Interferon-beta1b in the treatment of secondary progressive MS: impact on quality of life.
BACKGROUND
The recent randomized, controlled trial of interferon-beta1b (IFN-beta1b) 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 10(6) IU of IFN-beta1b 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-beta1b 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.
Freeman
J A
JA
Institute of Neurology, University College London, United Kingdom.
Thompson
A J
AJ
Fitzpatrick
R
R
Hutchinson
M
M
Miltenburger
C
C
Beckmann
K
K
Dahlke
F
F
Kappos
L
L
Polman
C
C
Pozzilli
C
C
D000203:Activities of Daily Living / Q000145:classification / Q000523:psychology; D000328:Adult; D000553:Ambulatory Care; D004185:Disability Evaluation; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000068556:Interferon beta-1a; D000068576:Interferon beta-1b; D016899:Interferon-beta / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D020528:Multiple Sclerosis, Chronic Progressive / Q000188:drug therapy* / Q000523:psychology; D011788:Quality of Life; D016896:Treatment Outcome
D000068576:Interferon beta-1b; D016899:Interferon-beta; D000068556:Interferon beta-1a