Patients with multiple sclerosis say they do better on daclizumab.
Patients reported greater benefit with daclizumab (Zinbryta/Biogen,Abbvie) than with interferon beta-1a (Avonex/Biogen) in a recently published analysis of patient-reported outcomes (PROs) from a study of the treatments for relapsing-remitting multiple sclerosis (RRMS).
The patient perspective favoring treatment with daclizumab corresponds to the previously reported objective clinical measures from the DECIDE study, a phase 3, randomized, double-blind controlled trial comparing daclizumab to Interferon beta-1a in approximately 1,800 subjects over a treatment period of between 96 to 144 weeks.
The importance of including patient report measures in addition to such primary outcomes in MS treatment as relapse rate, disability progression, and brain lesions visualized on magnetic resonance imaging () was described by DECIDE study investigators Ying Liu, PhD, Biogen, and colleagues.
"Use of PROS in clinical trials can provide valuable information on the physical and psychological burden of MS and treatment benefits beyond that provided by objective and clinician-assessed clinical/radiographic outcomes," the investigators indicated.
The principle PRO measures in the DECIDE study were the 29-item Multiple Sclerosis Impact Scale (MSIS-29) and the EuroQol 5-Dimensions (EQ-5D). The investigators describe the MSIS as a disease-specific instrument to evaluate the impact of MS on physical and psychological functioning from the patient's viewpoint. The EQ-5D is used to assess patient's view of their general health status. It is not disease-specific, however, and the investigators acknowledge that it may lack sensitivity in capturing the health problems important to quality of life in patients with MS.
The measures were applied at baseline and every 24 weeks through 96 weeks of treatment. This is the first study, the investigators point out, to report longitudinal MSIS-29 outcomes, and to demonstrate improved outcomes on the MSIS-29/EQ-5D for daclizumab versus an active comparator.
The daclizumab-treated patients demonstrated mean improvements from baseline in both the MSIS-29 physical and psychiatric subscales at the first measurement at 24 weeks, which persisted through measurements over 96 weeks. In comparison, those receiving treatment with interferon beta-1a had a mean decline in MSIS-29 physical subscale score at week 96.
The results of the EQ-5D corresponded to those of the MSIS-29, with daclizumab-treated patients reporting greater improvement in their general health status. There was a relatively smaller difference in mean changes from baseline between the treatment groups, however, which the investigators suggest might be attributed to the measure not being disease specific.
"Results of these PRO measures from DECIDE suggest that treatment with daclizumab provides greater benefits in terms of reductions in the physical and psychological impact of MS and greater improvements in general health status versus interferon beta-1a in patients with relapsing-remitting multiple sclerosis," the investigators concluded.
The patient-reported outcomes from the DECIDE study comparing daclizumab to interferon beta-1a, "Impact of daclizumab versus interferon beta-1a on patient-reported outcomes in relapsing-remitting multiple sclerosis," was published in the January issue of Multiple Sclerosis and Related Disorders.