An exploratory analysis of the efficacy of cladribine tablets 3.5mg/kg in patients with relapsing multiple sclerosis stratified according to age above and below 45 years in the CLARITY study
Author(s): ,
G. Giovannoni
Queen Mary University of London, Blizard Institute, Barts and The London School of Medicine and Dentistry, London, United Kingdom
K. Rammohan
University of Miami School of Medicine, Department of Neurology, MS Research Center, Miami, FL
S. Cook
Rutgers, The State University of New Jersey, New Jersey Medical School, Newark, NJ, United States
P. Soelberg-Sorensen
Danish MS Center, Department of Neurology, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark
P. Vermersch
University of Lille, CHU Lille, LIRIC - INSERM U995, FHU Imminent, Lille, France
B. Keller
Merck KGaA, Darmstadt, Germany
E. Verdun di Cantogno
Merck KGaA, Darmstadt, Germany
ECTRIMS Online Library. Giovannoni G. Oct 12, 2018; 229044; P1204
Gavin Giovannoni
Gavin Giovannoni
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Abstract: P1204

Type: Poster Sessions

Abstract Category: Therapy - Immunomodulation/Immunosuppression

Introduction: In the CLARITY study, treatment with Cladribine Tablets 3.5 mg/kg (CT3.5) showed strong efficacy vs placebo (PBO) over 2 years in a large cohort of patients with relapsing multiple sclerosis (RMS). Age-related variability in response to disease modifying treatments has been observed in patients with MS .
Objectives: In post hoc analyses, the effect of CT3.5mg/kg treatment was evaluated in patients with RMS above and below the age of 45 years.
Methods: The intention-to-treat population for the CT3.5 and PBO treatment groups of CLARITY was stratified according to age (≤45 and >45 years). Efficacy analyses were conducted for endpoints of qualifying relapse, all relapses, mean and cumulative numbers of new T1 gadolinium-enhancing (Gd+), active T2 and combined unique (CU) lesions.
Results: 649 patients were ≤45 years (CT3.5 N=330; median age of 34.5 years) and 221 were >45 years (CT3.5 N=103; median age of 51 years). There was a higher proportion of females in the older group (CT3.5 77.7%) than in the younger group (CT3.5 66.1%). Annualised qualifying relapse rate comparison at Week 96 showed that CT3.5 was associated with significant relative risk reduction vs PBO in both age groups (≤45 years: relative risk [RR] 0.39 [95% confidence interval (CI) 0.31,0.51], p< 0.0001; >45 years: RR 0.5 [95%CI 0.31,0.80] p=0.004). 'All relapse' data were comparable for the same age groups, respectively: 0.4 [95%CI 0.34, 0.49], p< 0.0001 and 0.52 [95%CI 0.37, 0.72], p< 0.0001. The number of cumulative new T1 Gd+ lesions at Week 96 was reduced with CT3.5 compared to PBO in both age groups. The mean number of active T2 lesions per patient per scan at Week 96 was also significantly reduced with CT3.5 versus PBO in both age groups (≤45 years: -0.667 [95%CI -0.67, -0.50], p< 0.0001; >45 years: -0.167 [95%CI -0.33, 0.00], p< 0.0001), as were mean number of CU lesions per patient per scan (≤45 years: -0.667 [95%CI -1.00, -0.67] p< 0.0001; >45 years; -0.333 [95%CI -0.33, 0.00] p< 0.0001).
Conclusions: CT3.5 treatment was efficacious in patients both above and below 45 years of age with respect to reduction of relapse frequency and number of MRI lesions, consistent with previous similar analyses.
The CLARITY study: NCT00213135
Disclosure: This study was sponsored by EMD Serono Inc, a business of Merck KGaA, Darmstadt, Germany (in the USA), and Merck Serono SA, Geneva, an affiliate of Merck KGaA Darmstadt, Germany (ROW).Author disclosures GG has received speaker honoraria and consulting fees from Abbvie, Atara Bio, Bayer Schering Pharma, Biogen Idec FivePrime, GlaxoSmithKline, GW Pharma, Merck, Pfizer Inc, Protein Discovery Laboratories, Teva Pharmaceutical Industries Ltd, Sanofi-Genzyme, UCB, Vertex Pharmaceuticals, Ironwood, and Novartis; and has received research support unrelated to this study from Biogen Idec, Merck, Novartis, and Ironwood. KR has received honoraria for lectures and steering committee meetings from EMD Serono, Biogen Idec, Sanofi-Aventis, Genzyme, Novartis, Teva Neurosciences, Acorda and Roche/Genentech. SC has received honoraria for lectures/consultations from Merck Serono, Bayer HealthCare, Sanofi-Aventis, Neurology Reviews, Biogen Idec, Teva Pharmaceuticals, and Actinobac Biomed Inc.; has served on advisory boards for Bayer HealthCare, Merck, Actinobac Biomed, Teva Pharmaceuticals, and Biogen Idec; and received grant support from Bayer HealthCare. PSS has served on advisory boards for Biogen, Merck, Novartis, Teva, MedDay Pharmaceuticals, and GSK; on steering committees or independent data monitoring boards in trials sponsored by Merck, Teva, GSK, and Novartis; has received speaker honoraria from Biogen Idec, Merck Serono, Teva, Sanofi-Aventis, Genzyme, and Novartis. His department has received research support from Biogen, Merck, Teva, Novartis, Roche, and Genzyme. PV has received honoraria or consulting fees from Biogen, Sanofi-Genzyme, Bayer, Novartis, Merck, GSK, Roche and Almirall; and research support from Biogen, Sanofi-Genzyme, Bayer, and Merck. BK and EVdC are employees of Merck KGaA, Darmstadt, Germany

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