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Neurology 2001;57:1870-1875
© 2001 American Academy of Neurology


Articles

Interferon-ß1b in the treatment of secondary progressive MS

Impact on quality of life

J. A. Freeman, PhD, A. J. Thompson, MD, R. Fitzpatrick, PhD, M. Hutchinson, MD, C. Miltenburger, PhD, K. Beckmann, MSc, F. Dahlke, MD, L. Kappos, MD, C. Polman, PhD, C. Pozzilli, PhD and the European Study Group on Interferon-ß1b in Secondary Progressive MS

From the Institute of Neurology (Drs. Freeman and Thompson), University College London; Institute of Health Sciences (Dr. Fitzpatrick), University of Oxford, United Kingdom; Department of Neurology (Dr. Hutchinson), St Vincent’s Hospital, Dublin, Ireland; Schering AG (Drs. Miltenburger and Dahlke, and K. Beckmann), Berlin, Germany; Department of Neurology (Dr. Kappos), University Hospital Basel, Switzerland; Department of Neurology (Dr. Polman), University Hospital Free University, Amsterdam, the Netherlands; and Universita "La Sapienza" di Roma (Dr. Pozzilli), Italy.

Address correspondence and reprint requests to Dr. A.J. Thompson, Department of Clinical Neurology, Queen Square, London WC1 N3BG, UK; e-mail: A.Thompson{at}ion.ucl.ac.uk

Background:— The recent randomized, controlled trial of interferon-ß1b (IFN-ß1b) in 718 patients with secondary progressive MS (SP-MS) demonstrated a significant effect on the development of disability as evaluated by the physician. Its effect on patient-reported health-related quality of life (HrQoL) is reported herein.

Methods:— In this multicenter, double-blind, randomized, placebo-controlled trial, outpatients with SP-MS scoring between 3.0 and 6.5 on the Expanded Disability Status Scale received either 8 x 106 IU of IFN-ß1b or placebo for up to 3 years. A range of outcomes was measured, including HrQoL, which was assessed using the Sickness Impact Profile (SIP), a self-report questionnaire validated for use in MS. Measurements were undertaken at baseline and at 6-monthly intervals thereafter for 36 months.

Results:— A slight positive effect on the HrQoL of the IFN group in comparison with the placebo group was found, which reached significance in the physical scale of the SIP at 6 and 12 months and at last visit. There was moderate correlation between physician-assessed evaluation of change and patient-reported change.

Conclusions:— IFN-ß1b may delay sustained deterioration in patient-reported HrQoL in SP-MS. Methods of interpreting change in HrQoL are currently insufficiently developed to determine how clinically important these changes are for this population.




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