Postmarketing Safety Profile of Subcutaneous Interferon Beta-1a Given 3 Times Weekly: A Retrospective Administrative Claims Analysis

Abstract

BACKGROUND: Health insurance administrative claims databases represent a valuable source of information regarding the safety profile of marketed products as used in actual clinical practice in a broader range of patients than that assessed in clinical trials. Interferon beta-1a administered sub-

Reasons for discontinuation of subcutaneous interferon β-1a three times a week among patients with multiple sclerosis: a real-world cohort study

“…Poor adherence is a common problem among patients with many types of chronic disease, including MS, and improvements in treatment adherence may have a larger effect on society and health than most therapeutic advances [2, 19]. Many factors that contribute to poor adherence to long-term therapy in patients with MS are recognised; [6] indeed, recent retrospective [7, 20] and prospective [19] observational studies indicate that the most common reasons to discontinue IFN-β therapy in real-world settings are adverse events (such as influenza-like symptoms, depression and injection-site reactions) and increased disease activity (including radiographic progression, relapses, and disability progression). Although in this study indices of disability progression were not reported, an association between relapses and discontinuation was observed at years 2 and 3, and the association with an increasing number of MRI scans may be an indicator of radiographic progression.…”

“…Furthermore, although overall time on treatment was not associated with discontinuation, a change was observed in the drivers of discontinuation as time on therapy increases. In the short-term (up to and including 1 year), the main drivers (an increase in laboratory investigations and an increase in the use of anxiolytics) could be associated with the common emergent adverse effects of treatment with sc IFN β-1a tiw [7]. Even though the adverse-event profile of sc IFN β-1a tiw is well-documented, consistent and stable during both clinical trials and in real-world experience, [7] adverse events can still lead to considerable discomfort and patient anxiety.…”

“…In the short-term (up to and including 1 year), the main drivers (an increase in laboratory investigations and an increase in the use of anxiolytics) could be associated with the common emergent adverse effects of treatment with sc IFN β-1a tiw [7]. Even though the adverse-event profile of sc IFN β-1a tiw is well-documented, consistent and stable during both clinical trials and in real-world experience, [7] adverse events can still lead to considerable discomfort and patient anxiety. Pharmacological and non-pharmacological approaches to prevent discontinuation due to adverse events have not been widely implemented in patients who discontinue sc IFN β-1a tiw therapy, resulting in missed opportunities to improve retention [16].…”

“…MS patients with comorbid depression are about half as likely to be adherent to a DMD than MS patients without depression [26]. In addition, in a real-world US health insurance-claims-based study of more than 8000 patients, depression was also a recognised adverse effect of treatment with IFN therapy (incidence rate 7.75 [95% CI 7.32–8.20]) [7]. As the current analysis shows, further investigation is required to corroborate the validity of new prescriptions of antidepressants as a driver of discontinuation at and beyond 2 years, or whether this is associated with a decrease in quality of life as a consequence of increased disease activity.…”

“…Of the DMDs available for the treatment of MS, interferon (IFN) β-based therapies are some of the most widely prescribed [7]. Continued treatment with IFN-β therapy is important to achieve maximum treatment efficacy, [8] but data from clinical trials and registries show that IFN-β therapies have a treatment discontinuation rate of between 14 and 44%, which may lead to disease reactivation [9].…”