Cases of COVID-19 in Alemtuzumab-Treated Patients With MS: Pharmacovigilance Report (2059)

Objective: To report pharmacovigilance data from alemtuzumab-treated patients with MS and laboratory-confirmed or suspected infection with the novel 2019 coronavirus (SARS-CoV-2), the causative agent of COVID-19. Background: The safety and efficacy of MS treatments in patients infected with SARS-CoV-2 is largely unknown. Preliminary case studies of COVID-19 in patients with MS treated with alemtuzumab, an anti-CD52 antibody that depletes circulating lymphocytes, have generally reported outcomes similar to the general population. Design/Methods: A search in the Sanofi global safety database was performed to identify all SARS-CoV-2 infection cases reported from 01-Nov-2019 to 13-Sep-2020. Infections were considered confirmed when positive diagnostic tests were reported. Infections were considered suspected if patients exhibited COVID-19-related symptoms without laboratory confirmation. Age, sex, and time since last alemtuzumab infusion were among the characteristics recorded. Outcomes were classified as reported by the investigator: recovered, recovering, not recovered, fatal, or unknown. Results: As of 13-Sep-2020, there were 109 COVID-19 cases in alemtuzumab-treated patients with MS: 40 (37%) had confirmed infection (median age [range], 35 [21–61] years; women, 73%) and 69 (63%) had suspected infection (median age [range], 41 [22–60] years; women, 62%). In patients with confirmed infection and known time from alemtuzumab administration to COVID-19 onset (n=26), 16 (62%), 6 (23%), and 4 (15%) tested positive in 2 years since last alemtuzumab infusion, respectively. In patients with confirmed infection and known COVID-19 outcome (n=30), 22 (73%) recovered, 3 (10%) had not recovered by the time their reports were filed, and 5 (17%) were recovering. No fatalities were reported among confirmed and suspected COVID-19 cases. Outcome was unknown for 37 (34%) patients. Conclusions: This preliminary COVID-19 case assessment does not suggest any unexpected safety signals in alemtuzumab-treated patients with MS. In-depth analysis is ongoing and will be available at the time of the meeting. Disclosure: Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Atara Bio. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Giovannoni has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi-Genzyme. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck KGaA. Dr. Giovannoni has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Actelion. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Celgene. Dr. Giovannoni 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. Giovannoni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Giovannoni 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. Giovannoni 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. Dr. Giovannoni has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Medscape. Dr. Giovannoni has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Oxford Health Policy Forum. Dr. Giovannoni has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Neurology Academy. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Peervoice. Dr. Giovannoni has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier. Dr. Giovannoni has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Bristows . Aaron L. Boster, MD has nothing to disclose. The institution of Dr. Berkovich has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Alexion, Biogen, Genentec, Mallincrodt, Sanofi, Novartis, . Dr. Berkovich has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen, Genentec, Sanofi, Merck . Dr. Berkovich has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Alexion, Biogen, Sanofi, Merck, Mallincrodt . The institution of Dr. Berkovich has received research support from Biogen, Sanofi, Merck. Krzystof Selmaj has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Krzystof Selmaj has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Krzystof Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Krzystof Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Krzystof Selmaj has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Celgene. Krzystof Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Mylan. Krzystof Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Krzystof Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Krzystof Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche . Krzystof Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Luke Chung has received personal compensation for serving as an employee of Sanofi Genzyme. Luke Chung has received stock or an ownership interest from Sanofi Genzyme. Debora Shiota has received personal compensation for serving as an employee of Sanofi Genzyme. Salman Afsar has nothing to disclose.