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Multiple Sclerosis International
Volume 2012, Article ID 935921, 6 pages
http://dx.doi.org/10.1155/2012/935921
Clinical Study

Combination Therapy of Interferon Beta-1b and Tacrolimus: A Pilot Safety Study

1Division of Neurology, CSSSG-Hull Pavillion, Clinique Neuro-Outaouais, 147 Boulevard d'Europe, Gatineau, QC, Canada J9J A05
2Research Institute, Children's Hospital of Eastern Ontario, 401 Smyth Road, Ottawa, ON, Canada K1H 8L1
3Division of Neurology, Ottawa Hospital, Nepean Medical Center, 1 Centrepointe Drive, Suite 407, Ottawa, ON, Canada K2G 6E2
4Division of Neurology, Charles Lemoynes Hospital Montreal, Clinique Neuro Rive-Sud, 4896 Boulevard Taschereau, Suite 250, Greenfield Park, QC, Canada J4V 2J2

Received 22 March 2012; Revised 10 June 2012; Accepted 3 July 2012

Academic Editor: H. P. Hartung

Copyright © 2012 F. Jacques et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Tacrolimus is a calcineurin inhibitor which works to induce immune suppression by preventing cytokine transcription and lymphocyte activation. Combining the immunomodulator interferon beta-1b (Betaseron) with the immunosuppressant tacrolimus (Prograf) may have the potential of additive therapeutic benefit through the complementary mechanisms of action of these two therapeutics. In this randomized, open-label, multicenter, two-arm pilot study, the authors examined the safety and tolerability of the combination of interferon beta-1b and tacrolimus in relapsing remitting (RRMS) and secondary progressive (SPMS) multiple sclerosis patients who have failed one or more immunomodulatory therapies. Patients ( 𝑛 = 2 5 ) received a combination of interferon beta-1b subcutaneously every other day and oral tacrolimus (low blood level tacrolimus, 1–5 ng/mL, or high blood level tacrolimus, 5–10 ng/mL) for a period of 38 weeks. The combination therapy of interferon beta-1b and tacrolimus over the 10-month period of the study was shown to be safe and relatively well tolerated. There were no unexpected adverse events occurring as the result of the combination therapy. Further study of this combination therapy in patients with multiple sclerosis unresponsive to conventional therapy is warranted.