Vedolizumab for Inflammatory Bowel Disease: Two‐Year Results of the Initiative on Crohn and Colitis (ICC) Registry, A Nationwide Prospective Observational Cohort Study

Biemans, Vince B C; Woude, C. Janneke van der; Dijkstra, Gerard; Jong, Andrea E. van der Meulen–de; Oldenburg, Bas; Boer, Nanne K. H. de; Löwenberg, Mark; Srivastava, Nidhi; Bodelier, Alexander; West, Rachel; Jansen, Jeroen M.; Vries, Annemarie C. de; Haans, J; Jong, Dirk J. de; Pierik, Marie J.; Hoentjen, Frank

doi:10.1002/cpt.1712

Cited by 26 publications

(36 citation statements)

References 23 publications

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“…With 89 treatment‐related adverse events per 100 patient years, the rate of adverse events in tofacitinib‐treated patients was relatively high when compared with other treatments given to anti‐TNF exposed patients . A recent review of clinical trials showed a comparable safety profile of tofacitinib when compared with vedolizumab and anti‐TNF with the exception of herpes zoster infections/reactivations .…”

Section: Discussionmentioning

confidence: 99%

“…We were able to compare the real‐world total number of tofacitinib‐related adverse events with other treatments prescribed to anti‐TNF refractory patients such as vedolizumab (inflammatory bowel disease [IBD]) and ustekinumab (Crohn's disease [CD]) following an identical methodology from our ICC Registry . This comparison yielded 30 treatment‐related adverse events per 100 patient years for vedolizumab, 24 treatment‐related adverse events per 100 patient years for ustekinumab and 89 treatment‐related adverse events per 100 patient years for tofacitinib, suggesting a less desirable profile in terms of adverse events for the latter. The rate of infections was relative low with no severe infections and 43 mild‐to‐moderate infections per 100 patient years including 4 herpes zoster reactivations.…”

Section: Discussionmentioning

confidence: 99%

“…The ICC Registry is a prospective, nationwide and observational registry of inflammatory bowel disease (IBD) patients initiating pre‐specified IBD therapies in everyday care in the Netherlands. The design and rationale have previously been described in detail . In short, IBD patients aged 16 years or older are included in eight university and seven non‐university hospitals.…”

Section: Methodsmentioning

confidence: 99%

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Tofacitinib for ulcerative colitis: results of the prospective Dutch Initiative on Crohn and Colitis (ICC) registry

Biemans

Sleutjes

Vries

et al. 2020

Aliment Pharmacol Ther

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Background: Tofacitinib is a Janus kinase inhibitor approved for the treatment of ulcerative colitis (UC).Aim: To evaluate effectiveness, safety and use of tofacitinib in daily practice.Methods: UC patients initiating tofacitinib were prospectively enrolled in 15 hospitals in the Netherlands. Corticosteroid-free clinical remission (short clinical colitis activity index [SCCAI] ≤2), biochemical remission (faecal calprotectin level ≤250 µg/g), combined corticosteroid-free clinical and biochemical remission, predictors of remission, safety outcomes, treatment dose and effect on lipids were determined at weeks 12 and 24. Endoscopic outcomes were evaluated in centres with routine endoscopic evaluation.Results: In total, 123 UC patients (95% anti-TNF, 62% vedolizumab and 3% ustekinumab experienced) were followed for a median duration of 24 weeks (interquartile range 12-26). The proportion of patients in corticosteroid-free clinical, biochemical, and combined corticosteroid-free clinical and biochemical remission rate at week 24 was 29% (n: 22/77), 25% (n: 14/57), and 19% (n: 11/57) respectively. Endoscopic remission (Mayo = 0) was achieved in 21% of patients at week 12 (n: 7/33). Prior vedolizumab exposure was associated with reduced clinical remission (odds ratio 0.33, 95% confidence interval [CI] 0.11-0.94). At week 24, 33% (n: 14/42) of patients still on tofacitinib treatment used 10 mg twice daily. In total, 33 tofacitinib-related adverse events (89 per 100 patient years) occurred, 7 (6% of total cohort) resulted in | 881 BIEMANS Et Al. How to cite this article: Biemans VBC, Sleutjes JAM, de Vries AC, et al; on behalf of the Dutch Initiative on Crohn and Colitis (ICC). Tofacitinib for ulcerative colitis: results of the prospective Dutch Initiative on Crohn and Colitis (ICC) registry. Aliment Pharmacol Ther. 2020;51:880-888. https://doi.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Tofacitinib for ulcerative colitis: results of the prospective Dutch Initiative on Crohn and Colitis (ICC) registry

Biemans

Sleutjes

Vries

et al. 2020

Aliment Pharmacol Ther

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“…Third, approximately two‐thirds of patients treated with anti‐TNF fail this treatment over time due to primary or secondary loss of response or adverse events 31,32 . Although there is limited data for vedolizumab, ustekinumab and tofacitinib on this topic, real‐world data show, especially for Crohn's disease, a high rate of loss of response between the first and third year for vedolizumab 15,33 . Therefore, optimising thiopurine therapy before switching to biologicals remains important to preserve treatment options for generally young patients with a life‐long chronic incurable disease.…”

Section: Discussionmentioning

confidence: 99%

“…In this multicenter cohort study, LDTA patients of ≥16 years with prior failure to conventional thiopurines due to adverse events and without biological treatment at baseline were identified in the prospective, multicenter Dutch ‘Initiative on Crohn and Colitis’ (ICC) Registry. The ICC Registry was developed to determine the effectiveness, safety and usage of specific IBD treatments in the Netherlands, as previously described 14,15 . In short, IBD patients initiating LDTA were included in four tertiary referral centres and one teaching hospital and were followed for 2 years with a predefined follow‐up schedule of outpatient visits designed to closely follow regular care (week 0, 12, 24, 52, and 104).…”

Section: Methodsmentioning

confidence: 99%

A comparative analysis of tioguanine versus low‐dose thiopurines combined with allopurinol in inflammatory bowel disease patients

Savelkoul

Gabriëls

Simsek

et al. 2020

Aliment Pharmacol Ther

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| on behalf of the Dutch Initiative on Crohn's Colitis (ICC)This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. SummaryBackground: Both tioguanine and low-dose thiopurines combined with allopurinol (LDTA) can be considered for the treatment of inflammatory bowel disease (IBD) when conventional thiopurines fail due to adverse events. Aim:To compare the safety of tioguanine and LDTA in IBD patients. Methods:Inflammatory bowel disease patients who failed conventional thiopurines due to adverse events and initiated LDTA in standard care were identified in the prospective ICC Registry. IBD patients who failed conventional thiopurines due to adverse events and initiated tioguanine were enrolled in three university hospitals.Patients on concomitant biologicals were excluded. The primary outcome was discontinuation of therapy due to adverse events. Secondary outcomes included: safety outcomes and surgery-, biological-and corticosteroid-free clinical remission (physician global assessment = 0) after 104 weeks. Both multiple logistic regression and propensity score matching were used to correct for confounders. Results:In total, 182 IBD patients treated with tioguanine (n = 94) or LDTA (n = 88) were included with a median follow-up of 104 weeks (IQR 91-104). Of these, 19% (tioguanine: 20%, LDTA: 18%) of patients discontinued therapy due to adverse events. After adjusting for confounders, there were no differences in terms of discontinuation rate due to adverse events (OR 0.50, 95% CI 0.15-1.68, P = 0.26), adverse events (OR 0.89, 95% CI 0.44-1.81, P = 0.75), infections (OR 1.05, 95% CI 0.40-2.73, P = 0.93), hospitalisations (OR 2.00, 95% CI 0.64-6.23, P = 0.23) or clinical remission (OR 0.74, 95%CI 0.33-1.68, P = 0.48). All results are comparable with the propensity score matched cohort.

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Dose Escalation Patterns of Advanced Therapies in Crohn’s Disease and Ulcerative Colitis: A Systematic Literature Review

et al. 2023

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Introduction Dose escalation is one of the treatment approaches studied and suggested in advanced therapies for Crohn’s disease (CD) and ulcerative colitis (UC). This study aimed to identify and characterize the dosing escalation patterns of advanced therapies in CD and UC. Methods Two systematic literature reviews (SLRs) were conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. MEDLINE ® , Embase ® , and Cochrane Library were searched for articles published between January 2011 and October 2021 and limited to non-interventional studies in English language. Congress and bibliographic searches were also conducted. Articles were screened by two independent researchers. Dose escalation patterns were described and summarized considering the regional regulatory label recommendation (in North America [NA] or outside of North America [ONA]). Results Among 3190 CD and 2116 UC articles identified in the Ovid searches, 100 CD and 54 UC studies were included in the SLR, with more studies conducted ONA. Most studies reported an initial maintenance dose pattern aligned with the lower starting dose per local regulatory label; however, several ONA studies ( n = 13 out of 14) reported ustekinumab every 8 weeks as starting maintenance pattern in CD. In ONA studies, the median within-guideline escalation rates in CD and UC were 43% in ustekinumab (CD only), 33% and 32% for vedolizumab; 29% and 39% for adalimumab; and 14% and 10% for infliximab. Evidence regarding dose escalation patterns for tofacitinib, certolizumab pegol, and golimumab was limited. Some dose escalation patterns outside of label recommendations were observed including ustekinumab every 8 weeks to every 4 weeks and vedolizumab every 8 weeks to every 6 weeks. Conclusion Dose escalation strategies are widely documented in the literature. The reported dose escalation patterns and escalation rates vary by region and by CD and UC. Most escalation patterns reported were aligned with regulatory recommendations while some reported more diverse or aggressive dose escalation. Prospero Registration CRD42021289251. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-023-02457-6.

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Vedolizumab for Inflammatory Bowel Disease: Two‐Year Results of the Initiative on Crohn and Colitis (ICC) Registry, A Nationwide Prospective Observational Cohort Study

Cited by 26 publications

References 23 publications

Tofacitinib for ulcerative colitis: results of the prospective Dutch Initiative on Crohn and Colitis (ICC) registry

Tofacitinib for ulcerative colitis: results of the prospective Dutch Initiative on Crohn and Colitis (ICC) registry

A comparative analysis of tioguanine versus low‐dose thiopurines combined with allopurinol in inflammatory bowel disease patients

Dose Escalation Patterns of Advanced Therapies in Crohn’s Disease and Ulcerative Colitis: A Systematic Literature Review

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