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Conference/Presentation Title: | Clinical experience with cladribine in patients with relapsing-remitting multiple sclerosis. | Authors: | Parratt J.;Jack D.;Hodgkinson S.;Lizak N.;Butler E. ;Lechner-Scott J.;Slee M.;McCombe P.;Shaw C.;Skibina O.;Vucic S.;Shuey N.;Barnett M.;Butzkueven H.;Jokubaitis V.G.;Kalincik T.;Fabris J. | Institution: | (Lizak, Kalincik, Jokubaitis) CORe Department of Medicine, University of Melbourne, Melbourne, Australia (Hodgkinson) Liverpool Hospital, Sydney, Australia (Butler) Monash Medical Centre, Monash University, Melbourne, Australia (Lechner-Scott) Hunter New England health and Hunter Medical Research Institute, University of Newcastle, Australia (Slee) Flinders University, Adelaide, Australia (McCombe) Royal Brisbane and Women's Hospital, University of Queensland, Brisbane, Australia (Shaw) Geelong Hospital, Geelong, Deakin University, Melbourne, Australia (Lizak, Skibina, Butzkueven) Alfred Hospital, Melbourne, Australia (Vucic) Westmead Hospital, Sydney, Australia (Shuey) St Vincent's Hospital, Melbourne, Australia (Barnett) Brain and Mind Centre, Sydney, Australia (Parratt) Royal North Shore Hospital, Sydney, Australia (Butzkueven) Central Clinical School, Monash University, Melbourne, Australia (Jack) Merck Serono Ltd., Middlesex, United Kingdom (Fabris) Merck Serono Australia Pty Ltd., Frenchs Forest, NSW, Australia (Kalincik, Jokubaitis) Department of Neurology, Royal Melbourne Hospital, Melbourne, Australia | Presentation/Conference Date: | 10-Dec-2020 | Copyright year: | 2020 | Publisher: | SAGE Publications Ltd | Publication information: | Multiple Sclerosis Journal. Conference: Pan-Asian Committee for Treatment and Research in Multiple Sclerosis Congress, PACTRIMS 2019. Singapore Singapore. 26 (9) (pp NP64-NP65), 2020. Date of Publication: August 2020. | Abstract: | Background: Cladribine has recently been introduced to the armamentarium of therapies for relapsing MS. Objective(s): To report relapses and disability in patients who were treated with cladribine as part of a product familiarisation program in Australia in 2011. Method(s): Patients exposed to oral cladribine, cumulative dose 1.75 mg/kg, between January and July 2011, enrolled in the MSBase registry were included. Incidence of relapses and disability (EDSS) were reported by the patients' treating physicians and recorded in the MSBase database. Result(s): This cohort of patients were older and had a higher EDSS at commencing oral cladribine than patients in the clinical trials of oral cladribine. Mean age at commencing cladribine was 47 years, age at MS onset was 34 years, duration of MS was 13 years and median EDSS score was 5.25. Disability trajectories suggested an overall increasing trend prior to treatment with cladribine, which was reduced during the 2 years following treatment. Based on EDSS scores, approximately 80% of patients were free from progression, 65% of patients remained relapse free after 2 years and median time to next DMT was 1.7 years. Conclusion(s): The data from the Australian oral cladribine product familiarisation program complement the information form clinical trials and a head-to-head comparison of observational data. This information suggests cladribine is associated with reduction in the rate of disability worsening for at least two years from the initial treatment administration. The studied data are limited and representative post-marketing studies, including safety surveillance, are needed. | Conference Start Date: | 2019-11-13 | Conference End Date: | 2019-11-15 | DOI: | http://monash.idm.oclc.org/login?url=http://dx.doi.org/10.1177/1352458520925277 | ISSN: | 1477-0970 | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/35006 | Type: | Conference Abstract | Subjects: | incidence adult clinical trial cohort analysis conference abstract controlled study drug therapy Expanded Disability Status Scale female human male middle aged *multiple sclerosis physician postmarketing surveillance *relapse *remission *cladribine adult clinical trial cohort analysis conference abstract postmarketing surveillance physician *multiple sclerosis human incidence male middle aged *relapse *remission controlled study drug therapy Expanded Disability Status Scale female |
Type of Clinical Study or Trial: | Observational study (cohort, case-control, cross sectional or survey) |
Appears in Collections: | Conferences |
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