Efficacy and safety of tacrolimus in 101 consecutive patients with rheumatoid arthritis

Abstract

The objective of this study was to assess the usefulness of tacrolimus (TAC) for rheumatoid arthritis (RA) patients. The first 101 consecutive RA patients in whom TAC treatment was initiated were prospectively registered and their data analyzed. Clinical variables were extracted from the Institute of Rheumatology, Rheumatoid Arthritis (IORRA) database. The 101 patients included 85 females and 16 males. Average doses of TAC were 1.62 mg/day at entry and 2.13 mg/day at month 12. The average doses of concomitantly prescribed prednisolone (6.92 mg/day) and methotrexate (MTX; 8.59 mg/week) were higher than those in all RA patients in the IORRA cohort. At month 12, 57 patients remained on TAC therapy; 18 patients had discontinued TAC due to side effects, and 16 patients had discontinued due to inefficacy. Adverse reactions responsible for discontinuation included gastrointestinal symptoms, renal dysfunction, and infection. According to the European League Against Rheumatism (EULAR) response criteria, 56.5% of the patients who continued TAC at 12 months experienced "good" or "moderate" responses. Through the use of last observation carried forward (LOCF) methodology, the average Disease Activity Score (DAS) 28 significantly improved. We confirmed the usefulness of TAC for the treatment of RA and found that TAC is suitable for RA patients who are unable to use biologic agents or to tolerate a high dose of MTX because of their complications or background factors.

Use of tacrolimus for managing csDMARD-failed rheumatoid arthritis: A real- time experience from a single tertiary care centre

“…16 Several studies have concluded on the usefulness and economic benefits of tacrolimus in managing RA in patients who are unable to use biologic agents. 20,21 In addition, tacrolimus can be used as an add-on to RA patients with inadequate response to methotrexate+TNF inhibitors and abatacept-methotrexate combination. [21][22][23][24] The combination of methotrexate and tacrolimus had equal response and was non-inferior to leflunomide and methotrexate.…”

“…20,21 In addition, tacrolimus can be used as an add-on to RA patients with inadequate response to methotrexate+TNF inhibitors and abatacept-methotrexate combination. [21][22][23][24] The combination of methotrexate and tacrolimus had equal response and was non-inferior to leflunomide and methotrexate. 25 Adverse events reported were minor and gastrointestinal symptoms were common and did not cause any serious safety problems.…”

Drug survival and the associated predictors in South Korean patients with rheumatoid arthritis receiving tacrolimus

“…Hence, our study provided more comprehensive data on TAC survival in clinical practice. Kitahama et al [ 27 ] and Kanzaki et al [ 29 ] also assessed the retention of TAC in Japanese patients with RA. However, these studies did not show the exact figures for the survival rate and cannot be generalized because of short follow-up period (12 months) and the small sample size (n = 24) in Kitahama et al [ 27 ]’s and Kanzaki et al [ 29 ]’s studies, respectively.…”

“…First, we retrieved the drug survival data for TAC only; thus, direct comparisons between TAC and other DMARDs were not possible. However, a majority of previous studies on drug survival have analyzed a single agent, except for studies on TNF-α inhibitors [ 16 - 19 , 27 , 29 ]. Thus, we think that our data also provide useful clinical information regarding the long-term retention rate of TAC.…”

“…After TAC was approved for the first time in the world for treating RA in Canada in February 2004, it was also available as a DMARD for patients with RA in Japan and South Korea in April 2005 and October 2008, respectively. Then, several observational studies regarding the tolerability and effectiveness including radiographic changes of TAC treatment in Japanese patients with RA in various clinical settings, have been published [ 27 - 30 ]. However, long-term follow-up data about drug survival and the associated factors among patients with RA receiving TAC are still lacking to date, especially in South Korea.…”