Journal Article

An update on Peginterferon beta-1a Management in Multiple Sclerosis: results from an interdisciplinary Board of German and Austrian Neurologists and dermatologists

Sunderkötter, Cord, Meuth, Sven G., Kolb-Mäurer, Annette, Kukowski, Borries

2019

Overview

Background Interferon (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 text 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 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. Conclusions 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.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adult / Austria / Best practices / Biological response modifiers / Care and treatment / Clinical trials / Comparative analysis / Complications and side effects / Debate / Demyelinating diseases / Dermatologists / Dermatology / Diagnostic imaging / Disability / Dosage / Dosage and administration / Drug dosages / Female / Fever / Flu-like symptoms / Germany / Headache / Hepatitis / Hospitals / Humans / Immunosuppressive Agents - therapeutic use / Influenza / Injection site reactions / Interferon / Interferon beta / Interferon-beta - therapeutic use / Magnetic resonance imaging / Male / Management / Medicine / Medicine & Public Health / Multiple sclerosis / Multiple Sclerosis, Relapsing-Remitting - drug therapy / Neurochemistry / Neurologists / Neurology / Neurosurgery / Patients / Peginterferon bet-1a / Polyethylene glycol / Polyethylene Glycols - therapeutic use / Side effects / Skin / Strategic planning (Business) / Viral antigens