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Abstract Details

Cladribine: a multicentre LOng-term efficacy Biomarker Australian Study (CLOBAS)
Multiple Sclerosis
P7 - Poster Session 7 (5:30 PM-6:30 PM)
9-009
To conduct a real-world study of cladribine tablets in an MS population and evaluate re-initiation of treatment after the second course.
The current dosing schedule for treatment of Multiple Sclerosis (MS) with cladribine is for 2 courses, given a year apart. Each course consists of two treatment weeks, 1 month apart. Cladribine is effective for up to 4 years in most patients.  Re-initiation of therapy after the second course has not been studied.  Lymphocyte monitoring is recommended prior to each course, with delay of the second course recommended if lymphocyte count is <800 cells/mm3.  There are no recommendations for delay of the second week dosing.

Patients will be recruited to participant in a six-year trial. After year 3, patients will have the option for re-dosing, if required or to switch therapy. Throughout the study we will assess blood-based biomarkers including lymphocyte subsets, serum neurofilament light chain, DNA methylation and MRI findings (brain volume/lesion load) and cognitive performance.  We also perform lymphocyte monitoring prior to the second dose of each course and delay treatment until lymphocyte count reaches a minimum of 700 cells/mm3.
30 patients have been recruited and 18 have completed the first course.  Of these 18, 3 were treatment naïve, the remaining had received prior therapy [teriflunomide (3), glatiramer acetate (1), fingolimod (2), alemtuzumab (2), ocrelizumab (1), natalizumab (1), dimethyl fumarate (4)].  Lymphocyte counts prior to the second week dosing did not differ between pre-treated and naïve patients (mean 1300 cells/mm3 vs. 1100 cells/mm3 P>0.05), with the exception of the two patients who had previously taken alemtuzumab (650 cells/mm3 ).
This will be the first trial of cladribine which offers re-initiation of therapy after year 3. Preliminary data suggests extra caution should be used when treating ex-alemtuzumab patients with cladribine tablets to avoid lymphopenia
Authors/Disclosures

PRESENTER 		No disclosure on file
No disclosure on file
Mastura Monif, MBBS, PhD (Alfred Health) Dr. Monif has nothing to disclose.
Trevor J. Kilpatrick, MBBS, PhD (Melbourne Neuroscience Institute, University of Melbourne) Dr. Kilpatrick has received stock or an ownership interest from Mx3 diagnostics. The institution of Dr. Kilpatrick has received research support from NHMRC. The institution of Dr. Kilpatrick has received research support from NMSS. The institution of Dr. Kilpatrick has received research support from MSRA. Dr. Kilpatrick has received intellectual property interests from a discovery or technology relating to health care. Dr. Kilpatrick has received publishing royalties from a publication relating to health care.
Helmut Butzkueven, MD, MBBS Dr. Butzkueven has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Oxford Health Policy Forum. The institution of Dr. Butzkueven has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. The institution of Dr. Butzkueven has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck. The institution of Dr. Butzkueven has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. The institution of Dr. Butzkueven has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche. Dr. Butzkueven has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for MSBase . The institution of Dr. Butzkueven has received research support from NHMRC. The institution of Dr. Butzkueven has received research support from Biogen. The institution of Dr. Butzkueven has received research support from Roche. The institution of Dr. Butzkueven has received research support from Novartis.
Bruce Taylor (Menzies Research Institue Tasmania) Bruce Taylor has nothing to disclose.
Pamela A. McCombe, MD (Dr PA McCombe Medical Pty Ltd) Dr. McCombe has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. McCombe has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. McCombe has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genzyme. The institution of Dr. McCombe has received research support from Motor Neurone Disease Resaerch Institute of Australia.
Suzanne J. Hodgkinson, MD, MBBS, PhD, FRACP The institution of Dr. Hodgkinson has received research support from MERCK. The institution of Dr. Hodgkinson has received research support from Atara. The institution of Dr. Hodgkinson has received research support from Biogen . The institution of Dr. Hodgkinson has received research support from Genzyme. The institution of Dr. Hodgkinson has received research support from ROCHE. The institution of Dr. Hodgkinson has received research support from Novartis.
Marzena Pedrini, PhD (Perron Institute for Neurological and Translational Science) Dr. Pedrini has nothing to disclose.
Allan G. Kermode, MD, MBBS, FRACP (SJOG Clinic, Suite 314) Dr. Kermode has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Kermode has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Roche.
No disclosure on file
Tomas Kalincik Tomas Kalincik has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Tomas Kalincik has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi Genzyme. Tomas Kalincik has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Tomas Kalincik has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck. Tomas Kalincik has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Tomas Kalincik has received personal compensation in the range of $500-$4,999 for serving as a Consultant for National Health and Medical Research Council. Tomas Kalincik has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MS Research Australia. Tomas Kalincik has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Tomas Kalincik has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Tomas Kalincik has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi Genzyme. Tomas Kalincik has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Tomas Kalincik has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Tomas Kalincik has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Tomas Kalincik has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb. Tomas Kalincik has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for WebMD Global. Tomas Kalincik has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Novartis. Tomas Kalincik has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen. Tomas Kalincik has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sanofi Genzyme. Tomas Kalincik has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Teva. Tomas Kalincik has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for BioCSL. Tomas Kalincik has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Merck. Tomas Kalincik has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Eisai. The institution of Tomas Kalincik has received research support from Biogen. The institution of Tomas Kalincik has received research support from Novartis. The institution of Tomas Kalincik has received research support from Genzyme. The institution of Tomas Kalincik has received research support from Roche. The institution of Tomas Kalincik has received research support from Celgene. The institution of Tomas Kalincik has received research support from Merck. The institution of Tomas Kalincik has received research support from MSBase Foundation. The institution of Tomas Kalincik has received research support from ARSEP and EDMUS Foundations. The institution of Tomas Kalincik has received research support from MS Research Australia. The institution of Tomas Kalincik has received research support from National Health and Medical Research Council. The institution of Tomas Kalincik has received research support from Australian Research Council. The institution of Tomas Kalincik has received research support from MS Society. The institution of Tomas Kalincik has received research support from Trish Foundation. Tomas Kalincik has a non-compensated relationship as a scientific leadership group chair with MSBase Foundation that is relevant to AAN interests or activities.
Jeannette Lechner-Scott, MD, PhD, FRACP (HNEAH) The institution of Prof. Lechner-Scott has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. The institution of Prof. Lechner-Scott has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. The institution of Prof. Lechner-Scott has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. The institution of Prof. Lechner-Scott has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. The institution of Prof. Lechner-Scott has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for elsevier. The institution of Prof. Lechner-Scott has received research support from Merck. The institution of Prof. Lechner-Scott has received research support from Biogen.