3,721
Views
8
CrossRef citations to date
0
Altmetric
Neurology

Efficacy of cladribine tablets in high disease activity patients with relapsing multiple sclerosis: post hoc analysis of subgroups with and without prior disease-modifying drug treatment

, , , , , & show all
Pages 459-464 | Received 12 Nov 2020, Accepted 15 Dec 2020, Published online: 01 Feb 2021

References

  • Spelman T, Freilich J, Anell B, et al. Patients with high-disease-activity relapsing–remitting multiple sclerosis in real-world clinical practice: a population-based study in Sweden. Clin Ther. 2020;42(2):240–250.
  • Huisman E, Papadimitropoulou K, Jarrett J, et al. Systematic literature review and network meta-analysis in highly active relapsing–remitting multiple sclerosis and rapidly evolving severe multiple sclerosis. BMJ Open. 2017;7(3):e013430.
  • Enzinger C, Fuchs S, Pichler A, et al. Predicting the severity of relapsing–remitting MS: the contribution of cross-sectional and short-term follow-up MRI data. Mult Scler. 2011;17(6):695–701.
  • Ohlmeier C, Gothe H, Haas J, et al. Epidemiology, characteristics and treatment of patients with relapsing remitting multiple sclerosis and incidence of high disease activity: real world evidence based on German claims data. PLoS One. 2020;15(5):e0231846.
  • Farber RS, Sand IK. Optimizing the initial choice and timing of therapy in relapsing–remitting multiple sclerosis. Ther Adv Neurol Disord. 2015;8(5):212–232.
  • Giovannoni G, Butzkueven H, Dhib-Jalbut S, et al. Brain health: time matters in multiple sclerosis. Mult Scler Relat Disord. 2016;9:S5–S48.
  • Johnson KM, Zhou H, Lin F, et al. Real-world adherence and persistence to oral disease-modifying therapies in multiple sclerosis patients over 1 year. JMCP. 2017;23(8):844–852.
  • Fernandez O. Is there a change of paradigm towards more effective treatment early in the course of apparent high-risk MS? Mult Scler Relat Disord. 2017;17:75–83.
  • eMC. Mavenclad 10mg tablets [Internet]. London (UK): EMC; 2017 [cited 2017 Dec 18]. Available from: https://www.medicines.org.uk/emc/medicine/34044
  • Giovannoni G, Comi G, Cook S, et al. A placebo-controlled trial of oral cladribine for relapsing multiple sclerosis. N Engl J Med. 2010;362(5):416–426.
  • Giovannoni G, Cook S, Rammohan K, et al. Sustained disease-activity-free status in patients with relapsing–remitting multiple sclerosis treated with cladribine tablets in the CLARITY study: a post-hoc and subgroup analysis. Lancet Neurol. 2011;10(4):329–337.
  • Giovannoni G, Soelberg Sorensen P, Cook S, et al. Efficacy of cladribine tablets in high disease activity subgroups of patients with relapsing multiple sclerosis: a post hoc analysis of the CLARITY study. Mult Scler. 2019;25(6):819–827.
  • Siddiqui MK, Khurana IS, Budhia S, et al. Systematic literature review and network meta-analysis of cladribine tablets versus alternative disease-modifying treatments for relapsing–remitting multiple sclerosis. Curr Med Res Opin. 2018;34(8):1361–1371.
  • Polman CH, Reingold SC, Edan G, et al. Diagnostic criteria for multiple sclerosis: 2005 revisions to the “McDonald Criteria”. Ann Neurol. 2005;58(6):840–846.
  • Dixon JR Jr. The International Conference on Harmonization Good Clinical Practice guideline. Qual Assur. 1998;6(2):65–74.
  • Leist T, Cook S, Comi G, et al. Long-term safety data from the cladribine tablets clinical development program in multiple sclerosis. Mult Scler Relat Disord. 2020;46:102572.
  • Bermel RA, You X, Foulds P, et al. Predictors of long-term outcome in multiple sclerosis patients treated with interferon β. Ann Neurol. 2013;73(1):95–103.
  • Rudick RA, Polman CH. Current approaches to the identification and management of breakthrough disease in patients with multiple sclerosis. Lancet Neurol. 2009;8(6):545–559.
  • Mowry EM. Natural history of multiple sclerosis: early prognostic factors. Neurol Clin. 2011;29(2):279–292.
  • Alroughani R, Inshasi JS, Deleu D, et al. An overview of high-efficacy drugs for multiple sclerosis: Gulf region expert opinion. Neurol Ther. 2019;8(1):13–23.
  • Guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis. Amsterdam (The Netherlands): European Medicine Agency; 2015.
  • Giovannoni G, Comi G, Cook S, et al. Clinical efficacy of cladribine tablets in patients with relapsing–remitting multiple sclerosis (RRMS): final results from the 120-week phase IIIb extension trial to the CLARITY study. Neurology. 2016;86(16 Supplement):P3.028.