Efficacy of add-on tacrolimus on methotrexate to maintain clinical remission after rediscontinuation of a tumor necrosis factor inhibitor in rheumatoid arthritis patients who relapsed shortly after discontinuation of the same tumor necrosis factor inhibitor due to clinical remission

Abstract

Objectives: To describe the efficacy of adding tacrolimus to maintain remission in patients with rheumatoid arthritis (RA) on methotrexate after discontinuation of tumor necrosis factor inhibitor (TNFi) therapy.

Methods: Consecutive patients with RA, who resumed a TNFi to treat flares after initial TNFi-free remission and discontinued a TNFi again after achieving remission and adding tacrolimus were enrolled. The lengths of remission after discontinuation of TNFi without or with tacrolimus were analyzed.

Results: Thirteen TNFi-free periods in six patients, in which seven were without and six were with tacrolimus were analyzed. All were seropositive females with a median age of 46 years and symptom duration of 1.2 years at the onset of TNFi therapy. Two were treated with infliximab and four were with etanercept. The median dose of tacrolimus was 2 mg/day with trough level of 4.5 ng/ml. The length of time to flare after discontinuation of TNFi therapy with tacrolimus was significantly longer than those without tacrolimus (median 107 weeks [range 4–207] versus 13 weeks [2–36]). After adding tacrolimus, only one patient resumed TNFi therapy and three had no flare until final observation.

Conclusions: Add-on tacrolimus was effective in maintaining TNFi-free remission in patients with RA who ever relapsed after TNFi-free remission.

Keywords:

• Remission
• rheumatoid arthritis
• tacrolimus
• tumor necrosis factor inhibitor

Conflict of interest

T. Naniwa has received research grants and lecture fees (<$5000) from Mitsubishi Tanabe Pharma Corporation and Astellas Pharma Corporation and lecture fees (<$5000) from Pfizer Co. Ltd. The other authors declare no conflicts of interest.