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The concept of SIRT is characterized by brief exposure to active substances with long-term effectiveness, repopulation of lymphocytes, and maintenance of immune competence. In consequence, cladribine tablets allow patients to enter a prolonged treatment-free period, which offers time windows for family planning and vaccinations. Long-term control of disease activity has been linked to the sustained reduction of memory B cells. Based on more than 17\u00a0years of follow-up, the favorable safety profile is characterized by manageable front loading side effects and a low cumulative risk. Overall, therapy with cladribine tablets is associated with a low monitoring burden and leads to high treatment satisfaction. Meanwhile, 15\u00a0years after primary results from the pivotal trial were published, a vast amount of new data has emerged, including central effects of cladribine tablets. This narrative review discusses existing and emerging efficacy and safety data for cladribine tablets in MS and links these learnings to different patient profiles encountered in clinical practice. These include young patients with newly diagnosed RMS, young patients with highly active disease, and older patients switching from anti-CD20 antibodies or spingosine-1-phosphate modulators.<\/jats:p>","DOI":"10.1007\/s00415-025-13530-1","type":"journal-article","created":{"date-parts":[[2025,11,27]],"date-time":"2025-11-27T18:46:25Z","timestamp":1764269185000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Is therapy-free remission a realistic goal with cladribine tablets in multiple sclerosis? New insights into the mechanism of action and clinical implications of immune reconstitution with cladribine tablets in MS therapy"],"prefix":"10.1007","volume":"272","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1650-8875","authenticated-orcid":false,"given":"C.","family":"Kleinschnitz","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8550-335X","authenticated-orcid":false,"given":"T.","family":"Skripuletz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5171-4845","authenticated-orcid":false,"given":"S.","family":"Pfeuffer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3080-2277","authenticated-orcid":false,"given":"M.","family":"Pawlitzki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6921-0135","authenticated-orcid":false,"given":"P.","family":"Rieckmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6746-1034","authenticated-orcid":false,"given":"I.-K.","family":"Penner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-5062-1093","authenticated-orcid":false,"given":"J.","family":"Knaup","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-7479-4311","authenticated-orcid":false,"given":"T.","family":"Wagner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"H\u00fcbschen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4467-9011","authenticated-orcid":false,"given":"K.","family":"Hellwig","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8940-9317","authenticated-orcid":false,"given":"R.","family":"Pul","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,11,27]]},"reference":[{"key":"13530_CR1","first-page":"571","volume":"11","author":"G Giovannoni","year":"2022","unstructured":"Giovannoni G, Mathews J (2022) Cladribine tablets for relapsing-remitting multiple sclerosis: a clinician\u2019s review. 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September 24-26, 2025"}],"container-title":["Journal of Neurology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00415-025-13530-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00415-025-13530-1\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00415-025-13530-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T15:30:04Z","timestamp":1765812604000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s00415-025-13530-1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11,27]]},"references-count":107,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2025,12]]}},"alternative-id":["13530"],"URL":"https:\/\/doi.org\/10.1007\/s00415-025-13530-1","relation":{},"ISSN":["0340-5354","1432-1459"],"issn-type":[{"value":"0340-5354","type":"print"},{"value":"1432-1459","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,11,27]]},"assertion":[{"value":"5 September 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"14 November 2025","order":2,"name":"revised","label":"Revised","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"15 November 2025","order":3,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"27 November 2025","order":4,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Christoph Kleinschnitz received honoraria for lecturing and travel expenses for attending meetings from Alexion, Almirall, Astra Zenica, Bayer, Biogen, Biontech, Boehringer Ingelheim Bristol Myers-Squibb, C.T.I., Daiichi Sankyo, Docspert, Merck Healthcare Germany GmbH, Weiterstadt, an affiliate of Merck KGaA, Mylan\/Viatris, Novartis, Pfizer, Roche, Sanofi-Aventis, Stada, Teva, Janssen-Cilag, Horizon Therapeutics, Medscape LLC, Baumgart Consultants, StreamedUp!, Hexal\/Sandoz, Agentur S\u00fcss, Viatris. Thomas Skripuletz reports research support from Alnylam, CSL Behring, Merck Healthcare Germany GmbH, Weiterstadt, an affiliate of Merck KGaA, Novartis, Siemens; honoraria for lectures, travel support for meeting attendance, and\/or consultancy fees from Alexion, Alnylam, argenx, Bayer, Biogen, Bristol Myers Squibb, Centogene, CSL Behring, Grifols, Hexal AG, Horizon, Janssen, Merck Healthcare Germany GmbH, Weiterstadt, an affiliate of Merck KGaA, Novartis, Pfizer, Roche, Sanofi, Siemens, SOBI, Teva, Viatris. Steffen Pfeuffer received honoraria for lecturing and for serving on advisory boards from argenx, Alexion, Biogen, Hexal, Merck Healthcare Germany GmbH, Weiterstadt, an affiliate of Merck KGaA, Novartis, Roche, and Sanofi Aventis; travel reimbursements from Alexion, Biogen, Merck Healthcare Germany GmbH, Weiterstadt, an affiliate of Merck KGaA, neuraxpharm, and Roche; research support from Biogen, Merck Healthcare Germany GmbH, Weiterstadt, an affiliate of Merck KGaA, and Novartis. Marc Pawlitzki received honoraria for lecturing and travel expenses for attending meetings from Alexion, ArgenX, Bayer Health Care, Biogen, Hexal, Merck Healthcare Germany GmbH, Weiterstadt, an affiliate of Merck KGaA, Novartis, Roche, Sanofi-Aventis, Takeda and Teva. His research is funded by ArgenX, Biogen, Demecan, Hexal, Horizon, Merck Healthcare Germany GmbH, Weiterstadt, an affiliate of Merck KGaA, Novartis, Roche, Viatris, Takeda and Teva, all outside the scope of this work. His research is funded by the by the German Multiple Sclerosis Foundation (DMSG), the B.Braun Foundation and the German Alzheimer Society. Peter Rieckmann received honoraria for lectures from Almirall, Apple Healthcare, Baxter, Bayer, Biogen Idec, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, Genpharm, Genzyme, Medtronic, Merck Healthcare Germany GmbH, Weiterstadt, an affiliate of Merck KGaA, Novartis, Pfizer, Roche, Sanofi, Siemens AG, and Teva. He received research grants from Brainlight, German Neurology Foundation, h\/p\/Cosmos, Max Aicher Foundation, Oberfranken-Stiftung, Red Bull, and Teva. He served on advisory boards or steering committees for Aycan, Bayer, Biogen Idec, Canada Drug Review, the German Multiple Sclerosis Society, Novartis, Merck Healthcare Germany GmbH, Weiterstadt, an affiliate of Merck KGaA, and Teva. Iris-Katharina Penner received honoraria for speaking at scientific meetings, serving at scientific advisory boards and consulting activities from Almirall, Celgene, Sanofi-Genzyme, Janssen, Merck Healthcare Germany GmbH, Weiterstadt, an affiliate of Merck KGaA, Novartis, Roche, and Teva. She received research support from the German MS Society, Celgene, Novartis, Roche, and Teva. Judith Knaup, Torsten Wagner and Michael H\u00fcbschen are employees of Merck Healthcare Germany GmbH, Weiterstadt, an affiliate of Merck KGaA. Kerstin Hellwig received research support, honoraria for lecturing and travel expenses for attending meetings from Alexion, Almirall, Bayer, Biogen, Merck Healthcare Germany GmbH, Weiterstadt, an affiliate of Merck KGaA, Mylan\/Viatris, Novartis, Pfizer, Roche, Sanofi-Aventis, Teva, Horizon Therapeutics, Medscape LLC, StreamedUp!, Hexal\/Sandoz. Refik Pul received honoraria for lecturing and consulting from Alexion, Amgen, Bayer Healthcare, Biogen, Bristol Myers Squibb\/Celgene, Chiesi, Janssen, Juvis\u00e9, Merck Healthcare Germany GmbH, Weiterstadt, an affiliate of Merck KGaA, Neuraxpharm, Novartis, Roche, Sanofi Genzyme and Viatris. He received research funds from Merck Healthcare Germany GmbH, Weiterstadt, an affiliate of Merck KGaA, Neuraxpharm, and Novartis.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}}],"article-number":"788"}}