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Optimization of the safety and efficacy of interferon beta 1b and azathioprine combination therapy in multiple sclerosis

Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA

C N Bash

Uniformed Services University of Health Sciences, Bethesda, MD 20814, USA and National Institutes of Health, Experimental Imaging Section, Laboratory of Diagnostic Radiology Research, Bethesda, MD 20892, USA

K Costello

Department of Neurology, University of Maryland School of Medicine, Baltimore, MD 21201, USA

A Said

Department of Neurology, University of Maryland School of Medicine, Baltimore, MD 21201, USA

C Cuffari

Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA

J L Wilterdink

Department of Clinical Neurosciences, Rhode Island Hospital-Brown University, Providence, RI 02903, USA

J M Rogg

Department of Clinical Neurosciences, Rhode Island Hospital-Brown University, Providence, RI 02903, USA

P Mills

Department of Clinical Neurosciences, Rhode Island Hospital-Brown University, Providence, RI 02903, USA

P A Calabresi

Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA, calabresi{at}jhmi.edu

We conducted an open-label pilot clinical trial to evaluate the safety and efficacy of adding oral azathioprine to the treatment regimen of 15 multiple sclerosis patients breaking through monotherapy with interferon ß-1b. There were no serious adverse events. Gastrointestinal side effects and leukopenia were the most common adverse events and limited dose escalation. There was a 65% reduction in the number of gadolinium-enhanced magnetic resonance imaging (MRI) lesions on combination therapy compared to the baseline values (P=0.003). A total WBC count less than 4800/mm³ was the best predictor of MRI response.

Key Words: immunosuppression • MRI • therapy • 6-thioguanine • toxicity

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