Post-approval safety of subcutaneous interferon β-1a in the treatment of multiple sclerosis, with particular reference to respiratory viral infections

Background: Subcutaneous interferon β-1a (sc IFN β-1a) is a well-established disease-modifying therapy for relapsing multiple sclerosis (RMS) Since its introduction to the market, the estimated cumulative exposure to sc IFN β-1a amounts to 1,766,525 patient-years (to 03 May 2020) In recent months the COVID-19 pandemic has become a concern for MS patients and their healthcare providers in terms of the associated safety of their diseasemodifying therapy Objectives: To report on the post-approval safety profile of sc IFN β-1a in patients with RMS, including COVID-19 and other respiratory viral infections 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, with 6 6% of events classified as serious No new safety concern has been identified, and there was no trend towards increased respiratory viral infections occurring during sc IFN β-1a treatment An analysis of the top five most common respiratory viral infection AEs reported spontaneously (influenza, viral infection, H1N1 influenza, viral bronchitis, and viral upper respiratory tract infection) did not reveal any abnormal trend outside the known safety profile of sc IFN β-1a, and cases were typically non-serious The most commonly reported respiratory viral infection was influenza with 2369 cases (constituting 0 45% of all AEs), followed by viral infection (319), H1N1 influenza (15), viral bronchitis (6), and viral upper respiratory tract infection (5) There was also 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 9 June 2020, the Merck safety database included 23 cases of confirmed COVID-19 in sc IFN β-1a treated MS patients An update on latest findings on COVID-19 infections will be presented Conclusions: Cumulative to May 2020, no new safety concern has been identified from the post-approval data of sc IFN β-1a, including no increased risk for respiratory viral infections