasible option for those patients who have started with the full weekly dose of [subcutaneous tocilizumab].
By Laura Cowen
medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group
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