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10.1212/NXI.0000000000000477

http://scihub22266oqcxt.onion/10.1212/NXI.0000000000000477
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C6047834!6047834!30027104
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suck abstract from ncbi


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pmid30027104      Neurol+Neuroimmunol+Neuroinflamm 2018 ; 5 (5): ä
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  • Cladribine tablets added to IFN-? in active relapsing MS: The ONWARD study #MMPMID30027104
  • Montalban X; Leist TP; Cohen BA; Moses H; Campbell J; Hicking C; Dangond F; Comi G; Gallo P; Pozzilli C; Gasperini C; Morra VB; Boyko AN; Amelina O; Kotov SV; Novikova L; Patrusheva O; Zavalishin I; Khabirov F; Maslova N; Malkova N; Poverennova IE; Montalban X; Martinez Yelamos S; Izquierdo G; Fernandez O; Rodriguez-Antiguedad A; Sempere AP; Arroyo R; Casanova B; Arias M; Cascione M; Cohen BA; Fox E; Berkovich R; Kaufman M; Leist T; Jacobs D; Miller T; Moses H; Racke M; Hutton G; Singer B; Kresa-Reahl K; Pharr E; Carter JL; Wendt J; Tandan R; Bomprezzi R; Ford C; Kamin S; Pless M; Garmany GP; Gazda S; English J; Green B; Garwacki D; Gould J; LaGanke C
  • Neurol Neuroimmunol Neuroinflamm 2018[Sep]; 5 (5): ä PMID30027104show ga
  • Objective: To evaluate the safety and efficacy of cladribine tablets in patients still experiencing active relapsing MS despite interferon (IFN)-? treatment. Methods: A 96-week phase II study, randomizing patients treated with IFN-? to cladribine tablets 3.5 mg/kg/IFN-? or placebo/IFN-?. Patients were to receive cladribine tablets 3.5 mg/kg/IFN-? or placebo/IFN-? 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-? recipients vs 0% of placebo/IFN-? recipients reported lymphopenia as an AE, with grade 3/4 lymphopenia (laboratory lymphocyte count < 500 cells/mm3) experienced by 79/124 (63.7%) vs 1 (2.1%), respectively. Patients treated with cladribine tablets 3.5 mg/kg/IFN-? were 63% less likely to have a qualifying relapse than placebo/IFN-? recipients, and cladribine tablets 3.5 mg/kg/IFN-? reduced most MRI measures of disease activity. Conclusions: In patients with active relapsing MS despite IFN-? treatment, cladribine tablets 3.5 mg/kg/IFN-? reduced relapses and MRI lesion activity over 96 weeks compared with placebo/IFN-? 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-? treatment, cladribine tablets added to IFN-? reduced relapses and MRI lesion activity over 96 weeks and increased the incidence of lymphopenia. Clinical trial registration: NCT00436826.
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