Risk of serious infection, malignancy, or death in Japanese rheumatoid arthritis patients treated with a combination of abatacept and tacrolimus: a retrospective cohort study
- 29 October 2020
- journal article
- research article
- Published by Springer Science and Business Media LLC in Clinical Rheumatology
- Vol. 40 (5), 1811-1817
- https://doi.org/10.1007/s10067-020-05476-8
Abstract
To evaluate whether combinatorial use of abatacept (ABT) and tacrolimus (Tac) increases the risk of adverse events compared to their individual use in Japanese rheumatoid arthritis (RA) patients. We conducted a retrospective cohort study of RA patients using the Japanese multicenter database and analyzed the data of RA patients registered from April 2010 to March 2019 by comparing three treatment groups who received Tac, ABT, or a combination of both. We included patients who had initiated treatment with ABT or Tac and excluded patients who used tumor necrosis factor inhibitors, IL-6 inhibitors, and Jak inhibitors in the first year of our study. The primary outcome was the occurrence of adverse events such as infections that required hospitalization, newly diagnosed malignancy, or death from any cause after initiation of ABT or Tac. Of the 27,032 RA patients in the registry, 2009 patients were included. The Tac, ABT, and combination groups consisted of 1328, 563, and 118 patients, respectively. Primary outcome occurred in 149 (13.4%), 62 (13.5%), and 14 (13.9%) patients of the Tac, ABT, and combination groups, respectively. The incidence of adverse events between groups was not significantly different (p = 0.638). A Cox regression analysis which was adjusted for potential confounders such as age, disease activity, and concomitant use of prednisolone revealed no significant differences between groups. The combinatorial use of ABT and Tac, or ABT alone does not increase the risk of adverse events when compared to the use of Tac alone in RA patients in Japan. Key Points • This study included Japanese rheumatoid arthritis data and found that there was no significant risk when patients were treated with a combination of Tac and ABT or each drug alone.This publication has 11 references indexed in Scilit:
- Clinical effectiveness and safety of additional administration of tacrolimus in rheumatoid arthritis patients with an inadequate response to abatacept: A retrospective cohort studyInternational Journal of Rheumatic Diseases, 2019
- 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid ArthritisArthritis Care & Research, 2015
- Concomitant methotrexate and tacrolimus augment the clinical response to abatacept in patients with rheumatoid arthritis with a prior history of biological DMARD useRheumatology International, 2015
- Treating rheumatoid arthritis to target: 2014 update of the recommendations of an international task forceAnnals Of The Rheumatic Diseases, 2015
- Comparison of efficacy and safety of tacrolimus and methotrexate in combination with abatacept in patients with rheumatoid arthritis; a retrospective observational study in the TBC RegistryModern Rheumatology, 2015
- Risk of hospitalised infection in rheumatoid arthritis patients receiving biologics following a previous infection while on treatment with anti-TNF therapyAnnals Of The Rheumatic Diseases, 2014
- Co-stimulatory modulation in rheumatoid arthritis: The role of (CTLA4-Ig) abataceptAutoimmunity Reviews, 2008
- Cyclosporine and tacrolimus for the treatment of rheumatoid arthritisCurrent Opinion in Rheumatology, 2007
- Disease Activity Score 28 (DAS28) using C-reactive protein underestimates disease activity and overestimates EULAR response criteria compared with DAS28 using erythrocyte sedimentation rate in a large observational cohort of rheumatoid arthritis patients in JapanAnnals Of The Rheumatic Diseases, 2007
- Efficacy and safety of tacrolimus in patients with rheumatoid arthritis: A double‐blind trialArthritis & Rheumatism, 2003