Objective: We investigated the clinical efficacy and safety of low-dose tacrolimus (less than 1 mg/day) in active rheumatoid arthritis (RA) patients who were followed up for more than 2 years.
Methods: The present study included 49 patients (26 were < 65 years old and 23 were ≧ 65 years old) with RA who had started tacrolimus therapy before April 2007. Adverse effects, persistence rate, and disease activity score 28/C reactive protein (DAS28-CRP) were compared between patients younger than 65 and older than 65.
Results: A total of 22 patients (7 younger than 65 and 15 older than 65) had several adverse effects, and 15 patients (6 younger than 65 and 9 older than 65) discontinued tacrolimus therapy. Older patients tended to have more adverse effects than younger patients did, and 10 older patients changed from tacrolimus to other drugs because of adverse effects. In the patients who continued to receive tacrolimus, DAS28-CRP improved from a baseline mean of 3.81±0.82 to 3.14±0.93 and 2.96±1.15 at 6 and 24 months after the start of therapy, respectively The efficacy of tacrolimus in patients older than 65 was as good as that in patients younger than 65.
Conclusion: When tacrolimus is administered to older patients or to those whose RA has complications, we must be particularly aware of the potential for adverse effects.
