Efficacy and safety of a new vedolizumab subcutaneous formulation in Japanese patients with moderately to severely active ulcerative colitis

Ito, Hiroaki; Ashida, Toshifumi; Yokoyama, Tadashi; Nagahori, Masakazu; Inaba, Tomoki; Shikamura, Mitsuhiro; Yamaguchi, Takayoshi; Hori, Tetsuharu; Pinton, Philippe; Watanabe, Mamoru; Hibi, Toshifumi

doi:10.5217/ir.2020.00026

Cited by 12 publications

(12 citation statements)

References 24 publications

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“…An ad hoc subgroup analysis (n = 22) of data from VIS-IBLE 1 suggest that the efficacy of subcutaneous vedolizumab in Japanese patients with moderately to severely active UC was similar to that seen in the overall VISIBLE 1 study population and to that established for intravenous vedolizumab [12].…”

Section: In Patients With Moderately To Severely Active Ucmentioning

confidence: 68%

“…Moreover, no evident increase in adverse reactions or injection-site reactions was seen during the re-initiation of subcutaneous vedolizumab therapy following a treatment interruption period of up to 46 weeks [3]. The safety and tolerability of subcutaneous vedolizumab in Japanese patients with moderately to severely active UC appears to generally reflect that seen in the overall VISIBLE 1 study population and established for intravenous vedolizumab [12].…”

Section: What Is the Tolerability Profile Of Subcutaneous Vedolizumab?mentioning

confidence: 99%

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Subcutaneous vedolizumab in moderately to severely active ulcerative colitis or Crohn’s disease: a profile of its use

Hoy

2021

Drugs Ther Perspect

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Vedolizumab (Entyvio ® ), a humanized monoclonal antibody targeting the α4β7 integrin, is effective and generally well tolerated as an induction and maintenance therapy for adults with moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor (TNF)-α antagonist. Initially approved as a lyophilised powder for reconstitution and administration via intravenous infusion, more recently, a solution for subcutaneous injection has been developed (and approved in various countries, including those of the EU, for these patient populations) to provide patients, caregivers and healthcare providers with an alternative route of administration for vedolizumab maintenance treatment, potentially providing convenience benefits. In clinical studies in these UC and CD patient populations, subcutaneous vedolizumab as a maintenance therapy improved clinical remission rates and health-related quality of life (HR-QOL) relative to placebo over 52 weeks, with clinical benefits maintained for up to 2 years in the UC patient population. Its safety profile did not differ to a clinically relevant extent from that seen with intravenous vedolizumab, although, as expected, injection-site reactions (mostly erythema and pruritus) were more frequently reported with subcutaneous administration. Thus, subcutaneous vedolizumab extends the options available for the maintenance treatment of adults with moderately to severely active UC and CD. Plain Language SummaryUlcerative colitis (UC) and Crohn's disease (CD) are types of inflammatory bowel disease. The aim of treatment is to stop the inflammation and prevent further flare-ups. Among the treatment options is the biologic vedolizumab (Entyvio ® ). Initially available for controlled administration into the bloodstream, a version of vedolizumab for subcutaneous injection once every 2 weeks has recently been developed. In adults with moderately to severely active UC or CD who initially responded to intravenous vedolizumab, the use of subcutaneous vedolizumab for 1 year induced and maintained remission, and improved quality of life. These benefits were maintained for up to 2 years in the UC patient population. The safety of subcutaneous vedolizumab is similar to that of intravenous vedolizumab, although, as expected, injection-site reactions (mostly redness and itch) were more frequently reported with subcutaneous administration. Thus, subcutaneous vedolizumab extends the options available for the maintenance treatment of adults with moderately to severely active UC and CD.

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Section: In Patients With Moderately To Severely Active Ucmentioning

confidence: 68%

Section: What Is the Tolerability Profile Of Subcutaneous Vedolizumab?mentioning

confidence: 99%

Subcutaneous vedolizumab in moderately to severely active ulcerative colitis or Crohn’s disease: a profile of its use

Hoy

2021

Drugs Ther Perspect

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“…The outcomes needed to be defined separately with reference to the included studies. [36][37][38][39][40][41] The primary efficacy endpoint was clinical remission (defined as a total Mayo score of ⩽2 and no individual subscore of >1). The following scores were considered: Harvey-Bradshaw index (HBI) score ⩽4 or patient-reported outcomes-CD (PRO2-CD) score ⩽11 in patients with CD and simple clinical colitis activity index (SCCAI) score ⩽2 or PRO2-UC score = 0 in patients with UC.…”

Section: Study Outcomesmentioning

confidence: 99%

Vedolizumab subcutaneous formulation maintenance therapy for patients with IBD: a systematic review and meta-analysis

Tang

Liu

et al. 2023

Therap Adv Gastroenterol

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Background: The application of vedolizumab (VDZ) subcutaneous (SC) formulation has brought more convenience and hope to patients with moderate-to-severe inflammatory bowel diseases (IBDs) in the coronavirus disease 2019 context. Objective: This study aimed to systematically evaluate all previous studies that used VDZ SC formulation for maintenance therapy in patients with IBD. Design: Systematic review and meta-analysis. Data Sources and Methods: The search was conducted using the subject and free terms related to ‘Vedolizumab’, ‘Subcutaneous’, and ‘IBD’, in Embase, PubMed, Web of Science, Cochrane, and at ClinicalTrials.gov databases between 2008 and 2022. The methodological quality of randomized controlled trials (RCTs) and cohort studies was assessed using the Cochrane Handbook of Systematic Reviews and the Newcastle–Ottawa Scale, respectively. The endpoints included efficacy, safety, and immunogenicity. Results: A total of 60 studies and 2 completed clinical registry trials were retrieved, of which 3 RCTs with high methodological quality, and 3 cohort studies with large heterogeneity were included in the meta-analysis. In the RCT study design, patients with ulcerative colitis (UC) under different conditions after treated with VDZ SC were significantly distinct than those for placebo (PBO) in clinical remission, endoscopic remission, and biochemical remission. In Crohn’s disease (CD), the aforementioned parameters were slightly higher than those for PBO, but there was not statistically significant in endoscopic remission and the efficacy of anti-tumor necrosis factor-naive patients. The clinical remission, endoscopic remission, and biochemical remission in patients with UC after VDZ SC treatment were similar to those after intravenous (IV) treatment. The risk ratios in patients experiencing adverse events (AEs) and serious AEs after VDZ SC and PBO treatments were 86% and 89% in UC, and 96% and 80% in CD, respectively. Compared with IV, safety was not statistically different. The risk of developing anti-VDZ antibody after VDZ SC treatment was only 20% of that after PBO in patients with UC, but it was 9.38 times in CD. Conclusion: VDZ SC treatment maintained the clinical efficacy of IV induction in patients with IBD without increasing the safety risk, and the efficacy was more pronounced in patients with UC. Immunogenicity might be a potential factor for the decrease in efficacy rate in patients with IBD. Registration: INPLASY 2022120115

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“…The example of vedolizumab paved the way for the current development of additional drugs with a similar mode of action. Abrilumab, another anti-α4β7 integrin antibody that is subcutaneously administered, successfully completed phase II trials for moderate-to-severe UC ( 104 – 106 ). Moreover, the oral small molecule α4 integrin inhibitor AJM300 successfully attenuated inflammation and cell infiltration in the adoptive T cell transfer colitis model ( 107 ) and currently undergoes phase III testing in UC.…”

Section: Targeting Trafficking On the T Cell Side – A Story Of Successmentioning

confidence: 99%

Targeting Immune Cell Trafficking – Insights From Research Models and Implications for Future IBD Therapy

et al. 2021

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Inflammatory bowel diseases (IBDs), including Crohn’s disease (CD) and ulcerative colitis (UC) are multifactorial diseases with still unknown aetiology and an increasing prevalence and incidence worldwide. Despite plentiful therapeutic options for IBDs, the lack or loss of response in certain patients demands the development of further treatments to tackle this unmet medical need. In recent years, the success of the anti-α4β7 antibody vedolizumab highlighted the potential of targeting the homing of immune cells, which is now an important pillar of IBD therapy. Due to its complexity, leukocyte trafficking and the involved molecules offer a largely untapped resource for a plethora of potential therapeutic interventions. In this review, we aim to summarise current and future directions of specifically interfering with immune cell trafficking. We will comment on concepts of homing, retention and recirculation and particularly focus on the role of tissue-derived chemokines. Moreover, we will give an overview of the mode of action of drugs currently in use or still in the pipeline, highlighting their mechanisms and potential to reduce disease burden.

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Efficacy and safety of a new vedolizumab subcutaneous formulation in Japanese patients with moderately to severely active ulcerative colitis

Cited by 12 publications

References 24 publications

Subcutaneous vedolizumab in moderately to severely active ulcerative colitis or Crohn’s disease: a profile of its use

Subcutaneous vedolizumab in moderately to severely active ulcerative colitis or Crohn’s disease: a profile of its use

Vedolizumab subcutaneous formulation maintenance therapy for patients with IBD: a systematic review and meta-analysis

Targeting Immune Cell Trafficking – Insights From Research Models and Implications for Future IBD Therapy

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