180 CLINICAL CHARACTERISTICS, CLINICAL RESPONSE, AND CLINICAL REMISSION STATUS IN ADULTS TREATED WITH USTEKINUMAB IN THE PHASE 3 UNITI STUDIES AT WEEK 6 AND WEEK 44 BY AGE AT CROHN'S DISEASE ONSET

2021 ◽  
Vol 160 (6) ◽  
pp. S-44
Author(s):  
Stanley A. Cohen ◽  
Anne M. Griffiths ◽  
Jeffrey S. Hyams ◽  
Joel R. Rosh ◽  
Dan Turner ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Response ◽  
Clinical Remission ◽  
Clinical Characteristics ◽  
Disease Onset ◽  
Phase 3 ◽  
Remission Status

scholarly journals OP23 Efficacy and safety of vedolizumab SC in patients with moderately to severely active Crohn’s disease: Results of the VISIBLE 2 study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S020-S021
Author(s):  
S Vermeire ◽  
W Sandborn ◽  
F Baert ◽  
S Danese ◽  
T Kobayashi ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Response ◽  
Clinical Remission ◽  
Maintenance Treatment ◽  
Activity Index ◽  
Study Drug ◽  
Open Label ◽  
Phase 3 ◽  
Double Blind

Abstract Background Vedolizumab (VDZ) is a gut-selective, humanised, monoclonal α 4β 7 integrin antibody for the treatment of patients with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD). VDZ is currently an intravenous (IV) therapy; a subcutaneous (SC) formulation is under development to provide patients with an alternative route of administration for maintenance treatment for UC and CD. Here we present the first data from the phase 3 study of VDZ SC maintenance treatment in CD. Methods VISIBLE 2 (NCT02611817; EudraCT 2015-000481-58) was a randomised, double-blind, placebo (PBO)-controlled phase 3 trial of VDZ SC as maintenance treatment in adults with moderately to severely active CD. Patients (n = 644) received open-label VDZ 300mg IV induction therapy at Weeks 0 and 2. At Week 6, clinical responders (defined as patients with a ≥70-point decrease in CD Activity Index [CDAI] from baseline) were randomly assigned to receive vedolizumab SC (108 mg every 2 weeks [Q2W]), or placebo (Q2W) for up to 52 weeks. The primary endpoint was clinical remission at Week 52 (defined as CDAI score ≤150). Rank-ordered secondary endpoints were enhanced clinical response at Week 52 (a drop of ≥100 in CDAI score), corticosteroid (CS)-free clinical remission at Week 52, and clinical remission at Week 52 in anti-tumour necrosis factor (TNF)-naïve patients. Finally, VDZ immunogenicity and predefined adverse events of special interest were assessed. Results Patients who responded to VDZ IV induction at Week 6 (n = 409) were randomised to VDZ SC (n = 275) or PBO (n = 134) maintenance and received at least 1 dose of study drug; 61% and 53%, respectively, were previously exposed to anti-TNF therapy. At Week 52, 48.0% of patients on VDZ SC vs. 34.3% on PBO were in clinical remission (p = 0.008, Figure). Enhanced clinical response at Week 52 was reached by 52.0% vs. 44.8% of patients on VDZ SC vs. PBO, respectively (p = 0.167). Among patients on concomitant CS at baseline (VDZ SC, n = 95; PBO, n = 44), 45.3% receiving VDZ SC vs. 18.2% receiving PBO achieved CS-free clinical remission at Week 52. Of anti-TNF-naïve patients (VDZ SC, n = 107; PBO, n = 63), 48.6% vs. 42.9% were in clinical remission at Week 52 in the VDZ SC and PBO arms, respectively. Injection-site reactions were reported for <3% of patients treated with VDZ SC. Serious infections, malignancy, and liver injury were ≤5% for both arms. Anti-VDZ antibodies were detected in 7 (2.5%) patients treated with VDZ SC arm; 4 of 7 patients developed neutralising antibodies. No new safety signals were observed. Conclusion Among VDZ IV induction responders, significantly more patients on maintenance VDZ SC than PBO achieved clinical remission at Week 52. The safety findings with VDZ SC remain in line with the known safety profile of VDZ IV in patients with CD.

scholarly journals OP26 Risankizumab induces early clinical remission and response in patients with Moderate-to-Severe Crohn’s Disease: Results from the phase 3 ADVANCE and MOTIVATE studies

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S026-S027
Author(s):  
S W Schreiber ◽  
M Ferrante ◽  
R Panaccione ◽  
J F Colombel ◽  
T Hisamatsu ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Response ◽  
Induction Therapy ◽  
Clinical Remission ◽  
Activity Index ◽  
Unmet Need ◽  
Inadequate Response ◽  
Biologic Treatment ◽  
Double Blind

Abstract Background Present therapies leave an unmet need for early and effective treatment for patients with Crohn’s disease (CD). Risankizumab (RZB), a humanized immunoglobulin G1 monoclonal antibody against the p19 subunit of interleukin-23, was evaluated as an induction therapy to induce early clinical remission and response in patients with moderate-to-severe CD in two double-blind, randomized, placebo (PBO)-controlled studies (ADVANCE [NCT03104413] and MOTIVATE [NCT03105128]). Methods Patients with moderate-to-severe CD (CD Activity Index [CDAI] of 220–450, Simple Endoscopic Score for CD [SES-CD] ≥ 6 [≥ 4 for isolated ileal disease] excluding the narrowing component, and average daily [liquid/very soft] stool frequency [SF] ≥ 4 and/or average daily abdominal pain [AP] score ≥ 2) who had inadequate response or intolerance to conventional and/or biologic treatment (ADVANCE), or biologic treatment only (MOTIVATE) were randomised 2:2:1 (ADVANCE) or 1:1:1 (MOTIVATE) to receive intravenous RZB 600 mg, RZB 1200 mg, or PBO as induction therapy at weeks 0, 4, and 8. Clinical remission (per either CDAI or a composite of SF and AP criteria), clinical response (per CDAI criterion), and enhanced clinical response (per a composite of SF and AP criteria) were evaluated at weeks 4, 8, and 12 (endpoints defined in Figure 1 footnotes). Safety was assessed throughout the studies. Results A total of 1419 patients from ADVANCE (N = 850) and MOTIVATE (N = 569) respectively, were randomised and included in the intention-to-treat population. In both studies, starting at week 4 (the first prespecified measurement), greater proportions of RZB 600 mg or RZB 1200 mg- vs PBO-treated patients achieved clinical remission per either CDAI (P = .01/P < .05) or SF/AP criteria (P < .01/P < .01), clinical response per CDAI criterion (P = .001/P < .01), and enhanced clinical response per SF/AP criteria (P < .01/P = .14) (Figure 1). For both RZB 600 mg and RZB 1200 mg, the efficacy and treatment effect increased through week 12 (P ≤ .001/P ≤ .001) (Figure 1). Treatment with RZB 600 mg or 1200 mg was well tolerated, and no new safety risks were identified.1,2 Conclusion Induction therapy with both RZB 600 mg and 1200 mg intravenous resulted in significantly greater clinical remission and response vs PBO as early as week 4 and sustained through week 12 in patients with moderate-to-severe CD who had inadequate response or intolerance to conventional and/or biologic treatment. References

scholarly journals DOP16 An evaluation of the exposure–efficacy relationship for subcutaneous vedolizumab maintenance treatment of Crohn’s disease: Pharmacokinetic findings from VISIBLE 2

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S056-S057
Author(s):  
C Chen ◽  
M Rosario ◽  
D Polhamus ◽  
N Dirks ◽  
W Zhang ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Response ◽  
Clinical Remission ◽  
Maintenance Treatment ◽  
Activity Index ◽  
Controlled Trial ◽  
Enzyme Linked Immunosorbent Assay ◽  
Serum Concentrations ◽  
Efficacy Outcome

Abstract Background The exposure–efficacy relationship and immunogenicity rates of the new vedolizumab subcutaneous (SC) formulation have been established for maintenance treatment of ulcerative colitis (UC).1 Here, we report vedolizumab SC exposure–efficacy and immunogenicity in Crohn’s disease (CD). Methods VISIBLE 2 (NCT02611817; EudraCT 2015-000481-58) was a pivotal, phase 3, randomised, double-blind, placebo-controlled trial evaluating the efficacy and safety of vedolizumab SC (108 mg every 2 weeks) as maintenance treatment in patients with moderately to severely active CD. Following intravenous (IV) vedolizumab (300 mg Week 0 and 2) induction, patients with a clinical response at Week 6 (≥70-point decrease in CD activity index [CDAI] from Week 0) were randomised to blinded maintenance treatment and included in the analyses. Vedolizumab serum concentrations were measured prior to dosing using an enzyme-linked immunosorbent assay. Immunogenicity was assessed with a drug-tolerant electrochemiluminescence assay. Predicted vedolizumab trough concentrations at Week 52 were grouped by quartiles (Q), and Week 52 efficacy outcome rates calculated for each Q. Missing efficacy outcome data were imputed as failures. Efficacy outcomes were clinical remission (CDAI ≤150) and enhanced clinical response (≥100-point decrease in CDAI from Week 0 at Week 52). Results Following vedolizumab IV induction (N = 644), patients with a clinical response were randomised and received vedolizumab SC (N = 275) or placebo (N = 134) as maintenance treatment. At Week 52, patients on vedolizumab SC maintenance had a positive exposure–efficacy relationship for clinical remission (Q1: 37.7%; Q4: 50.7%) and enhanced clinical response (Q1: 37.7%; Q4: 53.6%; Figures 1 and 2). Overall, 7/275 (2.5%) patients on vedolizumab SC (following vedolizumab IV induction) developed anti-vedolizumab antibodies (AVAs): 3/7 patients were persistently AVA positive and 4/7 had neutralising antibodies. Five of 7 AVA-positive patients on vedolizumab SC did not achieve clinical remission and enhanced clinical response at Week 52; 2 of those patients were persistently AVA-positive. Immunogenicity was not associated with injection-site reactions or hypersensitivity reactions. Conclusion These preliminary results suggest a trend for higher vedolizumab SC serum concentrations with greater efficacy in CD, but the association was less pronounced than was reported in UC. (1) The AVA rate was similar to what was observed in prior vedolizumab IV studies. (2) In this study, vedolizumab immunogenicity appeared to be associated with clinical outcome. References

scholarly journals P577 Ustekinumab in actual clinical practice: our centre experience

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S485-S486
Author(s):  
J M LOPEZ TOBARUELA ◽  
A D Sanchez-Capilla ◽  
E J Ortega-Suazo ◽  
M C Fernandez-Cano ◽  
M Herrador-Paredes ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Response ◽  
Safety Profile ◽  
Clinical Remission ◽  
Clinical Manifestations ◽  
Previous Treatment ◽  
Biological Therapies ◽  
Response Predictors ◽  
Wide Variability

Abstract Background Crohn’s disease is an entity with wide variability in its clinical manifestations, which mainly affects the gastrointestinal tract, and may also involve another organs. We have a wide variety of treatments available, being the most recent ones biological therapies. One of them is ustekinumab, which due to its innovative mechanism of action has improved the quality of life of many patients with an excellent safety profile. Our objective was to analyze the baseline situation of 37 patients undergoing treatment with ustekinumab in our centre and the evolution of different clinical and analytical parameters at 12, 24 and 52 weeks after starting it. Methods 37 patients currently receiving ustekinumab treatment with indication of Crohn’s disease at Virgen de las Nieves Hospital were selected (Tables 1 and 2). Clinical response was analyzed according to the Harvey–Bradshaw Index (HBI) (clinical remission <4, clinical response decrease ≥3 points above the baseline), blood and stool test (CRP and calprotectin) at weeks 12, 24 and 52, need for surgery and safety profile (Table 3). Results There are no significant differences in HBI or baseline CRP depending on previous or not treatment with anti-TNF or vedolizumab. No differences in HBI, CRP at weeks 12, 24 and 52 depending on if previous treatment with anti-TNF or vedolizumab. The decrease in the median values of HBI was statistically significant at weeks 12, 24 and 52; as well as CRP values at weeks 24 and 52 (Table 3). According to HBI, clinical response was obtained in 41,38%, 50% and 61,11% of patients at weeks 12, 24 and 52 and clinical remission in 20,69%, 33,33% and 27,78% respectively (Table 3). No response predictors were identified at week 12 except for non-perianal fistulas associated with a greater response (58,3% vs. 41,7%; p = 0,0459) (Table 4). Conclusion In this group of patients potentially difficult to treat (62% previous surgery, long-term disease, 95% previous treatment with immunomodulators and/or biological therapies (66% ≥2 anti-TNF), etc.), ustekinumab achieves clinical response in 41,38%, 50%, 61,11% at week 12, 24 and 52. Surgery was required in 2 cases and only 3 patients suffered relevant adverse effects. In a pivotal study of ustekinumab UNITI-1, 50,6% of patients who received the induction dose of 6 mg/kg had previously been treated with ≥2 anti-TNF, in our group, 65,71%. In our cohort, only 29,73% of patients received corticosteroids concomitantly at the start of ustekinumab treatment vs. 43,3% at UNITI-1. Despite these differences against our group, clinical response and remission data are similar to UNITI-1 (41,38% vs. 37,8% and 20,69% vs. 20,9% respectively). Prospective studies with more patients could identify who would benefit most from this treatment.

Mucosal Biomarker of Innate Immune Activation Predicts Response to Vedolizumab in Crohn’s Disease

2019 ◽  
Author(s):  
Mark T Osterman ◽  
Ilyssa O Gordon ◽  
Elisabeth M Davis ◽  
Matthew Ciorba ◽  
Sarah C Glover ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Response ◽  
Immune Activation ◽  
Clinical Remission ◽  
Response Rate ◽  
Intestinal Inflammation ◽  
Innate Immune ◽  
Clinical Response Rate ◽  
Innate Immune Activation

Abstract Objective Mucosal barrier dysfunction plays a crucial role in intestinal inflammation in Crohn’s disease (CD). Intestinal epithelial cell (IEC) death resulting from innate immune activation, termed pyroptosis, was recently found to be a cause of this barrier defect. The aim of this study was to determine the predictive value of pretreatment ileal biopsy pyroptosis as a biomarker for clinical response to vedolizumab in CD. Design Crohn’s disease patients ranging 18 to 80 years old from 5 IBD centers with pre-vedolizumab ileal biopsies during colonoscopy were enrolled. Biopsies were stained for activated caspases, and levels of ileal IEC pyroptosis levels were quantified. The primary outcome was clinical response 6 months after therapy, defined as a reduction of Harvey-Bradshaw Index (HBI) of ≥5 points from baseline. Secondary outcomes included clinical remission, defined as HBI <5, and endoscopic improvement, as measured by the Simple Endoscopic Score for Crohn’s Disease (SES-CD). Results One hundred CD patients (45 male, 55 female), median age 47 (19, 78) years, were included; clinical response rate was 60%, and clinical remission was 36%. The response rate in patients with ileal pyroptosis <14 positive cells per 1000 IECs was significantly higher than those above the threshold: 89% (25 of 28) vs 49% (35 of 72), odds ratio (OR) 8.8 (95% CI, 2.3–48.6; P < 0.001). Corresponding remission rates were 54% (15 of 28) vs 29% (21 of 72; OR 2.8 [1.03–7.59; P = 0.036]). For endoscopic improvement, ileal pyroptosis of 22 positive cells per 1000 IECs was the optimal threshold that determines the magnitude SES-CD change. Conclusions Ileal biopsy IEC pyroptosis was predictive of clinical response and endoscopic improvement to vedolizmab in CD patients.

scholarly journals P613 Use of adalimumab biosimilar ABP 501 in Crohn’s disease: A real-life experience

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S510-S511
Author(s):  
D G Ribaldone ◽  
M Vernero ◽  
R Pellicano ◽  
M Morino ◽  
G M Saracco ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Adverse Events ◽  
Clinical Response ◽  
Clinical Remission ◽  
Retention Rate ◽  
Real Life ◽  
University Hospital ◽  
Clinical Response Rate ◽  
Abp 501

Abstract Background The use of biologics in Crohn’s disease (CD) entails an increasing cost on national health systems. The use of biosimilars of adalimumab in CD is based on the concept of extrapolation of the results obtained in rheumatoid arthritis and in psoriasis, while no study about the efficacy and safety on CD of the biosimilars approved in Europe have been published. The aim of our study was to analyse, for the first time in literature, the effectiveness and safety of ABP 501 in CD patients naïve to adalimumab and its retention rate in CD patients who switched from adalimumab originator. Methods We performed an observational study on patients prospectively followed at the gastroenterology clinic of the Turin University Hospital. Inclusion criteria are (a) CD diagnosed according to ECCO criteria; (b) age ≥16 years; (c) initiation of therapy with ABP 501. Exclusion criterian is follow-up duration of less than 3 months for adalimumab-naïve patients, less than 6 months for patients who switched to ABP 501. Primary outcomes were (a) for patients treated with ABP 501 as first adalimumab: clinical response rate at 12 weeks and (b) for patients who switched to ABP 501: drug retention at 24 weeks. Secondary outcomes were (a) clinical remission rate at week 12 (for patients treated with ABP 501 as first adalimumab); (b) HBI and CRP reduction at week 12 (for patients treated with ABP 501 as first adalimumab), no significant change in HBI and CRP values at week 24 (for patients who switched to ABP 501); (c) analysis of predictors; and (d) adverse events incidence. Results Eighty-seven patients were included, of which 25 were naïve to adalimumab originator and 62 were switched to ABP 501. In adalimumab-naïve patients, the clinical response at 3 months was 60% (15/25), clinical remission at 3 months was 56% (14/25). At 6 months, 95.2% (59/62) of the patients switched to ABP 501 were still in therapy, without a significant increment of clinical activity (Harvey–Bradshaw Index from 3.4, 95% CI = 2.4 – 4.4, to 3.8, 95% CI = 2.7 – 4.9, p = 0.23), and inflammatory biomarker (CRP from 4.2 mg/l, 95% CI = 2.5 mg/l – 5.9 mg/l, to 3.6 mg/l, 95% CI = 2.2 mg/l – 5 mg/l, p = 0.32). No unexpected adverse events occurred during the study period. Conclusion Our results support ABP 501 as an efficacious and well-tolerated drug, at least in the short-term, and its interchangeability with its originator in the treatment of CD.

scholarly journals DOP13 Clinical and endoscopic response to ustekinumab in Crohn’s disease: Week 16 interim analysis of the STARDUST trial

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S049-S052 ◽  
Author(s):  
S Danese ◽  
S Vermeire ◽  
G D’Haens ◽  
J Panés ◽  
A Dignass ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Response ◽  
Clinical Remission ◽  
Disease Duration ◽  
Activity Index ◽  
Standard Of Care ◽  
Treat To Target ◽  
Faecal Calprotectin ◽  
Intention To Treat

Abstract Background Treat-to-target (T2T) strategy may optimise IBD disease management. We describe interim clinical and endoscopic results of the STARDUST trial in Crohn’s disease (CD) patients, following 16 weeks (W) of ustekinumab (UST) induction. Methods STARDUST, an ongoing phase 3b randomised strategy trial, enrolled adults with moderate–severely active CD (CD activity index [CDAI] 220–450) and simple endoscopic index for CD [SES-CD] ≥3) who failed conventional therapy ±1 biologic. At W0, patients received intravenous, weight-based UST of ~6mg/kg (approved label) and at W8, subcutaneous UST 90mg. At W16, patients with CDAI reduction ≥70 points were randomised (1:1) to T2T or standard of care. Key endpoints (intention-to-treat [ITT] set, as observed) were analysed at W8 and W16: % patients in clinical remission (CDAI score &lt;150); % patients with a clinical response (CDAI &lt;150 or decrease vs. baseline [BL] ≥100 points); faecal calprotectin (FCal) and C-reactive protein (CRP) levels: normalisation of FCal or/and CRP; improvement ≥50% vs. BL (patients with elevated FCal and CRP subpopulations); change vs. BL in CDAI and Inflammatory Bowel Disease Questionnaire (IBDQ) total scores. Patients randomised to T2T underwent colonoscopy at W16 and were analysed for change in SES-CD score vs. BL, endoscopic response (decrease in SES-CD score ≥50% vs. BL) and endoscopic remission (SES-CD score ≤2) (central reading). Results The ITT full set included 500 patients with BL mean (SD) CDAI score 282.3 (65.8), SES-CD 13.1 (8.1), CRP 15.7 (23.4) mg/l, FCal 1741.9 (2932.1) mg/g and disease duration 9.4 (8.7) years; 58.4% previously failed 1 biologic. At W16, 79.4% of patients had a clinical response and 66.6% were in clinical remission. About half of the patients showed ≥50% improvement in FCal and CRP levels, which normalised in about 1/3 of patients. Results were similar irrespective of previous biologic (Table 1); 84% of patients in response at W16 were in clinical remission. Statistically significant changes from BL in CDAI, FCal, and CRP were observed at W8, and in IBDQ scores at W16 (Table 2). In the T2T set (n = 220; CDAI 70 responders), BL characteristics were similar to the full analysis set; SES-CD score was 13.4 (8.8). At W16, 36.8% and 11.4% of patients in the T2T set achieved endoscopic response and remission, respectively. The endoscopic response was independent of BL SES-CD score and disease duration, but numerically better for colonic vs. ileal disease. No new safety signals were reported. Conclusion STARDUST is the first T2T trial in CD patients. After 16 W following induction with UST, 2/3 of patients achieved clinical remission. Thirty-seven per cent of those randomised to the T2T arm (CDAI 70 responders) showed endoscopic response by central reading at W16. Results were similar irrespective of being bio-naïve or failing 1 biologic.

scholarly journals Real-world effectiveness of vedolizumab in inflammatory bowel disease: week 52 results from the Swedish prospective multicentre SVEAH study

2021 ◽  
Vol 14 ◽  
pp. 175628482110233
Author(s):  
Carl Eriksson ◽  
Sara Rundquist ◽  
Vyron Lykiardopoulos ◽  
Ruzan Udumyan ◽  
Per Karlén ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Response ◽  
Real World ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Real World Data ◽  
Inflammatory Bowel

Background: Prospectively and systematically collected real-world data on vedolizumab are scarce. We aimed to assess the long-term clinical effectiveness of vedolizumab in inflammatory bowel disease (IBD). Methods: This study was a prospective, observational, multicentre study. Overall, 286 patients with active IBD were included (Crohn’s disease, n = 169; ulcerative colitis, n = 117). The primary outcomes were clinical response at week 12 and clinical remission at week 52, based on the Harvey Bradshaw Index and the partial Mayo Clinic score. Secondary outcomes included clinical remission at week 12, clinical response at week 52, corticosteroid-free clinical remission at week 52, changes in biochemical measures, and health-related quality of life (HRQoL). Results: At baseline, 88% of the patients were exposed to anti-TNF and 41% of the patients with Crohn’s disease had undergone ⩾1 surgical resection. At week 12, clinical response was 27% and remission 47% in Crohn’s disease; corresponding figures in ulcerative colitis were 52% and 34%. Clinical response, remission and corticosteroid-free remission at week 52 were 22%, 41% and 40% in Crohn’s disease and 49%, 47% and 46% in ulcerative colitis, respectively. A statistically significant decrease in median faecal-calprotectin and C-reactive protein was observed at 12 and 52 weeks in patients with Crohn’s disease and ulcerative colitis. The HRQoL measures Short Health Scale and EuroQol 5-Dimensions improved in both Crohn’s disease and ulcerative colitis patients ( p < 0.001). Clinical disease activity at baseline was inversely associated with clinical remission at week 52. Conclusion: Vedolizumab proved effective for the treatment of refractory IBD in clinical practice.

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