Abstract Details

Title Reduction of Risk of Secondary Progressive Multiple Sclerosis Within Two Years of Treatment with Cladribine Tablets

Topic Multiple Sclerosis

Presentation(s) P7 - Poster Session 7 (5:30 PM-6:30 PM)

Poster/Presentation
Number 9-016

Objective Explore (post hoc) the relationship between baseline Expanded Disability Status Scale (EDSS) and risk of progression to secondary progressive multiple sclerosis (SPMS) or to EDSS ≥6.0 in CLARITY.

Background Cladribine tablets (CT) 10mg, cumulative dose 3.5 mg/kg (CT3.5; N=433) over 2 years showed efficacy vs placebo (PBO; N=437) in patients with relapsing multiple sclerosis in the CLARITY study.

Design/Methods As progression to SPMS was not recorded during the trial, a proxy composite definition was used: confirmed disability progression (CDP), CDP within the leading EDSS-defined functional system (FS) score, EDSS post-baseline ≥4.0, pyramidal FS ≥2, all conditions met for at least 3 months (mo) in the absence of a relapse. Patients progressing to EDSS ≥6.0 were defined by having ≥1 post-baseline EDSS ≥6.0 with 3 or 6mo CDP.

Results Overall, proxy SPMS progression was seen in 6.7% of CT3.5 patients vs 13.5% for PBO (odds ratio [OR] 0.46; p=0.0024). In the baseline EDSS ≤3.0 subgroup (CT3.5 n=257; PBO n=235), proxy SPMS progression occurred in 3.5% vs 7.7% (CT3.5 vs PBO; OR 0.44; p=0.0471). In the baseline EDSS ≥3.5 subgroup (CT3.5 n=148; PBO n=157), proxy SPMS progression occurred in 12.2% vs 22.4% (CT3.5 vs PBO; OR 0.48; p=0.0212). Similar effects have been observed for each proxy SPMS component vs PBO. Proportions of patients with at least one EDSS value ≥6.0 post-baseline were 6.4% vs 14.5% (CT3.5 vs PBO; OR 0.4; p=0.0004). Corresponding proportions for patients with 3mo CDP with EDSS ≥6.0 were 3.5% vs 8.0% (CT3.5 vs PBO; OR 0.42; p=0.0114) and for patients with 6mo CDP with EDSS ≥6.0 were 2.8% vs 5.8% (CT3.5 vs PBO; OR 0.48; p=0.0566).

Conclusions The risks of progressing to SPMS (proxy) within 2 years of treatment, or experiencing EDSS ≥6.0, are significantly reduced with CT3.5 vs PBO, regardless of baseline EDSS (≤3.0 or ≥3.5).

Authors/Disclosures
Patrick Vermersch (CHR de Lille) PRESENTER	Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AB Science. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Imcyse. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS-Celgene. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ad Scientiam. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for La revue des microbiotes. The institution of Patrick Vermersch has received research support from Roche. The institution of Patrick Vermersch has received research support from Sanofi.
Gavin Giovannoni, MD (QMUL)	Dr. Giovannoni has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck KGaA. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche-Genentech. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Moderna. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Astoria Biologica. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zenas. Dr. Giovannoni 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. Giovannoni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Giovannoni has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Medscape.
Per Soelberg Sorensen	No disclosure on file
Kottil W. Rammohan, MD (University of Miami)	Dr. Rammohan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Rammohan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Rammohan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech. Dr. Rammohan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion. Dr. Rammohan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genzyme. Dr. Rammohan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Serono. The institution of Dr. Rammohan has received research support from Genentech. The institution of Dr. Rammohan has received research support from Genzyme. The institution of Dr. Rammohan has received research support from EMD Serono. The institution of Dr. Rammohan has received research support from Alexion.
Stuart D. Cook, MD, F�鶹��ýӳ�� (Rutgers)	No disclosure on file
Birgit Keller	Birgit Keller has received personal compensation for serving as an employee of Merck Healthcare KGaA.
Sanjeev Roy	Sanjeev Roy has received personal compensation for serving as an employee of Merck KgGA.

�鶹��ýӳ��

�鶹��ýӳ��