Abstract: Post-Approval Safety of Subcutaneous Interferon β-1a in the Treatment of Multiple Sclerosis, with Particular Reference to Respiratory Viral Infections (2022 Annual Meeting of the Consortium of Multiple Sclerosis Centers)

DMT40
Post-Approval Safety of Subcutaneous Interferon β-1a in the Treatment of Multiple Sclerosis, with Particular Reference to Respiratory Viral Infections

Thursday, June 2, 2022

Prince George's Exhibit Hall (Gaylord National Resort & Convention Center)

Mark S Freedman, MSc, MD , Department of Medicine and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada

Milorad Todorović, PhD , the healthcare business of Merck KGaA, Darmstadt, Germany

Zuzana Murgašová, MD , Merck spol. s r.o., an affiliate of Merck KGaA, Darmstadt, Germany, Bratislava, Slovakia

Dominic Jack, PhD , Merck Serono Ltd, Feltham, UK, an affiliate of Merck KGaA, Darmstadt, Germany, Feltham, United Kingdom

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Background: sc IFNβ-1a is a well-established disease-modifying therapy for RMS, with an estimated cumulative exposure of 1,831,698 patient-years (to 30 April 2021).

Objectives: To report on the post-approval safety profile of subcutaneous interferon beta-1a (sc IFNβ-1a) in patients with relapsing multiple sclerosis (RMS), including COVID-19 and other respiratory viral infections.

Methods: Serious and non-serious adverse events (AEs)/adverse drug reactions (ADRs) from post‑approval spontaneous individual case safety reports are presented cumulative to May 2021. AE rates are shown as total number of patients. Current COVID-19 findings are summarized.

Results: A total of 527,833 ADRs have been reported; 6.6% of events were serious. Analysis of the most common respiratory viral infection ADRs reported spontaneously (influenza [2374 cases, constituting 0.45% of all ADRs], viral infection [319], H1N1 influenza [15], viral bronchitis [6], and viral upper respiratory tract infection [5]) did not reveal any abnormal trend outside the known safety profile of sc IFNβ-1a; cases were typically non-serious. There was no suggestion of an increased risk of more severe respiratory viral infection or other ADRs in RMS patients who experienced such infection while being treated with sc IFNβ-1a. As of 07 December 2021, the Merck KGaA safety database included 1470 suspected or confirmed cases of COVID-19 in sc IFNβ-1a treated RMS patients; the majority were non-serious events. Among confirmed cases (n=1221), 131 patients were hospitalized with 7 being admitted to the ICU or requiring mechanical ventilation. There were 30 fatalities (24 fatal COVID-19 events and 6 other fatalities unconfirmed for COVID-19 involvement). At time of reporting, around half of COVID-19 confirmed AEs were recovered or resolving.

Conclusions: Cumulative to 07 December 2021, there was no increased risk of COVID-19 in sc IFNβ-1a treated RMS patients and the majority of cases were non-serious, consistent with previously reported registries. No new safety concern was identified from post-approval cases in scope of this review.

DMT40 Post-Approval Safety of Subcutaneous Interferon β-1a in the Treatment of Multiple Sclerosis, with Particular Reference to Respiratory Viral Infections

DMT40
Post-Approval Safety of Subcutaneous Interferon β-1a in the Treatment of Multiple Sclerosis, with Particular Reference to Respiratory Viral Infections