Abstract Details

Title Long Term Impact of Early Initiation of Interferon beta-1b after a First Clinical Event Suggestive of Multiple Sclerosis: Additional Relapse Rate, EDSS, and MSSS Analyses after 8 Years

Topic MS and Related Diseases

Presentation(s) P07 - (-)

Poster/Presentation
Number 117

Objective

Background BACKGROUND: Long-term observations are necessary to understand the chronic disease course of patients with MS. The BENEFIT Extension Study evaluated the impact of early treatment with interferon beta-1b (IFNB-1b) in patients with a first event suggestive of MS (clinically isolated syndrome) over an 8-year period.

Design/Methods DESIGN/METHODS: In BENEFIT, patients were randomized (2:1) to IFNB-1b 250 [mu]g sc, eod or placebo for 2 years or until diagnosis of clinically definite MS, followed by a prospective phase where all patients were offered IFNB-1b but remained double-blinded regarding initial randomization for a total of 5 years. An observational extension study including all patients in the original cohort was then conducted.

Results RESULTS: 284 (IFNB-1b: 176, placebo: 106) of the original 468 patients in the trial enrolled in the extension study, with maximum follow-up of 8.7 years. Annualized relapse rate was lower in patients initially randomized to IFNB-1b than placebo across years 1 and 2 (0.2333 [95% CI, 0.1946-0.2774] vs 0.3255 [95% CI, 0.2675-0.3923], p=0.0073 Wald type Chi-square test from generalized linear Poisson regression model; RR 0.7052, 95% CI, 0.5464-0.9100) and from years 3 to 8 (0.1795 [95% CI, 0.1569-0.2045] vs 0.2230 [95% CI, 0.1902-0.2599]; p=0.0368; RR 0.8071, 95% CI, 0.6600-0.9869). EDSS scores were stable and MSSS scores remained low for the study population throughout the 8 years of follow-up.

Conclusions CONCLUSIONS: Patients in the early treatment arm showed a reduced risk of relapse after 8 years relative to patients in the delayed treatment arm. Stable and low EDSS and MSSS scores in both arms indicated a benefit of long-term treatment in the overall study population. Data support early initiation of IFNB-1b in these patients.

Authors/Disclosures
Gilles Edan, MD PRESENTER	No disclosure on file
Ludwig Kappos, MD, FAAN (RC2NB, University Hospital Basel)	Dr. Kappos has nothing to disclose.
	No disclosure on file
Xavier Montalban, MD, PhD, FAAN (Vall Hebron University Hospital-Multiple Sclerosis Centre of Catalonia)	The institution of Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. The institution of Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck/ EMD Serono. The institution of Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. The institution of Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva. The institution of Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Hoffmann-La Roche. The institution of Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Actelion/ Janssen Pharmaceuticals. The institution of Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for BMS/ Celgene. The institution of Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi/ Genzyme. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BIAL PD. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PeerVoice. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Samsung Biosys. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zenas BioPharma. Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Actelion/ Janssen Pharmaceuticals. Dr. Montalban has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BMS/ Celgene. Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck/ EMD Serono. Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Hoffmann-La Roche. Dr. Montalban has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi-Genzyme. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunic Therapeutics. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Viatris/ Mylan. The institution of Dr. Montalban has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sandoz. The institution of Dr. Montalban has received research support from Biogen. The institution of Dr. Montalban has received research support from Hoffmann-La Roche. The institution of Dr. Montalban has received research support from Sanofi/ Genzyme. The institution of Dr. Montalban has received research support from Merck/ EMD Serono. The institution of Dr. Montalban has received research support from Novartis. The institution of Dr. Montalban has received research support from Teva Pharmaceuticals. The institution of Dr. Montalban has received research support from Actelion/ Janssen Pharmaceuticals. The institution of Dr. Montalban has received research support from BMS/ Celgene.
Chris H. Polman, MD (MS Center, VU Medical Center)	No disclosure on file
	No disclosure on file
Hans-Peter Hartung, MD, FAAN (Heinrich Heine University Medical Faculty)	Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS Celgene. Dr. Hartung has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Geneuro. Dr. Hartung has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Hartung has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bayer. Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. Dr. Hartung 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. Hartung has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Frontiers Neurology.
David E. Miller, MD (Good Samaritan Hospital)	No disclosure on file
Frederik Barkhof, MD, PhD (Image Analysis Center)	Frederik Barkhof has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Frederik Barkhof has received personal compensation in the range of $0-$499 for serving as a Consultant for Biogen. Frederik Barkhof has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Combinostics. Frederik Barkhof has received personal compensation in the range of $500-$4,999 for serving as a Consultant for IXICO. Frederik Barkhof has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Frederik Barkhof has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EISAI.
	No disclosure on file
	No disclosure on file
	No disclosure on file
Brigitte Stemper, MD (Bayer AG)	No disclosure on file
Christoph Pohl, MD	No disclosure on file
Rupert Sandbrink, MD, PhD (SDDCCS Sandbrink Drug Development Consulting & Clinical Services)	Dr. Sandbrink has received personal compensation for serving as an employee of Topas Therapeutics. Dr. Sandbrink has received personal compensation for serving as an employee of Vico Therapeutics. Dr. Sandbrink has received stock or an ownership interest from Forward Pharma. Dr. Sandbrink has received stock or an ownership interest from Topas Therapeutics. Dr. Sandbrink has received stock or an ownership interest from Vico Therapeutics. Dr. Sandbrink has received stock or an ownership interest from Bayer.
Dirk Pleimes, MD (Bayer Healthcare)	No disclosure on file

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