Discontinuation of concomitant methotrexate in Japanese patients with rheumatoid arthritis treated with tocilizumab: An interventional study

Modern Rheumatology
Shuji AsaiToshihisa Kojima

Abstract

Objectives: To evaluate the efficacy and safety of methotrexate (MTX) discontinuation in Japanese rheumatoid arthritis (RA) patients with sustained low disease activity undergoing combination therapy with tocilizumab (TCZ) plus MTX.Methods: This multicenter, open-label, uncontrolled, prospective study included RA patients maintaining low disease activity (Clinical Disease Activity Index (CDAI) ≤10) for ≥12 weeks with TCZ plus MTX. Methotrexate was discontinued following 12 weeks of biweekly administration while continuing TCZ therapy. The primary endpoint was the proportion of patients maintaining low disease activity with no flare at week 36.Results: A total of 49 patients completed 36 weeks of therapy. The proportion of patients maintaining low disease activity at week 36 was 75.5%. The lower limit of the 95% confidence interval exceeded the assumed threshold response rate of 60%, demonstrating the clinical feasibility of MTX discontinuation. The prevalence of gastroesophageal reflux disease, defined as a Frequency Scale for Symptoms of Gastroesophageal reflux disease score ≥8, significantly decreased from week 0 to 12 (27.1-18.4%; p= .025).Conclusion: Discontinuation of concomitant MTX is clinically feasible for maintaining ...Continue Reading

References

Mar 6, 2004·Lancet·Lars KlareskogUNKNOWN TEMPO (Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes) study investigators
Nov 27, 2004·Journal of Gastroenterology·Motoyasu KusanoMasatomo Mori
Aug 11, 2006·Arthritis Research & Therapy·Tadamitsu Kishimoto
Feb 19, 2011·Annals of the Rheumatic Diseases·Moetaza M SolimanUNKNOWN British Society for Rheumatology Biologics Register
Aug 7, 2013·Annals of the Rheumatic Diseases·Paul EmeryTom W J Huizinga
Nov 8, 2015·Arthritis & Rheumatology·Jasvinder A SinghTimothy McAlindon
Sep 1, 2018·International Journal of Rheumatic Diseases·Shuji AsaiToshihisa Kojima

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