DOP79 Dose escalation of upadacitinib in Crohn’s disease patients with an inadequate response: Data from the randomised CELEST study

Abstract Background Patients with Crohn’s disease (CD) may lose response to treatment, requiring dose adjustments. This analysis from the CELEST study evaluated efficacy and safety in patients with CD who required an escalated dose of upadacitinib (UPA), an oral selective JAK1 inhibitor. Methods CELEST (NCT02365649) was a placebo-controlled phase 2 study of adults with moderate-to-severe CD refractory to immunosuppressants/biologics. Patients were randomised to placebo or UPA 3, 6, 12, or 24 mg twice daily (BID) or 24mg once daily (QD) for 16 weeks (weeks), followed by a 36-week double-blind maintenance period to receive 3, 6 or 12mg BID or 24mg QD (Figure 1). Patients who met criteria for inadequate response (average daily liquid/soft stool frequency [SF] >2.2 or average daily abdominal pain score >1.8, and increase in hs-CRP >1 mg/l from baseline [BL] or hs-CRP ≥5 mg/l at previous or current visit) at or after week 20 were eligible to receive open-label (OL) therapy with UPA 12mg BID. Patients with inadequate response at or after 4 weeks of OL 12 mg BID could further escalate to OL 24 mg BID. Data were analysed using descriptive statistics of clinical/endoscopic improvement, change from BL in hs-CRP and faecal calprotectin (FC), and AEs at week 52. Results Among 220 randomised patients, 180 were re-randomised into the maintenance period; 60 had inadequate response and received OL 12 mg BID. Of the 60 patients, 25 (42%) were in clinical response at week 16. After receiving OL 12 mg, 27 patients (45%) required escalation to OL 24 mg BID. A higher proportion of patients who received OL 24 mg received 2 or more prior TNF antagonists, and had higher BL FC, SF, and Simplified Endoscopic Score for CD (SES-CD) compared with patients who remained on OL 12 mg BID (Table 1). At week 52, 15% of patients who received OL 12 mg achieved clinical remission and 10% achieved endoscopic response. Of the patients who escalated to OL 24 mg, 39% achieved clinical remission and 41% were in endoscopic response at week 52 (Table 2). At week 52, change from BL in FC and hs-CRP was −2123 ± 2475 µg/g and −5.1 mg/l, respectively, for patients who received OL 24 mg vs. −423 ± 2953 and −6.4 mg/l for OL 12 mg. Serious infection was reported in 3 patients (2 receiving OL 12 mg and 1 receiving OL 24 mg). Two nonserious herpes zoster events were reported (1 on each dose), but neither event led to discontinuation of UPA. No malignancies, cardiovascular events, thromboembolic events, intestinal perforations, tuberculosis, or deaths were reported for patients who dose-escalated. Conclusion Patients with non-response or loss of response during CELEST gained clinical remission and endoscopic response with UPA 12 mg BID or further escalation to 24 mg BID. No new safety risks were observed for either dose of UPA, consistent with double-blind CELEST results.

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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

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab075.025 ◽

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

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

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.022 ◽

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.

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Efficacy and safety of adalimumab in Chinese patients with moderately to severely active Crohn’s disease: results from a randomized trial

Therapeutic Advances in Gastroenterology ◽

10.1177/1756284820938960 ◽

2020 ◽

Vol 13 ◽

pp. 175628482093896

Author(s):

Baili Chen ◽

Xiang Gao ◽

Jie Zhong ◽

Jianlin Ren ◽

Xuan Zhu ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Clinical Remission ◽

Activity Index ◽

High Sensitivity ◽

Phase Iii ◽

Chinese Patients ◽

Efficacy And Safety ◽

Open Label ◽

Double Blind

Background and Aims: Efficacy of adalimumab in Crohn’s disease (CD) has not been shown in China. The aim of this study was to evaluate the efficacy and safety of adalimumab in Chinese patients with CD. Methods: This 26-week, multicenter, phase III study evaluated patients with moderately to severely active CD and elevated high-sensitivity C-reactive protein (⩾3 mg/l) who were naïve to anti–tumor necrosis factor therapy. Patients were randomized to double-blind adalimumab 160/80 mg at weeks 0/2 and 40 mg at weeks 4/6 or placebo at weeks 0/2 followed by blinded adalimumab 160/80 mg at weeks 4/6. At week 8, all patients received open-label 40 mg adalimumab every other week through week 26. The primary endpoint was clinical remission [CD activity index (CDAI) <150] at week 4. Clinical remission at week 26 was assessed in week-8 responders (decrease in CDAI ⩾70 points at week 8 from baseline) and compared with a clinically meaningful threshold of 30%. Adverse events (AEs) were recorded throughout the study. Results: At baseline, 205 patients were enrolled, with mean [standard deviation (SD)] age of 32.9 (9.9) years and CD duration of 2.7 (3.0) years. At week 4, 38/102 patients (37%) receiving adalimumab and 7/103 (7%) receiving placebo ( p < 0.001) achieved clinical remission. Among week-8 responders, 93/144 (65%) achieved clinical remission at week 26 ( p < 0.001). No unexpected AEs and no malignancies, active tuberculosis, or deaths were reported. Conclusions: Adalimumab induced and maintained remission in Chinese patients with CD. Safety results were consistent with the known safety profile of adalimumab. identifier: NCT02499783

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P095 AMISELIMOD SAFETY PROFILE FOR CROHN’S DISEASE, STRATIFIED BY PREVIOUS TREATMENT WITH ANTI-TNF AGENTS

Inflammatory Bowel Diseases ◽

10.1093/ibd/zaa010.000 ◽

2020 ◽

Vol 26 (Supplement_1) ◽

pp. S1-S1

Author(s):

Geert R A M D’Haens ◽

Neal Slatkin ◽

Robert Israel ◽

Zeev Heimanson

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Safety Data ◽

Previous Treatment ◽

Treatment Phase ◽

Prior Treatment ◽

Open Label ◽

Double Blind ◽

Clinical Benefits ◽

Previously Treated

Abstract Background Anti-TNF agents are an established treatment modality for ulcerative colitis (UC); however, as many as 30% of patients do not respond to anti-TNF agents, and almost 50% of responders lose clinical benefits after a year of treatment. Furthermore, numerous safety concerns are associated with long-term use of anti-TNF agents. An alternative treatment in development for autoimmune-mediated diseases, including Crohn’s disease (CD) and UC, are sphingosine 1-phosphate receptor modulators such as amiselimod (AMS). Methods The safety and efficacy of oral AMS 0.4 mg/d in adults with moderate to severe active CD over 14 wks were evaluated in a multicenter, randomized, double-blind, parallel-group, placebo (PBO)-controlled (DBPC), phase 2a clinical trial, followed by an open-label extension (OLE) study with AMS for up to 36 wks. Patients had previously used anti-TNF-α agents, immunosuppressants, or corticosteroids. Safety data (adverse events [AEs]) were stratified by patients with and without prior anti-TNF treatment. Results Of the 78 patients randomized 1:1 to receive AMS (n=40) or PBO (n=38), 78% (n=61) completed the DBPC treatment phase. Of those patients continuing into the OLE, 26 patients (AMS/AMS [n=14]; PBO/AMS [n=12]) completed it. Oral AMS 0.4 mg for 12 wks did not have a significant effect on clinical disease activity in CD. Patients previously treated with anti-TNF agents had more serious AEs (SAEs) (27% AMS [n=22]; 4% PBO [n=25]) than did patients without prior anti-TNF treatment (0 AMS and 0 PBO patients). Relative numbers of treatment-emergent AEs (TEAEs) were similar between groups receiving prior anti-TNF agents (68% AMS [n=22]; 68% PBO [n=25]) and no prior treatment (65% AMS [n=17]; 31% PBO [n=13]). There was a trend toward more mild TEAEs and less severe AEs in patients not previously treated with anti-TNF agents compared to those previously treated. Conversely, in the OLE, patients not previously treated with anti-TNF agents had more AEs (100% AMS/AMS [n=11]; 67% PBO/AMS [n=9]) than those with prior treatment (60% AMS/AMS [n=10]; 87% PBO/AMS [n=16]). All of these TEAEs were mild or moderate. In the OLE, only 1 patient receiving AMS/AMS with no prior anti-TNF treatment had an SAE versus no patients with prior treatment. Conclusions Previous treatment with anti-TNF agents did not significantly affect the TEAEs associated with AMS. While SAEs appeared to be more common in previously treated patients in the DBPC, patients had fewer AEs during the OLE. This analysis suggests that previous treatment with anti-TNF agents should be considered when assessing the AE profile of AMS in future trials.

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Clinical remission in patients with moderate-to-severe Crohn's disease treated with filgotinib (the FITZROY study): results from a phase 2, double-blind, randomised, placebo-controlled trial

The Lancet ◽

10.1016/s0140-6736(16)32537-5 ◽

2017 ◽

Vol 389 (10066) ◽

pp. 266-275 ◽

Cited By ~ 171

Author(s):

Séverine Vermeire ◽

Stefan Schreiber ◽

Robert Petryka ◽

Tanja Kuehbacher ◽

Xavier Hebuterne ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Clinical Remission ◽

Controlled Trial ◽

Phase 2 ◽

Double Blind ◽

Study Results

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Randomised trial and open-label extension study of an anti-interleukin-6 antibody in Crohn’s disease (ANDANTE I and II)

Gut ◽

10.1136/gutjnl-2017-314562 ◽

2017 ◽

Vol 68 (1) ◽

pp. 40-48 ◽

Cited By ~ 37

Author(s):

Silvio Danese ◽

Séverine Vermeire ◽

Paul Hellstern ◽

Remo Panaccione ◽

Gerhard Rogler ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Interleukin 6 ◽

Randomised Trial ◽

Inadequate Response ◽

Open Label ◽

Link Type ◽

Induction Study ◽

Open Label Extension

ObjectiveNeutralising pro-inflammatory interleukin-6 (IL-6) may effectively treat Crohn’s disease (CD). Effects of PF-04236921, an anti-IL-6 antibody, in adults with CD are reported.DesignParallel-group, dose-ranging, double-blind trial with 4-week screening and 12-week treatment periods. After induction, patients entered 28-week follow-up or 48-week open-label extension (OLE) with 28-week follow-up. Adults with confirmed CD and inadequate response to anti-tumour necrosis factor (TNF) therapy were included. Induction study: 249 patients randomised 1:1:1:1 to placebo, PF-04236921 10, 50 or 200 mg by subcutaneous injection on days 1 and 28. OLE study: PF-04236921 50 mg every 8 weeks up to six doses followed by 28-week follow-up.Results247 patients were randomised and received treatment in the induction study. The 200 mg dose was discontinued due to safety findings in another study (NCT01405196) and was not included in the primary efficacy analysis. Crohn’s Disease Activity Index (CDAI)-70 response rates with PF-04236921 50 mg were significantly greater than placebo at weeks 8 (49.3% vs 30.6%, P<0.05) and 12 (47.4% vs 28.6%, P<0.05) and met the primary end point. Week 12 CDAI remission rates with PF-04236921 50 mg and placebo were 27.4% and 10.9%, respectively (16.5% difference; P<0.05). 191 subjects received treatment in the OLE. Common treatment-emergent and serious adverse events in both studies included worsening CD, abdominal pain and nasopharyngitis.ConclusionsPF-04236921 50 mg induced clinical response and remission in refractory patients with moderate-to-severe CD following failure of anti-TNF therapy. GI abscess and perforation were observed, a specific focus of attention during future clinical development.Trial registration numberNCT01287897 and NCT01345318.

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OP36 Risankizumab therapy induces improvements in endoscopic endpoints in patients with Moderate-to-Severe Crohn’s Disease: Results from the phase 3 ADVANCE and MOTIVATE studies

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab075.035 ◽

2021 ◽

Vol 15 (Supplement_1) ◽

pp. S033-S034

Author(s):

P Bossuyt ◽

M Ferrante ◽

F Baert ◽

S Danese ◽

B G Feagan ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Clinical Response ◽

Induction Therapy ◽

Activity Index ◽

Inadequate Response ◽

Biologic Treatment ◽

Double Blind ◽

Clinical Endpoints ◽

Endoscopic Remission

Abstract Background Endoscopic healing has become a critical treatment target in Crohn’s disease (CD). Risankizumab (RZB), a humanized immunoglobulin G1 monoclonal antibody against the p19 subunit of interleukin 23, is being investigated as a treatment for moderate-to-severe CD. This analysis assessed different endoscopic endpoints in patients treated with RZB induction therapy in two double-blind, randomised, 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 demonstrated prior inadequate response or intolerance to conventional and/or biologic treatment (ADVANCE) or to biologic treatment (MOTIVATE) were randomised 2:2:1 (ADVANCE) or 1:1:1 (MOTIVATE) to receive intravenous (IV) RZB 600 mg, RZB 1200 mg, or PBO at weeks 0, 4, and 8. This analysis evaluated the proportion of patients who achieved endoscopic remission ulcer-free endoscopy (ie, absence of ulcers), and composite endpoints of CDAI clinical response and endoscopic response, and enhanced clinical response and endoscopic response at week 12 (endpoints defined in Figure 1 footnotes). All endoscopies were centrally read by a blinded reviewer. Safety was assessed throughout the studies. Results In ADVANCE and MOTIVATE, 850 and 569 patients, respectively, were randomised and included in the intent-to-treat population for this analysis. At week 12 greater proportions of RZB- vs PBO-treated patients in both studies achieved endoscopic remission (P ≤ .001), ulcer-free endoscopy (P ≤ .01), CDAI clinical response and endoscopic response (P ≤ .001), and enhanced clinical response and endoscopic response (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 IV RZB 600 mg or 1200 mg resulted in improved outcomes at week 12 compared with PBO as assessed by endoscopy and by composite endoscopic-clinical endpoints in patients with moderate-to-severe CD. References

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Use of helminth therapy for management of ulcerative colitis and Crohn's disease: a systematic review

Parasitology ◽

10.1017/s0031182021001670 ◽

2021 ◽

pp. 1-10

Author(s):

Victoria Emma Shields ◽

Jan Cooper

Keyword(s):

Systematic Review ◽

Ulcerative Colitis ◽

Crohn’S Disease ◽

Crohn's Disease ◽

Placebo Effect ◽

Developed Countries ◽

Cochrane Central Register ◽

Open Label ◽

Double Blind ◽

Helminth Therapy

Abstract The incidence rate of inflammatory bowel diseases is increasing in developed countries. As such there is an increasing demand for new therapies. The aim of this systematic review was to investigate whether there is evidence to support the use of helminth therapy for the management of Crohn's disease and ulcerative colitis. Four databases (PubMed, Embase, Medline and the Cochrane Central Register of Control Trials) were searched for primary evidence in the form of clinical studies. Nine studies were suitable for inclusion: five double-blind randomized control trials and four open-label studies. This review divided the results of the studies into two categories: (a) the efficacy of helminth therapy and (b) the safety of helminth therapy. Results regarding the efficacy were mixed and a conclusive answer could not be reached, as there was not enough evidence to rule out a placebo effect. More research is needed, particularly studies with control groups to address the possibility of a placebo effect. Despite this, all nine studies concluded helminth therapy was safe and tolerable, and therefore there is currently no evidence against further exploration of this treatment option.

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Effects of vedolizumab in Japanese patients with Crohn’s disease: a prospective, multicenter, randomized, placebo-controlled Phase 3 trial with exploratory analyses

Journal of Gastroenterology ◽

10.1007/s00535-019-01647-w ◽

2019 ◽

Vol 55 (3) ◽

pp. 291-306 ◽

Cited By ~ 2

Author(s):

Kenji Watanabe ◽

Satoshi Motoya ◽

Haruhiko Ogata ◽

Takanori Kanai ◽

Toshiyuki Matsui ◽

...

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Activity Index ◽

Japanese Patients ◽

Future Research ◽

Induction Phase ◽

Double Blind Study ◽

Inadequate Response ◽

Phase 3 ◽

To Receive

Abstract Background Vedolizumab is a gut-selective humanized antibody that binds the α4β7 integrin. We evaluated efficacy and safety of vedolizumab in Japanese patients with moderate-to-severe Crohn’s disease (CD). Methods In this Phase 3, double-blind study (NCT02038920), 157 patients were randomized to receive intravenous vedolizumab 300 mg (n = 79) or placebo (n = 78) at Weeks 0, 2, and 6 (induction phase). Patients with CD activity index (CDAI)-70 response at Week 10 were randomized to receive vedolizumab 300 mg (n = 12) or placebo (n = 12) at Week 14, then every 8 weeks until Week 54 (maintenance phase). Primary endpoints were ≥ 100-point reduction in CDAI (CDAI-100 response) at Week 10 for induction, and clinical remission (CR: CDAI ≤ 150) at Week 60 for maintenance. Results At Week 10, 26.6% of patients who received vedolizumab and 16.7% who received placebo achieved CDAI-100 response (odds ratio [OR] [95% confidence interval (CI)] 1.80 [0.82–3.96]; p = 0.145). At Week 60, 41.7% of vedolizumab-treated patients and 16.7% of placebo-treated patients achieved CR (OR [95% CI] 3.57 [0.53–23.95]; p = 0.178). The incidence of adverse events was similar in both treatment groups in both induction and maintenance phases. In patients without prior anti-TNFα exposure or with inadequate response to anti-TNFα, vedolizumab showed improved outcomes over placebo in the induction phase. Age might be a possible predictive factor of CR for future research. Conclusion Vedolizumab showed a numerically greater efficacy versus placebo as induction therapy, but the difference was not statistically significant. Vedolizumab also showed a numerically greater efficacy in maintenance therapy, and was well tolerated.

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