RESEARCH - Safety of tacrolimus in the treatment of RA in elderly patients

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Rheumatology Advance Access originally published online on November 1, 2005

Rheumatology 2006 45(4):441-444; doi:10.1093/rheumatology/kei172

Safety of tacrolimus, an immunosuppressive agent, in the treatment of

rheumatoid arthritis in elderly patients

S. Kawai and K. Yamamoto1

Division of Rheumatology, Department of Internal Medicine, Toho

University School of Medicine and 1 Department of Allergy and

Rheumatology, University of Tokyo Graduate School of Medicine, Tokyo,

Japan.

Abstract

Objective. To prospectively evaluate the safety of tacrolimus in

active rheumatoid arthritis (RA) in elderly patients with insufficient

response to disease-modifying antirheumatic drugs (DMARDs).

Methods. Fifty-seven patients aged 65 yr with RA for 6 months were

enrolled in an open-label, non-controlled study. All DMARDs were

discontinued and tacrolimus was administered orally once daily after

the evening meal for 28 weeks. Tacrolimus, initiated at 1.5 mg/day,

was increased to 3 mg/day after 6 weeks if no abnormal changes

developed. Existing NSAID and oral corticosteroid (7.5 mg/day

prednisolone equivalent) therapy could be continued during the study.

Safety was evaluated as clinical symptoms, abnormal changes in

laboratory values and the development of infection. Treatment response

was determined using the American College of Rheumatology (ACR)

criteria for improvement. Whole blood concentrations of tacrolimus 12

h after administration were measured by high-performance liquid

chromatography and tandem mass spectrometry.

Results. Clinical adverse events developed in 25 patients (46.3%).

Abnormal changes in laboratory values occurred in 25 patients (46.3%).

Ten patients (18.5%) developed infection. An ACR20 response was

achieved by 50.0% of efficacy-evaluable patients and ACR20 success

rates (the proportion of patients achieving ACR20 response and

completing the study) was 46.3%. The ACR50 response rate was 18.5% of

evaluable patients. Mean blood concentration of tacrolimus was 3.3 and

5.3 ng/ml in patients receiving 1.5 and 3.0 mg daily, respectively. No

relationship between its concentration and adverse reactions was

observed.

Conclusion. In elderly patients with insufficient response to DMARD

therapy, tacrolimus at 1.5–3.0 mg/day is safe and well-tolerated and

provides clinical benefit.

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Read the full article here:

http://rheumatology.oxfordjournals.org/cgi/content/full/45/4/441

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