Korean J Intern Med.
2016 Jul;31(4):779-787. 10.3904/kjim.2015.066.
Efficacy and safety of low-dose tacrolimus for active rheumatoid arthritis with an inadequate response to methotrexate
- Affiliations
-
- 1Division of Rheumatology, Department of Internal Medicine, Research Institute of Clinical Medicine of Chonbuk National University-Biomedical Research Institute of Chonbuk National University Hospital, Jeonju, Korea. ywhim@jbnu.ac.kr
- 2Division of Rheumatology, Department of Internal Medicine, Gyeongsang National University Hospital, Jinju, Korea.
- 3Division of Rheumatology, Department of Internal Medicine, Wonkwang University Hospital, Iksan, Korea.
- 4Division of Rheumatology, Department of Internal Medicine, Pusan National University Hospital, Busan, Korea.
- 5Division of Rheumatology, Department of Internal Medicine, Chonnam National University Hospital, Gwangju, Korea.
- KMID: 2327756
- DOI: http://doi.org/10.3904/kjim.2015.066
Abstract
- BACKGROUND/AIMS
To determine the efficacy and safety of low-dose tacrolimus in Korean rheumatoid arthritis (RA) subjects with an inadequate response to methotrexate (MTX).
METHODS
This was a multicenter, open-label study conducted at five Korean sites. Fifty-six patients with active RA, despite treatment for ≥ 1 month with a stable, maximally tolerated dosage of oral MTX (median dosage, 15 mg/wk), were enrolled and received 1.5 mg/day of tacrolimus as a single oral dose once per day for 16 weeks while continuing to receive MTX. All other disease-modifying anti-rheumatic drugs were discontinued, whereas stable dosages of nonsteroidal anti-inflammatory drugs and oral corticosteroids (≤ 10 mg/day of prednisone or an equivalent corticosteroid) were allowed. The primary clinical response criterion was the American College of Rheumatology's definition of 20% improvement (ACR20) at the end of treatment.
RESULTS
The ACR20 response rate was 42.9% (24 of 56 patients) in patients who had received tacrolimus at least once. The overall ACR50 and ACR70 responses at the end of treatment for all patients were 30.4% and 10.7%, respectively. Throughout the treatment period, 37 patients experienced 71 adverse events (AEs) in total, and four patients left the study because of AEs. In addition, 15 patients in total experienced treatment-related AEs. Throughout the treatment period, two patients were reported to experience two serious AEs, and one patient left the study because of a serious AE.
CONCLUSIONS
In patients whose active RA persists despite treatment with MTX, low-dose tacrolimus in combination with MTX appears to be safe and well tolerated, and provides clinical benefit.
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