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Published online before print March 11, 2009, doi:10.1212/01.wnl.0000345970.73354.17)
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NEUROLOGY 2009;72:1976-1983
© 2009 American Academy of Neurology

Efficacy of treatment of MS with IFNβ-1b or glatiramer acetate by monthly brain MRI in the BECOME study

D. Cadavid, MD, L. J. Wolansky, MD, J. Skurnick, PhD, J. Lincoln, MD, J. Cheriyan, MD, K. Szczepanowski, BS, S. S. Kamin, MD, A. R. Pachner, MD, J. Halper, RN and S. D. Cook, MD

From the Departments of Neurology and Neuroscience (D.C., J.L., J.C., K.S., S.S.K., A.R.P., S.D.C.), Radiology (L.J.W.), and Preventive Medicine and Community Health (J.S.) of UMDNJ–New Jersey Medical School, Newark; and the Multiple Sclerosis Center at Holy Name Hospital (D.C., S.S.K., J.H.), Teaneck, NJ is currently affiliated with Experimental Neurology Group, Biogen Idec, Cambridge, MA. L.J.W. is currently affiliated with RadPharm, Inc., Princeton, NJ.

Address correspondence and reprint requests to Dr. D. Cadavid, Experimental Neurology Group, Biogen Idec, 14 Cambridge Center, Building 6A, 6th Floor, Cambridge, MA 02142 cadavidi{at}umdnj.edu

Background: There are no published MRI studies comparing interferon beta 1b (IFNβ-1b) and glatiramer acetate (GA) for treatment of relapsing multiple sclerosis (MS).

Objective: To compare the efficacy of IFNβ-1b and GA for suppression of MS disease activity as evidenced on frequent brain MRI.

Methods: A total of 75 patients with relapsing-remitting MS or clinically isolated syndromes were randomized to standard doses of IFNβ-1b or GA and followed by monthly brain MRI for up to 2 years with a protocol optimized to detect enhancement. The primary outcome was the number of combined active lesions (CAL) per patient per scan during the first year, which included all enhancing lesions and nonenhancing new T2/fluid-attenuated inversion recovery (FLAIR) lesions. Secondary outcomes were the number of new lesions and clinical exacerbations over 2 years.

Results: Baseline characteristics were similar between the groups. The primary outcome showed similar median (75th percentile) CAL per patient per scan for months 1–12, 0.63 (2.76) for IFNβ-1b, and 0.58 (2.45) for GA (p = 0.58). There were no differences in new lesion or clinical relapses for 2 years. Only 4.4% of CAL on monthly MRI scans were nonenhancing new T2/FLAIR lesions.

Conclusion: Patients with relapsing multiple sclerosis randomized to interferon beta 1b or glatiramer acetate showed similar MRI and clinical activity.

Abbreviations: ARR = annualized relapse rates; BECOME = Betaseron vs Copaxone in Multiple Sclerosis with Triple-Dose Gadolinium and 3-Tesla MRI Endpoints; CAL = combined active lesions; CIS = clinically isolated syndromes; EDSS = Expanded Disability Status Scale; GA = glatiramer acetate; IFNβ-1b = interferon beta 1b; FLAIR = fluid-attenuated inversion recovery; MS = multiple sclerosis; MSFC = Multiple Sclerosis Functional Composite; NEL = newly enhancing lesions; NL = new lesions; RRMS = relapsing-remitting MS; SNRS = Scripps Neurological Rating Scale.

Supplemental data at www.neurology.org

Editorial, page 1972

e-Pub ahead of print on March 11, 2009, at www.neurology.org.

*Diego Cadavid and Leo J. Wolansky were co-principal investigators and contributed equally to the BECOME study and therefore are considered co-first authors.

Disclosure: Author disclosures are provided at the end of the article.

Medications: Interferon β1b (Betaseron®; Bayer HealthCare Pharmeceuticals; Montville, NJ); glatiramer acetate (Copaxone®; Teva-Marion Partners;Kansas City, MO).

Received July 1, 2008. Accepted in final form December 17, 2008.




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