Abstract Details

Title The effect of cladribine tablets on delaying the time to conversion to CDMS or McDonald MS is consistent across subgroups in the ORACLE-MS study

Topic Multiple Sclerosis

Presentation(s) P3 - Poster Session 3 (5:30 PM-6:30 PM)

Poster/Presentation
Number 15-101

Objective To analyze the effect of cladribine tablets vs placebo on converstion to CDMS and McDonald MS across ORACLE-MS patient subgroups based on baseline characteristics.

Background In the Phase 3 randomized ORACLE-MS trial in 616 subjects with a first demyelinating event at high risk of converting to multiple sclerosis (MS), treatment with cladribine tablets 10 mg (3.5 mg/kg or 5.25 mg/kg cumulative dose over 2 years [CT3.5 and CT5.25, respectively]) significantly delayed both time to conversion to clinically definite multiple sclerosis (CDMS) according to Poser criteria (67% or 62% risk reduction [RR], respectively; both p<0.0001) and time to conversion to 2005 McDonald MS (50% or 57% RR, respectively; both p<0.0001), compared with placebo.

Design/Methods In this post-hoc analysis, time to conversion to CDMS or McDonald MS over the double-blind period was analyzed for patients treated with CT5.25 (N=204), CT3.5 (N=206) or placebo (N=206) across different subgroups. Subgroups were defined by baseline characteristics which have been investigated as potential predictors of CDMS conversion (age [<30 or ≥30 years], gender, first classification demyelinating event [monofocal or multifocal], presence of T1 Gd+ lesions and number of T2 lesions [<9 or ≥9 lesions]).

Results Treatment with CT3.5 or CT5.25 was consistently efficacious across the subgroups examined on conversion to CDMS compared with placebo for most comparisons (RR range: CT3.5, 39%–72%; CT5.25, 36%–79%). Similarly, treatment effect of both doses on conversion to 2005 McDonald MS was consistent across subgroups (CT3.5, 40%–59%; CT5.25, 42%–79%).

Conclusions This post-hoc analysis suggests that the effect of cladribine tablets on delaying the time to conversion to CDMS, or to McDonald MS, is consistent across subgroups.

Authors/Disclosures
James D. Bowen, MD (Swedish Neuroscience Institute) PRESENTER	Dr. Bowen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen IDEC. Dr. Bowen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for BristolMyers Squibb. Dr. Bowen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Genentech. Dr. Bowen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. The institution of Dr. Bowen has received research support from Biogen IDEC. The institution of Dr. Bowen has received research support from Genentech. The institution of Dr. Bowen has received research support from Genzyme. The institution of Dr. Bowen has received research support from Novartis. The institution of Dr. Bowen has received research support from Roche.
	No disclosure on file
Yann Hyvert, PhD (Merck Healthcare KGaA)	Dr. Hyvert has received personal compensation for serving as an employee of The healthcare business of Merck KGaA, Darmstadt, Germany. An immediate family member of Dr. Hyvert has received personal compensation for serving as an employee of The healthcare business of Merck KGaA, Darmstadt, Germany.
Fernando Dangond, MD, FAAN	Dr. Dangond has received personal compensation in the range of $1,000,000+ for serving as a Head, Global Clinical Development (employee for 12 years) with EMD Serono.
Daniel Jones, PhD (EMD Serono)	No disclosure on file
Megan Grosso	No disclosure on file
Thomas Leist, MD, PhD, FAAN (Thomas Jefferson University)	Dr. Leist has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Leist has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Leist has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Horizon. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech. Dr. Leist has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Genentech. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Horizon. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Seono. Dr. Leist has received personal compensation in the range of $10,000-$49,999 for serving as a Expert Wittness with DHHS HRSA.

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