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Azathioprine. Safety profile in multiple sclerosis patients.

L La Mantia¹, N Mascoli, C Milanese

¹Dipartimento di Neuroscienze, Multiple Sclerosis Center Fondazione IRCCS Istituto Neurologico C. Besta, Via Celoria 11, Milan, Italy. msgroup@istituto-besta.it

Neurological Sciences : Official Journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology

|January 5, 2008

Summary

Azathioprine (Aza) is an effective treatment for multiple sclerosis (MS), but requires careful monitoring for adverse events like gastrointestinal issues and leukopenia. Long-term use may increase cancer risk, necessitating vigilant patient management.

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Area of Science:

Neurology
Immunology
Pharmacology

Background:

Azathioprine (Aza) has been used for multiple sclerosis (MS) since 1971.
Recent studies show its efficacy in reducing MRI lesion load, particularly in IFN-treated MS patients.
Concerns regarding malignancy risk and unexpected adverse events (AEs) necessitate a safety profile review.

Purpose of the Study:

To systematically review the safety profile of Azathioprine (Aza) in multiple sclerosis (MS) patients.
To provide data supporting the clinical management of Aza therapy in MS.
To assess the risk of cancer and reproductive toxicity associated with Aza treatment.

Main Methods:

A systematic review of controlled and observational clinical studies published between 1971 and 2007.
Registration and frequency calculation of adverse events (AEs).
Consideration of cancer risk and reproductive toxicity.

Main Results:

Gastrointestinal complaints and leukopenia are the most frequent AEs (>10%).
Infections, allergy, anemia, thrombocytopenia, and pancytopenia are common (1-10%).
Pancreatitis is uncommon (<1%); cancer risk increases with duration and dose.

Conclusions:

Azathioprine (Aza) has an acceptable safety profile in MS when managed appropriately.
Management strategies for AEs, adherence to dosage, and long-term cancer risk monitoring are crucial.
No data on reproductive toxicity in MS patients treated with Aza are available.