Abstract Details

Title Durability of NEDA-3 status in patients with relapsing multiple sclerosis receiving cladribine tablets: CLARITY Extension

Topic Multiple Sclerosis

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

Poster/Presentation
Number 15-100

Objective

Post hoc analysis examining No Evidence of Disease Activity-3 (NEDA-3) in patients who received cladribine tablets in CLARITY and placebo or cladribine tablets in CLARITY Ext.

Background In CLARITY, NEDA-3 status (using 6-month Expanded Disability Status Scale [EDSS] progression) was achieved in more patients with relapsing multiple sclerosis (RMS) receiving cladribine tablets 10mg (3.5mg/kg cumulative dose over 2 years; 47%) vs. placebo (17%; p<0.0001) over 2 years.

Design/Methods Patients treated with cladribine tablets followed by placebo (CP3.5, n=98) or cladribine tablets (CC7.0, n=186) in CLARITY EXT were retrospectively analyzed for NEDA-3 status (no relapse, 6-month EDSS progression, or T1 gadolinium-enhancing/active T2 lesions) in Year 1 of CLARITY EXT. Bridging interval from the core and extension studies was used as a proxy for completion of the first year of CLARITY EXT. Patients with a bridging interval of ≤43 weeks were categorized in the Year (Y) 3-4 group and in the Y4-5 group for bridging intervals of >43 weeks. Confirmed NEDA-3 status in the first year of CLARITY EXT for Y3-4 was CP3.5; N=54, CC7.0; N=98 and for Y4-5, CP3.5; N=40, CC7.0; N=77. Between-group differences in NEDA-3 were analyzed by logistic regression, with treatment and bridging-interval duration as fixed effects.

Results In the Y3-4 group, annual NEDA-3 was achieved in 46% of patients in the CP3.5 group and 48% in the CC7.0 group. Up to Y5 end after commencing CLARITY, annual NEDA-3 was observed in 35% of patients receiving CP3.5 and 48% receiving CC7.0. There was no significant difference between CP3.5 (41.5%, 95%CI 32.4-60.0%) and CC7.0 (48.0%, 95%CI 40.2-64.4%; p=0.31). Similar patterns were observed in proportions of patients' annual relapse-free and annual 6-month EDSS progression-free.

Conclusions Following cladribine treatment in Years 1 and 2, annual NEDA-3 status was sustained in RMS patients treated with CP3.5 or CC7.0 in CLARITY EXT up to the end of Y4.

Authors/Disclosures
Gavin Giovannoni, MD (QMUL) PRESENTER	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.
Birgit Keller	Birgit Keller has received personal compensation for serving as an employee of Merck Healthcare KGaA.
Dominic Jack (Merck Serono Ltd)	Dominic Jack has received personal compensation for serving as an employee of Merck KGaA, Darmstadt, Germany.

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