Evaluation of the safety and therapeutic effect of Itolizumab in Camagüey patients with severe psoriasis
Keywords:
ITOLIZUMAB, MONOCLONAL ANTIBODY, SEVEREPSORIASISAbstract
Background: Psoriasis is a chronic inflammatory skin disease that affects the quality of life of the patients who suffer from it.Objective: To evaluate the safety and therapeutic effect of the monoclonal antibody Itolizumab in patients with severe psoriasis treated at “Manuel Ascunce Domenech” University Hospital of Camaguey, from September, 2012 to December, 2013.
Methods: A phase II, open, uncontrolled, nonrandomized clinical trial of the type Program of Expanded Clinical Use was conducted, as part of the study "Evaluation of the safety and therapeutic effect of the monoclonal antibody Itolizumab (T1h) for the treatment of patients with severe psoriasis", in patients with this diagnosis seen at the herein mentioned institution and during the said period. The study sample was made up of 10 patients. The data were taken from the medical histories and the main effect variable was the clinical index defined by the psoriasis area and severity index (PASI). The PASI was evaluated at different times by means of a computing graphic (PASI-3D).
Results: The clinical variant in plaques prevailed in the studied patients. The clinical response of whitening was achieved in more than two-thirds of the patients at the end of the maintenance phase, which was kept during the observation period, with few adverse events.
Conclusions: The study demonstrated that Itolizumab is a safe and effective medication in the treatment of severe psoriasis.
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References
Andrews GC. Tratado de dermatología. La Habana: Cientifíco-Técnica; 1984.
Gudjonsson JE, Elder JT. Psoriasis. En: Fitzpatrick TB, Eisen AZ, Wolff K, Freedberg IM, Austen KF. Dermatología en Medicina General. 7ma ed. Madrid: Médica Panamericana; 2008. p. 169-93.
Griffi CE, Barker JN. Psoriasis. Burns T, Breathnach S, Cox N, Griffiths C, editor. Rook's Textbook of Dermatology. 8th ed. Chicago: Blackwell Publishing; 2010. p.20.1- 20.60.
Arenas R. Dermatología. Atlas, diagnóstico y tratamiento. 4ta ed. México: McGraw-Hill, Interamericana; 2009.
Brache Sánchez R, Martínez López J, Castro Coto A. Consenso de México, Centroamérica y el Caribe para el tratamiento tópico de la psoriasis. México: Editorial Océano de México; 2010.
Sociedad Argentina de Dermatología. Consenso nacional de psoriasis. Guías de tratamiento. [en línea]. Argentina: Sociedad Argentina de Dermatología; 2010 [citado 14 de septiembre 2015]. Disponible en: http://www.sad.org.ar/file_download/17/psoriasis2010.pdf&sa=U&ei=m1bNU8X_KLHnsATlzICABA&ved=0CBIQFjAA&usg=AFQjCNG2XaJBPXcdt-OyKv7GC_FfFuUAvQ.
OMS. Informe Sobre Salud en el Mundo 2008. Ginebra: Organización Mundial de la Salud; 2008.
Gottlieb AB. Psoriasis. Immunopathology and immunomodulation. Dermatol Clin [revista en internet]. 2001 [citado 14 de septiembre 2015]; 19(4). Disponible en: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=11705352.
High WA, Fitzpatrick JE. Agentes citotóxicos y antimetabólicos. En: Fitzpatrick TB, Eisen AZ, Wolff K, Freedberg IM, Austen KF. Dermatología en Medicina General. 7ma.ed. Madrid: Médica Panamericana; 2008. p.2163-4.
Kim IH, West CE, Kwatra SG, Feldman SR, O'Neill JL. Comparative efficacy of biologics in psoriasis: a review. Am J Clin Dermatol [revista en internet]. 2012 [citado 14 de septiembre 2015]; 13(6). Disponible en: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=22967166.
Ferrándiz Foraster C, García-Díez A, Lizán Tudela L, Bermúdez-Rey L, Badia Llach X. [Impact of psoriasis on health-related quality of life]. Medicina Clínica [revista en internet]. 2007, Mar [citado 14 de septiembre 2015]; 128(9): 325-329. Disponible en: MEDLINE Complete.
Kwon HH, Kwon IH, Youn JI. Clinical study of psoriasis occurring over the age of 60 years: is elderly-onset psoriasis a distinct subtype? Int J Dermatol [revista en internet]. 2012 [citado 14 de septiembre 2014]; 51(1). Disponible en: http://www.ncbi.nlm.nih.gov/pubmed/22182378.
Pérez Rodríguez ZM, Falcón Lincheta L, Rodríguez Hernández E. Magnetoterapia en pacientes con psoriasis. Rev Cub Med Mil [revista en internet]. 2011, Dic [citado 14 de septiembre 2014]; 40(3-4): 278-284. Disponible en: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S0138-65572011000300010&lng=es.
Zaragoza V. Seguridad y eficacia de etanercept a largo plazo en el tratamiento de la psoriasis. Actas Dermosifiliogr [revista en internet]. 2010 [citado 14 de septiembre 2015]; 101(1): 47-53. Disponible en: http://www.actasdermo.org/es/seguridad-eficacia-etanercept-largo-plazo/articulo/S0001731009000027.
Zhu X, Zheng M, Song M, Shen YK, Chan D, Szapary PO, et al. Efficacy and safety of ustekinumab in Chinese patients with moderate to severe plaque-type psoriasis: results from a phase 3 clinical trial (LOTUS). J Drugs Dermatol [revista en internet]. 2013 [citado 14 de septiembre 2015]; 12(2). Disponible en: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=23377389.
Noda S, Mizuno K, Adachi M. Treatment effect of adalimumab and infliximab in Japanese psoriasis patients: results in a single community-based hospital. J Dermatol [revista en internet]. 2012 [citado 14 de septiembre 2015]; 39(3). Disponible en: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=22126280.
Villareal Martínez A, Gómez Florez M, Ocampo Candiani J. Agentes biológicos en el tratamiento de la psoriasis. Dermatología CMQ [revista en internet]. 2012 [citado 14 de septiembre 2015]; 10(3): 198-204. Disponible en: http://dcmq.com.mx/images/ediciones/DCMQ_2012_V10-N3.pdf.
Ríos Hidalgo MI. Efectividad del tratamiento combinado aloe crema 25% y técnicas de relajación- visualización en psoriasis vulgar. [Tesis]. Camagüey: Hospital universitario clínico quirúrgico Manuel Ascunse Domenech; 2010.
Reich K, Langley RG, Papp KA, Ortonne JP, Unnebrink K, Kaul M, et al. A 52-week trial comparing briakinumab with methotrexate in patients with psoriasis. N Engl J Med [[revista en internet]. 2012 [citado 14 de septiembre 2015]; 365(17). Disponible en: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=22029980.
Yang HZ, Wang K, Jin HZ, Gao TW, Xiao SX, Xu JH, et al. Infliximab monotherapy for Chinese patients with moderate to severe plaque psoriasis: a randomized, double-blind, placebo-controlled multicenter trial. Chin Med J (Engl) [revista en internet]. 2012 [citado 14 de septiembre 2015]; 125(11). Disponible en: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=22884040.
Igarashi A, Kato T, Kato M, Song M, Nakagawa H. Efficacy and safety of ustekinumab in Japanese patients with moderate-to-severe plaque-type psoriasis: long-term results from a phase 2/3 clinical trial. J Dermatol [revista en internet]. 2012 [citado 14 de septiembre 2015]; 39(3): Disponible en: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=21955098.
Queiro R, Alonso S, Ballina J. Terapias biológicas distintas de la terapia anti-TNFa en la psoriasis y la artritis psoriásica. Reumatol Clin [revista en internet]. 2010 [citado 14 de septiembre 2015]; 6(S1): 41–6. Disponible en: http://www.reumatologiaclinica.org/es/terapias-biologicas-distintas-terapia-anti-tnf/articulo/S1699258X10000240/.
Tsai TF, Ho JC, Song M, Szapary P, Guzzo C, Shen YK, et al. Efficacy and safety of ustekinumab for the treatment of moderate-to-severe psoriasis: a phase III, randomized, placebo-controlled trial in Taiwanese and Korean patients (PEARL). J Dermatol Sci [revista en internet]. 2011 [citado 14 de septiembre 2015]; 63(3). Disponible en: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=21741220.
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