Tags

Type your tag names separated by a space and hit enter

Efficacy and safety of tacrolimus in patients with rheumatoid arthritis: a double-blind trial.
Arthritis Rheum. 2003 Dec; 48(12):3328-37.AR

Abstract

OBJECTIVE

To evaluate the efficacy and safety of tacrolimus as monotherapy in controlling the signs and symptoms of patients with rheumatoid arthritis (RA).

METHODS

This was a 6-month, phase III, double-blind, multicenter study. Patients with active RA who had discontinued all disease-modifying antirheumatic drugs (DMARDs) for an appropriate washout period (at least 1 month) and who, after the washout period, had a stable joint count (at least 10 tender/painful joints and 7 swollen joints) were stratified according to DMARD intolerance or DMARD resistance, and randomized to receive a single daily oral dose of placebo, tacrolimus 2 mg, or tacrolimus 3 mg.

RESULTS

A total of 464 patients received at least 1 dose of study drug. Baseline characteristics were similar among the 3 treatment groups. American College of Rheumatology 20% improvement (ACR20) success (defined as completion of 6 months of treatment and an ACR20 response at the month 6 visit) for the placebo, tacrolimus 2 mg, and tacrolimus 3 mg groups was 10.2%, 18.8% (P < 0.05 versus placebo), and 26.8% (P < 0.0005 versus placebo), respectively. At the end of treatment, the ACR20 and ACR50 response rates in the 3-mg group were 32.0% (P < 0.005 versus placebo) and 11.8% (P < 0.05 versus placebo), respectively. DMARD-intolerant patients had better ACR response rates than did DMARD-resistant patients. Although serum creatinine levels increased by >/=40% from baseline at some time during the trial in 20% and 29% of patients receiving tacrolimus 2 mg/day and 3 mg/day, respectively, the serum creatinine level remained within the normal range throughout the trial in approximately 90% of patients.

CONCLUSION

Tacrolimus, at dosages of both 2 mg/day and 3 mg/day, is efficacious and safe as monotherapy for patients with active RA, but treatment with the 3-mg dose of tacrolimus resulted in generally better ACR response rates.

Authors+Show Affiliations

University of Arizona, Tucson, Arizona, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

14673984

Citation

Yocum, David E., et al. "Efficacy and Safety of Tacrolimus in Patients With Rheumatoid Arthritis: a Double-blind Trial." Arthritis and Rheumatism, vol. 48, no. 12, 2003, pp. 3328-37.
Yocum DE, Furst DE, Kaine JL, et al. Efficacy and safety of tacrolimus in patients with rheumatoid arthritis: a double-blind trial. Arthritis Rheum. 2003;48(12):3328-37.
Yocum, D. E., Furst, D. E., Kaine, J. L., Baldassare, A. R., Stevenson, J. T., Borton, M. A., Mengle-Gaw, L. J., Schwartz, B. D., Wisemandle, W., & Mekki, Q. A. (2003). Efficacy and safety of tacrolimus in patients with rheumatoid arthritis: a double-blind trial. Arthritis and Rheumatism, 48(12), 3328-37.
Yocum DE, et al. Efficacy and Safety of Tacrolimus in Patients With Rheumatoid Arthritis: a Double-blind Trial. Arthritis Rheum. 2003;48(12):3328-37. PubMed PMID: 14673984.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of tacrolimus in patients with rheumatoid arthritis: a double-blind trial. AU - Yocum,David E, AU - Furst,Daniel E, AU - Kaine,Jeffrey L, AU - Baldassare,Andrew R, AU - Stevenson,Jon T, AU - Borton,Mary Ann, AU - Mengle-Gaw,Laurel J, AU - Schwartz,Benjamin D, AU - Wisemandle,Wayne, AU - Mekki,Qais A, AU - ,, PY - 2003/12/16/pubmed PY - 2004/1/15/medline PY - 2003/12/16/entrez SP - 3328 EP - 37 JF - Arthritis and rheumatism JO - Arthritis Rheum VL - 48 IS - 12 N2 - OBJECTIVE: To evaluate the efficacy and safety of tacrolimus as monotherapy in controlling the signs and symptoms of patients with rheumatoid arthritis (RA). METHODS: This was a 6-month, phase III, double-blind, multicenter study. Patients with active RA who had discontinued all disease-modifying antirheumatic drugs (DMARDs) for an appropriate washout period (at least 1 month) and who, after the washout period, had a stable joint count (at least 10 tender/painful joints and 7 swollen joints) were stratified according to DMARD intolerance or DMARD resistance, and randomized to receive a single daily oral dose of placebo, tacrolimus 2 mg, or tacrolimus 3 mg. RESULTS: A total of 464 patients received at least 1 dose of study drug. Baseline characteristics were similar among the 3 treatment groups. American College of Rheumatology 20% improvement (ACR20) success (defined as completion of 6 months of treatment and an ACR20 response at the month 6 visit) for the placebo, tacrolimus 2 mg, and tacrolimus 3 mg groups was 10.2%, 18.8% (P < 0.05 versus placebo), and 26.8% (P < 0.0005 versus placebo), respectively. At the end of treatment, the ACR20 and ACR50 response rates in the 3-mg group were 32.0% (P < 0.005 versus placebo) and 11.8% (P < 0.05 versus placebo), respectively. DMARD-intolerant patients had better ACR response rates than did DMARD-resistant patients. Although serum creatinine levels increased by >/=40% from baseline at some time during the trial in 20% and 29% of patients receiving tacrolimus 2 mg/day and 3 mg/day, respectively, the serum creatinine level remained within the normal range throughout the trial in approximately 90% of patients. CONCLUSION: Tacrolimus, at dosages of both 2 mg/day and 3 mg/day, is efficacious and safe as monotherapy for patients with active RA, but treatment with the 3-mg dose of tacrolimus resulted in generally better ACR response rates. SN - 0004-3591 UR - https://www.unboundmedicine.com/medline/citation/14673984/Efficacy_and_safety_of_tacrolimus_in_patients_with_rheumatoid_arthritis:_a_double_blind_trial_ L2 - https://doi.org/10.1002/art.11363 DB - PRIME DP - Unbound Medicine ER -