Abstract Details

Title Direct Comparison of Azathioprine and beta Interferon Efficacy in Multiple Sclerosis

Topic MS and Related Diseases

Presentation(s) P01 - (-)

Poster/Presentation
Number 200

Objective

Background BACKGROUND: Following approval of Beta Interferons (IFN) for multiple sclerosis (MS), Azathioprine (AZA) has mainly been used as a second line treatment, although direct comparison of these medications has never been carried out.

Design/Methods DESIGN/METHODS: Eligible patients (n=150; relapsing-remitting MS; > 2 relapses in the last 2 years) were randomly assigned to AZA or to an IFN and followed for 2 years. Primary outcome was efficacy on relapse rate. Key secondary outcome was number of new brain lesion, measured by MRI via T2 weighted sequences. For MRI evaluation 122 patients were included. The efficacy of these treatments was compared by applying a non-inferiority design according to published guidelines.

Results RESULTS: As for baseline characteristics, the randomization generated comparable groups (n= 77 and 73). Clinical evaluation indicates that annualized relapse rate was lower in the AZA than in the IFN group and non-inferiority analysis showed that AZA exerts on this outcome measure at least the same effect of IFNs (0.67%, one sided 95% C.I.= 0.96; p= 0.03). New T2 lesion number analyzed in 97 patients, was similar in both groups indicating that AZA maintains also on this outcome at least 73% of the IFN efficacy (p= 0.05). Number of patients with adverse events (AE) and patients who discontinued treatment for AEs were similar in both the treatment groups although total AE number was higher in the AZA treated group.

Conclusions CONCLUSIONS: These data indicate for the first time, that in relapsing remitting MS AZA is at least as effective as IFNs on clinical outcome measures and that its efficacy on suppressing new brain lesions is equivalent to that of the IFNs.

Authors/Disclosures
Luca Massacesi (Osp. Policlinico Careggi) PRESENTER	The institution of Luca Massacesi has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Luca Massacesi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Luca Massacesi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Luca Massacesi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Luca Massacesi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck-Serono. Luca Massacesi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Johnson and Johnson. Luca Massacesi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion. Luca Massacesi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Horizon. The institution of Luca Massacesi has received research support from Tuscan Region Government. The institution of Luca Massacesi has received research support from Sanofi. The institution of Luca Massacesi has received research support from Roche. Luca Massacesi has received research support from Merck-Serono.
	No disclosure on file
	No disclosure on file
	No disclosure on file
Graziella Filippini, MD	No disclosure on file
	No disclosure on file
Alessandra Solari, MD	Dr. Solari has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck Serono. Dr. Solari has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. The institution of Dr. Solari has received research support from Fondazione Italiana Sclerosi Multipla.
	No disclosure on file
	No disclosure on file
Gioacchino Tedeschi, MD (University of Campania "L. Vanvitelli")	Dr. Tedeschi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Tedeschi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly. Dr. Tedeschi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis.
	No disclosure on file

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