Key clinical point: Raising infliximab dosage based on tumor necrosis factor–alpha levels at baseline did not lead to higher rates of sustained remission in RA patients.
Major finding: After 106 weeks, 23.5% of the programmed group and 21.6% of the standard group had maintained discontinuation of infliximab (–2.2% difference; 95% confidence interval, –6.6% to 11.0%; P = .631).
Study details: A multicenter, randomized trial of 337 patients with infliximab-naive RA and inadequate response to methotrexate.
Disclosures: The study was supported by a research grant from the Ministry of Health, Labor and Welfare of Japan. The authors reported numerous potential conflicts of interest, including receiving grants, consulting fees, speaking fees, and/or honoraria from various medical and pharmaceutical companies.
Tanaka Y et al. Ann Rheum Dis. 2019 Oct 19. doi: 10.1136/annrheumdis-2019-216169.
Biomarkers are of great interest in RA for predicting response to treatment and adjusting treatment strategies. This study looked at infliximab dose adjustment in an infliximab-naïve population of 337 RA patients who had an inadequate response to methotrexate. They were randomized to standard infliximab dosing of 3 mg/kg every 8 weeks versus an escalating dose up to 10 mg/kg every 8 weeks based on serum TNF-alpha levels. Patients in Simple Disease Activity Index (SDAI) remission at 54 weeks were allowed to discontinue infliximab. There were no differences in patients reaching sustained discontinuation (1 year of infliximab withdrawal) between the high- and low-dose groups. This study is limited by the fact that it was not blinded and the control arm was not treated with escalating infliximab based on disease activity, which is generally considered standard of care; both arms may not have been treated intensively enough.