nach oben

Erschienen in:

15.02.2024 | Original Article

Effectiveness of Tofacitinib in Ulcerative Proctitis Compared to Left Sided Colitis and Pancolitis

verfasst von: Arshdeep Singh, Ramit Mahajan, Vandana Midha, Kirandeep Kaur, Dharmatma Singh, Ramandeep Kaur, Shreya Garg, Kirti Arora, Namita Bansal, Ajit Sood

Erschienen in: Digestive Diseases and Sciences | Ausgabe 4/2024

Einloggen, um Zugang zu erhalten

Abstract

Background

Ulcerative proctitis (UP), though associated with high symptom burden and poor quality of life, is excluded from most of the randomized controlled trials in UC, including the OCTAVE trials. We aimed to analyse the effectiveness of tofacitinib in UP, and compare it to that in left sided colitis (LSC) and pancolitis (PC).

Methods

This was a prospective cohort study. Patients with either steroid-dependent or refractory ulcerative colitis, who received tofacitinib, were divided into three groups based on the disease extent [UP, LSC and PC]. The primary outcome was comparison of proportion of patients in clinical remission in the three groups, at weeks 8, 16 and 48. Safety outcomes were reported using incidence rate per patient year of exposure.

Results

Clinical remission was achieved in 47%(15/32), 24%(23/94), and 43%(23/54) of patients at week 8, 56%(18/32), 37%(35/94), and 56%(30/54) of patients at week 16, and 59%(19/32), 38%(36/94), and 24%(13/54) of patients at week 48 in groups UP, LSC and PC, respectively. Corticosteroid-free clinical remission rates were significantly higher in patients in groups UP at week 48. Five (15%) patients with UP were primary non-responders to tofacitinib at week 16, while three (9%) patients had secondary loss of response at week 48. The probability of sustained clinical response was highest in patients with UP. Patients with UP had the lowest incidence of adverse effects.

Conclusion

The effectiveness of tofacitinib in inducing and maintaining clinical remission is greater in patients with UP compared to LSC and PC.

Graphical Abstract

Nur mit Berechtigung zugänglich

Silverberg MS, Satsangi J, Ahmad T et al. Toward an integrated clinical, molecular and serological classification of inflammatory bowel disease: report of a Working Party of the 2005 Montreal World Congress of Gastroenterology. Can J Gastroenterol,. 2005;19:5 Suppl A-36A. https://doi.org/10.1155/2005/269076.CrossRef

Satsangi J, Silverberg MS, Vermeire S, Colombel J. The Montreal classification of inflammatory bowel disease: controversies, consensus, and implications. Gut. 2006;55:749–753. https://doi.org/10.1136/gut.2005.082909.CrossRefPubMedPubMedCentral

Dubois E, Moens A, Geelen R, Sabino J, Ferrante M, Vermeire S. Long-term outcomes of patients with ulcerative proctitis: analysis from a large referral centre cohort. United Eur Gastroenterol J. 2020;8:933–941. https://doi.org/10.1177/2050640620941345.CrossRef

Meucci G, Vecchi M, Astegiano M et al. The natural history of ulcerative proctitis: a multicenter, retrospective study. Gruppo di Studio per le Malattie Infiammatorie Intestinali (GSMII). Am J Gastroenterol. 2000;95:469–473. https://doi.org/10.1111/j.1572-0241.2000.t01-1-01770.x.CrossRefPubMed

Rutgeerts P, Sandborn WJ, Feagan BG et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005;353:2462–2476. https://doi.org/10.1056/NEJMoa050516.CrossRefPubMed

Feagan BG, Rutgeerts P, Sands BE et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013;369:699–710. https://doi.org/10.1056/NEJMoa1215734.CrossRefPubMed

Sands BE, Sandborn WJ, Panaccione R et al. Ustekinumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2019;381:1201–1214. https://doi.org/10.1056/NEJMoa1900750.CrossRefPubMed

Reinisch W, Sandborn WJ, Hommes DW et al. Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomised controlled trial. Gut. 2011;60:780–787. https://doi.org/10.1136/gut.2010.221127.CrossRefPubMed

Sandborn WJ, van Assche G, Reinisch W et al. Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2012;142:257–265. https://doi.org/10.1053/j.gastro.2011.10.032.CrossRefPubMed

10.

Sandborn WJ, Su C, Sands BE et al. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2017;376:1723–1736. https://doi.org/10.1056/NEJMoa1606910.CrossRefPubMed

11.

Lucaciu LA, Constantine-Cooke N, Plevris N et al. Real-world experience with tofacitinib in ulcerative colitis: a systematic review and meta-analysis. Therap Adv Gastroenterol. 2021;14:17562848211064004. https://doi.org/10.1177/17562848211064004.CrossRefPubMedPubMedCentral

12.

Ma C, Panaccione R, Xiao Y et al. REMIT-UC: real world effectiveness and safety of tofacitinib for moderate-to-severely active ulcerative colitis. Am J Gastroenterol. 2022. https://doi.org/10.14309/ajg.0000000000002129.CrossRefPubMedPubMedCentral

13.

Chaparro M, Garre A, Mesonero F et al. Tofacitinib in ulcerative colitis: real-world evidence from the ENEIDA Registry. J Crohns Colitis. 2021;15:35–42. https://doi.org/10.1093/ecco-jcc/jjaa145.CrossRefPubMed

14.

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;14:1385–1393. https://doi.org/10.1093/ecco-jcc/jjaa075.CrossRefPubMed

15.

Lair-Mehiri L, Stefanescu C, Vaysse T et al. Real-world evidence of tofacitinib effectiveness and safety in patients with refractory ulcerative colitis. Dig Liver Dis. 2020;52:268–273. https://doi.org/10.1016/j.dld.2019.10.003.CrossRefPubMed

16.

Raine T, Bonovas S, Burisch J et al. ECCO guidelines on therapeutics in ulcerative colitis: medical treatment. J Crohns Colitis. 2022;16:2–17. https://doi.org/10.1093/ecco-jcc/jjab178.CrossRefPubMed

17.

Sahami S, Wildenberg ME, Koens L et al. Appendectomy for Therapy-Refractory Ulcerative Colitis Results in Pathological Improvement of Colonic Inflammation: Short-Term Results of the PASSION Study. J Crohns Colitis. 2019;13:165–171. https://doi.org/10.1093/ecco-jcc/jjy127.CrossRefPubMed

18.

Amiot A, Bouguen G, Bonnaud G et al. Clinical guidelines for the management of inflammatory bowel disease: Update of a French national consensus. Dig Liver Dis. 2021;53:35–43. https://doi.org/10.1016/j.dld.2020.10.018.CrossRefPubMed

19.

Sood A, Ahuja V, Midha V et al. Colitis and Crohn’s Foundation (India) consensus statements on use of 5-aminosalicylic acid in inflammatory bowel disease. Intest Res. 2020;18:355–378. https://doi.org/10.5217/ir.2019.09176.CrossRefPubMedPubMedCentral

20.

Singh A, Mahajan R, Kedia S et al. Use of thiopurines in inflammatory bowel disease: an update. Intest Res. 2022;20:11–30. https://doi.org/10.5217/ir.2020.00155.CrossRefPubMed

21.

Lewis JD, Chuai S, Nessel L, Lichtenstein GR, Aberra FN, Ellenberg JH. Use of the noninvasive components of the Mayo score to assess clinical response in ulcerative colitis. Inflamm Bowel Dis. 2008;14:1660–1666. https://doi.org/10.1002/ibd.20520.CrossRefPubMed

22.

Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. N Engl J Med 1987;317:1625–1629. https://doi.org/10.1056/NEJM198712243172603.CrossRefPubMed

23.

Deepak P, Alayo QA, Khatiwada A et al. Safety of tofacitinib in a real-world cohort of patients with ulcerative colitis. Clin Gastroenterol Hepatol. 2021;19:1592-1601.e3. https://doi.org/10.1016/j.cgh.2020.06.050.CrossRefPubMed

24.

Viscido A, Valvano M, Stefanelli G et al. Systematic review and meta-analysis: the advantage of endoscopic Mayo score 0 over 1 in patients with ulcerative colitis. BMC Gastroenterol. 2022;22:92. https://doi.org/10.1186/s12876-022-02157-5.CrossRefPubMedPubMedCentral

25.

Ayres RC, Gillen CD, Walmsley RS, Allan RN. Progression of ulcerative proctosigmoiditis: incidence and factors influencing progression. Eur J Gastroenterol Hepatol. 1996;8:555–558. https://doi.org/10.1097/00042737-199606000-00011.CrossRefPubMed

26.

Chaparro M, Acosta D, Rodríguez C et al. Real-world evidence of tofacinitib in ulcerative colitis: short-term and long-term effectiveness and safety. Am J Gastroenterol. 2023. https://doi.org/10.14309/ajg.0000000000002145.CrossRefPubMed

27.

Long MD, Afzali A, Fischer M et al. Tofacitinib response in ulcerative colitis (TOUR): early response after initiation of tofacitinib therapy in a real-world setting. Inflamm Bowel Dis. 2022. https://doi.org/10.1093/ibd/izac121.CrossRefPubMedPubMedCentral

28.

Pineton de Chambrun G, Amiot A, Bouguen G et al. Efficacy of tumor necrosis factor antagonist treatment in patients with refractory ulcerative proctitis. Clin Gastroenterol Hepatol. 2020;18:620-627.e1. https://doi.org/10.1016/j.cgh.2019.05.060.CrossRefPubMed

29.

Bouguen G, Roblin X, Bourreille A et al. Infliximab for refractory ulcerative proctitis. Aliment Pharmacol Ther 2010;31:1178–1185. https://doi.org/10.1111/j.1365-2036.2010.04293.x.CrossRefPubMed

30.

Cooney RM, Warren BF, Altman DG, Abreu MT, Travis SPL. Outcome measurement in clinical trials for Ulcerative Colitis: towards standardisation. Trials. 2007;8:17. https://doi.org/10.1186/1745-6215-8-17.CrossRefPubMedPubMedCentral

Titel: Effectiveness of Tofacitinib in Ulcerative Proctitis Compared to Left Sided Colitis and Pancolitis
verfasst von: Arshdeep Singh
Ramit Mahajan
Vandana Midha
Kirandeep Kaur
Dharmatma Singh
Ramandeep Kaur
Shreya Garg
Kirti Arora
Namita Bansal
Ajit Sood
Publikationsdatum: 15.02.2024
Verlag: Springer US
Erschienen in: Digestive Diseases and Sciences / Ausgabe 4/2024
Print ISSN: 0163-2116
Elektronische ISSN: 1573-2568
DOI: https://doi.org/10.1007/s10620-024-08276-1

Leitlinien kompakt für die Innere Medizin

Mit medbee Pocketcards sicher entscheiden.

^{Seit 2022 gehört die medbee GmbH zum Springer Medizin Verlag}

Kostenlos registrieren

Update Innere Medizin

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.

Newsletter bestellen

Live-Webinar "Urologie und Sexualmedizin in der Praxis"

Springer Medizin

Effectiveness of Tofacitinib in Ulcerative Proctitis Compared to Left Sided Colitis and Pancolitis