TY - JOUR
T1 - Interferon-β1b in the treatment of secondary progressive MS
T2 - Impact on quality of life
AU - Freeman, J. A.
AU - Thompson, A. J.
AU - Fitzpatrick, R.
AU - Hutchinson, M.
AU - Miltenburger, C.
AU - Beckmann, K.
AU - Dahlke, F.
AU - Kappos, L.
AU - Polman, C.
AU - Pozzilli, C.
PY - 2001/11/27
Y1 - 2001/11/27
N2 - Background: The recent randomized, controlled trial of interferon-β1b (IFN-β1b) 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 × 106 IU of IFN-β1b 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-β1b 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.
AB - Background: The recent randomized, controlled trial of interferon-β1b (IFN-β1b) 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 × 106 IU of IFN-β1b 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-β1b 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.
UR - http://www.scopus.com/inward/record.url?scp=0035960527&partnerID=8YFLogxK
U2 - 10.1212/WNL.57.10.1870
DO - 10.1212/WNL.57.10.1870
M3 - Article
C2 - 11723278
AN - SCOPUS:0035960527
SN - 0028-3878
VL - 57
SP - 1870
EP - 1875
JO - Neurology
JF - Neurology
IS - 10
ER -