Patient Opinions on Zinbryta Seen to Match Phase 3 Trial Data, Supporting Questionnaire Use
More relapsing multiple sclerosis (MS) patients treated with Zinbryta (daclizumab) said they felt its health benefits than did those given Avonex (interferon beta-1a) — demonstrating that patient-reported outcomes do mirror objective measures of improved health in a clinical trial of the two drugs.
Patient-reported changes in both physical and psychological health contribute to a more comprehensive picture of a treatment’s benefits, and measures of these reports are increasingly used in developing new treatments.
The study, “Impact of daclizumab versus interferon beta-1a on patient-reported outcomes in relapsing-remitting multiple sclerosis,” was published in the journal Multiple Sclerosis and Related Disorders.
Researchers at Biogen analyzed data collected during a randomized Phase 3 trial (DECIDE, NCT01064401) comparing Zinbryta and Avonex. While the trial’s main objectives, reported in a 2015 published study, showed that Zinbryta lowered annualized relapse rates, the number of new brain lesions, and accumulated disability compared to Avonex, researchers did not know how well patients perceived these benefits.
Numerous factors can affect how a person experiences the benefit of a treatment, and some cannot be measured using standard assessments. Patient-reported outcomes, for this reason, help to capture information that’s impossible to otherwise pinpoint.
Of the 1,841 patients who entered DECIDE, 919 received Zinbryta and 922 received Avonex. Researchers used two questionnaires to assess how patients’ opinions of the treatment. Participants completed both questionnaires before treatment start, and then every 24 weeks until the study’s end at week 96.
One questionnaire, called the EuroQol 5-Dimensions (EQ-5D), measures patients’ general health status, focusing on mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. It also allows patients to rate how they feel on a visual analog scale (VAS) ranging from 0 to 100.
The other has one part focusing on physical aspects, and another dealing with psychological issues, allowing patients to rate how bothered they are with each issue.
Results showed that patients receiving Zinbryta perceived both their physical and mental health as better than did those receiving Avonex. While both groups had equal scores before treatment began, differences became apparent after 24 weeks and continued throughout the study, with responses to both questionnaires showing significant differences.
Importantly, the improvements in patient-reported outcomes mirrored the changes measured by objective assessments, such as annual relapse rates and brain imaging changes.