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S1170 Corticosteroid-Free Remission in Anti-TNF-Failed Crohn’s Disease Patients Treated With Vedolizumab as Second-Line Biologic Therapy: A Real World Data Review

2023; Lippincott Williams & Wilkins; Volume: 118; Issue: 10S Linguagem: Inglês

10.14309/01.ajg.0000954320.79155.c1

1572-0241

Christian Agboton, Dirk Lindner,

Microscopic Colitis

Introduction: Clinical response to vedolizumab has been reported as being significantly lower in patients exposed to anti-TNFs [1,2]. However, in most countries anti-TNFs remain the de facto first biologic therapies for patients with Crohn’s disease (CD). After failure of a first Anti-TNF drug, change of class of therapy is increasingly recommended in lieu of a second anti-TNF [3]. Using corticosteroid-free (CSF) remission as the main clinical outcome, we collected data on vedolizumab used as second biologic in CD patients who failed anti-TNF therapies. Methods: PubMed and Embase were searched for real world data from cohorts of adult patients with at least 95% of exposure to anti-TNFs, at least 6 months of data, direct access to patients’ data (no claims database), and CSF remissions (no cumulative data) were selected. Additionally, the use rates of corticosteroids and other concomitant medications at baseline were extracted. Results: A total of 10 studies met the search requirements, with patient numbers ranging from N=45 to N=161. One author from the Netherlands reported twice on the same registry, only one dataset was retained to avoid counting patients twice. Clinical remission was defined as either a Harvey Bradshaw index of less than or equal to 4 (8 studies) or as a CD activity index score < 150 without resort to surgery (1 study). Across studies, the rates of corticosteroid use at baseline varied from 15.5% in a 2017 French cohort to 51.0% in a 2018 US study. Rates of CSF remission at 6 months were not related to baseline corticosteroid use and ranged from 15.3% in a 2020 UK report to 58.2% in a 2021 French cohort. On average, CSF remission at 6 months was achieved in 37.1%, (95% CI 33.6 - 40.5%) of TNF failed CD patients treated with vedolizumab as second line biological therapy (Table 1, Figure 1). Clinical remission rates at 6 months were generally higher, but at 1 year, clinical remission and CSF remission rates were almost identical in most cohorts, highlighting the importance of achieving early CSF remission. Conclusion: Despite anti-TNF failure, a significant proportion of CD patients may respond to vedolizumab and achieve CSF remission, regardless of the baseline use of concomitant corticosteroids. This benefit is established within 6 months after induction. References: 1. Verstockt, B, et al. 2019. J Crohn’s and Colitis 14:332–41. 2. Gils, A, et al. 2017. Gastro 152:S380. 3. Zhuleku, E, et al. 2022. Therap Adv in Gastro 15:17562848221130554. Table 1. - Rates of clinical remission and corticosteroid-free (CSF) clinical remission in cohorts reported in the literature Source Clinical remission CSF clinical remission CD patients, N Clinical remission definition Baseline concomitant therapies Amiot A et al. (2017) Alimentary Pharmacology & Therapeutics 46:310–321.France W6: 31.2%W14: 36.4%W22: 37%W30: 31.8%W54: 30% W6: 19.1%W14: 30.6% W22: 33.5% W30: 27.7% W54: 27.2% 161 HBI ≤4 Corticosteroids: 15.5%Immunosuppressants (IS): 18.6%Steroids + IS: 6.8%No Steroids or IS: 59% Christensen B et al. (2018) Inflamm Bowel Dis 24:849–860.US W14: 38%W30: 62%W52: 51% W14: 22% W30: 44% W52:31% 94 HBI ≤4 Corticosteroids: 51%Thiopurines: 29%Methotrexate: 13%Calcineurin inhibitor: 9% Kolar M et al. (2019) Gastroenterol Hepatol 73:25–31.Czech republic W30-32: 58.1% W30-32: 45.2% 45 HBI ≤4 Corticosteroids: 20%Thiopurines/methotrexate: 46.7% Kopylov U et al. (2019) Digestive and Liver Disease 51:68–74.Israel W14: 35% W14: 29%W52: 21% 133 HBI ≤4, CDAI < 150 Corticosteroids: 36.8%Immunomodulators: 15.2% ǂ Biemans VBC et al. (2020) Aliment Pharmacol Ther 52:123–134.The Netherlands W12: 22.7% W24: 29.7% W52: 26.8% 128 HBI ≤4 Corticosteroids: 31.3%Immunosuppressant (IS): 18.8%Steroids + IS: 15.6% *Alric H et al. (2020) Aliment Pharmacol Ther 51:948–957.France W14: 47.7%W48: 37.1% W14: 34.8%W48: 31.8% 132 HBI ≤4 Corticosteroids: 48.5%Thiopurines 33.3%Methotrexate: 6.8%Other: 2.3%No: 57.6% *Townsend T et al. (2020) Aliment Pharmacol Ther 52:1341–1352.UK M2: 16.5%M4: 21.2%M6: 16.5%M12: 25.9% M2: 11.8%M4: 20% M6: 15.3% M12: 24.7% 85 HBI < 5 Corticosteroids: 35.3%Mercaptopurine: 12.9%Azathioprine: 25.9%Methotrexate: 8.2%None: 50.6%Unknown: 2.4% *Manlay L et al. (2021) Aliment Pharmacol Ther 53:1289–1299.France W14: 56.8% W24: 58.2% W54: 40.5% 88 CDAI < 150 without resort to surgery Corticosteroids: 31.8%Thiopurines: 14.8%Methotrexate: 4.6%No Immunosuppressant: 80.7% ǁ;Onali S et al. (2022) Am J Gastroenterol 117:1279–1287.Italy W26: 44.8%W52: 55.5% W26: 40.7% W52: 51.1% 132 HBI ≤4 Corticosteroids: 49.4%Immunomodulators: 9.5% ǂOverlaps with Biemans VBC et al. (2020) Clin Pharmacol Ther 107:1189–1199.*Data from unweighted cohort.ǁData from weighted cohort. Figure 1.: Corticosteroid-free remission after 6 months.