Año 2024 / Volumen 116 / Número 9
Revisión
Escenarios clínicos con tofacitinib en colitis ulcerosa

484-492

DOI: 10.17235/reed.2022.8660/2022

Carlos Taxonera, Daniel Carpio López, Ana Cabez Manas, Joaquin Ernesto Hinojosa del Val,

Resumen
There are aspects of Janus kinase (JAK) inhibitors, specially tofacitinib, that distinguish them from other drugs used in the treatment of ulcerative colitis (UC), such as their oral administration, short half-life, and lack of immunogenicity. With the scientific evidence currently available, we should mention tofacitinib quick action, flexibility of use, and efficacy profile in patients regardless of whether these have previously been exposed to TNF inhibitors (anti-TNF drugs) or other biologic agents. Moreover, their safety profile is known and manageable although certain considerations and precautions should be made before and during treatment. In this review, we have defined various scenarios pertaining to this drug like its use in the event of failure or intolerance to previous treatment with biologic agents when a quick response is required or in patients with other concomitant immune-mediated diseases.
Nuevo comentario
Comentarios

09/09/2024 18:35:40
.


Bibliografía
1. Agencia Española de Medicamentos y Productos Sanitarios (AEMPS). Informe de posicionamiento terapéutico de tofacitinib (Xeljanz®) en colitis ulcerosa. IPT 40/2019. AEMPS; 2019.
2. Vermeire S, Su C, Lawendy N, et al. Outcomes of tofacitinib dose reduction in patients with ulcerative colitis in stable remission from the randomised RIVETING Trial. J Crohns Colitis 2021;15(7):1130-41. DOI: 10.1093/ecco-jcc/jjaa249
3. Turner D, Ricciuto A, Lewis A, et al. STRIDE-II - An update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): determining therapeutic goals for treat-to-target strategies in IBD. Gastroenterology 2021;160(5):1570-83. DOI: 10.1053/j.gastro.2020.12.031
4. Muñoz F. Nuevas dianas terapéuticas en la enfermedad inflamatoria intestinal. Enferm Inflamatoria Intest al Día 2017;16:138-50. DOI: 10.1016/j.eii.2017.04.001
5. Danese S, Grisham M, Hodge J, et al. JAK inhibition using tofacitinib for inflammatory bowel disease treatment: a hub for multiple inflammatory cytokines. Am J Physiol Gastrointest Liver Physiol 2016;310(3):G155-62. DOI: 10.1152/ajpgi.00311.2015
6. López-Sanromán A, Esplugues JV, Domenech E. Pharmacology and safety of tofacitinib in ulcerative colitis. Gastroenterol Hepatol 2021;44(1):39-48. DOI: 10.1016/j.gastre.2020.04.007
7. Agencia Española de Medicamentos y Productos Sanitarios (AEMPS). Ficha técnica Xeljanz. AEMPS; 2022. Disponible en: https://cima.aemps.es/cima/dochtml/ft/1171178003/FT_1171178003.html
8. Casellas F, Guinard Vicens D, García-López S, et al. Consensus document on the management preferences of patients with ulcerative colitis: points to consider and recommendations. Eur J Gastroenterol Hepatol 2020;32(12):1514-22. DOI: 10.1097/MEG.0000000000001885
9. Edel Y, Sagy I, Pokroy-Shapira E, et al. A cross-sectional survey on the preference of patients with rheumatoid arthritis for route of administration of disease-modifying anti-rheumatic drugs: oral target-specific versus parenteral biologic. IMAJ 2020;22(3):154-9.
10. Hagelund LM, Elkjaer Stallknecht S, Jensen HH. Quality of life and patient preferences among Danish patients with ulcerative colitis - Results from a survey study. Curr Med Res Opin 2020;36(5):771-9. DOI: 10.1080/03007995.2020.1716704
11. Louder AM, Singh A, Saverno K, et al. Patient preferences regarding rheumatoid arthritis therapies: a conjoint analysis. Am Health Drug Benefits 2016;9(2):84-93.
12. Dassopoulos T, Cohen RD, Scherl EJ, et al. Ulcerative colitis care pathway. Gastroenterology 2015;149(1):238-45. DOI: 10.1053/j.gastro.2015.05.036
13. Sands BE, Armuzzi A, Marshall JK, et al. Efficacy and safety of tofacitinib dose de-escalation and dose escalation for patients with ulcerative colitis: results from OCTAVE Open. Aliment Pharmacol Ther 2020;51(2):271-80. DOI: 10.1111/apt.15555
14. Sandborn WJ, Su C, Sands BE, et al. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med 2017;376(18):1723-36. DOI: 10.1056/NEJMoa1606910
15. Sandborn WJ, Peyrin-Biroulet L, Quirk D, et al. Efficacy and safety of extended induction with tofacitinib for the treatment of ulcerative colitis. Clin Gastroenterol Hepatol 2022;20(8):1821-30.e3.
16. Colombel JF, Osterman MT, Thorpe AJ, et al. Maintenance of remission with tofacitinib therapy in patients with ulcerative colitis. Clin Gastroenterol Hepatol 2022;20(1):116-25.e5.
17. Panes J, Vermeire S, Dubinsky MC, et al. Efficacy and safety of tofacitinib retreatment for ulcerative colitis after treatment interruption: results from the OCTAVE clinical trials. J Crohns Colitis 2021;15(11):1852-63. DOI: 10.1093/ecco-jcc/jjab065
18. Wollenhaupt J, Lee EB, Curtis JR, et al. Safety and efficacy of tofacitinib for up to 9.5 years in the treatment of rheumatoid arthritis: final results of a global, open-label, long-term extension study. Arthritis Res Ther 2019;21(1):89. DOI: 10.1186/s13075-019-1866-2
19. Sandborn W, Dhaens G, Sands B, et al. S777 tofacitinib for the treatment of ulcerative colitis: up to 7.8 years of safety data from global clinical trials. Am J Gastroenterol 2021;116:S360-S. DOI: 10.14309/01.ajg.0000776640.47467.7e
20. Nash P, Coates LC, Kivitz AJ, et al. Safety and efficacy of tofacitinib in patients with active psoriatic arthritis: interim analysis of OPAL Balance, an Open-Label, Long-Term Extension Study. Rheumatol Ther 2020;7(3):553-80. DOI: 10.1007/s40744-020-00209-4
21. Sandborn WJ, Peyrin-Biroulet L, Sharara AI, et al. Efficacy and safety of tofacitinib in ulcerative colitis based on prior tumor necrosis factor inhibitor failure status. Clin Gastroenterol Hepatol 2022;20(3):591-601.e8.
22. Sandborn WJ, Lawendy N, Danese S, et al. Safety and efficacy of tofacitinib for treatment of ulcerative colitis: final analysis of OCTAVE Open, an open-label, long-term extension study with up to 7.0 years of treatment. Aliment Pharmacol Ther 2022;55(4):464-78.
23. Winthrop KL, Melmed GY, Vermeire S, et al. Herpes zoster infection in patients with ulcerative colitis receiving tofacitinib. Inflamm Bowel Dis 2018;24(10):2258-65. DOI: 10.1093/ibd/izy131
24. Ministerio de Sanidad, Consumo y Bienestar Social. Vacunas y programa de vacunación. Herpes zóster. Recomendaciones de vacunación actuales acordadas en el Consejo Interterritorial del Sistema Nacional de Salud. Disponible en: https://www.mscbs.gob.es/profesionales/saludPublica/prevPromocion/vacunaciones/vacunas/ciudadanos/zoster.htm
25. Grupo de trabajo de vacunación frente a herpes zóster de la Ponencia de Programa y Registro de Vacunaciones. Comisión de Salud Pública del Consejo Interterritorial del Sistema Nacional de Salud. Ministerio de Sanidad; 2021. Disponible en: https://www.mscbs.gob.es/profesionales/saludPublica/prevPromocion/vacunaciones/programasDeVacunacion/docs/HerpesZoster_RecomendacionesVacunacion.pdf
26. Agencia Española de Medicamentos y Productos Sanitarios (AEMPS). Notas de seguridad. Xeljanz (tofacitinib): nuevas precauciones de uso. AEMPS; 2022. Disponible en: https://www.aemps.gob.es/informa/notasinformativas/medicamentosusohumano-3/seguridad-1/2021-seguridad-1/xeljanz-tofacitinib-nuevas-precauciones-de-uso/
27. Sandborn WJ, Panés J, D’Haens GR, et al. Tofacitinib for the treatment of ulcerative colitis: up to 6.8 years of safety data from global clinical trials. Am J Gastroenterol 2020;115:S353-S4. DOI: 10.14309/01.ajg.0000704860.70861.89
28. Sands BE, Colombel JF, Ha C, et al. Lipid profiles in patients with ulcerative colitis receiving tofacitinib-implications for cardiovascular risk and patient management. Inflamm Bowel Dis 2021;27(6):797-808. DOI: 10.1093/ibd/izaa227
29. Sands BE, Long MD, Reinisch W, et al. Tofacitinib for the treatment of ulcerative colitis: analysis of nonmelanoma skin cancer rates from the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis 2022;28(2):234-45. DOI: 10.1093/ibd/izab056
30. Panes J, Gisbert JP. Efficacy of tofacitinib treatment in ulcerative colitis. Gastroenterol Hepatol 2019;42(6):403-12. DOI: 10.1016/j.gastre.2019.03.012
31. Dubinsky MC, Peyrin-Biroulet L, Melmed GY, et al. Efficacy of tofacitinib in patients with ulcerative colitis by prior tumor necrosis factor inhibitor treatment status: results from OCTAVE induction and maintenance studies. Disponible en: https://eventscribe.com/2017/wcogacg2017/ajaxcalls/PosterInfo.asp?efp=S1lVTUxLQVozODMy&PosterID=114733&rnd=5.004501E-02
32. Chaparro M, Garre A, Mesonero F, et al. Tofacitinib in ulcerative colitis: real-world evidence from the ENEIDA Registry. J Crohns Colitis 2021;15(1):35-42. DOI: 10.1093/ecco-jcc/jjaa145
33. Honap S, Chee D, Chapman TP, et al. Real-world effectiveness of tofacitinib for moderate to severe ulcerative colitis: a multicentre UK experience. J Crohns Colitis 2020;14(10):1385-93.
34. Biemans VBC, Sleutjes JAM, de Vries AC, et al. Tofacitinib for ulcerative colitis: results of the prospective Dutch Initiative on Crohn and Colitis (ICC) registry. Aliment Pharmacol Ther 2020;51(9):880-8. DOI: 10.1111/apt.15689
35. Singh S, Murad MH, Fumery M, et al. First- and second-line pharmacotherapies for patients with moderate to severely active ulcerative colitis: an updated network meta-analysis. Clin Gastroenterol Hepatol 2020;18(10):2179-91e6. DOI: 10.1016/j.cgh.2020.01.008
36. Taxonera C, Olivares D, Alba C. Real-world effectiveness and safety of tofacitinib in patients with ulcerative colitis: systematic review with meta-analysis. Inflamm Bowel Dis 2022;28(1):32-40. DOI: 10.1093/ibd/izab011
37. Hernández Martínez A, Navajas Hernández P, Martín Rodríguez MDM, et al. Efficacy and safety of tofacitinib in the treatment of ulcerative colitis: real-life experience in Andalusia. Rev Esp Enferm Dig 2022;114(9):516-21.
38. Sicilia B, Garcia-Lopez S, Gonzalez-Lama Y, et al. GETECCU 2020 guidelines for the treatment of ulcerative colitis. Developed using the GRADE approach. Gastroenterol Hepatol. 2020 Aug;43 Suppl 1:1-57.
39. Raine T, Bonovas S, Burisch J, et al. ECCO Guidelines on Therapeutics in Ulcerative Colitis: Medical Treatment. J Crohns Colitis. 2021 Oct. [Epub ahead of print]
40. Hanauer S, Panaccione R, Danese S, et al. Tofacitinib Induction Therapy Reduces Symptoms Within 3 Days for Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2019 Jan;17(1):139-47.
41. Berinstein JA, Sheehan JL, Dias M, et al. Tofacitinib for Biologic-Experienced Hospitalized Patients With Acute Severe Ulcerative Colitis: A Retrospective Case-Control Study. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2112-20 e1.
42. Kotwani P, Terdiman J, Lewin S. Tofacitinib for Rescue Therapy in Acute Severe Ulcerative Colitis: A Real-world Experience. J Crohns Colitis. 2020 Jul 30;14(7):1026-8.
43. Uzzan M, Bresteau C, Laharie D, et al. Tofacitinib as salvage therapy for 55 patients hospitalised with refractory severe ulcerative colitis: A GETAID cohort. Aliment Pharmacol Ther. 2021 Aug;54(3):312-9.
44. D'Amico F, Parigi TL, Fiorino G, et al. Tofacitinib in the treatment of ulcerative colitis: efficacy and safety from clinical trials to real-world experience. Therap Adv Gastroenterol. 2019;12:1756284819848631.
45. Argollo M, Gilardi D, Peyrin-Biroulet C, et al. Comorbidities in inflammatory bowel disease: a call for action. The lancet Gastroenterology & hepatology. 2019 Aug;4(8):643-54.
46. Pfizer’s XELJANZ® (tofacitinib) Receives Marketing Authorization in the European Union for the Treatment of Active Ankylosing Spondylitis. Available from: https://www.ema.europa.eu/en/medicines/human/summaries-opinion/xeljanz-2.
47. Kerschbaumer A, Smolen JS, Nash P, et al. Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a systematic literature research. RMD open. 2020;6(3):e001374.
48. Jamilloux Y, El Jammal T, Vuitton L, et al. JAK inhibitors for the treatment of autoimmune and inflammatory diseases. Autoimmun Rev. 2019 Nov;18(11):102390.
49. Damsky W, Peterson D, Ramseier J, et al. The emerging role of Janus kinase inhibitors in the treatment of autoimmune and inflammatory diseases. J Allergy Clin Immunol. 2021 Mar;147(3):814-26.
50. Silfen A, Cohen N, Traboulsi C, et al. Tofacitinib Therapy is Effective for Arthralgias Associated with Active Inflammatory Bowel Disease. Poster presentations: Clinical: Therapy and Observation 2021. Available from: https://www.ecco-ibd.eu/publications/congress-abstracts/item/p455-tofacitinib-therapy-is-effective-for-arthralgias-associated-with-active-inflammatory-bowel-disease.html.
51. Mease P, Hall S, FitzGerald O, et al. Tofacitinib or Adalimumab versus Placebo for Psoriatic Arthritis. N Engl J Med. 2017 Oct 19;377(16):1537-50.
52. Gladman D, Rigby W, Azevedo VF, et al. Tofacitinib for Psoriatic Arthritis in Patients with an Inadequate Response to TNF Inhibitors. N Engl J Med. 2017 Oct 19;377(16):1525-36.
53. Nash P, Coates LC, Fleischmann R, et al. Efficacy of Tofacitinib for the Treatment of Psoriatic Arthritis: Pooled Analysis of Two Phase 3 Studies. Rheumatology and therapy. 2018 Dec;5(2):567-82.
54. van der Heijde D, Deodhar A, Wei JC, et al. Tofacitinib in patients with ankylosing spondylitis: a phase II, 16-week, randomised, placebo-controlled, dose-ranging study. Ann Rheum Dis. 2017 Aug;76(8):1340-7.
55. Papp KA, Menter MA, Abe M, et al. Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: results from two randomized, placebo-controlled, phase III trials. Br J Dermatol. 2015 Oct;173(4):949-61.
56. Papp KA, Krueger JG, Feldman SR, et al. Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: Long-term efficacy and safety results from 2 randomized phase-III studies and 1 open-label long-term extension study. J Am Acad Dermatol. 2016 May;74(5):841-50.
57. Ruperto N, Brunner HI, Zuber Z, et al. Pharmacokinetic and safety profile of tofacitinib in children with polyarticular course juvenile idiopathic arthritis: results of a phase 1, open-label, multicenter study. Pediatr Rheumatol Online J. 2017 Dec 28;15(1):86.
58. Kennedy Crispin M, Ko JM, Craiglow BG, et al. Safety and efficacy of the JAK inhibitor tofacitinib citrate in patients with alopecia areata. JCI insight. 2016 Sep 22;1(15):e89776.
59. Kong X, Sun Y, Dai X, et al. Treatment efficacy and safety of tofacitinib versus methotrexate in Takayasu arteritis: a prospective observational study. Ann Rheum Dis. 2021 Aug 6.
60. Khanna D, Bush E, Nagaraja V, et al. Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis-Results of Phase I/II Investigator-Initiated, Double-Blind Randomized Placebo-Controlled Trial. Arthritis & rheumatology. 2019;71(10)
61. Liu LY, Strassner JP, Refat MA, et al. Repigmentation in vitiligo using the Janus kinase inhibitor tofacitinib may require concomitant light exposure. J Am Acad Dermatol. 2017 Oct;77(4):675-82 e1.
62. Orfaly VE, Kovalenko I, Tolkachjov SN, et al. Tofacitinib for the treatment of refractory pyoderma gangrenosum. Clin Exp Dermatol. 2021 Aug;46(6):1082-5.
63. Salmon Olavarria P, Rubio Iturria S, Nantes Castillejo O. Tofacitinib, a useful option for the treatment of pyoderma gangrenosum in an ulcerative colitis patient. Rev Esp Enferm Dig. 2021 Oct;113(10):733-4.
64. Levy LL, Urban J, King BA. Treatment of recalcitrant atopic dermatitis with the oral Janus kinase inhibitor tofacitinib citrate. J Am Acad Dermatol. 2015 Sep;73(3):395-9.
65. Chen Z, Wang X, Ye S. Tofacitinib in Amyopathic Dermatomyositis-Associated Interstitial Lung Disease. N Engl J Med. 2019 Jul 18;381(3):291-3.
66. Kurtzman DJ, Wright NA, Lin J, et al. Tofacitinib Citrate for Refractory Cutaneous Dermatomyositis: An Alternative Treatment. JAMA dermatology. 2016 Aug 1;152(8):944-5.
67. Damsky W, Thakral D, Emeagwali N, et al. Tofacitinib Treatment and Molecular Analysis of Cutaneous Sarcoidosis. N Engl J Med. 2018 Dec 27;379(26):2540-6.
68. Zhu KJ, Yang PD, Xu Q. Tofacitinib Treatment of Refractory Cutaneous Leukocytoclastic Vasculitis: A Case Report. Front Immunol. 2021;12:695768
Artículos relacionados

Editorial

Uso seguro de los inhibidores de la bomba de protones

DOI: 10.17235/reed.2023.9834/2023

Carta

Linfoma T hepatoesplénico y enfermedad inflamatoria intestinal

DOI: 10.17235/reed.2023.9472/2023

Carta

Neumonitis intersticial por mesalazina en la era COVID

DOI: 10.17235/reed.2022.8635/2021

Revisión

Enfermedad inflamatoria intestinal y trasplante de órganos sólido

DOI: 10.17235/reed.2020.7361/2020

Carta

Efecto del Adacolumn® en colitis ulcerosa con COVID-19

DOI: 10.17235/reed.2020.7156/2020

Carta

Síndrome de Sweet en el brote grave de colitis ulcerosa

DOI: 10.17235/reed.2020.6995/2020

Carta

Complicaciones vasculares tras paracentesis

DOI: 10.17235/reed.2020.6914/2020

Caso Clínico

Lesiones serradas en pacientes con enfermedad inflamatoria intestinal

DOI: 10.17235/reed.2019.5910/2018

Artículo Especial

Endoscopia y sedación: un binomio inseparable para el gastroenterólogo

DOI: 10.17235/reed.2018.5585/2018

Editorial

Redes sociales online y enfermedad inflamatoria intestinal

DOI: 10.17235/reed.2018.5496/2018

Carta al Editor

Hipertensión portal idiopática por tiopurinas

DOI: 10.17235/reed.2018.5256/2017

Carta al Editor

Colitis ulcerosa con afectación gástrica y duodenal

DOI: 10.17235/reed.2017.4685/2016

Original

Estudio multicéntrico de seguridad en endoscopia bariátrica

DOI: 10.17235/reed.2017.4499/2016

Instrucciones para citar
Taxonera C, Carpio López D, Cabez Manas A, Hinojosa del Val J. Escenarios clínicos con tofacitinib en colitis ulcerosa. 8660/2022


Descargar en un gestor de citas

Descargue la cita de este artículo haciendo clic en uno de los siguientes gestores de citas:

Métrica
Este artículo ha sido visitado 2416 veces.
Este artículo ha sido descargado 140 veces.

Estadísticas de Dimensions


Estadísticas de Plum Analytics

Ficha Técnica

Recibido: 28/01/2022

Aceptado: 10/03/2022

Prepublicado: 04/04/2022

Publicado: 09/09/2024

Tiempo de revisión del artículo: 35 días

Tiempo de prepublicación: 66 días

Tiempo de edición del artículo: 955 días


Compartir
Este artículo aun no tiene valoraciones.
Valoración del lector:
Valora este artículo:




Asociación Española de Ecografía Digestiva Sociedad Española de Endoscopia Digestiva Sociedad Española de Patología Digestiva
La REED es el órgano oficial de la Sociedad Española de Patología Digestiva, la SociedadEspañola de Endoscopia Digestiva y la Asociación Española de Ecografía Digestiva
Política de cookies Política de Privacidad Aviso Legal © Copyright 2025 y Creative Commons. Revista Española de Enfermedades Digestivas