TY - JOUR
T1 - Superior Effectiveness of Tofacitinib Compared to Vedolizumab in Anti-TNF-experienced Ulcerative Colitis Patients
T2 - A Nationwide Dutch Registry Study
AU - Straatmijer, Tessa
AU - Biemans, Vince B.C.
AU - Initiative on Crohn and Colitis
AU - Visschedijk, Marijn
AU - Hoentjen, Frank
AU - de Vries, Annemarie
AU - van Bodegraven, Adriaan A.
AU - Bodelier, Alexander
AU - de Boer, Nanne K.H.
AU - Dijkstra, Gerard
AU - Festen, Noortje
AU - Horjus, Carmen
AU - Jansen, Jeroen M.
AU - Jharap, Bindia
AU - Mares, Wout
AU - van Schaik, Fiona D.M.
AU - Ponsioen, Cyriel
AU - Romkens, Tessa
AU - Srivastava, Nidhi
AU - van der Voorn, Michael M.P.J.A.
AU - West, Rachel
AU - van der Woude, Janneke
AU - Wolvers, Marije D.J.
AU - Pierik, Marieke
AU - van der Meulen-de Jong, Andrea E.
AU - Duijvestein, Marjolijn
N1 - Funding
The Initiative on Crohn and Colitis is sponsered by Pfizer by an Independent
Investigator Sponsored Research Grant (Pfizer Tracking Number #57944353).
The Initiative on Crohn and Colitis fellowship is sponsored by AbbVie, Pfizer,
Takeda, Celgene, Janssen Pharmaceutica, Teva Pharmaceutical Industries,
Cablon Medical, Ferring Pharmaceuticals, Mundipharma, Dr Falk Pharma,
Sandoz, and Tramedico.
Publisher Copyright:
© 2023 The Authors
PY - 2023/1/1
Y1 - 2023/1/1
N2 - Background & Aims: 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. 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.
AB - Background & Aims: 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. 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.
UR - http://www.scopus.com/inward/record.url?scp=85135770756&partnerID=8YFLogxK
U2 - 10.1016/j.cgh.2022.04.038
DO - 10.1016/j.cgh.2022.04.038
M3 - Article
C2 - 35644343
AN - SCOPUS:85135770756
SN - 1542-3565
VL - 21
SP - 182-191.e2
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
IS - 1
ER -