ABSTRACT
BACKGROUND: In accordance with expert guidance, patients have typically continued to receive treatment with subcutaneous interferon beta-1a (sc IFN ß-1a) for relapsing multiple sclerosis (MS) during the COVID-19 pandemic. METHODS: We provide a summary of outcomes among sc IFN ß-1a-treated patients with adverse events related to confirmed or suspected COVID-19, as reported to the Merck Global Patient Safety Database (as of 2 February 2021). Serious COVID-19-related adverse events (as classified by the reporting clinician) included those leading to hospitalization, admission to intensive care, or death. Outcomes were classified per usual pharmacovigilance practice. RESULTS: The evaluable cohort comprised 603 patients of median age 43 (range, 13-84) years and 75.1% were female. COVID-19 was experienced at a median of 33.0 (range, 0-321.8) months after start of treatment with sc IFN ß-1a. A total of 136 (22.6%) patients experienced serious COVID-19 events, including 59 hospitalizations (4 patients admitted to intensive care) and 5 deaths (fatality rate, 0.8%). Regarding non-fatal outcomes, 47.8% of patients (289/603) with COVID-19 adverse events were recovered or recovering at time of analysis; similar findings were apparent for the serious and hospitalized cohorts. CONCLUSION: Findings of this analysis from the Merck Global Patient Safety Database suggest that, compared with available statistics for the general population and those with MS, patients receiving sc IFN ß-1a for treatment of relapsing MS have relatively low rates of serious disease and/or severe outcomes with COVID-19.
Subject(s)
COVID-19 , Multiple Sclerosis, Relapsing-Remitting , Multiple Sclerosis , Adult , Female , Humans , Injections, Subcutaneous , Interferon beta-1a/adverse effects , Multiple Sclerosis/drug therapy , Multiple Sclerosis/epidemiology , Multiple Sclerosis, Relapsing-Remitting/drug therapy , Multiple Sclerosis, Relapsing-Remitting/epidemiology , Pandemics , SARS-CoV-2 , Treatment OutcomeABSTRACT
At its October 2020 meeting, the Advisory Committee on Immunization Practices (ACIP)* approved the Recommended Immunization Schedule for Adults Aged 19 Years or Older, United States, 2021. After the Emergency Use Authorization of Pfizer-BioNTech COVID-19 vaccine by the Food and Drug Administration, ACIP issued an interim recommendation for use of Pfizer-BioNTech COVID-19 vaccine in persons aged ≥16 years at its December 12, 2020, emergency meeting (1). In addition, ACIP approved an amendment to include COVID-19 vaccine recommendations in the child and adolescent and adult immunization schedules. After Emergency Use Authorization of Moderna COVID-19 vaccine by the Food and Drug Administration, ACIP issued an interim recommendation for use of Moderna COVID-19 vaccine in persons aged ≥18 years at its December 19, 2020, emergency meeting (2).
Subject(s)
Immunization/standards , Practice Guidelines as Topic , Vaccines/administration & dosage , Adult , Advisory Committees , Centers for Disease Control and Prevention, U.S. , Humans , Immunization Schedule , United StatesABSTRACT
The outbreak of a severe acute respiratory syndrome caused by a novel coronavirus (COVID-19), has raised health concerns for patients with multiple sclerosis (MS) who are commonly on long-term immunotherapies. Managing MS during the pandemic remains challenging with little published experience and no evidence-based guidelines. We present five teriflunomide-treated patients with MS who subsequently developed active COVID-19 infection. The patients continued teriflunomide therapy and had self-limiting infection, without relapse of their MS. These observations have implications for the management of MS in the setting of the COVID-19 pandemic.