Einblicke in die Behandlung der Multiplen Sklerose mit Cladribin-Tabletten seit Beginn der COVID-19-Pandemie

Sellner, Johann

doi:10.1007/s00739-021-00761-w

Cited by 1 publication

(1 citation statement)

References 44 publications

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“…There is apparent interest in understanding the risk of an unfavorable COVID-19 outcome and efficacy of vaccination against SARS-CoV-2 in CLAD-treated patients [37]. Humoral responses to SARS-CoV-2 vaccines were unimpaired in CLAD-treated patients [38], and postvaccination seropositivity was independent of lymphocyte counts and age [39].…”

Section: Real-world Evidence For Clad Tablets and Covid-19mentioning

confidence: 99%

Real-world evidence for cladribine tablets in multiple sclerosis: further insights into efficacy and safety

Moser

Ziemssen

Sellner

2022

Wien Med Wochenschr

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SummaryCladribine (CLAD) is a purine nucleoside analog approved in tablet form to treat highly active multiple sclerosis (MS). CLAD tablets are the first oral therapy with an infrequent dosing schedule, administered in two annual treatment courses, each divided into two treatment cycles comprising 4–5 days of treatment. The efficacy and safety of CLAD tablets have been verified in randomized controlled clinical trials. Clinical observational studies are performed in more representative populations and over more extended periods, and thus provide valuable complementary insights. Here, we summarize the available evidence for CLAD tablets from post-marketing trials, including two observational, four long-term extensions, and two comparative studies. The patients in the post-marketing setting differed from the cohort recruited in the pivotal phase III trials regarding demographics and MS-related disability. The limited number of studies with small cohorts corroborate the disease-modifying capacity of oral CLAD and report on a durable benefit after active treatment periods. Skin-related adverse events were common in the studies focusing on safety aspects. In addition, single cases of CLAD-associated autoimmune events have been reported. Lastly, CLAD tablets appear safe regarding COVID-19 concerns, and patients mount a robust humoral immune response to SARS-CoV‑2 vaccination. We conclude that the current real-world evidence for CLAD tablets as immune reconstitution therapy for treatment of MS is based on a small number of studies and a population distinct from the cohorts randomized in the pivotal phase III trials. Further research should advance the understanding of long-term disease control after active treatment periods and the mitigation of adverse events.

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Section: Real-world Evidence For Clad Tablets and Covid-19mentioning

confidence: 99%