Abstract
BackgroundInterferon (IFN) beta drugs have been approved for the treatment of relapsing forms of multiple sclerosis (RMS) for more than 20 years and are considered to offer a favourable benefit-risk profile. In July 2014, subcutaneous (SC) peginterferon beta-1a 125 μg dosed every 2 weeks, a pegylated form of interferon beta-1a, was approved by the EMA for the treatment of adult patients with RRMS and in August 2014 by the FDA for RMS. Peginterferon beta-1a shows a prolonged half-life and increased systemic drug exposure resulting in a reduced dosing frequency compared to other available interferon-based products in MS. In the Phase 3 ADVANCE trial peginterferon beta-1a demonstrated significant positive effects on clinical and MRI outcome measures versus placebo after one year. Furthermore, in the ATTAIN extension study, sustained efficacy with long-term treatment for nearly 6 years was shown.Main textIn July 2016, an interdisciplinary panel of German and Austrian experts convened to discuss the management of side effects associated with peginterferon beta-1a and other interferon beta-based treatments in MS in daily practice. The panel was composed of experts from university hospitals and private clinics comprised of neurologists, dermatologists, and an MS nurse. In this paper we report recommendations regarding best practices for adverse event management, focussing on peginterferon beta-1a. Injection site reactions (ISRs) and influenza-like illness are the most common adverse effects of interferon beta therapies and can present a burden for MS patients leading to non-adherence and discontinuation of therapy. Peginterferon beta-1a shows improved pharmacological properties. In clinical trials, the adverse event (AE) profile of peginterferon beta-1a was similar to other interferon beta formulations. The most common AEs were mild to moderate ISRs, influenza-like illness, pyrexia, and headache. Current information on the underlying cause of skin reactions associated with SC interferon treatment, and the management strategies for these AEs are limited. In pivotal trials, ISRs were mainly characterized and classified by neurologists, while dermatologists were only rarely consulted.ConclusionsThis report addresses expert recommendations on the management of most relevant adverse effects related to peginterferon beta-1a and other interferon betas, based on literature and interdisciplinary experience.
Highlights
In July 2016, an interdisciplinary panel of German and Austrian experts convened to discuss the management of side effects associated with peginterferon beta-1a and other interferon beta-based treatments in Multiple sclerosis (MS) in daily practice
This report addresses expert recommendations on the management of most relevant adverse effects related to peginterferon beta-1a and other interferon betas, based on literature and interdisciplinary experience
The results demonstrated a significantly higher overall drug exposure (AUC0-336h was 60%; P < 0.0001) with SC peginterferon beta-1a compared to SC interferon beta-1a
Summary
Management of side effects associated with IFN beta therapy in MS Recommendations by the authors and participating experts of the advisory board on mitigation strategies of adverse events (AEs) are discussed below in the context of published data and the respective Summary of Product Characteristics (SmPC). Elevated serum hepatic enzyme levels, hepatitis, autoimmune hepatitis and hepatic failure has been reported in the post-marketing phase with interferon beta treatments In some cases, these reactions have occurred in the presence of other co-medications (e.g. ibuprofen, naproxen, indomethacin) that have been associated with hepatic injury. The expert panel recommended to follow monitoring rules according to the product information and local guidelines [51, 52]: In addition to laboratory tests normally required for monitoring patients with MS, complete blood and differential blood cell counts, platelet counts, and blood chemistries including liver enzyme tests (e.g. AST, ALT), renal and thyroid function are recommended prior to initiation, at regular quarterly intervals within the first year following introduction of interferon therapy and periodically thereafter in the absence of clinical symptoms, 1-2x per year (Table 3) [51, 52]. Patients with myelosuppression may require more intensive monitoring of complete blood cell counts, including differential and platelet counts
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
