Long-Term Effectiveness and Safety of Vedolizumab in Patients with Crohn’s Disease: 5-Year Cumulative Exposure of Gemini 2 Completers Rolling Into the Gemini Open-Label Extension Study

Vermeire, Séverine; Loftus, Edward V.; Colombel, Jean Fréd́eric; Feagan, Brian G.; Sandborn, William J.; Sands, Bruce E.; Danese, Silvio; D’Haens, Geert R.; Kaser, Arthur; Panaccione, Remo; Rubin, David T.; Shafran, Ira; O’Byrne, Sharon; Geransar, Parnia; Previtali, Alessandro; Khalid, Javaria Mona; Kaviya, Arpeat

doi:10.1016/s0016-5085(17)32147-9

Cited by 9 publications

(12 citation statements)

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“…Through a retrospective analysis of clinical data of patients receiving the drug in 3 referral centers, we initially showed that induction of remission at week 14 was achieved in more than one fifth of CD patients and nearly one third of UC. Additionally, clinical response at the same time point was seen in another one fifth of CD patients and UC patients, thus confirming previous real-life studies showing that nearly half of the IBD patients can benefit from vedolizumab treatment [14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31]. Altogether, these findings indicate the need to identify predictive factors of response to the drug in order to optimize the therapeutic strategy.…”

Section: Discussionsupporting

confidence: 83%

“…Vedolizumab is recommended for patients with active CD and active UC who have not responded to corticosteroids, immunosuppressants, or tumor necrosis factor (TNF) blockers. Almost half of the IBD patients respond to vedolizumab, but more than one-third of them relapse within 12-36 months from the induction phase [13][14][15][16][17][18][19][20][21][22][23]. These findings have boosted intensive research aimed at identifying predictors of response to the drug [14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31].…”

Section: Introductionmentioning

confidence: 99%

“…Almost half of the IBD patients respond to vedolizumab, but more than one-third of them relapse within 12-36 months from the induction phase [13][14][15][16][17][18][19][20][21][22][23]. These findings have boosted intensive research aimed at identifying predictors of response to the drug [14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31]. It is now evident that prior exposure to anti-TNF α drugs associates with a reduced induction of clinical and endoscopic remission [14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31].…”

Section: Introductionmentioning

confidence: 99%

“…These findings have boosted intensive research aimed at identifying predictors of response to the drug [14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31]. It is now evident that prior exposure to anti-TNF α drugs associates with a reduced induction of clinical and endoscopic remission [14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31]. Both CD and UC patients with a severe clinical activity at baseline are less likely to respond to vedolizumab, as compared to patients with mild-to-moderate disease [14][15][16][17][18][19][20][21][22][23][24][25]…”

Section: Introductionmentioning

confidence: 99%

“…It is now evident that prior exposure to anti-TNF α drugs associates with a reduced induction of clinical and endoscopic remission [14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31]. Both CD and UC patients with a severe clinical activity at baseline are less likely to respond to vedolizumab, as compared to patients with mild-to-moderate disease [14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31]. In addition to prior anti-TNF α therapy, active smoking, penetrant behavior, and active perianal disease at baseline are independent predictors of nonresponse to the drug in CD patients [19].…”

Section: Introductionmentioning

confidence: 99%

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Extent of Mucosal Inflammation in Ulcerative Colitis Influences the Clinical Remission Induced by Vedolizumab

Scarozza

Marafini

Laudisi

et al. 2020

JCM

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Randomized controlled clinical trials and real-life observations indicate that less than 50% of patients with Crohn’s disease (CD) or ulcerative colitis (UC) respond to vedolizumab, a humanized monoclonal antibody that blocks the α4β7 integrin. Since α4β7-expressing lymphocytes mainly infiltrate the left colon, we assessed whether localization of CD and UC influences vedolizumab-induced remission. One hundred and eighty-one patients (74 CD and 107 UC) receiving vedolizumab in 3 referral centers were retrospectively evaluated for clinical remission at week 14. Demographic and clinical characteristics were compared between remitters and non-responders, and multivariable multinomial analysis was performed to identify predictors of remission. Remission was achieved in 17 CD (23%) and 34 UC (32%) patients, respectively. In CD, localization of the lesions did not influence clinical remission. In UC, the remitters had more frequently a distal/left-sided colitis (21/34, 62%) as compared to the non-responders (9/47, 19%), and extensive colitis was more frequent in the non-responders (38/47, 81%) than in the remitters (13/34, 38%). The multivariable multinomial analysis showed that distal/left-sided colitis was associated with a higher probability of clinical remission while extensive colitis was inversely associated with induction of remission. Data indicate that UC patients with distal or left-sided colitis are more likely to achieve remission than patients with extensive colitis following vedolizumab treatment.

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Section: Discussionsupporting

confidence: 83%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Extent of Mucosal Inflammation in Ulcerative Colitis Influences the Clinical Remission Induced by Vedolizumab

Scarozza

Marafini

Laudisi

et al. 2020

JCM

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Ustekinumab is effective and safe for ulcerative colitis through 2 years of maintenance therapy

Panaccione¹,

Danese²,

Sandborn

et al. 2020

Aliment Pharmacol Ther

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SummaryBackgroundThe ongoing UNIFI long‐term extension evaluates subcutaneous ustekinumab for moderate‐to‐severe ulcerative colitis (UC) from weeks 44 through 220.AimsTo assess efficacy (through week 92) and safety (through week 96) during the long‐term extensionMethodsOverall, 399 responders to intravenous ustekinumab induction and who were randomised to maintenance therapy were treated in the long‐term extension (115 received subcutaneous placebo, 141 received ustekinumab 90 mg every 12 weeks [q12w], and 143 received ustekinumab 90 mg q8w). Placebo treatment was discontinued at unblinding after week 44. Partial Mayo scores were collected every 12 weeks and at each dosing visit after unblinding. Safety was evaluated throughout.ResultsAmong all patients randomised in maintenance, symptomatic remission rates (stool frequency = 0/1; rectal bleeding = 0) at week 92 were, 64.5% and 67.6% in the ustekinumab q12w and q8w groups, respectively. Among randomised patients treated in the long‐term extension, 78.7% and 83.2% of patients receiving q12w and q8w, respectively, attained symptomatic remission at week 92; >95% of patients in symptomatic remission at week 92 were corticosteroid‐free. Both ustekinumab groups maintained efficacy through week 92. From weeks 44 to 96, adverse events (AEs) per hundred patient‐years (PY) of follow‐up for combined ustekinumab vs placebo were: 255.68 vs 267.93; serious AEs, 9.34 vs 12.69; malignancies (including non‐melanoma skin cancers), 0.93 vs 1.49; and serious infections, 2.33 vs 2.99. One patient with multiple comorbidities who received one ustekinumab dose after dose adjusting from placebo experienced a fatal cardiac arrest.ConclusionsThe efficacy of ustekinumab in patients with UC was sustained through 92 weeks. No new safety signals were observed (ClinicalTrials.gov number, NCT02407236).

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Vedolizumab in Inflammatory Bowel Disease: West versus East

Debnath¹,

Rathi²

2021

Inflamm Intest Dis

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Background: Vedolizumab is a humanized immunoglobulin G1 monoclonal antibody, which binds to α4β7 integrin on T lymphocytes, thus disturbing the interaction with mucosal vascular addressin cell adhesion molecule 1 on the intestinal endothelial cells to interfere with lymphocyte trafficking to the gut. Summary: Vedolizumab is a safe and effective drug to induce and maintain clinical remission in patients with Crohn’s disease (CD) and ulcerative colitis (UC) in both clinical trials and real-world data. Various guidelines recommend vedolizumab as a first- or second-line treatment regimen for steroid-dependent, steroid, or immunomodulator refractory cases of UC and CD; however, it is more effective in anti-TNF-naive patients. The first head-to-head trial (VARSITY trial) comparing the efficacy of vedolizumab to adalimumab has shown better clinical remission and mucosal healing with vedolizumab. Key Messages: In this review, we have discussed guidelines recommendation of vedolizumab use, as well as its safety data, use in special population, in presence of extraintestinal complications, therapeutic drug monitoring, data from Asian patients, along with other evolving concepts. Because of its excellent safety data and low immunogenicity, vedolizumab is an impressive option for patients with prior malignancy and less chance of reactivation of tuberculosis; however, cost remains an issue.

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Long-Term Effectiveness and Safety of Vedolizumab in Patients with Crohn’s Disease: 5-Year Cumulative Exposure of Gemini 2 Completers Rolling Into the Gemini Open-Label Extension Study

Cited by 9 publications

References 0 publications

Extent of Mucosal Inflammation in Ulcerative Colitis Influences the Clinical Remission Induced by Vedolizumab

Extent of Mucosal Inflammation in Ulcerative Colitis Influences the Clinical Remission Induced by Vedolizumab

Ustekinumab is effective and safe for ulcerative colitis through 2 years of maintenance therapy

Vedolizumab in Inflammatory Bowel Disease: West versus East

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