Skip to main content
Erschienen in: Digestive Diseases and Sciences 8/2023

28.04.2023 | Original Article

Comparing Patient-Reported Outcomes Among Anti-TNF-Experienced Patients with Crohn’s Disease Initiating Vedolizumab Versus Ustekinumab

verfasst von: Michael D. Kappelman, J. D. Lewis, X. Zhang, F. C. Lin, L. Weisbein, W. Chen, J. Burris, J. E. Dorand, L. E. Parlett, K. Haynes, V. Nair, A. F. Kaul, A. Dobes, M. D. Long

Erschienen in: Digestive Diseases and Sciences | Ausgabe 8/2023

Einloggen, um Zugang zu erhalten

Abstract

Background

Primary and secondary non-response to anti-tumor necrosis factor (TNF) therapy is common in patients with Crohn’s disease (CD), yet limited research has compared the effectiveness of subsequent biological therapy.

Objective

We sought to compare the effectiveness of vedolizumab and ustekinumab in anti-TNF-experienced patients with CD, focusing on patient-prioritized patient-reported outcomes (PROs).

Methods

We conducted a prospective, internet-based cohort study nested within IBD Partners. We identified anti-TNF-experienced patients initiating with CD vedolizumab or ustekinumab and analyzed PROs reported approximately 6 months later (minimum 4 months, maximum 10 months). Co-primary outcomes were Patient-Reported Outcome Measurement Information System (PROMIS) domains of Fatigue and Pain Interference. Secondary outcomes included patient-reported short Crohn’s disease activity index (sCDAI), treatment persistence, and corticosteroid use. Inverse probability of treatment weighting (IPTW) was used to control for a number of potential confounders and incorporated into linear and logistic regression models for continuous and categorical outcomes, respectively.

Results

Overall, 141 vedolizumab and 219 ustekinumab initiators were included in our analysis. After adjustment, we found no differences between treatment groups in our primary outcomes of Pain Interference or Fatigue or the secondary outcome of sCDAI. However, vedolizumab was associated with lower treatment persistence (OR 0.4, 95% CI 0.2–0.6) and higher corticosteroid use at follow-up assessment (OR 1.7, 95% CI 1.1–2.6).

Discussion

Among anti-TNF experienced patients with CD, Pain Interference or Fatigue was not significantly different 4–10 months after starting ustekinumab or vedolizumab. However, reduced steroid use and increased persistence suggest superiority of ustekinumab for non-PRO outcomes.
Anhänge
Nur mit Berechtigung zugänglich
Literatur
1.
Zurück zum Zitat Kappelman MD, Moore KR, Allen JK et al. Recent trends in the prevalence of Crohn’s disease and ulcerative colitis in a commercially insured US population. Dig Dis Sci 2013;58:519–525.CrossRefPubMed Kappelman MD, Moore KR, Allen JK et al. Recent trends in the prevalence of Crohn’s disease and ulcerative colitis in a commercially insured US population. Dig Dis Sci 2013;58:519–525.CrossRefPubMed
2.
Zurück zum Zitat Kappelman MD, Rifas-Shiman SL, Porter CQ et al. Direct health care costs of Crohn’s disease and ulcerative colitis in US children and adults. Gastroenterology 2008;135:1907–1913.CrossRefPubMed Kappelman MD, Rifas-Shiman SL, Porter CQ et al. Direct health care costs of Crohn’s disease and ulcerative colitis in US children and adults. Gastroenterology 2008;135:1907–1913.CrossRefPubMed
3.
Zurück zum Zitat The global, regional, and national burden of inflammatory bowel disease in 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol 2020;5:17–30. The global, regional, and national burden of inflammatory bowel disease in 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol 2020;5:17–30.
4.
Zurück zum Zitat Longobardi T, Jacobs P, Bernstein CN. Work losses related to inflammatory bowel disease in the United States: results from the National Health Interview Survey. Am J Gastroenterol 2003;98:1064–1072.PubMed Longobardi T, Jacobs P, Bernstein CN. Work losses related to inflammatory bowel disease in the United States: results from the National Health Interview Survey. Am J Gastroenterol 2003;98:1064–1072.PubMed
5.
Zurück zum Zitat Ferguson A, Sedgwick DM, Drummond J. Morbidity of juvenile onset inflammatory bowel disease: effects on education and employment in early adult life. Gut 1994;35:665–668.CrossRefPubMedPubMedCentral Ferguson A, Sedgwick DM, Drummond J. Morbidity of juvenile onset inflammatory bowel disease: effects on education and employment in early adult life. Gut 1994;35:665–668.CrossRefPubMedPubMedCentral
6.
Zurück zum Zitat Cohen RD. The quality of life in patients with Crohn’s disease. Aliment Pharmacol Ther 2002;16:1603–1609.CrossRefPubMed Cohen RD. The quality of life in patients with Crohn’s disease. Aliment Pharmacol Ther 2002;16:1603–1609.CrossRefPubMed
7.
Zurück zum Zitat Akobeng AK, Suresh-Babu MV, Firth D et al. Quality of life in children with Crohn’s disease: a pilot study. J Pediatr Gastroenterol Nutr 1999;28:S37–S39.CrossRefPubMed Akobeng AK, Suresh-Babu MV, Firth D et al. Quality of life in children with Crohn’s disease: a pilot study. J Pediatr Gastroenterol Nutr 1999;28:S37–S39.CrossRefPubMed
8.
Zurück zum Zitat Gomollón F, Dignass A, Annese V et al. 3rd European Evidence-based Consensus on the Diagnosis and Management of Crohn’s Disease 2016: Part 1: Diagnosis and Medical Management. J Crohns Colitis 2017;11:3–25.CrossRefPubMed Gomollón F, Dignass A, Annese V et al. 3rd European Evidence-based Consensus on the Diagnosis and Management of Crohn’s Disease 2016: Part 1: Diagnosis and Medical Management. J Crohns Colitis 2017;11:3–25.CrossRefPubMed
9.
Zurück zum Zitat Dassopoulos T, Sultan S, Falck-Ytter YT et al. American Gastroenterological Association Institute technical review on the use of thiopurines, methotrexate, and anti-TNF-α biologic drugs for the induction and maintenance of remission in inflammatory Crohn’s disease. Gastroenterology 2013;145:1464–78.e1-5.CrossRefPubMed Dassopoulos T, Sultan S, Falck-Ytter YT et al. American Gastroenterological Association Institute technical review on the use of thiopurines, methotrexate, and anti-TNF-α biologic drugs for the induction and maintenance of remission in inflammatory Crohn’s disease. Gastroenterology 2013;145:1464–78.e1-5.CrossRefPubMed
10.
Zurück zum Zitat Harbord M, Eliakim R, Bettenworth D et al. Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 2: Current Management. J Crohns Colitis 2017;11:769–784.CrossRefPubMed Harbord M, Eliakim R, Bettenworth D et al. Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 2: Current Management. J Crohns Colitis 2017;11:769–784.CrossRefPubMed
11.
Zurück zum Zitat Dassopoulos T, Cohen RD, Scherl EJ et al. Ulcerative Colitis Care Pathway. Gastroenterology 2015;149:238–245.CrossRefPubMed Dassopoulos T, Cohen RD, Scherl EJ et al. Ulcerative Colitis Care Pathway. Gastroenterology 2015;149:238–245.CrossRefPubMed
12.
Zurück zum Zitat Bressler B, Marshall JK, Bernstein CN et al. Clinical practice guidelines for the medical management of nonhospitalized ulcerative colitis: the Toronto consensus. Gastroenterology 2015;148:1035-1058.e3.CrossRefPubMed Bressler B, Marshall JK, Bernstein CN et al. Clinical practice guidelines for the medical management of nonhospitalized ulcerative colitis: the Toronto consensus. Gastroenterology 2015;148:1035-1058.e3.CrossRefPubMed
13.
Zurück zum Zitat Billioud V, Sandborn WJ, Peyrin-Biroulet L. Loss of response and need for adalimumab dose intensification in Crohn’s disease: a systematic review. Am J Gastroenterol 2011;106:674–684.CrossRefPubMed Billioud V, Sandborn WJ, Peyrin-Biroulet L. Loss of response and need for adalimumab dose intensification in Crohn’s disease: a systematic review. Am J Gastroenterol 2011;106:674–684.CrossRefPubMed
14.
Zurück zum Zitat Karmiris K, Paintaud G, Noman M et al. Influence of trough serum levels and immunogenicity on long-term outcome of adalimumab therapy in Crohn’s disease. Gastroenterology 2009;137:1628–1640.CrossRefPubMed Karmiris K, Paintaud G, Noman M et al. Influence of trough serum levels and immunogenicity on long-term outcome of adalimumab therapy in Crohn’s disease. Gastroenterology 2009;137:1628–1640.CrossRefPubMed
15.
Zurück zum Zitat Feagan BG, Rubin DT, Danese S et al. Efficacy of Vedolizumab Induction and Maintenance Therapy in Patients With Ulcerative Colitis, Regardless of Prior Exposure to Tumor Necrosis Factor Antagonists. Clin Gastroenterol Hepatol 2017;15:229-239.e5.CrossRefPubMed Feagan BG, Rubin DT, Danese S et al. Efficacy of Vedolizumab Induction and Maintenance Therapy in Patients With Ulcerative Colitis, Regardless of Prior Exposure to Tumor Necrosis Factor Antagonists. Clin Gastroenterol Hepatol 2017;15:229-239.e5.CrossRefPubMed
16.
Zurück zum Zitat Sands BE, Sandborn WJ, Van Assche G et al. Vedolizumab as Induction and Maintenance Therapy for Crohn’s Disease in Patients Naive to or Who Have Failed Tumor Necrosis Factor Antagonist Therapy. Inflamm Bowel Dis 2017;23:97–106.CrossRefPubMed Sands BE, Sandborn WJ, Van Assche G et al. Vedolizumab as Induction and Maintenance Therapy for Crohn’s Disease in Patients Naive to or Who Have Failed Tumor Necrosis Factor Antagonist Therapy. Inflamm Bowel Dis 2017;23:97–106.CrossRefPubMed
17.
Zurück zum Zitat Feagan BG, Sandborn WJ, Gasink C et al. Ustekinumab as Induction and Maintenance Therapy for Crohn’s Disease. N Engl J Med 2016;375:1946–1960.CrossRefPubMed Feagan BG, Sandborn WJ, Gasink C et al. Ustekinumab as Induction and Maintenance Therapy for Crohn’s Disease. N Engl J Med 2016;375:1946–1960.CrossRefPubMed
18.
Zurück zum Zitat 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.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.CrossRefPubMed
19.
Zurück zum Zitat Sandborn WJ, Su C, Sands BE et al. Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis. New England Journal of Medicine 2017;376:1723–1736.CrossRefPubMed Sandborn WJ, Su C, Sands BE et al. Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis. New England Journal of Medicine 2017;376:1723–1736.CrossRefPubMed
20.
Zurück zum Zitat Peyrin-Biroulet L, Lopez A, Sandborn W. Head-to-head Comparative Studies: Challenges and Opportunities? J Crohns Colitis 2017;11:S567–S575.PubMed Peyrin-Biroulet L, Lopez A, Sandborn W. Head-to-head Comparative Studies: Challenges and Opportunities? J Crohns Colitis 2017;11:S567–S575.PubMed
21.
Zurück zum Zitat Ungaro RC, Colombel JF. Editorial: biologics in inflammatory bowel disease—time for direct comparisons. Alimentary Pharmacology & Therapeutics 2017;46:68–69.CrossRef Ungaro RC, Colombel JF. Editorial: biologics in inflammatory bowel disease—time for direct comparisons. Alimentary Pharmacology & Therapeutics 2017;46:68–69.CrossRef
22.
Zurück zum Zitat Townsend T, Razanskaite V, Dodd S et al. Comparative effectiveness of ustekinumab or vedolizumab after one year in 130 patients with anti-TNF-refractory Crohn’s disease. Aliment Pharmacol Ther 2020;52:1341–1352.PubMed Townsend T, Razanskaite V, Dodd S et al. Comparative effectiveness of ustekinumab or vedolizumab after one year in 130 patients with anti-TNF-refractory Crohn’s disease. Aliment Pharmacol Ther 2020;52:1341–1352.PubMed
23.
Zurück zum Zitat Alric H, Amiot A, Kirchgesner J et al. The effectiveness of either ustekinumab or vedolizumab in 239 patients with Crohn’s disease refractory to anti-tumour necrosis factor. Alimentary Pharmacology & Therapeutics 2020;51:948–957.CrossRef Alric H, Amiot A, Kirchgesner J et al. The effectiveness of either ustekinumab or vedolizumab in 239 patients with Crohn’s disease refractory to anti-tumour necrosis factor. Alimentary Pharmacology & Therapeutics 2020;51:948–957.CrossRef
24.
Zurück zum Zitat Parrot L, Dong C, Carbonnel F et al. Systematic review with meta-analysis: the effectiveness of either ustekinumab or vedolizumab in patients with Crohn’s disease refractory to anti-tumour necrosis factor. Aliment Pharmacol Ther 2022;55:380–388.CrossRefPubMed Parrot L, Dong C, Carbonnel F et al. Systematic review with meta-analysis: the effectiveness of either ustekinumab or vedolizumab in patients with Crohn’s disease refractory to anti-tumour necrosis factor. Aliment Pharmacol Ther 2022;55:380–388.CrossRefPubMed
25.
Zurück zum Zitat Biemans VBC, van der Woude CJ, Dijkstra G et al. Ustekinumab is associated with superior effectiveness outcomes compared to vedolizumab in Crohn’s disease patients with prior failure to anti-TNF treatment. Aliment Pharmacol Ther 2020;52:123–134.CrossRefPubMedPubMedCentral Biemans VBC, van der Woude CJ, Dijkstra G et al. Ustekinumab is associated with superior effectiveness outcomes compared to vedolizumab in Crohn’s disease patients with prior failure to anti-TNF treatment. Aliment Pharmacol Ther 2020;52:123–134.CrossRefPubMedPubMedCentral
26.
Zurück zum Zitat Manlay L, Boschetti G, Pereira B et al. Comparison of short- and long-term effectiveness between ustekinumab and vedolizumab in patients with Crohn’s disease refractory to anti-tumour necrosis factor therapy. Aliment Pharmacol Ther 2021;53:1289–1299.CrossRefPubMed Manlay L, Boschetti G, Pereira B et al. Comparison of short- and long-term effectiveness between ustekinumab and vedolizumab in patients with Crohn’s disease refractory to anti-tumour necrosis factor therapy. Aliment Pharmacol Ther 2021;53:1289–1299.CrossRefPubMed
27.
Zurück zum Zitat Lenti MV, Dolby V, Clark T et al. A propensity score-matched, real-world comparison of ustekinumab vs vedolizumab as a second-line treatment for Crohn’s disease. The Cross Pennine study II. Aliment Pharmacol Ther 2022;55:856–866.CrossRefPubMed Lenti MV, Dolby V, Clark T et al. A propensity score-matched, real-world comparison of ustekinumab vs vedolizumab as a second-line treatment for Crohn’s disease. The Cross Pennine study II. Aliment Pharmacol Ther 2022;55:856–866.CrossRefPubMed
28.
Zurück zum Zitat Onali S, Pugliese D, Caprioli FA, et al. Objective comparison of vedolizumab and ustekinumab effectiveness in Crohn's disease patients failure to TNF-alpha inhibitors. Am J Gastroenterol 2022. Onali S, Pugliese D, Caprioli FA, et al. Objective comparison of vedolizumab and ustekinumab effectiveness in Crohn's disease patients failure to TNF-alpha inhibitors. Am J Gastroenterol 2022.
29.
Zurück zum Zitat Long MD, Kappelman MD, Martin CF et al. Development of an internet-based cohort of patients with inflammatory bowel diseases (CCFA Partners): methodology and initial results. Inflamm Bowel Dis 2012;18:2099–2106.CrossRefPubMed Long MD, Kappelman MD, Martin CF et al. Development of an internet-based cohort of patients with inflammatory bowel diseases (CCFA Partners): methodology and initial results. Inflamm Bowel Dis 2012;18:2099–2106.CrossRefPubMed
30.
Zurück zum Zitat Chung AE, Sandler RS, Long MD et al. Harnessing person-generated health data to accelerate patient-centered outcomes research: the Crohn’s and Colitis Foundation of America PCORnet Patient Powered Research Network (CCFA Partners). Journal of the American Medical Informatics Association 2016;23:485–490.CrossRefPubMedPubMedCentral Chung AE, Sandler RS, Long MD et al. Harnessing person-generated health data to accelerate patient-centered outcomes research: the Crohn’s and Colitis Foundation of America PCORnet Patient Powered Research Network (CCFA Partners). Journal of the American Medical Informatics Association 2016;23:485–490.CrossRefPubMedPubMedCentral
31.
Zurück zum Zitat Validation of an Internet-Based Cohort of Inflammatory Bowel Disease (CCFA Partners): Validation of an Internet-Based Cohort of Inflammatory Bowel Disease (CCFA Partners):
32.
Zurück zum Zitat Kappelman MD, Long MD, Martin C et al. Evaluation of the patient-reported outcomes measurement information system in a large cohort of patients with inflammatory bowel diseases. Clin Gastroenterol Hepatol 2014;12:1315–23.e2.CrossRefPubMed Kappelman MD, Long MD, Martin C et al. Evaluation of the patient-reported outcomes measurement information system in a large cohort of patients with inflammatory bowel diseases. Clin Gastroenterol Hepatol 2014;12:1315–23.e2.CrossRefPubMed
34.
Zurück zum Zitat Shalhoub H, Reaney M. PROMIS® tools as endpoints in clinical trials: what should you know? A review of PROMIS® capabilities and the current regulatory space, 2016. Shalhoub H, Reaney M. PROMIS® tools as endpoints in clinical trials: what should you know? A review of PROMIS® capabilities and the current regulatory space, 2016.
35.
Zurück zum Zitat Thia K, Faubion WA, Jr., Loftus EV, Jr., et al. Short CDAI: development and validation of a shortened and simplified Crohn's disease activity index. Inflamm Bowel Dis;17:105–11. Thia K, Faubion WA, Jr., Loftus EV, Jr., et al. Short CDAI: development and validation of a shortened and simplified Crohn's disease activity index. Inflamm Bowel Dis;17:105–11.
36.
Zurück zum Zitat Khanna R, Zou G, D’Haens G et al. A retrospective analysis: the development of patient reported outcome measures for the assessment of Crohn’s disease activity. Aliment Pharmacol Ther 2015;41:77–86.CrossRefPubMed Khanna R, Zou G, D’Haens G et al. A retrospective analysis: the development of patient reported outcome measures for the assessment of Crohn’s disease activity. Aliment Pharmacol Ther 2015;41:77–86.CrossRefPubMed
Metadaten
Titel
Comparing Patient-Reported Outcomes Among Anti-TNF-Experienced Patients with Crohn’s Disease Initiating Vedolizumab Versus Ustekinumab
verfasst von
Michael D. Kappelman
J. D. Lewis
X. Zhang
F. C. Lin
L. Weisbein
W. Chen
J. Burris
J. E. Dorand
L. E. Parlett
K. Haynes
V. Nair
A. F. Kaul
A. Dobes
M. D. Long
Publikationsdatum
28.04.2023
Verlag
Springer US
Erschienen in
Digestive Diseases and Sciences / Ausgabe 8/2023
Print ISSN: 0163-2116
Elektronische ISSN: 1573-2568
DOI
https://doi.org/10.1007/s10620-023-07942-0

Weitere Artikel der Ausgabe 8/2023

Digestive Diseases and Sciences 8/2023 Zur Ausgabe

Leitlinien kompakt für die Innere Medizin

Mit medbee Pocketcards sicher entscheiden.

Seit 2022 gehört die medbee GmbH zum Springer Medizin Verlag

Echinokokkose medikamentös behandeln oder operieren?

06.05.2024 DCK 2024 Kongressbericht

Die Therapie von Echinokokkosen sollte immer in spezialisierten Zentren erfolgen. Eine symptomlose Echinokokkose kann – egal ob von Hunde- oder Fuchsbandwurm ausgelöst – konservativ erfolgen. Wenn eine Op. nötig ist, kann es sinnvoll sein, vorher Zysten zu leeren und zu desinfizieren. 

Wo hapert es noch bei der Umsetzung der POMGAT-Leitlinie?

03.05.2024 DCK 2024 Kongressbericht

Seit November 2023 gibt es evidenzbasierte Empfehlungen zum perioperativen Management bei gastrointestinalen Tumoren (POMGAT) auf S3-Niveau. Vieles wird schon entsprechend der Empfehlungen durchgeführt. Wo es im Alltag noch hapert, zeigt eine Umfrage in einem Klinikverbund.

Das Risiko für Vorhofflimmern in der Bevölkerung steigt

02.05.2024 Vorhofflimmern Nachrichten

Das Risiko, im Lauf des Lebens an Vorhofflimmern zu erkranken, ist in den vergangenen 20 Jahren gestiegen: Laut dänischen Zahlen wird es drei von zehn Personen treffen. Das hat Folgen weit über die Schlaganfallgefährdung hinaus.

VHF-Ablation nützt wohl nur bei reduzierter Auswurfleistung

02.05.2024 Ablationstherapie Nachrichten

Ob die Katheterablation von Vorhofflimmern bei Patienten mit Herzinsuffizienz die Komplikationsraten senkt, scheint davon abzuhängen, ob die Auswurfleistung erhalten ist oder nicht. Das legen die Ergebnisse einer Metaanalyse nahe.

Update Innere Medizin

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