DX30
Durable Efficacy of Cladribine Tablets in Patients with Multiple Sclerosis: Analysis of Relapse Rates and Relapse-Free Patients in the CLARITY and CLARITY Extension Studies

Thursday, May 25, 2017
B2 (New Orleans Convention Center)
Gavin Giovannoni, MD , Queen Mary University of London, Blizard Institute, Barts and The London School of Medicine and Dentistry, London, United Kingdom
Giancarlo Comi, MD , University Vita-Salute San Raffaele, Milan, Italy
Stuart Cook, MD , Rutgers, The State University of New Jersey, Newark, NJ
Peter Rieckmann, MD , Akademisches Krankenhaus Sozialstiftung Bamberg, Bamberg, Germany
Kottil Rammohan, MD , Ohio State University Hospital, Columbus, OH
Per Soelberg-Sorensen, MD , Copenhagen University Hospital, Copenhagen, Denmark
Patrick Vermersch, MD , University of Lille, Lille, France
Christine Hicking, MS , Merck KGaA, Darmstadt, Germany
Abidemi Adeniji, PhD , EMD Serono, Inc., Billerica, MA
Fernando Dangond, MD , EMD Serono, Inc., Billerica, MA
Mary Lee, NA , Caudex, New York, NY
Michele Springer, BA , Caudex, New York, NY
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Background: Cladribine tablets (CT), given annually for 2 years in short-duration courses in CLARITY, significantly reduced relapse rates and slowed disability progression in patients with relapsing multiple sclerosis (RMS). After a treatment gap (median duration ~41 weeks), the CLARITY Extension (EXT) study compared the effects of 2 years' additional CT treatment vs no additional treatment.

Objectives: To assess efficacy in patients treated with 2 courses of CT or placebo (PBO) in CLARITY and 2 additional courses of CT or PBO in CLARITY EXT.

Methods: In CLARITY EXT, patients with RMS who had received PBO in CLARITY were assigned to CT 3.5mg/kg body weight; those treated with CT (3.5 or 5.25mg/kg) were re-randomized 2:1 to CT 3.5mg/kg or PBO. Annualized relapse rates (ARR) and the proportions of patients qualifying relapse free were compared for CLARITY vs CLARITY EXT in: patients who received CT 3.5mg/kg in CLARITY and PBO in CLARITY EXT (CP 3.5mg/kg; n=90); CT 3.5mg/kg in CLARITY and CT 3.5mg/kg in CLARITY EXT (CC 7mg/kg; n=165); CT 5.25mg/kg in CLARITY and CT 3.5mg/kg in CLARITY EXT (CC 8.75mg/kg; n=172); PBO in CLARITY and CT 3.5mg/kg in CLARITY EXT (PC 3.5mg/kg; n=226). Proportions of patients free from 3- or 6-month confirmed disability progression (CDP) were also assessed during CLARITY EXT only.

Results: There were no significant differences in ARR for CLARITY vs CLARITY EXT except in patients who received PBO in CLARITY and CT 3.5mg/kg in CLARITY EXT (PC 3.5mg/kg, 0.26 vs 0.10, p<0.0001). The proportion of patients who qualified relapse free was >70% and was similar between CLARITY vs CLARITY EXT across all groups, except patients treated with PBO in CLARITY and CT 3.5mg/kg in CLARITY EXT (PC 3.5mg/kg, 58.0% vs 79.6%, p<0.0001). The proportion of patients without confirmed 3-m CDP in CLARITY EXT ranged from 81.6 to 90.2%, and the proportion without confirmed 6-m CDP ranged from 86.7 to 93.5%.

Conclusions: Comparing CLARITY vs CLARITY EXT demonstrates the durable efficacy of CT: clinical benefits (lower relapse rates) were maintained in patients who received CT in CLARITY and PBO in CLARITY EXT. In patients who received CT in CLARITY and CT in CLARITY EXT, no additional clinical benefit was seen with two further courses of CT compared to patients who received CT only in CLARITY. For patients who received PBO in CLARITY, switching to CT in CLARITY EXT significantly reduced ARR and increased the proportion of relapse-free patients.

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