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Cladribine Tablets and COVID-19

• EMD Serono is continuing to conduct safety surveillance to identify and evaluate drug safety risks

• As of 15 January 2021, 272 suspected cases of COVID-19 occurring in patients treated with Cladribine Tablets have been reported to the Merck KGaA, Darmstadt, Germany safety database

• Of these 272 cases, 160 cases are positively confirmed COVID-19

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  • Please direct any queries relating to Cladribine Tablets and COVID-19 to the US medical information team.
  • ‘Medically significant’ specified by the case reporter. For simplicity of presentation, the outcome ‘Not reported’ also includes those with missing or pending outcomes. aIncludes 11 patients with compatible COVID-19 symptoms but not evaluated further given negative PCR tests; bIncludes 18 patients who were asymptomatic; cFollow-up ongoing.

Favorable outcomes after COVID-19 infection in multiple sclerosis patients treated with Cladribine Tablets

Jack D, Nolting A, Galazka A

Mult Scler Relat Disord 2020;102469

https://doi.org/10.1016/j.msard.2020.102469

DJ and AN are employees of Merck KGaA, Darmstadt, Germany. AG is an employee of Merck, Aubonne, Switzerland, a division of Merck KGaA, Darmstadt, Germany.

 

• Letter to the editor reporting outcomes of patients receiving Cladribine Tablets who have contracted COVID-19 and have been reported to the Merck KGaA, Darmstadt, Germany Global Patient Safety Database (data cut-off 29 June 2020)

Analysis of Influenza and Varicella Zoster Virus Vaccine Antibody Titers in Patients with Relapsing Multiple Sclerosis Treated with Cladribine Tablets

Roy S, Boschert U

Presented at the ACTRIMS Virtual Congress, 25–27 February, 2021

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• Retrospective analysis of seroprotective antibody levels against varicella zoster or seasonal influenza in patients who received vaccinations before or during treatment with Cladribine Tablets in the MAGNIFY-MS study

Evaluating the Impact of Cladribine Tablets on the Development of Antibody Titers: Interim Results from The CLOCK-MS Influenza Vaccine Substudy

Wu G.F, Boschert U, Hayward B et al

Presented at ACTRIMS Forum, 25–27 February, 2021

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• Contains information on seroprotective antibody levels against seasonal influenza in a subset of patients with relapsing-remitting MS and secondary progressive MS who received vaccinations during treatment with Cladribine Tablets in the CLOCK-MS study