Abstract Details

Title Updated Post-Approval Safety of Cladribine Tablets in the Treatment of Multiple Sclerosis, With Particular Reference to Respiratory Viral Infections and COVID-19

Topic Multiple Sclerosis

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

Poster/Presentation
Number 196

Objective To update on the post-approval safety profile of cladribine tablets 10 mg (3.5 mg/kg cumulative dose over 2 years [CT3.5]) in patients with relapsing multiple sclerosis (MS), including COVID-19 and other respiratory viral infections.

Background Several integrated analyses have reported on the safety of CT3.5 during clinical development for treatment of relapsing MS. Additional real-life safety data have accrued since the approval of CT3.5 in many countries worldwide. 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 disease-modifying therapy

Design/Methods Serious and non-serious adverse events (AEs) from post-approval sources (including spontaneous individual case safety reports, non-interventional post-marketing studies, and reports from other solicited sources) are presented to July 2020. AE rates are shown as crude incidences.

Results 3357 AEs were spontaneously reported for the first 18,463 patients who received CT3.5 post-approval; 435 (13%) of these events were serious. Crude incidences for AEs of special interest: severe lymphopenia, 0.21%; herpes zoster, 1.07%; tuberculosis, 0.05%; severe infections, 1.23%; progressive multifocal leukoencephalopathy, 0%; opportunistic infections, 0.04%; malignancies, 0.23%; and congenital anomalies, 0%. The pattern of respiratory viral infections (typically non-serious) with post-approval use of CT3.5 was also consistent with that of the clinical development program; crude incidences: H1N1 influenza, 0.01%; influenza, 0.68%; viral infection, 0.27%; and viral upper respiratory tract infection, 0.04%. As of 7 September 2020, the Merck KGaA safety database included 85 cases of suspected COVID-19 in CT3.5-treated patients (confirmed by test, n=38). An update on latest findings on COVID-19 infections will be presented, including analysis of time of infection since treatment where available.

Conclusions The safety profile of CT3.5, including respiratory viral infections, is consistent with previously published integrated safety analyses of the clinical development data.

Authors/Disclosures
Gavin Giovannoni, MD (QMUL) PRESENTER	Dr. Giovannoni has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. 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 $10,000-$49,999 for serving as a Consultant for Roche-Genentech. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Moderna. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Astoria Biologica. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zenas. 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. Dr. Giovannoni has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Medscape.
Joseph R. Berger, MD, FAAN	Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squibb/Celgene. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cycle Pharma. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Dice Therapeutics. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech/Roche. Dr. Berger has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Gilead. Dr. Berger has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck/. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Morphic. Dr. Berger has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Takeda. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for MAPI. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ExcisionBio. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Population Bio. Dr. Berger has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for TG Therapeutics. Dr. Berger has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Assorted .
Thomas Leist, MD, PhD, FAAN (Thomas Jefferson University)	Dr. Leist has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Leist has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Leist has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Horizon. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech. Dr. Leist has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Genentech. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Horizon. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Seono. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving as a Expert Wittness with DHHS HRSA.
Dominic Jack (Merck Serono Ltd)	Dominic Jack has received personal compensation for serving as an employee of Merck KGaA, Darmstadt, Germany.
	No disclosure on file
	No disclosure on file
	No disclosure on file

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