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

• Published in: Multiple sclerosis Vol. 11; no. 2; pp. 169 - 174
• Main Authors: Pulicken, M, Bash, C N, Costello, K, Said, A, Cuffari, C, Wilterdink, J L, Rogg, J M, Mills, P, Calabresi, P A
• Format: Journal Article
• Language: English
• Published: Thousand Oaks, CA SAGE Publications 01-04-2005; Arnold; Sage Publications Ltd
• Subjects: Adjuvants, Immunologic - administration & dosage; Adjuvants, Immunologic - adverse effects; Adult; Azathioprine - administration & dosage; Azathioprine - adverse effects; Biological and medical sciences; Degenerative and inherited degenerative diseases of the nervous system. Leukodystrophies. Prion diseases; Drug Therapy, Combination; Female; Humans; Immunomodulators; Immunosuppressive Agents - administration & dosage; Immunosuppressive Agents - adverse effects; Interferon beta-1b; Interferon-beta - administration & dosage; Interferon-beta - adverse effects; Male; Medical sciences; Middle Aged; Multiple Sclerosis - drug therapy; Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis; Neurology; Pharmacology. Drug treatments; Pilot Projects; Treatment Outcome; toxicity; immunosuppression; MRI; therapy; 6-thioguanine; Multiple sclerosis; Toxicity; Gadolinium; Hemopathy; Tioguanine; Gastrointestinal; Optimization; Inflammatory disease; Limit dose; Complication; Clinical trial; Degenerative disease; Safety; immunosuppression; MRI; therapy; 6-thioguanine; Human; Drug combination; Nervous system diseases; Leukopenia; Oral administration; Nuclear magnetic resonance imaging; Immunosuppression; Central nervous system disease; Beta interferon; Combined treatment; Azathioprine
• ISSN: 1352-4585; 1477-0970
• DOI: 10.1191/1352458505ms1141oa

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 β-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.