Optimization of the safety and efficacy of interferon beta 1b and azathioprine combination therapy in multiple sclerosis.
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 beta-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.
Pulicken
M
M
Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA.
Bash
C N
CN
Costello
K
K
Said
A
A
Cuffari
C
C
Wilterdink
J L
JL
Rogg
J M
JM
Mills
P
P
Calabresi
P A
PA
D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D001379:Azathioprine / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000068576:Interferon beta-1b; D016899:Interferon-beta / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy*; D010865:Pilot Projects; D016896:Treatment Outcome
D000276:Adjuvants, Immunologic; D007166:Immunosuppressive Agents; D000068576:Interferon beta-1b; D016899:Interferon-beta; D001379:Azathioprine