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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\u20135\u00a0days 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\u00a0III 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\u00a0durable 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\u00a0robust humoral immune response to SARS-CoV\u20112 vaccination. We conclude that the current real-world evidence for CLAD tablets as immune reconstitution therapy for treatment of MS is based on a\u00a0small number of studies and a\u00a0population distinct from the cohorts randomized in the pivotal phase\u00a0III trials. Further research should advance the understanding of long-term disease control after active treatment periods and the mitigation of adverse events.<\/jats:p>","DOI":"10.1007\/s10354-022-00931-4","type":"journal-article","created":{"date-parts":[[2022,4,22]],"date-time":"2022-04-22T11:04:12Z","timestamp":1650625452000},"page":"365-372","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":27,"title":["Real-world evidence for cladribine tablets in multiple sclerosis: further insights into efficacy and safety","Real-World-Evidenz f\u00fcr Cladribin-Tabletten bei multipler Sklerose: weitere Erkenntnisse hinsichtlich Wirksamkeit und Sicherheit"],"prefix":"10.1007","volume":"172","author":[{"given":"Tobias","family":"Moser","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tjalf","family":"Ziemssen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8749-5533","authenticated-orcid":false,"given":"Johann","family":"Sellner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,4,22]]},"reference":[{"issue":"6","key":"931_CR1","doi-asserted-by":"publisher","first-page":"343","DOI":"10.1177\/135245859600100612","volume":"1","author":"JC Sipe","year":"1996","unstructured":"Sipe\u00a0JC, Romine\u00a0JS, Koziol\u00a0JA, McMillan\u00a0R, Zyroff\u00a0J, Beutler\u00a0E. 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