ABSTRACT
Objective: 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. 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). Design/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 17 August 2021, the Merck KGaA safety database included 1256 suspected or confirmed cases of COVID-19 in sc IFNβ-1a treated RMS patients;the majority were non-serious events. Among confirmed cases (n=1029), 110 patients were hospitalized with 5 requiring mechanical ventilation. There were 24 fatalities (18 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 17 August 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.
ABSTRACT
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.