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2020, Number 2

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Rev Cub Med Mil 2020; 49 (2)

Efficacy and clinical safety of Itolizumab in the induction phase in patients with severe psoriasis

Batista RM, Gray LOR, Falcón LL, Pérez AT, Mantecón FB, Urquiza RA, Almenares SL, Saumell NY, Valls HAR, Vicente GI

Language: Spanish
References: 23
Page: 246-261
PDF size: 330.58 Kb.


ABSTRACT

Introduction: Psoriasis, systemic inflammatory skin disease, has serious adverse consequences for the physical, mental and social well-being of people; its treatments are expensive and with marked adverse effects. Itolizumab, a humanized anti-CD6 monoclonal antibody, acts as an immunomodulator of T cells and plays an important role in its pathogenesis.
Objective: To evaluate the efficacy and clinical safety of itolizumab in 80 patients with severe psoriasis vulgaris.
Methods: An expanded clinical use program was carried out, promoted by the Molecular Immunology Center. The clinical response was measured by the severity index and area of psoriasis involvement and for effectiveness these elements were combined with safety, through a complementary clinical analysis of the data generated during the induction phase. Absolute numbers, percent and average and association statistics such as Pearson's correlation tests or Lambda's test were used as summary measures.
Results: The area of psoriasis involvement analysis showed a rapid and sustained decrease in its values; adverse events related to the administration of the product under investigation prevailed, light onset, very probable and not serious.
Conclusions: Itolizumab is safe and effective in 96% of severe psoriatic patients during the induction phase.


REFERENCES

  1. Departamento de medicamentos de uso humano. Informe de Posicionamiento Terapéutico de Brodalumab (Kyntheum(r)) en psoriasis en placas. España: Agencia española de medicamentos y productos sanitarios; 2018.

  2. Gudjonsson JE, Elder JT. Psoriasis. En: Fitzpatrick TB, Eisen AZ, Wolff K, Freedberg IM, Austen KF. Dermatología en Medicina General. 9na ed. Madrid: Médica Panamericana; 2018:169-93.

  3. Alfonso Trujillo I, Díaz García MA, Torres Gemeil O, Torres Barbosa F, Falcón Lincheta L, Pérez Hernández M. Psoriasis vulgar. Estudio descriptivo de 200 pacientes. Rev. Cubana Med. 2002[acceso: 24/02/2019];41(1):[aprox. 6 pant.]. Disponible en: https://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S0034-75232002000100003

  4. Contreras C, Di Martino Ortiz B, Rodríguez Masi M, Knopfelmacher O, Bolla de Lezcano L, Samudio M. Síndrome Metabólico en pacientes con psoriasis de la Cátedra de Dermatología del Hospital de Clínicas. Mem Inst Investig Cienc Salud. 2014[acceso: 28/03/2019]; 12(2):25-32. Disponible en: https://scielo.iics.una.py/pdf/iics/v12n2/v12n2a06.pdf

  5. Romero Herraiz M, Pereyra Rodríguez JJ. La genética de la psoriasis. Med Cutan Iber Lat Am. 2016[acceso: 28/03/2019];44(3):159-166. Disponible en: https://www.medigraphic.com/pdfs/cutanea/mc-2016/mc163b.pdf

  6. Esquivel-García R, Estévez-Delgado G, Rodríguez-Orozco AR, Ochoa-Zarzosa A, García-Pérez ME. La psoriasis: de la investigación básica y clínica al desarrollo de nuevos tratamientos. Gac Med Mex. 2018[acceso: 20/03/2019]; 154:502-8. Disponible en: https://www.medigraphic.com/pdfs/gaceta/gm-2018/gm184o.pdf

  7. Roshni Menon, Brinda G. Itolizumab - a humanized anti-CD6 monoclonal antibody with a better side effects profile for the treatment of psoriasis. Clinical, Cosmetic and Investigational Dermatology. Pondicherry, India. 2015[acceso: 20/03/2019]; 8:215-22. Disponible en: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4407739/

  8. Bughani U, Saha A, Kuriakose A, Nair R, Sadashivarao RB, Venkataraman R, et al. T cell activation and differentiation are modulated by a CD6 domain 1 antibody Itolizumab. PLoS ONE. 2017[acceso: 20/03/2019]; 12(7):e0180088. Disponible en: Disponible en: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5495335/

  9. Krupashankar DS, Dogra S, Kura M, Saraswat A, Budamakuntla L, Sumathy TK, et al. Efficacy and safety of Itolizumab, a novel anti-CD6 monoclonal antibody, in patients with moderate to severe chronic plaque psoriasis: results of a double-blind, randomized, placebo-controlled, phase-III study. J Am Acad Dermatology. 2014[acceso: 20/03/2019]; 71:484-92. Disponible en: Disponible en: https://www.jaad.org/article/S0190-9622(14)01028-7/abstract

  10. Consuegra-Fernández M, Lin Feng, Fox DA, Lozano F. Evidencia clínica y experimental para atacar a los CD6 en trastornos de base inmunológica. Comentarios de autoinmunidad. 2018[acceso: 29/03/2019]; 17(5):493-503. Disponible en: https://doi.org/10.1016/j.autrev.2017.12.004

  11. Izquierdo Cano LM, Espinosa Estrada EE, Hernández Padrón C, Ramón Rodríguez LG, Ávila Cabrera OM, Hernández Ramírez P, et al. Anticuerpo monoclonal humanizado Itolizumab (anti-cd6) en síndromes linfoproliferativos cd 6+.Experiencia preliminar. Revista Cubana de Hematol, Inmunol y Hemoter. 2014[acceso: 27/02/2019]; 30(3):257-64. Disponible en: Disponible en: https://www.jaad.org/article/S0190-9622(14)01028-7/abstract

  12. Sociedad Argentina de Dermatología. Consenso Nacional de Psoriasis: Guía de Tratamiento. 2018. [acceso: 20/03/2019]. Disponible en: Disponible en: https://sad.org.ar/wp-content/uploads/2019/09/Consenso-Psoriasis-2018-FINAL-14122018.pdf

  13. Batista Romagosa M, Soriano González BI, Bergues Cabrales LE. Tratamiento de pacientes con psoriasis vulgar mediante campo electromagnético de extremada baja frecuencia. MEDISAN. 2012[acceso: 20/03/2019]; 16(9):1399. Disponible en: https://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S1029-30192012000900010

  14. Aira LE, López-Requena A, Fuentes D, Sánchez L, Pérez T, Urquiza A, et al. Immunological and histological evaluation of clinical samples from psoriasis patients treated with anti-CD6 Itolizumab. mAbs. 2014[acceso: 25/03/2019]; 6(3):782-92. Disponible en: Disponible en: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4011922/

  15. Ortega-Hernández A, Restrepo-López N, Rosero YS, Úsuga-Úsuga F, Luis Alfonso Correa-Londoño LA, Marín-Agudelo ND, et al. Características epidemiológicas, clínicas e histopatológicas de pacientes con psoriasis y factores asociados con las formas vulgar y pustulosa. Dermatol Rev Mex. 2018[acceso: 25/02/2019]; 62(3):193-205. Disponible en: Disponible en: https://www.medigraphic.com/pdfs/derrevmex/rmd-2018/rmd183b.pdf

  16. Muñoz- Estrada VF, Rochin-Tolosa M, Valenzuela-Paz GA, Trejo Acuña JR. Estudio clínico de psoriasis. Rev Med UAS Nueva época. 2010[acceso: 28/03/2019]; 1(4):12-19. Disponible en: https://hospital.uas.edu.mx/revmeduas/pdf/v1/Numero%204/Estudio-%20clinico%20de%20psoriasis.pdf

  17. Padilla Tresierra YD. Sobrepeso, hipertensión arterial y diabetes como factores asociados a psoriasis vulgar. Hospital Lazarte. Universidad Privada Antenor Orrego: Trujillo, Perú. 2016. [tesis para obtener el título de médico cirujano] [acceso: 28/03/2019]. Disponible en: https://repositorio.upao.edu.pe/bitstream/upaorep/2061/1/RE_MED.-HUM_YANINA.PADILLA_HIPERTENSION.-ARTERIAL.Y.DIABETES%2cPSORIASIS_DATOS.pdf

  18. Marrero Chávez Y, Mantecón Fernández B, López Gutiérrez I, Gómez Martínez Y, Cardoso Ramírez L. Evaluación de la seguridad y el efecto terapéutico del Itolizumab en pacientes de Camagüey con psoriasis severa. Revista electrónica Dr. Zoilo E. Marinello Vidaurreta. 2015[acceso: 28/03/2019]; 40(10):[aprox. 16 pant.]. Disponible en: http://revzoilomarinello.sld.cu/index.php/zmv/article/view/334/html_98

  19. Anand A, Assudani D, Nair P, Krishnamurthy S, Deodhar S, Arumugam M, et al. Safety, efficacy and pharmacokinetics of T1h, a humanized anti-CD6 monoclonal antibody, in moderate to severe chronic plaque psoriasis - results from a randomized phase II trial. J Immunology. 2010[acceso: 19/03/2019]; 184(1 suppl.):96.13. Disponible en: Disponible en: https://www.jimmunol.org/content/184/1_Supplement/96.13

  20. Lerman JB, Joshi AA, Chaturvedi A, Aberra TM, Dey AK, Rodante JA, et al. Coronary plaque characterization in psoriasis reveals high-risk features that improve after treatment in a prospective observational study. Circulation. 2017[acceso: 19/03/2019];136(3):263-76. Disponible en: Disponible en: https://www.ahajournals.org/doi/full/10.1161/CIRCULATIONAHA-.116.026859

  21. Pai G, Pai AH. Itolizumab - A New Biologic for Management of Psoriasis and Psoriatic Arthritis. Case Rep Dermatology. 2017[acceso: 19/02/2019]; 9:141-145. Disponible en: Disponible en: https://www.karger.com/Article/FullText/475519

  22. Hernández P, Montero E, Suárez E, Cuenca I, Fernández A, Chong E, et al. Itolizumab, anticuerpo monoclonal humanizado, un tratamiento novedoso para los pacientes con psoriasis severa. Anales de la Academia de Ciencias de Cuba. 2014 [acceso: 12/03/2019];5(3):[aprox. 10 p.]. Disponible en: https://www.revistaccuba.cu/index.php/revacc/article/view/285/285

  23. Schmitt J, Rosumeck S, Thomaschewski G, Sporbeck B, Haufe E, Nast A. Efficacy and safety of systemic treatments for moderate-to-severe psoriasis: meta-analysis of randomized controlled trials. Br J Dermatology. 2014[acceso: 12/03/2019];170(2):274-303. Disponible en: https://onlinelibrary.wiley.com/doi/epdf/10.1111/bjd.12663




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