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Cases fulfilling the criteria of hospitalized, medically significant, or fatal were designated as serious and outcomes were classified per usual pharmacovigilance practice. The COVID pandemic continues to cause unprecedented disruption to normal social and economic life, with For patients with multiple sclerosis MS , the pandemic has been of particular concern because of the co-morbidities of this disease as well as the disease-modifying therapies DMTs used in its management.
Indeed, we previously published a summary of real-world outcomes for 46 cladribine tablets-treated patients with MS and confirmed or suspected COVID as of 29 June Jack et al. Here, we report an update on our original findings. In the current analysis, also conducted on data extracted from the Merck KGaA Global Patient Safety Database, COVID cases were defined as confirmed if a diagnostic test was reported as positive, while cases were described as suspected if no confirmatory test was performed or reported.
Since our initial report, the pharmacovigilance database now includes patients with confirmed or suspected COVID as of 15 January As per our earlier report Jack et al. Several patients who experienced COVID onset shortly before commencing Year 2 of treatment with cladribine tablets had treatment delayed until symptoms resolved, but were successfully treated thereafter. Outcomes are summarized in Fig. Among the suspected COVID cases one fatality was reported, a patient who died in late having experienced pneumonia and renal failure; the results of COVID testing were not provided.
This case fatality rate of 0. Summary of outcomes to 15 January , including outcomes according to age a. The time to onset of COVID from the most recent preceding treatment with cladribine tablets is of interest because of the reduction in circulating lymphocyte counts that occurs following each annual treatment course at the beginning of Years 1 and 2. The total lymphocyte nadir occurs in months 2β3 after the start of each annual course, with lower lymphocyte counts usually observed in Year 2 of treatment.
