dc.contributor.author | Giovannoni, G | en_US |
dc.contributor.author | Soelberg Sorensen, P | en_US |
dc.contributor.author | Cook, S | en_US |
dc.contributor.author | Rammohan, K | en_US |
dc.contributor.author | Rieckmann, P | en_US |
dc.contributor.author | Comi, G | en_US |
dc.contributor.author | Dangond, F | en_US |
dc.contributor.author | Adeniji, AK | en_US |
dc.contributor.author | Vermersch, P | en_US |
dc.date.accessioned | 2018-04-09T08:20:40Z | |
dc.date.issued | 2018-10 | en_US |
dc.date.submitted | 2017-10-12T14:22:20.821Z | |
dc.identifier.uri | http://qmro.qmul.ac.uk/xmlui/handle/123456789/36264 | |
dc.description.abstract | BACKGROUND: In the 2-year CLARITY study, cladribine tablets significantly improved clinical and magnetic resonance imaging (MRI) outcomes (vs placebo) in patients with relapsing-remitting multiple sclerosis (MS). OBJECTIVE: To assess the safety and efficacy of cladribine treatment in a 2-year Extension study. METHODS: In this 2-year Extension study, placebo recipients from CLARITY received cladribine 3.5 mg/kg; cladribine recipients were re-randomized 2:1 to cladribine 3.5 mg/kg or placebo, with blind maintained. RESULTS: A total of 806 patients were assigned to treatment. Adverse event rates were generally similar between groups, but lymphopenia Grade ⩾ 3 rates were higher with cladribine than placebo (Grade 4 lymphopenia occurred infrequently). In patients receiving cladribine 3.5 mg/kg in CLARITY and experiencing lymphopenia Grade ⩾ 3 in the Extension, >90% of those treated with cladribine 3.5 mg/kg and all treated with placebo in the Extension, recovered to Grade 0-1 by study end. Cladribine treatment in CLARITY produced efficacy improvements that were maintained in patients treated with placebo in the Extension; in patients treated with cladribine 3.5 mg/kg in CLARITY, approximately 75% remained relapse-free when given placebo during the Extension. CONCLUSION: Cladribine tablets treatment for 2 years followed by 2 years' placebo treatment produced durable clinical benefits similar to 4 years of cladribine treatment with a low risk of severe lymphopenia or clinical worsening. No clinical improvement in efficacy was apparent following further treatment with cladribine tablets after the initial 2-year treatment period in this trial setting. | en_US |
dc.description.sponsorship | This study was sponsored by EMD Serono, Inc., a business of Merck KGaA, Darmstadt, Germany (in the United States), and Merck Serono SA, Geneva, an affiliate of Merck KGaA Darmstadt, Germany (rest of the world). | en_US |
dc.format.extent | 1594 - 1604 | en_US |
dc.language | eng | en_US |
dc.relation.ispartof | Mult Scler | en_US |
dc.rights | This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage). | |
dc.subject | CLARITY Extension | en_US |
dc.subject | Relapsing–remitting multiple sclerosis | en_US |
dc.subject | cladribine tablets | en_US |
dc.subject | efficacy | en_US |
dc.subject | randomized trial | en_US |
dc.subject | safety | en_US |
dc.title | Safety and efficacy of cladribine tablets in patients with relapsing-remitting multiple sclerosis: Results from the randomized extension trial of the CLARITY study. | en_US |
dc.type | Article | |
dc.rights.holder | © The Author(s), 2017. | |
dc.identifier.doi | 10.1177/1352458517727603 | en_US |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/28870107 | en_US |
pubs.issue | 12 | en_US |
pubs.notes | No embargo | en_US |
pubs.notes | Open access | en_US |
pubs.publication-status | Published | en_US |
pubs.volume | 24 | en_US |