Year 2024 / Volume 116 / Number 9
Review
Clinical settings with tofacitinib in ulcerative colitis

484-492

DOI: 10.17235/reed.2022.8660/2022

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

Abstract
There are aspects of Janus kinase (JAK) inhibitors, specifically tofacitinib, that distinguish them from other drugs used in the treatment of ulcerative colitis (UC), such as their oral administration, their short half-life and their lack of immunogenicity. With the available evidence, we can highlight tofacitinib's quick action and flexibility of use, and its efficacy in patients, irrespective of whether or not they have previously been exposed to TNF inhibitors (anti-TNF drugs) and other biologic agents. Moreover, their safety profile is known and manageable, with certain considerations and precautions being factored in before and during treatment. In this review, we have defined various scenarios pertaining to this drug, e.g. its use in the event of failure or intolerance to previous treatment with biologics, when a quick response is required or in patients with other concurrent immune-mediated diseases.
Share Button
New comment
Comments

09/09/2024 18:35:40
.


References
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
Related articles

Letter

Tofacitinib-induced eosinophilia

DOI: 10.17235/reed.2023.9831/2023

Letter

Hepatosplenic T-cell lymphoma and inflammatory bowel disease

DOI: 10.17235/reed.2023.9472/2023

Letter

Perianal Paget’s disease

DOI: 10.17235/reed.2022.9304/2022

Letter

Chinese dragon sign of ulcerative colitis

DOI: 10.17235/reed.2022.9154/2022

Letter

Ulcerative colitis exacerbated by strongyloidiasis

DOI: 10.17235/reed.2022.9044/2022

Letter

Mesalazine induced interstitial pneumonitis in the COVID era

DOI: 10.17235/reed.2022.8635/2021

Letter

Anal neoplasia and perianal Crohn’s disease: myth or reality?

DOI: 10.17235/reed.2021.8317/2021

Letter

Apoptotic colopathy as a manifestation of Good’s syndrome

DOI: 10.17235/reed.2021.8297/2021

Original

Radon exposure and inflammatory bowel disease in a radon prone area

DOI: 10.17235/reed.2021.8239/2021

Review

Inflammatory bowel disease and solid organ transplantation

DOI: 10.17235/reed.2020.7361/2020

Letter

The effect of Adacolumn® on ulcerative colitis with COVID-19

DOI: 10.17235/reed.2020.7156/2020

Letter

Sweet syndrome in severe ulcerative flare

DOI: 10.17235/reed.2020.6995/2020

Letter

Hemorrhagic complications following paracentesis

DOI: 10.17235/reed.2020.6914/2020

Editorial

Is celiac disease really associated with inflammatory bowel disease?

DOI: 10.17235/reed.2019.6779/2019

Original

Megacolon in inflammatory bowel disease: response to infliximab

DOI: 10.17235/reed.2020.6394/2019

Editorial

Diet in the etiology of inflammatory bowel disease

DOI: 10.17235/reed.2018.6119/2018

Case Report

Serrated Lesions in patients with Inflammatory Bowel Disease.

DOI: 10.17235/reed.2019.5910/2018

Special Article

Endoscopy and sedation: an inseparable binomial for the gastroenterologist

DOI: 10.17235/reed.2018.5585/2018

Editorial

Online social networks and inflammatory bowel disease

DOI: 10.17235/reed.2018.5496/2018

Letter to the Editor

Idiopathic portal hypertension with regard to thiopurine treatment

DOI: 10.17235/reed.2018.5256/2017

Letter to the Editor

Lactulose enemas in the treatment of hepatic encephalopathy. Do we help or harm?

DOI: 10.17235/reed.2017.5106/2017

Letter to the Editor

Propofol sedation Quality and safety. Failure mode and effects analysis.

DOI: 10.17235/reed.2017.4976/2017

Letter to the Editor

Ulcerative colitis with gastric and duodenal involvement

DOI: 10.17235/reed.2017.4685/2016

Editorial

Specialist care in the management of inflammatory bowel disease

DOI: 10.17235/reed.2016.4628/2016

Original

Mercaptopurine and inflammatory bowel disease: the other thiopurine

DOI: 10.17235/reed.2016.4546/2016

Original

Multicenter study on the safety of bariatric endoscopy

DOI: 10.17235/reed.2017.4499/2016

Case Report

Mesalamine-induced myopericarditis - A case report

DOI: 10.17235/reed.2016.4016/2015

Citation tools
Taxonera C, Carpio López D, Cabez Manas A, Hinojosa del Val J. Clinical settings with tofacitinib in ulcerative colitis. 8660/2022


Download to a citation manager

Download the citation for this article by clicking on one of the following citation managers:

Metrics
This article has received 797 visits.
This article has been downloaded 100 times.

Statistics from Dimensions


Statistics from Plum Analytics

Publication history

Received: 28/01/2022

Accepted: 10/03/2022

Online First: 04/04/2022

Published: 09/09/2024

Article revision time: 35 days

Article Online First time: 66 days

Article editing time: 955 days


Share
This article hasn't been rated yet.
Reader rating:
Valora este artículo:




Asociación Española de Ecografía Digestiva Sociedad Española de Endoscopia Digestiva Sociedad Española de Patología Digestiva
The Spanish Journal of Gastroenterology is the official organ of the Sociedad Española de Patología Digestiva, the Sociedad Española de Endoscopia Digestiva and the Asociación Española de Ecografía Digestiva
Cookie policy Privacy Policy Legal Notice © Copyright 2023 y Creative Commons. The Spanish Journal of Gastroenterology