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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 Vincents 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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