Cladribine tablets added to IFN-β in active relapsing MS: The ONWARD study. Issue 5 (September 2018)

• Record Type: Journal Article
• Authors: Montalban, Xavier; Leist, Thomas P.; Cohen, Bruce A.; Moses, Harold; Campbell, Jackie; Hicking, Christine; Dangond, Fernando; Comi, Giancarlo; Gallo, Paolo; Pozzilli, Carlo; Gasperini, Claudio; Morra, Vincenzo Brescia; Boyko, Alexey N; Amelina, Olga; Kotov, Sergey V; Novikova, Lilia; Patrusheva, Olga; Zavalishin, Igor; Khabirov, Farid; Maslova, Natalia; Malkova, Nadezda; Poverennova, Irina E; Montalban, Xavier; Martinez Yelamos, Sergio; Izquierdo, Guillermo; Fernandez, Oscar; Rodriguez-Antiguedad, Alfredo; Sempere, Angel Perez; Arroyo, Rafael; Casanova, Bonaventura; Arias, Manual; Cascione, Mark; Cohen, Bruce Arnold; Fox, Edward; Berkovich, Regina; Kaufman, Michael; Leist, Thomas; Jacobs, Dina; Miller, Tamara; Moses, Harold; Racke, Michael; Hutton, George; Singer, Barry; Kresa-Reahl, Kiren; Pharr, Emily; Carter, Jonathan L; Wendt, Jeanette; Tandan, Rup; Bomprezzi, Roberto; Ford, Corey; Kamin, Stephen; Pless, Misha; Garmany, George P; Gazda, Suzanne; English, Jeffrey; Green, Barbara; Garwacki, Dennis; Gould, Jeffrey; LaGanke, Chris;
• Is Part Of: Neurology. Volume 5:Issue 5(2018)
• Publication Date: 2018-09
• Subjects: Neuroimmunology -- Periodicals; Neurology -- Periodicals; 616.8
• DOI: 10.1212/NXI.0000000000000477
• Languages: English
• ISSNs: 2332-7812

Abstract

Abstract : Objective: To evaluate the safety and efficacy of cladribine tablets in patients still experiencing active relapsing MS despite interferon (IFN)-β treatment. Methods: A 96-week phase II study, randomizing patients treated with IFN-β to cladribine tablets 3.5 mg/kg/IFN-β or placebo/IFN-β. Patients were to receive cladribine tablets 3.5 mg/kg/IFN-β or placebo/IFN-β in a 2:1 ratio (n = 172) with safety and exploratory efficacy outcomes being assessed. Results: Adverse events (AEs) and serious AEs were similar across treatment groups, except lymphopenia. Fifty of 124 (40.3%) cladribine/IFN-β recipients vs 0% of placebo/IFN-β recipients reported lymphopenia as an AE, with grade 3/4 lymphopenia (laboratory lymphocyte count < 500 cells/mm 3 ) experienced by 79/124 (63.7%) vs 1 (2.1%), respectively. Patients treated with cladribine tablets 3.5 mg/kg/IFN-β were 63% less likely to have a qualifying relapse than placebo/IFN-β recipients, and cladribine tablets 3.5 mg/kg/IFN-β reduced most MRI measures of disease activity. Conclusions: In patients with active relapsing MS despite IFN-β treatment, cladribine tablets 3.5 mg/kg/IFN-β reduced relapses and MRI lesion activity over 96 weeks compared with placebo/IFN-β but led to an increased incidence of lymphopenia. Classification of evidence: This study provides Class I evidence that for patients with active relapsing MS despite IFN-β treatment, cladribine tablets added to IFN-β reduced relapses and MRI lesion activity over 96 weeks and increased the incidence of lymphopenia. Clinical trial registration: NCT00436826.