Interferon-beta 1b in the treatment of secondary progressive MS - Impact on quality of life

Background: The recent randomized, controlled trial of interferon-beta 1b ( IFN-beta 1b) in 718 patients with secondary progressive MS (SP-MS) demonstr ated a significant effect on the development of disability as evaluated by the physician. Its effect on patient-reported health-related quality of lif e (HrQoL) is reported herein. Methods: In this multicenter, double-blind, r andomized, 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-beta 1b or placebo for up to 3 years. A range of outcomes was measured, including HrQoL, which was assessed using the Sickness Impact Pr ofile (SIP), a self-report questionnaire validated for use in MS. Measureme nts were undertaken at baseline and at 6-monthly intervals thereafter for 3 6 months. Results: A slight positive effect on the HrQoL of the IFN group i n comparison with the placebo group was found, which reached significance i n 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 a nd patient-reported change. Conclusions: IFN-beta 1b may delay sustained de terioration in patient-reported HrQoL in SP-MS. Methods of interpreting cha nge in HrQoL are currently insufficiently developed to determine how clinic ally important these changes are for this population.