2018, Number 1
Next >>
Rev Clin Esc Med 2018; 8 (1)
Actualidad en el papel de la Cladribina en el tratamiento de la Esclerosis Múltiple tipo brote-remisión
Sequeira QCM, Villegas RJD
Language: Spanish
References: 33
Page: 11-22
PDF size: 292.71 Kb.
ABSTRACT
Multiple sclerosis is a chronic inflammatory
disease of autoimmune nature characterized by
compromise of the central nervous system white
substance and neurodegeneration. Multiple
sclerosis can be catalogued as primary
progressive, secondary progressive and relapseremission.
At the moment, the Food and Drugs
Administration (FDA) has approved a total of 11
drugs for the therapeutic approach of relapseremission
multiple sclerosis. In Costa Rica
treatment for this entity is mainly dictated by the
National Guideline of Treatment for Multiple
Sclerosis, which includes oral and parenteral
options in both first and second line of treatment.
Around the world, research and pharmacological
breakthroughs pertaining multiple sclerosis have
been geared towards developing oral options.
Among the variety of options studied for this
goal is cladribine, a synthetic purine analogue,
which even though presented positive results in
its clinical trials, was removed from
consideration for an approval license due to
concerns related to a possible causality link with
infections and cancer, intrinsic to the action
mechanism of the cladribine. Recent clinical
trials nonetheless have questioned this doubts
and cladribine is gearing towards approval in
Europe and incorporation in the respective
guidelines for the treatment of relapse-remission
multiple sclerosis.
REFERENCES
Valverde A, Vargas R, Parajeles, A et al. Guía Nacional para el Tratamiento de la Esclerosis Múltiple. Neuroeje, 2015; 28 (2): 69-120.
Daroff R, Jankovic J, Mazziotta J et al. Bradley’s Neurology in Clinical Practice. Seventh Edition. Chapter 80: Multiple Sclerosis and Other Inflammatory Demyelinating Diseases of the Central Nervous System. Elsevier. 2016; 1159-1186.
Hauser L, Stephenson A. Harrison’s Neurology in Clinical Medicine. 4th Edition. Chapter 45: Multiple Sclerosis and Other Demyelinating Diseases. McGrawHill Education. 2017;513-532.
Rooper A, Samuels M, Klein J. Adams and Victor’s Principles of Neurology. Chapter 36: Multiple Sclerosis and Other Inflammatory Demyelinating Diseases. McGraw-Hill education, 2014;915-945.
Montalban X, Hauser S, Kappos L. Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis. N Engl J Med 2017; 376(3): 209-220.
Roche. Media ReleaseFDA approves Roche’s OCREVUS™ (ocrelizumab) for relapsing and primary progressive forms of multiple sclerosis. Obtenido de: http://www.roche.com/media/store/releases/ med-cor-2017-03-29.htm
FDA. FDA Approves new drug to treat multiple sclerosis. Obtenido de https://www.fda.gov/newsevents/newsroom/ pressannouncements/ucm549325. htm
Kim W, Edler M, Kim S et al. Oral Disease-Modifying Therapies for Multiple Sclerosis. J ClinNeurol 2015 Jan; 11(1): 9–19.
Paul F. Cladribine in multiple sclerosis: pitfalls in a new treatment landscape. Expert Opinion on Pharmacotherapy 2013; 14(1).
Gonzalez A. Esclerosis Múltiple afecta a tres mujeres por cada hombre. 2015. Obtenido de: http://www.revistaperfil.- com/salud/Esclerosis-multiple-afectamujeres- hombre_0_743925601.html
Solis M. CCSS mantiene bajo tratamiento a 264 pacientes con Esclerosis Múltiple. 2013. Obtenido de: https://www.ccss.sa.cr/noticia?ccssmantiene- bajo-tratamiento-a-264-pacientes- con-esclerosis-multiple
Singh V, Prajeeth C, Gudi V et al. 2- Chlorodeoxyadenosine (cladibrine) induces apoptosis in human monocytederived dendritic cells. ClinExpImmunol2013 Aug; 173(2): 288–297.
Alvarez C, Adams A, Mathews J et al. Cladribine to treat disease exacerbation after fingolimod discontinuation in progressive multiple sclerosis.Ann ClinTransl Neurol. 2017 Jul; 4(7): 506– 511
Mitozek S, Tabarkiewiz J, Wilczynska B et al. Impact of cladribine therapy on changes in circulating dendritic cell subsets, T cells and B cells in patients with multiple sclerosis. J Neurol Sci. 2013 Sep 15;332(1-2):35-40
Laugel B, Borlat F, Galibert L et al. Cladribine inhibits cytokine secretion by T cells independently of deoxycytidine kinasaactivity.J Neuroimmunol. 2011 Dec 15;240-241
Baker D, Herrod S, Alvarez C et al. Both cladribine and alemtuzumab may effect MS via B-cell depletion. NeurolNeuroimmunolNeuroinflamm. 2017 Jul; 4(4): e360.
Savic R, Novakovic A, Ekblom M et al. Population Pharmacokinetics of Cladribine in Patients with Multiple Sclerosis. ClinPharmacokinet. 2017.
Rice GP, Filippi M, Comi G. Cladribine and progressive MS: clinical and MRI outcomes of a multicenter controlled trial. Cladribine MRI Study Group. Neurology 2000; 54: 1145–1155
Leist T, Comi G, Cree B. Effect of oral cladribine on time to conversion to clinically definite multiple sclerosis in patients with a first demyelinating event (ORACLE MS): a phase 3 randomised trial.Lancet Neurol. 2014 Mar;13(3):257-67.
EMD Serono. Oral Cladribine in Early Multiple Sclerosis (MS) (ORACLE MS). 2013. Obtenido de: https://clinicaltrials.gov/ct2/show/NCT0 0725985
Cook S, Vermersch P, Comi G et al. Safety and tolerability of cladribine tablets in multiple sclerosis: the CLARITY (CLAdRibine Tablets treating multiple sclerosis orally) study. MultScler. 2011 May;17(5):578-93
Comi G, Cook S, Giovannoni G. MRI outcomes with cladribine tablets from multiple sclerosis in the CLARITY study.J Neurol. 2013 Apr;260(4):1136- 46.
Ali S, Paracha N, Cook S et al. Reduction in healthcare and societal resource utilization associated with cladribine tablets in patients with relapsing-remitting multiple sclerosis: analysis of economic data from the CLARITY Study.Clin Drug Investig. 2012 Jan 1;32(1):15-27.
Comi G, Hartung H, Kurukulasuriya N et al. Cladribine tablets for the treatment of relapsing-remitting multiple sclerosis. Expert OpinPharmacother. 2013 Jan;14(1):123- 36
Pakpoor J, Disanto G, Altmann D et al. No evidence for higher risk of cancer in patients with multiple sclerosis taking cladribine.NeurolNeuroimmunolNeuroi nflamm. 2015 Dec; 2(6): e158.
Helwick V. Cladribine back in the Running for Multiple Sclerosis. Medscape 2017. Obtenido de: http://www.medscape.com/viewarticle/8 80990#vp_2.
Afolabi D, Albor C, Zalewski L et al. Positive impact of cladribine on quality of life in people with relapsing multiple sclerosis. MultScler. 2017 Aug 1:1352458517726380
De Stefano N, Giorgio A, Battaglini M et al. Reduced brain atrophy rates are associated with lower risk of disability progression in patients with relapsing multiple sclerosis treated with cladribine tablets.MultScler. 2017 Jan 1:1352458517690269
MS Society. Cladribine. 2017. Obtenido de: https://www.mssociety.org.uk/cladribine
Brooks M. CHMP Recommends Cladribine (Mavenclad) for Multiple Sclerosis. 2017. Obtenido de: http://www.medscape.com/viewarticle/8 82043
Mstrust. Cladribine (Mavenclad). 2017. Obtenido de: https://www.mstrust.org. uk/a-z/cladribine-mavenclad
Merck. Cladribinetablets receives positive CHMP Opinion for Treatment of Relapsing Forms of Multiple Sclerosis.2017. Obtenido de: https://www.merckgroup.com/content/d am/web/corporate/non-images/press-releases/ 2017/jun/en/Mavenclad-CHMP- 23-06-2017-EN.pdf
EMD Serono. Prospective Observational Long-Term Safety Registry of Multiple Sclerosis Patients who Have Participated in Cladribine Clinical Trials (PREMIERE).2017. Obtenido de: https://clinicaltrials.gov/ct2/show/NCT0 1013350