Post-approval Safety of Subcutaneous Interferon β-1a in the Treatment of Multiple Sclerosis, with Particular Reference to Respiratory Viral Infections (1916)

Objective: To report on the post-approval safety profile of subcutaneous interferon β-1a (sc IFN β-1a) in patients with relapsing multiple sclerosis (RMS), including COVID-19 and other respiratory viral infections. Background: sc IFN β-1a is a well-established disease-modifying therapy for RMS, with an estimated cumulative exposure of 1,766,525 patient-years (to 3 May 2020). Design/Methods: Serious and non-serious adverse events (AEs) from post-approval spontaneous individual case safety reports are presented from February 1998 to May 2020. AE rates are shown as total number of patients. Up-to-date COVID-19 findings are summarized. Results: A total of 525,268 AEs have been reported; 6.6% of events were serious. No new safety concern has been identified. Analysis of the most common respiratory viral infection AEs reported spontaneously (influenza [2369 cases, constituting 0.45% of all AEs], 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 IFN β-1a; cases were typically non-serious. There was no suggestion of an increased risk of more severe respiratory viral infection or other adverse drug reactions in patients with RMS and experiencing a respiratory viral infection while being treated with sc IFN β-1a. As of 4 August 2020, the Merck KGaA safety database included 102 confirmed cases of COVID-19 in sc IFN β-1a treated RMS patients: 15 patients were hospitalized. Of these 102 patients, none required mechanical ventilation and there were 3 fatalities (1 fatal COVID-19 event [76-year-old male patient, with the cause of death stated as sepsis, bilateral pneumonia, and novel coronavirus] and 2 other fatalities unconfirmed for COVID-19 involvement). Conclusions: Cumulative to 4 August 2020, there was no increased risk of COVID-19 in sc IFN β-1a treated RMS patients and cases were relatively mild, consistent with previously reported registries. Disclosure: The institution of Dr. Freedman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Actelion(Janssen/J&J). The institution of Dr. Freedman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion. The institution of Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BiogenIdec. The institution of Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS/Celgene. The institution of Dr. Freedman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Inc. The institution of Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi-Genzyme. The institution of Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. The institution of Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. The institution of Dr. Freedman has received personal compensation in the range of $0-$499 for serving as a Consultant for Teva Canada Innovation. Dr. Freedman has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Actelion (Janssen/J&J). Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Atara Biotherapeutics. Dr. Freedman has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Bayer Healthcare. Dr. Freedman has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for BiogenIdec. Dr. Freedman has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Clene Nanomedicine. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GRI Bio. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Magenta Therapeutics. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck Serono. Dr. Freedman has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for MedDay. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Freedman has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi Genzyme. Dr. Freedman has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi Genzyme. Dr. Freedman has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. The institution of Dr. Freedman has received research support from Sanofi Genzyme. Hans Guehring has received personal compensation for serving as an employee of EMD Serono. Zuzana Murgasova has nothing to disclose. Dominic Jack has received personal compensation for serving as an employee of Merck KGaA, Darmstadt, Germany.