http://www.neurology.org/cgi/content/abstract/57/10/1870
Neurology 2001;57:1870-1875
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.
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.
© 2001 American Academy of Neurology