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Enhanced Benefit of Increasing Interferon Beta-1a Dose and Frequency in Relapsing Multiple Sclerosis
The EVIDENCE Study
Steven R. Schwid, MD;
John Thorpe, MD;
Mohammad Sharief, MD;
Magnhild Sandberg-Wollheim, MD;
Kottil Rammohan, MD;
Jeanette Wendt, MD;
Hillel Panitch, MD;
Douglas Goodin, MD;
David Li, MD;
Peter Chang, PhD;
Gordon Francis, MD; for the EVIDENCE (Evidence of Interferon Dose-Response: European North American Comparative Efficacy) Study Group and the University of British Columbia MS/MRI Research Group
Arch Neurol. 2005;62:785-792.
Background The EVIDENCE (Evidence of Interferon Dose-Response: European North American Comparative Efficacy) Study demonstrated that patients with multiple sclerosis (MS) who initiate interferon beta-1a therapy with 44 µg 3 times weekly (TIW) were less likely to have a relapse or activity on magnetic resonance imaging (MRI) compared with those who initiate therapy at a dosage of 30 µg 1 time weekly (QW).
Objective To determine the effect of changing the dosage from 30 µg QW to 44 µg TIW in this extension of the EVIDENCE Study.
Design/Patients Patients with relapsing MS originally randomized to interferon beta-1a, 30 µg QW, during the comparative phase of the study changed to 44 µg TIW, whereas patients originally randomized to 44 µg TIW continued that regimen. Patients were followed up, on average, for an additional 32 weeks.
Main Outcome Measure The within-patient pretransition to posttransition change in relapse rate.
Results At the transition visit, 223 (73%) of 306 patients receiving 30 µg QW converted to 44 µg TIW, and 272 (91%) of 299 receiving 44-µg TIW continued the same therapy. The posttransition annualized relapse rate decreased from 0.64 to 0.32 for patients increasing the dose (P<.001) and from 0.46 to 0.34 for patients continuing 44-µg TIW (P = .03). The change was greater in those increasing dose and frequency (P = .047). Patients converting to the 44-µg TIW regimen had fewer active lesions on T2-weighted MRI compared with before the transition (P = .02), whereas those continuing the 44-µg TIW regimen had no significant change in T2 active lesions. Patients who converted to high-dose/high-frequency interferon beta-1a therapy had increased rates of adverse events and treatment terminations consistent with the initiation of high-dose subcutaneous interferon therapy.
Conclusions Patients receiving interferon beta-1a improved on clinical and MRI disease measures when they changed from 30µg QW to 44 µg TIW.
Author Affiliations: Departments of Neurology, University of Rochester, Rochester, NY (Dr Schwid), Cambridge University, Cambridge, England (Dr Thorpe), Guy’s Hospital, London, England (Dr Sharief), University Hospital, Lund, Sweden (Dr Sandberg-Wollheim), The Ohio State University, Columbus (Dr Rammohan), University of Vermont College of Medicine, Burlington (Dr Panitch), and University of California–San Francisco (Dr Goodin); Tucson Neurology Associates, Tucson, Ariz (Dr Wendt); Department of Radiology, University of British Columbia, Vancouver (Dr Li); and Serono Inc, Rockland, Mass (Drs Chang and Francis).
Group Information: A list of members of the EVIDENCE Study and University of British Columbia MS/MRI Research groups appears above.
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