Superior Effectiveness of Tofacitinib Compared to Vedolizumab in Anti-TNF-experienced Ulcerative Colitis Patients: A Nationwide Dutch Registry Study.

Humans Colitis, Ulcerative / drug therapy Gastrointestinal Agents / therapeutic use Prospective Studies Registries Treatment Outcome Tumor Necrosis Factor Inhibitors / therapeutic use Tumor Necrosis Factor-alpha / antagonists & inhibitors Janus Kinase Inhibitors / therapeutic use

Real-world Data Tofacitinib Ulcerative Colitis Vedolizumab

Journal

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association

ISSN: 1542-7714

Titre abrégé: Clin Gastroenterol Hepatol

Pays: United States

ID NLM: 101160775

Informations de publication

Date de publication:
01 2023

Historique:

received: 27 01 2022

revised: 21 04 2022

accepted: 29 04 2022

pubmed: 2 6 2022

medline: 27 12 2022

entrez: 1 6 2022

Statut: ppublish

Résumé

Clinicians face difficulty in when and in what order to position biologics and Janus kinase inhibitors in patients with anti-tumor necrosis factor-alpha (TNF) refractory ulcerative colitis (UC). We aimed to compare the effectiveness and safety of vedolizumab and tofacitinib in anti-TNF-exposed patients with UC in our prospective nationwide Initiative on Crohn and Colitis Registry. Patients with UC who failed anti-TNF treatment and initiated vedolizumab or tofacitinib treatment were identified in the Initiative on Crohn and Colitis Registry in the Netherlands. We selected patients with both clinical as well as biochemical or endoscopic disease activity at initiation of therapy. Patients previously treated with vedolizumab or tofacitinib were excluded. Corticosteroid-free clinical remission (Simple Clinical Colitis Activity Index ≤2), biochemical remission (C-reactive protein ≤5 mg/L or fecal calprotectin ≤250 μg/g), and safety outcomes were compared after 52 weeks of treatment. Inverse propensity score-weighted comparison was used to adjust for confounding and selection bias. Overall, 83 vedolizumab- and 65 tofacitinib-treated patients were included. Propensity score-weighted analysis showed that tofacitinib-treated patients were more likely to achieve corticosteroid-free clinical remission and biochemical remission at weeks 12, 24, and 52 compared with vedolizumab-treated patients (odds ratio [OR], 6.33; 95% confidence interval [CI], 3.81-10.50; P < .01; OR, 3.02; 95% CI, 1.89-4.84; P < .01; and OR, 1.86; 95% CI, 1.15-2.99; P = .01; and OR, 3.27; 95% CI, 1.96-5.45; P < .01; OR, 1.87; 95% CI, 1.14-3.07; P = .01; and OR, 1.81; 95% CI, 1.06-3.09; P = .03, respectively). There was no difference in infection rate or severe adverse events. Tofacitinib was associated with superior effectiveness outcomes compared with vedolizumab in anti-TNF-experienced patients with UC along with comparable safety outcomes.

Sections du résumé

BACKGROUND & AIMS

METHODS

Patients with UC who failed anti-TNF treatment and initiated vedolizumab or tofacitinib treatment were identified in the Initiative on Crohn and Colitis Registry in the Netherlands. We selected patients with both clinical as well as biochemical or endoscopic disease activity at initiation of therapy. Patients previously treated with vedolizumab or tofacitinib were excluded. Corticosteroid-free clinical remission (Simple Clinical Colitis Activity Index ≤2), biochemical remission (C-reactive protein ≤5 mg/L or fecal calprotectin ≤250 μg/g), and safety outcomes were compared after 52 weeks of treatment. Inverse propensity score-weighted comparison was used to adjust for confounding and selection bias.

RESULTS

Overall, 83 vedolizumab- and 65 tofacitinib-treated patients were included. Propensity score-weighted analysis showed that tofacitinib-treated patients were more likely to achieve corticosteroid-free clinical remission and biochemical remission at weeks 12, 24, and 52 compared with vedolizumab-treated patients (odds ratio [OR], 6.33; 95% confidence interval [CI], 3.81-10.50; P < .01; OR, 3.02; 95% CI, 1.89-4.84; P < .01; and OR, 1.86; 95% CI, 1.15-2.99; P = .01; and OR, 3.27; 95% CI, 1.96-5.45; P < .01; OR, 1.87; 95% CI, 1.14-3.07; P = .01; and OR, 1.81; 95% CI, 1.06-3.09; P = .03, respectively). There was no difference in infection rate or severe adverse events.

CONCLUSIONS

Tofacitinib was associated with superior effectiveness outcomes compared with vedolizumab in anti-TNF-experienced patients with UC along with comparable safety outcomes.

Identifiants

DOI: 10.1016/j.cgh.2022.04.038 PMID: 35644343

pubmed: 35644343

pii: S1542-3565(22)00510-9

doi: 10.1016/j.cgh.2022.04.038

pii:

doi:

Substances chimiques

Gastrointestinal Agents 0

tofacitinib 87LA6FU830

Tumor Necrosis Factor Inhibitors 0

Tumor Necrosis Factor-alpha 0

vedolizumab 9RV78Q2002

Janus Kinase Inhibitors 0

Types de publication

Comparative Study Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

182-191.e2

Investigateurs

Malena Schlotter (M)

Martine van Workum (M)

Dirk de Jong (D)

Willemijn van Dop (W)

S van der Marel (S)

Hayat El Ghabzouri (H)

Kamila Talhaoui (K)

Bas Oldenburg (B)

Nynke Boontje (N)

Herma Fidder (H)

Meike Hirdes (M)

Rob H Creemers (RH)

J Hoekstra (J)

Jael Smid (J)

Zlatan Mujagic (Z)

Marthe François-Verweij (M)

Toos Schakel-van den Berge (T)

Jeroen Maljaars (J)

Rosaline Theeuwen (R)

Denise van den Berg (D)

Suzanne Gerretsen (S)

Xenia Yocarini (X)

Geert D'Haens (G)

Mark Lowenberg (M)

Joep Grootjans (J)

Krisztina Gecse (K)

Gerd Bouma (G)

Petra Waaijenberg (P)

Bart Muskens (B)

Commentaires et corrections

Type : CommentIn