Long-term therapy with itolizumab is safe and effective for patients with moderate to severe psoriasis: Results from an expanded-access program

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dc.contributor.affiliationFalcón Lincheta, L., “Dr. Carlos J. Finlay” Hospital, Havana, Cuba
dc.contributor.affiliationSaumell Nápoles, Y., Clinical Research Division, Center of Molecular Immunology, Havana, Cuba
dc.contributor.affiliationGray Lovio, O.R., “Manuel Fajardo” Hospital, Havana, Cuba
dc.contributor.affiliationViqueira Fuentesfría, A.M., “Manuel Fajardo” Hospital, Havana, Cuba
dc.contributor.affiliationPérez Alonso, T., “Hermanos Ameijeiras” Hospital, Havana, Cuba
dc.contributor.affiliationBatista Romagoza, M., “Joaquin Castillo Duany” Hospital, Santiago de Cuba, Cuba
dc.contributor.affiliationUrquiza Rodríguez, A., Medical and Surgical Research Center (CIMEQ), Havana, Cuba
dc.contributor.affiliationMantecón Fernández, B., “Manuel Ascunce” Hospital, Camagüey, Cuba
dc.contributor.affiliationBautista Jerez, H.A., “Manuel Fajardo” Hospital, Havana, Cuba
dc.contributor.affiliationFernández de Armas, D., “Dr. Carlos J. Finlay” Hospital, Havana, Cuba
dc.contributor.affiliationMartínez Matute, E.S., “Hermanos Ameijeiras” Hospital, Havana, Cuba
dc.contributor.affiliationLeón García, Y., Medical and Surgical Research Center (CIMEQ), Havana, Cuba
dc.contributor.affiliationOramas Fernández, D.K., Medical and Surgical Research Center (CIMEQ), Havana, Cuba
dc.contributor.affiliationMarrero Chavez, Y., “Manuel Ascunce” Hospital, Camagüey, Cuba
dc.contributor.affiliationFernandez Lorente, A., Clinical Research Division, Center of Molecular Immunology, Havana, Cuba
dc.contributor.affiliationValls Hung, A.R., Clinical Research Division, Center of Molecular Immunology, Havana, Cuba
dc.contributor.affiliationLorenzo-Luaces, P., Clinical Research Division, Center of Molecular Immunology, Havana, Cuba
dc.contributor.affiliationValenzuela Silva, C., Clinical Research Division, Center of Molecular Immunology, Havana, Cuba
dc.contributor.affiliationMoreno, E., University of Medellin, Medellin, Colombia
dc.contributor.affiliationHernández-Casaña, P., Clinical Research Division, Center of Molecular Immunology, Havana, Cuba
dc.contributor.authorFalcón Lincheta L
dc.contributor.authorSaumell Nápoles Y
dc.contributor.authorGray Lovio O.R
dc.contributor.authorViqueira Fuentesfría A.M
dc.contributor.authorPérez Alonso T
dc.contributor.authorBatista Romagoza M
dc.contributor.authorUrquiza Rodríguez A
dc.contributor.authorMantecón Fernández B
dc.contributor.authorBautista Jerez H.A
dc.contributor.authorFernández de Armas D
dc.contributor.authorMartínez Matute E.S
dc.contributor.authorLeón García Y
dc.contributor.authorOramas Fernández D.K
dc.contributor.authorMarrero Chavez Y
dc.contributor.authorFernandez Lorente A
dc.contributor.authorValls Hung A.R
dc.contributor.authorLorenzo-Luaces P
dc.contributor.authorValenzuela Silva C
dc.contributor.authorMoreno E
dc.contributor.authorHernández-Casaña P.
dc.date.accessioned2024-07-31T21:07:00Z
dc.date.available2024-07-31T21:07:00Z
dc.date.issued2024
dc.descriptionItolizumab is a humanized monoclonal antibody that selectively targets the CD6-ALCAM pathway. This article reports on the safety and efficacy of itolizumab in the treatment of moderate-to-severe plaque psoriasis in a clinical study conducted in Cuba in the setting of an expanded-access program (EAP). The study included 84 patients who had previously received conventional anti-psoriatic systemic therapies but were either intolerant, had an inadequate response, or had contraindications to these therapies. It consisted of multiple phases, including a 12-week induction phase, a 40-week maintenance phase, and a 24-week off-treatment follow-up phase, using either a 0.4 or 1.6 mg/Kg dose. The results showed that itolizumab monotherapy was safe and effective during 52 weeks of continuous treatment and the subsequent 24 follow-up weeks. Itolizumab treatment resulted in a significant improvement (PASI 75) in 80 % of patients at the end of the induction phase, and this effect was sustained till week 52 during the maintenance phase. Moreover, 24 weeks after treatment stopped nearly two-thirds of patients still showed a PASI ≥ 75. The observed effects were dose-dependent, with 1.6 mg/kg being the most convenient dose. This study further supports the strategy of targeting the CD6-ALCAM signaling pathway for the treatment of psoriasis and the use of itolizumab as a valuable asset in the armamentarium of anti-psoriasis drugs. © 2024 Elsevier B.V.
dc.identifier.doi10.1016/j.intimp.2024.112225
dc.identifier.instnameinstname:Universidad de Medellínspa
dc.identifier.issn15675769
dc.identifier.reponamereponame:Repositorio Institucional Universidad de Medellínspa
dc.identifier.repourlrepourl:https://repository.udem.edu.co/
dc.identifier.urihttp://hdl.handle.net/11407/8441
dc.language.isoeng
dc.publisherElsevier B.V.spa
dc.publisher.facultyFacultad de Ciencias Básicasspa
dc.relation.citationvolume134
dc.relation.isversionofhttps://www.scopus.com/inward/record.uri?eid=2-s2.0-85193274823&doi=10.1016%2fj.intimp.2024.112225&partnerID=40&md5=e4fd0403cc70bf82f63d956ae0103458
dc.relation.referencesGreen, L., An overview and update of psoriasis (2011) Nurs. Stand., 25, pp. 47-55
dc.relation.referencesParisi, R., Symmons, D.P., Griffiths, C.E., Ashcroft, D.M., Identification and management of psoriasis and associated comorbidiTy (IMPACT) project team, Global epidemiology of psoriasis: a systematic review of incidence and prevalence (2013) J. Invest. Dermatol., 133, pp. 377-385
dc.relation.referencesTrujillo, A., Díaz García, M.A., Torres Gemeil, O., Torres Barbosa, F., Falcón Lincheta, L., Pérez Hernández, M., Descriptive study with 200 patients (2002) Rev. Cubana Med., 41, pp. 12-15
dc.relation.referencesOliveira Mde, F., Rocha Bde, O., Duarte, G.V., Psoriasis: classical and emerging comorbidities (2015) An. Bras. Dermatol., 90, pp. 9-20
dc.relation.referencesBu, J., Ding, R., Zhou, L., Chen, X., Shen, E., Epidemiology of psoriasis and comorbid diseases: a narrative review (2022) Front. Immunol., 13, p. e880201
dc.relation.referencesDamiani, G., Bragazzi, N.L., Karimkhani Aksut, C., Wu, D., Alicandro, G., The global, regional, and national burden of psoriasis: results and insights from the global burden of disease 2019 study (2021) Front. Med., 16, p. e743180
dc.relation.referencesLee, H.J., Kim, M., Challenges and future trends in the treatment of Psoriasis (2023) Int. J. Mol. Sci., 24, p. 13313
dc.relation.referencesEstevinho, T., Lé, A.M., Torres, T., Deucravacitinib in the treatment of psoriasis (2023) J. Dermatolog. Treat., 34, p. 2154122
dc.relation.referencesKoren, J., Lambert, J.L.W., Thomsen, S.F., McAteer, H., Fabbrocini, G., Elevating the standard of care for patients with psoriasis: 'calls to action' from epicensus, a multistakeholder pan-european initiative (2023) Dermatol. Ther., 13, pp. 245-268
dc.relation.referencesVelasco-de Andrés, M., Casadó-Llombart, S., Català, C., Leyton-Pereira, A., Lozano, F., Aranda, F., Soluble CD5 and CD6: lymphocytic class I scavenger receptors as immunotherapeutic agents (2020) Cells., 9, p. 2589
dc.relation.referencesGonçalves, C.M., Henriques, S.N., Santos, R.F., Carmo, A.M., CD6, a rheostat-type signalosome that tunes T Cell activation (2018) Front. Immunol., 9, p. 2994
dc.relation.referencesCasadó-Llombart, S., Gheitasi, H., Ariño, S., Consuegra-Fernández, M., Armiger-Borràs, N., Kostov, B., Gene variation at immunomodulatory and cell adhesion molecules loci impacts primary sjögren's syndrome (2022) Front. Med., 9
dc.relation.referencesMa, C., Wu, W., Lin, R., Ge, Y., Zhang, C., Critical role of CD6highCD4+ T cells in driving Th1/Th17 Cell immune responses and mucosal inflammation in IBD (2019) J. Crohns Colitis., 13, pp. 510-524
dc.relation.referencesPinto, M., Carmo, A.M., CD6 as a therapeutic target in autoimmune diseases: successes and challenges (2013) BioDrugs., 27, pp. 191-202
dc.relation.referencesKofler, D.M., Farkas, A., von Bergwelt-Baildon, M., Hafler, D.A., The link between CD6 and autoimmunity: genetic and cellular associations (2016) Curr. Drug Targets., 17, pp. 651-665
dc.relation.referencesConsuegra-Fernández, M., Julià, M., Martínez-Florensa, M., Aranda, F., Català, C., Genetic and experimental evidence for the involvement of the CD6 lymphocyte receptor in psoriasis (2018) Cell Mol Immunol., 15, pp. 898-906
dc.relation.referencesHernández, P., Moreno, E., Aira, L.E., Rodríguez, P.C., Therapeutic targeting of CD6 in autoimmune diseases: a review of cuban clinical studies with the antibodies IOR-T1 and Itolizumab (2016) Curr. Drug Targets., 17, pp. 666-677
dc.relation.referencesDogra, S., Rajagopalan, S.D.M., Anti-CD6 mAbs for the treatment of psoriasis (2020) Expert Opin Biol. Ther., 20, pp. 1215-1222
dc.relation.referencesAnand, A., Assudani, D., Nair, P., Krishnamurthy, S., Deodhar, S., 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 (2010) J. Immunol., 184, p. 96.13
dc.relation.referencesKrupashankar, D.S., Dogra, S., Kura, M., Saraswat, A., Budamakuntla, L., 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 (2014) J. Am. Acad. Dermatol., 71, pp. 484-492
dc.relation.referencesJayaraman, K., Biocon's first-in-class anti-CD6 mAb reaches the market (2013) Nat. Biotechnol., 31, pp. 1062-1063
dc.relation.referencesRodriguez, P.C., Torres-Moya, R., Reyes, G., Molinero, C., Prada, D., A clinical exploratory study with itolizumab, an anti-CD6 monoclonal antibody, in patients with rheumatoid arthritis (2012) Results Immunol., 2, pp. 204-211
dc.relation.referencesChopra, A., Chandrashekara, S., Iyer, R., Rajasekhar, L., Shetty, N., Itolizumab in combination with methotrexate modulates active rheumatoid arthritis: safety and efficacy from a phase 2, randomized, open-label, parallel-group, dose-ranging study (2016) Clin. Rheumatol., 35, pp. 1059-1064
dc.relation.referencesRodríguez, P.C., Prada, D.M., Moreno, E., Aira, L.E., Molinero, C., The anti-CD6 antibody itolizumab provides clinical benefit without lymphopenia in rheumatoid arthritis patients: results from a 6-month, open-label Phase I clinical trial (2018) Clin. Exp. Immunol., 191, pp. 229-239
dc.relation.referencesCaballero, A., Filgueira, L.M., Betancourt, J., Sánchez, N., Hidalgo, C., Treatment of COVID-19 patients with the anti-CD6 antibody itolizumab (2020) Clin. Transl. Immunol., 9, p. 1218
dc.relation.referencesKumar, S., De Souza, R., Nadkar, M., Guleria, R., Trikha, A., A two-arm, randomized, controlled, multi-centric, open-label phase-2 study to evaluate the efficacy and safety of Itolizumab in moderate to severe ARDS patients due to COVID-19 (2021) Expert Opin. Biol. Ther., 21, pp. 675-686
dc.relation.referencesFeldman, S.R., Krueger, G.G., Psoriasis assessment tools in clinical trials (2005) Ann. Rheum. Dis., 64, pp. 65-68
dc.relation.referencesFredriksson, T., Pettersson, U., Severe psoriasis – oral therapy with a new retinoid (1978) Dermatology., 157, pp. 238-244
dc.relation.referencesKamaria, M., Liao, W., Koo, J.Y., How long does the benefit of biologics last? an update on time to relapse and potential for rebound of biologic agents for psoriasis (2010) Psoriasis Forum., 16, pp. 36-42. , http://www.ncbi.nlm.nih.gov/pmc/articles/pmc4205949/
dc.relation.referencesBughani, U., Saha, A., Kuriakose, A., Nair, R., Sadashivarao, R.B., T cell activation and differentiation is modulated by a CD6 domain 1 antibody Itolizumab (2017) PLoS One., 12, p. e0180088
dc.relation.referencesNair, P., Melarkode, R., Rajkumar, D., Montero, E., CD6 synergistic co-stimulation promoting proinflammatory response is modulated without interfering with the activated leucocyte cell adhesion molecule interaction (2010) Clin. Exp. Immunol., 162, pp. 116-130
dc.relation.referencesAira, L.E., López-Requena, A., Fuentes, D., Sánchez, L., Pérez, T., Immunological and histological evaluation of clinical samples from psoriasis patients treated with anti-CD6 itolizumab (2014) Mabs., 6, pp. 783-793
dc.relation.referencesLevine, D., Gottlieb, A., Evaluation and management of psoriasis: an internist's guide (2009) Med. Clin. North Am., 93, pp. 1291-1303
dc.relation.referencesRachakonda, T.D., Schupp, C.W., Armstrong, A.W., Psoriasis prevalence among adults in the United States (2014) J. Am. Acad. Dermatol., 70, pp. 512-516
dc.relation.referencesFerrándiz, C., Bordas, X., García-Patos, V., Puig, S., Pujol, R., Prevalence of psoriasis in Spain (Epiderma Project: phase I) (2001) J. Eur. Acad. Dermatol. Venereol., 15, pp. 20-23
dc.relation.referencesGelfand, J.M., Weinstein, R., Porter, S.B., Neimann, A.L., Berlin, J.A., Prevalence and treatment of psoriasis in the United Kingdom (2005) Arch. Dermatol., 141, pp. 1537-1541
dc.relation.referencesBø, K., Thoresen, M., Dalgard, F., Smokers report more psoriasis, but not atopic dermatitis or hand eczema: results from a norwegian population survey among adults (2008) Dermatology., 216, pp. 40-45
dc.relation.referencesStern, R.S., Nijsten, T., Feldman, S.R., Margolis, D.J., Rolstad, T., Psoriasis is common, carries a substantial burden even when not extensive, and is associated with widespread treatment dissatisfaction (2004) J. Investig. Dermatol. Symp. Proc., 9, pp. 136-139
dc.relation.referencesAugustin, M., Glaeske, G., Radtke, M.A., Christophers, E., Reich, K., Epidemiology and comorbidity of psoriasis in children (2010) Br. J. Dermatol., 162, pp. 633-636
dc.relation.referencesIcen, M., Crowson, C.S., McEvoy, M.T., Dann, F.J., Gabriel, S.E., Trends in incidence of adult-onset psoriasis over three decades: a population-based study (2009) J. Am. Acad. Dermatol., 60, pp. 394-401
dc.relation.referencesSinniah, B., Saraswathy Devi, S., Prashant, B.S., Epidemiology of psoriasis in malaysia: a hospital based study (2010) Med. J. Malaysia., 65, pp. 112-114. , http://www.ncbi.nlm.nih.gov/pubmed/23756793
dc.relation.referencesAguilar, M., Bhuket, T., Torres, S., Liu, B., Wong, R.J., Prevalence of the metabolic syndrome in the United States, 2003–2012 (2015) JAMA., 313, pp. 1973-1974
dc.relation.referencesFeldman, S.R., Zhao, Y., Shi, L., Tran, M.H., Economic and Comorbidity Burden Among Patients with Moderate-to-Severe Psoriasis (2015) J. Manag. Care Spec. Pharm., 21, pp. 874-888
dc.relation.referencesKimball, A.B., Robinson, D., Jr., Wu, Y., Guzzo, C., Yeilding, N., Cardiovascular disease and risk factors among psoriasis patients in two US healthcare databases, 2001-2002 (2008) Dermatology, 217, pp. 27-37. , https://doi.org/10.1159/000121333
dc.relation.referencesYang, Y.W., Keller, J.J., Lin, H.C., Medical comorbidity associated with psoriasis in adults: a population-based study (2011) Br. J. Dermatol., 165, pp. 1037-1043
dc.relation.referencesParthasaradhi, A., Safety and efficacy of itolizumab in the treatment of psoriasis: a case series of 20 patients (2016) J. Clin. Diagn. Res., 10, p. WD01-WD03. , https://doi.org/10.7860%2FJCDR%2F2016%2F21040.8848
dc.relation.referencesParthasaradhi, A., Singh, V., Parasramani, S.G., Yadav, N., Krupashankar, D.S., A real-world study to assess the effectiveness of itolizumab in patients with chronic plaque psoriasis (2017) Indian Dermatol. Online J., 8, pp. 246-249
dc.relation.referencesTakeshita, J., Wang, S., Shin, D.B., Mehta, N.N., Kimmel, S.E., Effect of psoriasis severity on hypertension control: a population-based study in the United Kingdom (2015) JAMA Dermatol., 151, pp. 161-169. , https://doi.org/10.1001%2Fjamadermatol.2014.2094
dc.relation.referencesFang, H.Y., Liao, W.C., Lin, C.L., Chen, C.H., Kao, C.H., Association between psoriasis and asthma: a population-based retrospective cohort analysis (2015) Br. J. Dermatol., 172, pp. 1066-1071
dc.relation.referencesWeidinger, S., Willis-Owen, S.A., Kamatani, Y., Baurecht, H., Morar, N., A genome-wide association study of atopic dermatitis identifies loci with overlapping effects on asthma and psoriasis (2013) Hum. Mol. Genet., 22, pp. 4841-4856
dc.relation.referencesXu, G., Xia, M., Jiang, C., Yu, Y., Wang, G., Comparative efficacy and safety of thirteen biologic therapies for patients with moderate or severe psoriasis: a network meta-analysis (2019) J. Pharmacol. Sci., 139, pp. 289-303
dc.relation.referencesArmstrong, A.W., Soliman, A.M., Betts, K.A., Wang, Y., Gao, Y., Comparative efficacy and relative ranking of biologics and oral therapies for moderate-to-severe plaque psoriasis: a network meta-analysis (2021) Dermatol. Ther. (heidelb), 11, pp. 885-905
dc.relation.referencesJohnson, M.C., Heron, C.E., Ghamrawi, R.I., Balogh, E.A., Feldman, S.R., Speed of psoriasis treatment response for biologic agents: a review OF PHAse III clinical trials (2021) J. Psoriasis Psoriatic Arthritis., 6, pp. 99-105
dc.relation.referencesMasson Regnault, M., Shourick, J., Jendoubi, F., Tauber, M., Paul, C., Time to relapse after discontinuing systemic treatment for psoriasis: a systematic review (2022) Am. J. Clin. Dermatol., 23, pp. 433-447
dc.relation.referencesBudamakuntla, L., Madaiah, M., Sarvajnamurthy, S., Kapanigowda, S., Itolizumab provides sustained remission in plaque psoriasis: a 5-year follow-up experience (2015) Clin Exp Dermatol., 40, pp. 152-155
dc.relation.referencesImafuku, S., Torisu-Itakura, H., Nishikawa, A., Zhao, F., Cameron, G.S., Efficacy and safety of ixekizumab treatment in Japanese patients with moderate-to-severe plaque psoriasis: subgroup analysis of a placebo-controlled, phase 3 study (UNCOVER-1) (2017) J. Dermatol., 44, pp. 1285-1290
dc.relation.referencesMcMichael, A., Desai, S.R., Qureshi, A., Rastogi, S., Alexis, A.F., Efficacy and Safety of Brodalumab in Patients with Moderate-to-Severe Plaque Psoriasis and Skin of Color: Results from the Pooled AMAGINE-2/-3 Randomized Trials (2019) Am. J. Clin. Dermatol., 20, pp. 267-276
dc.relation.referencesNakagawa, H., Niiro, H., Ootaki, K., Japanese brodalumab study group. Brodalumab, a human anti-interleukin-17-receptor antibody in the treatment of Japanese patients with moderate-to-severe plaque psoriasis: Efficacy and safety results from a phase II randomized controlled study (2016) J. Dermatol. Sci., 81, pp. 44-52
dc.relation.referencesReich, K., Armstrong, A.W., Foley, P., Song, M., Wasfi, Y., Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: Results from the phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial (2017) J. Am. Acad. Dermatol., 76, pp. 418-431
dc.relation.referencesWu, J.J., Contemporary management of moderate to severe plaque psoriasis (2017) Am. J. Manag. Care., 23, pp. S403-S416
dc.relation.referencesYu, C., Wang, G., Burge, R.T., Ye, E., Dou, G., Outcomes of Biologic Use in Asian Compared with Non-Hispanic White Adult Psoriasis Patients from the CorEvitas Psoriasis Registry (2023) Dermatol. Ther. (heidelb), 13, pp. 187-206. , 10.1007%2Fs13555-022-00843-6
dc.relation.referencesKishimoto, M., Komine, M., Kamiya, K., Sugai, J., Mieno, M., Drug survival of biologic agents for psoriatic patients in a real-world setting in Japan (2020) J. Dermatol., 47, pp. 33-40
dc.relation.referencesDogra, S., (2015), https://doi.org/10.1016/j.jaad.2015.03.040, D. S. K., L. Budamakuntla, C.R. Srinivas, U. Khopkar, et al, Long-term efficacy and safety of itolizumab in patients with moderate-to-severe chronic plaque psoriasis: A double-blind, randomized-withdrawal, placebo-controlled study, J. Am. Acad. Dermatol. 73 331-3.e1
dc.relation.referencesBudamakuntla, L., Shree-Lakshmi, H.V.M., Bansal, A., Venkatarayaraju, S.K., Spotlight on itolizumab in the treatment of psoriasis – current perspectives from India (2019) Psoriasis (auckl)., 9, pp. 19-27
dc.rights.accessrightsinfo:eu-repo/semantics/restrictedAccess
dc.sourceInternational Immunopharmacology
dc.sourceInt. Immunopharmacol.
dc.sourceScopus
dc.subjectAutoimmune diseaseeng
dc.subjectCD6eng
dc.subjectImmunotherapyeng
dc.subjectItolizumabeng
dc.subjectPsoriasiseng
dc.titleLong-term therapy with itolizumab is safe and effective for patients with moderate to severe psoriasis: Results from an expanded-access programeng
dc.typearticle
dc.type.localArtículospa
dc.type.versioninfo:eu-repo/semantics/publishedVersion

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