RESEARCH - Safety of long-term tacrolimus therapy for RA: an open-label, uncontrolled study in non-elderly patients

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Mod Rheumatol. 2008 Apr 22 [Epub ahead of print]

Safety of long-term tacrolimus therapy for rheumatoid arthritis: an

open-label, uncontrolled study in non-elderly patients.

Kawai S, Tanaka K, Ohno I, Utsunomiya K, Seino Y.

Division of Rheumatology, Department of Internal Medicine, Toho

University School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo,

143-8541, Japan.

In this study we focused on the safety of long-term tacrolimus therapy

in non-elderly patients with rheumatoid arthritis who were treated

with tacrolimus or mizoribine in a previous double-blind study. The

patients received oral tacrolimus at a dose </=3 mg once daily for 76

weeks. The safety analysis population included 115 patients aged 20-64

years. Adverse drug reactions presented as symptomatic events in 39

patients (33.9%), laboratory abnormalities in 38 patients (33.0%), and

infections in 19 patients (16.5%). The major reactions were

gastrointestinal disorders and hypertension as symptomatic events,

increases of creatinine, urinary N-acetyl-beta-D: -glucosamidase and

hemoglobin A(1C) as laboratory abnormalities, and the common cold

syndrome as infections. After 76 weeks of tacrolimus treatment, the

ACR20 response rates of patients who had also received tacrolimus

during the preceding double-blind study was 61.5% (compared with the

status at baseline in the preceding study). The corresponding response

rate for patients who had previously received mizoribine was 66.0%.

The mean blood concentration of tacrolimus was 3.8-4.8 ng/mL. In

conclusion, safety profiles of tacrolimus treatment for long-term

seems to be similar to those of previous studies in patients with

rheumatoid arthritis.

PMID: 18427723

http://www.ncbi.nlm.nih.gov/pubmed/18427723

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