Efficacy of vedolizumab for induction of clinical response and remission in patients with moderate to severe inflammatory bowel disease who failed at least two TNF antagonists

Vos, Martine De; Dhooghe, Barbara; Vermeire, Séverine; Louis, Édouard; Mana, Fazia; Elewaut, Dirk; Bossuyt, Peter; Baert, Filip; Reenaers, Cathérine; Gossum, M. Van; Macken, Elisabeth; Ferrante, Marc; Hindryckx, Pieter; Dewit, Olivier; Holvoet, Tom; Franchimont, Denis

doi:10.1177/2050640617722310

Cited by 15 publications

(17 citation statements)

References 20 publications

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“…2,3 Although the efficacy and safety of VDZ induction and maintenance therapy in CD has been confirmed in real-life cohorts, only limited data are available on endoscopic and histological remission. [4][5][6][7][8] Endoscopic remission is an important treatment goal in CD that is associated with improved clinical outcomes, including reduced hospitalization and surgery rates. 9,10 Moreover, endoscopic response is recommended as a co-primary endpoint in clinical trials by regulatory agencies.…”

Section: Background and Aimsmentioning

confidence: 99%

Vedolizumab Induces Endoscopic and Histologic Remission in Patients With Crohn’s Disease

et al. 2019

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See editorial on page 925. BACKGROUND & AIMS:We evaluated the ability of vedolizumab to induce endoscopic and histologic remission in patients with Crohn's disease (CD). METHODS: We performed a prospective study of 110 patients with active CD, based on CD activity index (CDAI) scores >220 and mucosal ulcerations, who received open-label vedolizumab (300 mg) infusions at weeks 0, 2, and 6, and every 8 weeks thereafter through week 52 at tertiary centers in Europe. Patients received an additional infusion at week 10 if their CDAI score had not decreased by 70 points. Patients underwent ileocolonoscopy with collection of biopsies at baseline and weeks 26 and 52; a local and central reader determined simple endoscopic index for CD (SES-CD) scores. Histologic features were assessed by a blinded pathologist at week 26. Serum concentrations of vedolizumab were measured at serial time points. The primary outcome was endoscopic and histologic remission in patients with active CD treated with vedolizumab for 52 weeks. RESULTS: At weeks 26 and 52, 36 patients (29%) and 34 patients (31%), respectively, were in corticosteroid-free clinical remission (CDAI score <150), respectively. Based on intent-to-treat analysis, endoscopic remission (SES-CD score <4) was achieved by 36 patients (33%) and 40 patients (36%) at weeks 26 and 52. Endoscopic responses (decrease in SES-CD score 50%) occurred in 44 patients (40%) at week 26 and 5 patients (45%) at week 52. Serum concentrations of vedolizumab were higher at weeks 2, 10, and 22 in patients with lower SES-CD scores. Histologic remission at week 26 was observed in 43 (64%) of 67 patients based on Geboes Score and 37 (66%) of 56 patients based on Robarts Histopathology Index scores in analyses of paired biopsies with inflammation at baseline. Serum concentrations of vedolizumab above 10 mg/L at week 22 were associated with endoscopic remission at week 26. CONCLUSIONS: In a prospective trial, we found that approximately one-third of patients with CD achieve endoscopic remission after 52 weeks of treatment with vedolizumab and two-thirds achieve histologic remission at week 26. Higher serum concentrations of vedolizumab were associated with better outcomes. EUDRACT no: 2014-005376-29.

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Section: Background and Aimsmentioning

confidence: 99%

Vedolizumab Induces Endoscopic and Histologic Remission in Patients With Crohn’s Disease

et al. 2019

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“…The pivotal large-scale GEMINI clinical trials have demonstrated safety and efficacy of vedolizumab in both CD and UC with clinical remission rates of 39% and 42% maintained at 12 months [15,16]. Vedolizumab is effective in the treatment of anti-TNF naive and anti-TNF failure patients and benefits may continue long-term regardless of exposure status [17][18][19]. However, anti-TNF naive CD patients tend to respond better than those with previous exposure [18,20].…”

Section: Introductionmentioning

confidence: 99%

Experiences of using vedolizumab in the treatment of inflammatory bowel disease in the East Midlands UK – a retrospective observational study

White

Din

Ingram

et al. 2020

Scandinavian Journal of Gastroenterology

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Purpose: Clinical trials have demonstrated efficacy of vedolizumab in ulcerative colitis (UC) and Crohn's disease (CD). Further real-world data is needed to inform clinical practice. The primary outcome was to assess corticosteroid-free and clinical remission after vedolizumab initiation. Secondary outcomes included effect on disease activity scores, biochemical markers, concomitant drug use, endoscopic remission, surgical intervention, hospital admissions and adverse events. Materials and methods: A multi-centre retrospective observational study was conducted with patients initiated on vedolizumab across seven UK hospitals 1/11/14-30/11/16. Clinical disease activity was assessed using the partial Mayo Scores (pMS) and Harvey Bradshaw Index (HBI). Clinical remission was defined as HBI 4 or pMS <2 with a combined stool frequency and rectal bleeding sub score of 1. Clinical response was defined as 2-point decrease from baseline in pMS and 3-point decrease from baseline in HBI. Results: One hundred ninety-two patients were included in the final analysis. 45% of UC and 10% of CD patients were anti-TNF naive. Over the observation period corticosteroid-free remission rates for UC and CD were 46% and 45%, while clinical remission rates were 52% and 44%, respectively. Time to corticosteroid free remission for UC and CD was 17.6 [IQR: 8.7-29.6] and 14.1 [QR: 6.0-21.7] weeks, respectively. Time to clinical response for UC was 9.4 [IQR: 5.7-15.4] and CD was 9.5 [IQR: 6.1-18.2] weeks. There was a substantial decrease in the concomitant use of immunomodulators and a similar decrease in concomitant corticosteroid use over the study period. Conclusions: Results in this predominately anti-TNF experienced population mirror other published real-world data, demonstrating good clinical effectiveness and a comparable safety profile.

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“…Considering the highly selective character of trial enrollment, it is always fundamental to observe whether real‐life settings support the initially reported results of a new drug . Real‐world publications on this field are accumulating, with some conflicting results, but only a few of them include long‐term evaluation at 1 year with endoscopic assessment . Therefore, we presented an Italian single‐center study on VDZ long‐standing effectiveness and tolerability in patients with UC and CD at a tertiary referral setting.…”

Section: Introductionmentioning

confidence: 99%

Long‐term efficacy and safety of vedolizumab in patients with inflammatory bowel diseases: A real‐life experience from a tertiary referral center

Dragoni

Bagnoli

Grazie

et al. 2019

J of Digest Diseases

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Objective: The study aimed to evaluate the long-term efficacy and safety of vedolizumab in a real-life cohort of patients with inflammatory bowel diseases enrolled at a tertiary referral center.The primary outcomes were clinical response and remission at 14, 24, and 52 weeks, and steroid-free remission rate (SFRR) at 52 weeks. Endoscopic response and remission rates at 52 weeks were the secondary outcomes. Results: Altogether 49 patients (22 with ulcerating colitis [UC] and 27 with Crohn'sDisease [CD]) were enrolled. The clinical response rate gradually dropped from 85% and 50% in CD and UC, respectively, at week 14 to 59% and 25% at week 52, with significantly a higher response in CD at week 14. The endoscopic response at week 52 was 55% in CD and 25% in UC (P = 0.21). CD group had a higher SFRR than UC group (41% vs 20%) at 52 weeks, although the difference was not statistically significant. Similar clinical and endoscopic rates were observed in biologic-naive and -experienced patients. We reported no discontinuation due to adverse drug reactions, and only mild to moderate events.Conclusions: In our cohort the clinical response in the induction phase was similar to those of registered trials, despite surprising better results for CD. During the maintenance phase we observed an higher drop out than in the reported literatures. Of note, its good safety profile makes vedolizumab a reliable choice in patients with contraindications to anti-tumor necrosis factor agents. K E Y W O R D Sadverse event, anti-integrin, endoscopic remission, inflammatory bowel diseases, maintenance, swap therapy

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Efficacy of vedolizumab for induction of clinical response and remission in patients with moderate to severe inflammatory bowel disease who failed at least two TNF antagonists

Abstract: Up to 70% TNF-refractory/intolerant UC and CD patients achieved a clinical response after 10 to 14 weeks of vedolizumab treatment in this real-life cohort.

Cited by 15 publications

References 20 publications

Vedolizumab Induces Endoscopic and Histologic Remission in Patients With Crohn’s Disease

Vedolizumab Induces Endoscopic and Histologic Remission in Patients With Crohn’s Disease

Experiences of using vedolizumab in the treatment of inflammatory bowel disease in the East Midlands UK – a retrospective observational study

Long‐term efficacy and safety of vedolizumab in patients with inflammatory bowel diseases: A real‐life experience from a tertiary referral center

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