Abstract Details

Title Cases of COVID-19 in Teriflunomide-Treated Patients With MS: Pharmacovigilance Report

Topic Multiple Sclerosis

Presentation(s) MS and CNS Inflammatory Disease Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 020

Objective To report pharmacovigilance data from teriflunomide-treated patients with MS and infection with SARS-CoV-2, causative agent of COVID-19.

Background The COVID-19 pandemic has presented unique challenges on the use of MS disease-modifying therapies. Preliminary case studies of COVID-19 in teriflunomide-treated patients with MS have reported low disease severity, with patients mostly developing mild, self-limiting courses of infection.

Design/Methods A search was performed to identify all SARS-CoV-2 infection cases reported from 01-Nov-19 to 13-Sep-20 in the Sanofi global safety database. Infections were considered confirmed when positive diagnostic tests were reported. Suspected infections included patients exhibiting COVID-19-related symptoms, with no confirmed laboratory testing. Patients’ characteristics, including age and sex, were recorded. COVID-19 outcomes were classified as reported by the investigator: recovered, recovering, not recovered, fatal, or unknown.

Results As of 13-Sep-20, there were 176 COVID-19 cases in teriflunomide-treated patients with MS: 79 (45%) with confirmed infection (median age [range], 51 [24?75] years; women, 75%) and 97 (55%) with suspected infection (median age [range], 54 [20?83] years; women, 74%). In patients with confirmed infection and known, nonfatal COVID-19 outcome (n=49), 25 (51%) recovered without sequelae, 1 (2%) recovered with sequelae, 10 (20%) were recovering, and 13 (27%) had not recovered by the time their reports were filed. Overall, 72/176 (41%) patients had an unknown outcome. There were 9 deaths reported among confirmed (n=5) and suspected (n=4) COVID-19 cases (median age, 61 years [n=8]; age not reported [n=1]). The majority of fatal cases had comorbidities contributing to COVID-19-related adverse events, most commonly hypertension (n=5), followed by hypercholesterolemia (n=4), obesity (n=4), and diabetes (n=3); one patient had chronic kidney disease.

Conclusions Data from pharmacovigilance registries may have a potential bias towards more severe cases. An in-depth analysis of these data is being performed and will be available at the time of the meeting.

Authors/Disclosures
Celine Louapre (Hôpital Pitié Salpêtrière, APHP) PRESENTER	Celine Louapre has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Celine Louapre has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Celine Louapre has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Celine Louapre has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Celine Louapre has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Oculis.
Jose Manuel Garcia Dominguez (Hospital General Universitario Gregorio Marañón)	Jose Manuel Garcia Dominguez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi Genzyme. Jose Manuel Garcia Dominguez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Jose Manuel Garcia Dominguez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Jose Manuel Garcia Dominguez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Almirall. Jose Manuel Garcia Dominguez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Jose Manuel Garcia Dominguez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb. Jose Manuel Garcia Dominguez has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Jose Manuel Garcia Dominguez has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Jose Manuel Garcia Dominguez has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi Genzyme. Jose Manuel Garcia Dominguez has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Jose Manuel Garcia Dominguez has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Jose Manuel Garcia Dominguez has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Johnson & Johnson. Jose Manuel Garcia Dominguez has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Almirall. Jose Manuel Garcia Dominguez has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bristol Myers Squibb.
Lucia Moiola, MD, PhD (Fondazione Centro San Raffaele)	Dr. Moiola has nothing to disclose.
Massimo Filippi, MD, FAAN (Ospedale San Raffaele, Neuroimaging Research Unit)	Dr. Filippi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion, Almirall, Biogen, Merck, Novartis, Roche, Sanofi. Dr. Filippi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion, Biogen, Bristol-Myers Squibb, Merck, Novartis, Roche, Sanofi, Sanofi-Aventis, Sanofi-Genzyme, Takeda. Dr. Filippi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bayer, Biogen, Celgene, Chiesi Italia SpA, Eli Lilly, Genzyme, Janssen, Merck-Serono, Neopharmed Gentili, Novartis, Novo Nordisk, Roche, Sanofi, Takeda, and TEVA. Dr. Filippi has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Springer Nature. The institution of Dr. Filippi has received research support from Biogen Idec, Merck-Serono, Novartis, Roche, the Italian Ministry of Health, the Italian Ministry of University and Research, and Fondazione Italiana Sclerosi Multipla.
Carlo S. Tornatore, MD (Medstar Georgetown University Hospital)	Dr. Tornatore has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Serono. Dr. Tornatore has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Tornatore has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Tornatore has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen.
Janneke Van Wingerden	Janneke Van Wingerden has received personal compensation for serving as an employee of Sanofi Genzyme.
	No disclosure on file

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