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dc.contributor.authorPakpoor, Jen_US
dc.contributor.authorDisanto, Gen_US
dc.contributor.authorAltmann, DRen_US
dc.contributor.authorPavitt, Sen_US
dc.contributor.authorTurner, BPen_US
dc.contributor.authorMarta, Men_US
dc.contributor.authorJuliusson, Gen_US
dc.contributor.authorBaker, Den_US
dc.contributor.authorChataway, Jen_US
dc.contributor.authorSchmierer, Ken_US
dc.date.accessioned2016-06-06T12:09:39Z
dc.date.available2015-08-05en_US
dc.date.issued2015-12en_US
dc.date.submitted2015-11-04T18:07:27.716Z
dc.identifier.issn2332-7812en_US
dc.identifier.other10.1212/NXI.0000000000000158
dc.identifier.urihttp://qmro.qmul.ac.uk/xmlui/handle/123456789/12681
dc.description.abstractOBJECTIVE: To compare the cancer risk of cladribine and other disease-modifying drugs (DMDs) in trials of people with relapsing multiple sclerosis (pwRMS). METHODS: Meta-analysis of phase III trials of licensed DMDs for pwRMS and a phase III trial of cladribine (CLARITY). Cancer rates were compared using Fisher exact test. RESULTS: Eleven trials were included. Investigated treatments included cladribine, dimethyl fumarate, fingolimod, teriflunomide, natalizumab, alemtuzumab, and glatiramer acetate. The cancer rate in the CLARITY treatment group (0.34%) was not increased compared to all other treatment groups, whether including placebo-controlled trials only (0.6%, p = 0.4631) or all trials, i.e., including those with an active comparator arm (0.67%, p = 0.3669). No cancer was reported in the CLARITY placebo group, whereas the combined cancer rate of all other placebo groups was 1.19% (p = 0.0159). The cancer rate of zero in the CLARITY placebo group was also lower than that in the phase III trial of cladribine in people with clinically isolated syndrome (ORACLE MS, 2.91%, p = 0.0012). In fact, no difference was detected between cancer rates in the treatment groups of CLARITY (0.34%) and ORACLE MS (0.49%) (p = 0.6546). CONCLUSIONS: Our study does not support an increased cancer risk from cladribine in the doses used in CLARITY and ORACLE MS, which previously contributed to refusal of market authorization of cladribine in Europe. Longer-term follow-up is required to assess the safety profile of cladribine, as well as currently licensed DMDs, to definitively assess cancer risk.en_US
dc.description.sponsorshipK.S. has been supported by a Higher Education Funding Council for England (HEFCE) Clinical Senior Lectureship. The authors are grateful to Barts Charity for funding to cover publication costsen_US
dc.format.extente158 - ?en_US
dc.languageengen_US
dc.language.isoenen_US
dc.relation.ispartofNeurol Neuroimmunol Neuroinflammen_US
dc.titleNo evidence for higher risk of cancer in patients with multiple sclerosis taking cladribine.en_US
dc.typeArticle
dc.rights.holderAmerican Academy of Neurology
dc.identifier.doi10.1212/NXI.0000000000000158en_US
pubs.author-urlhttps://www.ncbi.nlm.nih.gov/pubmed/26468472en_US
pubs.issue6en_US
pubs.notesNo embargoen_US
pubs.publication-statusPublished onlineen_US
pubs.volume2en_US
dcterms.dateAccepted2015-08-05en_US


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