{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T08:17:08Z","timestamp":1790410628426,"version":"4.1.0"},"reference-count":24,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2011,1,12]],"date-time":"2011-01-12T00:00:00Z","timestamp":1294790400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Mult Scler"],"published-print":{"date-parts":[[2011,5]]},"abstract":"<jats:p>Background: Cladribine is a synthetic deoxyadenosine analogue in development as an oral multiple sclerosis (MS) therapy.<\/jats:p>\n                  <jats:p>Objective: To report in detail the safety findings from the 96-week, phase III, double-blind CLARITY study, which evaluated treatment with cladribine tablets in relapsing\u2013remitting MS.<\/jats:p>\n                  <jats:p>Methods: A total of 1,326 patients were randomized 1\u2009:\u20091\u2009:\u20091 to two short-course regimens of cladribine tablets (3.5 or 5.25\u2009mg\/kg cumulative dose over 96 weeks) or placebo. Safety assessments included monitoring for adverse events (AEs), routine physical and neurologic examinations and frequent laboratory parameter assessments.<\/jats:p>\n                  <jats:p>Results: Of the randomized patients, 88.6% completed treatment with cladribine tablets versus 86.3% with placebo. Lymphopenia was the most commonly reported AE in patients treated with cladribine tablets and was anticipated based on the mechanism of action. The incidence of infections was 48.3% with cladribine tablets and 42.5% with placebo, with 99.1% and 99.0% rated mild-to-moderate by investigators. Herpes zoster infections developed in 20 (2.3%) cladribine-treated patients; all cases were dermatomal. There were no herpes zoster infections in the placebo group. Nine (1.0%) patients experienced events related to uterine leiomyomas in the cladribine tablets groups versus one (0.2%) with placebo. Three isolated cases of malignancy were reported in cladribine-treated patients during the study; a fourth was reported during post-study surveillance. A pre-malignant cervical carcinoma in situ was also reported. The incidence of malignancies during the study did not exceed the expected rate in a population standardized for country, gender and age.<\/jats:p>\n                  <jats:p>Conclusion: The safety and tolerability profile observed in the CLARITY study together with the reported efficacy support the potential for cladribine tablets as an MS therapy.<\/jats:p>","DOI":"10.1177\/1352458510391344","type":"journal-article","created":{"date-parts":[[2011,1,12]],"date-time":"2011-01-12T20:57:00Z","timestamp":1294865820000},"page":"578-593","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":122,"title":["Safety and tolerability of cladribine tablets in multiple sclerosis: the CLARITY (CLAdRIbine Tablets treating multiple sclerosis orallY) study"],"prefix":"10.1177","volume":"17","author":[{"given":"S","family":"Cook","sequence":"first","affiliation":[{"name":"University of Medicine and Dentistry, New Jersey Medical School, Newark, NJ, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P","family":"Vermersch","sequence":"additional","affiliation":[{"name":"University of Lille \u2013 Nord de France, Lille, France."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G","family":"Comi","sequence":"additional","affiliation":[{"name":"Department of Neurology and Institute of Experimental Neurology, Universit\u00e0 Vita-Salute San Raffaele, Milan, Italy."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G","family":"Giovannoni","sequence":"additional","affiliation":[{"name":"Queen Mary University London, Blizard Institute of Cell and Molecular Science, Barts and The London School of Medicine and Dentistry, London, UK."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K","family":"Rammohan","sequence":"additional","affiliation":[{"name":"Department of Neurology, University of Miami, Miami, FL, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P","family":"Rieckmann","sequence":"additional","affiliation":[{"name":"Department of Neurology, Bamberg Hospital and University of Erlangen, Bamberg, Germany."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P Soelberg","family":"S\u00f8rensen","sequence":"additional","affiliation":[{"name":"Danish Multiple Sclerosis Center, Copenhagen University and Department of Neurology, Rigshospitalet, Copenhagen, Denmark."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A","family":"Hamlett","sequence":"additional","affiliation":[{"name":"Merck Serono S.A. \u2013 Geneva, Geneva, Switzerland."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M","family":"Miret","sequence":"additional","affiliation":[{"name":"Merck Serono S.A. \u2013 Geneva, Geneva, Switzerland."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J","family":"Weiner","sequence":"additional","affiliation":[{"name":"Merck Serono S.A. \u2013 Geneva, Geneva, Switzerland."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"V","family":"Viglietta","sequence":"additional","affiliation":[{"name":"Merck Serono S.A. \u2013 Geneva, Geneva, Switzerland."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"B","family":"Musch","sequence":"additional","affiliation":[{"name":"Merck Serono S.A. \u2013 Geneva, Geneva, Switzerland."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"SJ","family":"Greenberg","sequence":"additional","affiliation":[{"name":"Merck Serono S.A. \u2013 Geneva, Geneva, Switzerland."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2011,1,12]]},"reference":[{"key":"bibr1-1352458510391344","doi-asserted-by":"publisher","DOI":"10.1185\/030079907X233142"},{"key":"bibr2-1352458510391344","first-page":"4","volume":"9","author":"Cohen BA","year":"2007","journal-title":"Int J MS Care"},{"key":"bibr3-1352458510391344","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.93.4.1716"},{"key":"bibr4-1352458510391344","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.54.5.1145"},{"key":"bibr5-1352458510391344","doi-asserted-by":"publisher","DOI":"10.1046\/j.1525-1381.1999.09115.x"},{"key":"bibr6-1352458510391344","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(94)91046-4"},{"key":"bibr7-1352458510391344","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0902533"},{"key":"bibr8-1352458510391344","unstructured":"International Agency for Research on Cancer (IARC). 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