Breaking News
November 19, 2018 - Experts debate over whether gut or brain is more important in regulating appetite
November 19, 2018 - Playing on fear and fun, hospitals follow pharma in direct-to-consumer advertising
November 19, 2018 - Low-Carb Diets May Work By Boosting Calorie Burn
November 19, 2018 - Key molecule responsible for learning and memory discovered
November 19, 2018 - New blood test developed for early diagnosis of ovarian cancer
November 19, 2018 - Researchers identify molecule to fight myotubular myopathy
November 19, 2018 - Immune cells trigger OCD-like behaviour in multiple sclerosis, study finds
November 19, 2018 - Scientists equip new virus that kills carcinoma cells with protein
November 19, 2018 - Novel approach could provide painless, efficient alternative for treating eye diseases
November 19, 2018 - Protein in cell membranes of sperm plays key role in finding their way to eggs
November 19, 2018 - Parents who decline flu vaccination for their child may be exposed to limited information
November 19, 2018 - Mirati Presents Data From Ongoing Phase 2 Clinical Trial Of Mocetinostat In Combination With Durvalumab At The SITC 33rd Annual Meeting
November 19, 2018 - FDA warns of common diabetes meds’ link to dangerous genital infection
November 19, 2018 - New methods for preserving shoulder function, quality of life in breast cancer patients
November 19, 2018 - Surprising discovery about BH4 may rekindle interest in once-promising pathway
November 19, 2018 - Nabriva Therapeutics Completes Submission of New Drug Application to U.S. Food and Drug Administration for Intravenous Contepo to Treat Complicated Urinary Tract Infections
November 19, 2018 - Beating breast cancer only to die of opioid use – a sad Appalachian story
November 19, 2018 - Workplace bullying or violence linked to higher risk of cardiovascular problems
November 19, 2018 - Changes in Risk Indicators of MetS Severity Tied to T2DM Risk
November 19, 2018 - ‘Game-changing’ skin sensor could improve life for a million hydrocephalus patients
November 19, 2018 - Alcohol ads on social media sites with pro-drinking comments increase desire to drink
November 19, 2018 - Neural networks could replace marker genes in RNA sequencing
November 19, 2018 - Obese adolescents feel less food enjoyment than those with normal weight, study reveals
November 18, 2018 - Goodbye ‘Gluten-Free’? Celiac Disease Vaccine May Make It Possible
November 18, 2018 - Skin ages when the main cells in the dermis lose their identity and function
November 18, 2018 - Rainforest vine compound makes pancreatic cancer cells susceptible to nutrient starvation
November 18, 2018 - A new mechanism in the control of inflammation
November 18, 2018 - Age-related decline in abstract reasoning ability predicts depressive symptoms over time
November 18, 2018 - Scientists succeed in increasing stability, biocompatibility of light-transducing nanoparticles
November 18, 2018 - Sugar, a ‘sweet’ tool to understand brain injuries
November 18, 2018 - Pharmacist-Led Effort Cuts Inappropriate Rx in Older Adults
November 18, 2018 - Novel discovery could lead to new cancer, autoimmune disease therapy
November 18, 2018 - AHA and ADA launch new initiative to help people with type 2 diabetes reduce heart disease risk
November 18, 2018 - Balanced production of pro and anti-inflammatory cytokines at two years of age protects against malaria
November 18, 2018 - New pharmacological agent shows promise for prevention of heart rhythm disorders
November 18, 2018 - All That Social Media May Boost Loneliness, Not Banish It
November 18, 2018 - Scientists shine new light on link between obesity and cancer
November 18, 2018 - Risk factors for cardiovascular disease closely track with changes in diet patterns
November 18, 2018 - Biogen Scoops Sixth Prix Galien Award with UK Win for Life-Changing Rare Disease Medicine
November 18, 2018 - Detectable HIV-1 in treated human liver cells found to be inert
November 18, 2018 - Using light to control crucial step in embryonic development
November 18, 2018 - Unusual case of father-to-son HIV transmission reported
November 18, 2018 - FDA Approves Aemcolo (rifamycin) to Treat Travelers’ Diarrhea
November 18, 2018 - Poverty blamed on widening north-south gap in young adult deaths in England
November 18, 2018 - Progress in meningitis lags far behind other vaccine-preventable diseases, analysis shows
November 18, 2018 - Consensus Statement Issued on Management of Foot, Ankle Gout
November 18, 2018 - Fine particle air pollution is a public health emergency hiding in plain sight
November 18, 2018 - In-hospital mortality higher among patients with drug-resistant infections
November 17, 2018 - Research shines new, explanatory light on link between obesity and cancer
November 17, 2018 - FIND explores new diagnostic assays for confirmatory HCV diagnosis in community settings
November 17, 2018 - Tracking Preemies’ Head Size May Yield IQ Clues
November 17, 2018 - Scientists call for unified standards in 3-D genome and epigenetic data
November 17, 2018 - Lab Innovations 2018 has beaten all records by attracting 3,113 attendees
November 17, 2018 - New strategy to hinder emergence of antimicrobial-resistant pathogens
November 17, 2018 - Sexuality education before age 18 may reduce risk of sexual assault in college
November 17, 2018 - Reducing cellular proliferation could help deplete HIV reservoir and lead to a functional cure
November 17, 2018 - New model of FSHD could be useful to study effectiveness of experimental therapeutics
November 17, 2018 - FDA approves antibacterial drug to treat travelers’ diarrhea
November 17, 2018 - Lab Innovations 2018 confirmed as a major hit with visitors, exhibitors and speakers
November 17, 2018 - Largest parasitic worm genetic study hatches novel treatment possibilities
November 17, 2018 - UCLA biologists uncover how head injuries can lead to serious brain disorders
November 17, 2018 - Static and dynamic physical activities offer varying protection against heart disease
November 17, 2018 - Obesity significantly increases risk of Type 2 diabetes and coronary artery disease
November 17, 2018 - New method to analyze cell membrane complexes could revolutionize the way we study diseases
November 17, 2018 - Researchers show how proteins interact in hypoxic conditions to facilitate mitochondrial fission
November 17, 2018 - People with rare cancers can benefit from genomic profiling, shows research
November 17, 2018 - NIH awards over $1.8 million to husband-and-wife doctors to test new breast cancer approach
November 17, 2018 - Four-in-one antibody used to fight flu shows promise in mice
November 17, 2018 - New approach allows pathogens to be starved by blocking important enzymes
November 17, 2018 - Higher body mass index could cause depression even without health problems
November 17, 2018 - Protein which plays role in sensing cell damage serves as new target to treat pulmonary hypertension
November 17, 2018 - FDA Approves Adcetris (brentuximab vedotin) in Combination with Chemotherapy for Adults with Previously Untreated Systemic Anaplastic Large Cell Lymphoma or Other CD30-Expressing Peripheral T-Cell Lymphomas
November 17, 2018 - ID specialist input improves outcomes for outpatient parenteral antimicrobial therapy
November 17, 2018 - UT Southwestern scientists selected to receive 2019 Edith and Peter O’Donnell Awards
November 17, 2018 - New clinical algorithm to help individuals manage type 2 diabetes when fasting during Ramadan
November 17, 2018 - Researchers identify LZTR1 as evolutionarily conserved component of RAS pathway
November 17, 2018 - Heart Disease Leading Cause of Death in Low-Income Counties
November 17, 2018 - Estrogen Levels Test: MedlinePlus Lab Test Information
November 17, 2018 - Research reveals link between immunity, diabetes
November 17, 2018 - Research shows how to achieve improved smoking cessation outcomes within California’s Medicaid population
Takeda presents vedolizumab phase 3 VISIBLE 1 trial results for treatment of moderately to severely active ulcerative colitis

Takeda presents vedolizumab phase 3 VISIBLE 1 trial results for treatment of moderately to severely active ulcerative colitis

image_pdfDownload PDFimage_print

Takeda Pharmaceutical Company Limited today announced results from the phase 3 VISIBLE 1 clinical trial evaluating the efficacy and safety of an investigational subcutaneous (SC) formulation of the gut-selective biologic vedolizumab for maintenance therapy in adult patients with moderately to severely active ulcerative colitis (UC) who achieved clinical response at week 6 following two doses of open-label vedolizumab intravenous (IV) induction therapy. At week 52, a statistically significant proportion of patients receiving vedolizumab SC achieved clinical remission compared to patients receiving placebo (46.2% vs. 14.3%; p<0.001). A similar rate of clinical remission was observed in the vedolizumab IV reference arm (42.6%). These results were presented at the 2018 United European Gastroenterology (UEG) Week congress in Vienna, Austria.

“The VISIBLE 1 results highlight that the investigational subcutaneous formulation of vedolizumab helped patients with moderately to severely active ulcerative colitis achieve and maintain clinical remission, mucosal healing and durable clinical response, after responding to vedolizumab IV induction therapy. These data indicate that the subcutaneous formulation of vedolizumab had an efficacy and safety profile similar to the IV reference arm, and further add to the collective dataset for vedolizumab in ulcerative colitis,” said Professor William J. Sandborn, lead investigator for the VISIBLE 1 trial and Director of the Inflammatory Bowel Disease Center at UC San Diego.

Furthermore, vedolizumab SC was statistically superior to placebo in key secondary endpoints of mucosal healing (56.6% vs. 21.4%; p<0.001) and durable clinical response (64.2% vs. 28.6%; p<0.001). Vedolizumab SC was also numerically higher to placebo in achieving durable clinical remissionǂǂ (15.1% vs. 5.4%; p=0.076) and corticosteroid-free clinical remission (28.9% vs. 8.3%; p=0.067), with these results not being of statistical significance. Similar findings were observed for these endpoints in the vedolizumab IV reference arm. Additionally, a subgroup analysis showed clinical remission rates were significantly higher with vedolizumab SC compared to placebo in anti-tumor necrosis factor-alpha (TNFα)-naïve (53.7% vs. 18.9%; p<0.001) and anti-TNFα-failure patients (33.3% vs. 5.3%; p=0.023).

Adverse event rates, including severe adverse events and infections, were similar in the vedolizumab SC and IV groups. Injection-site reactions were mild and experienced by 9.4% of patients in the vedolizumab SC treatment group (vs. 0 in the placebo group), with none leading to treatment discontinuation. The rate of anti-vedolizumab antibodies (AVAs) was similar between the vedolizumab SC and IV groups (5.7% and 5.6%, respectively).

“These results mark an important milestone for Takeda in our efforts to better meet the needs of patients with inflammatory bowel disease. We hope to make the subcutaneous formulation of vedolizumab available to provide more choice for patients and their physicians. The patient’s experience is very important to us, and we are committed to providing physicians with treatment options that suit the individual needs and preferences of their patients, whether that is intravenous or subcutaneous,” said Jeff Bornstein, Executive Medical Director, Takeda.

VISIBLE 1 is a pivotal phase 3, randomized, double-dummy, double-blind, placebo-controlled study, with a vedolizumab IV reference arm, to evaluate the safety and efficacy of an investigational SC formulation of vedolizumab as maintenance therapy in adult patients with moderately to severely active UC who have achieved clinical response at week 6 following two doses of open-label vedolizumab IV therapy at weeks 0 and 2. The study enrolled 383 patients, all of whom had inadequate response with, loss of response to, or intolerance to corticosteroids, immunomodulators, or anti-TNFα therapy prior to being enrolled. Patients who achieved clinical response at week 6 (n=216, 56.4%) were randomized into one of three treatment groups, vedolizumab SC 108 mg and placebo IV (n=106), vedolizumab IV 300 mg and placebo SC (n=54), or placebo SC and placebo IV (n=56). Subcutaneous doses were administered every two weeks and intravenous doses were administered every eight weeks.

Source:

https://www.takeda.com/newsroom/newsreleases/2018/investigational-subcutaneous-vedolizumab-achieves-and-maintains-clinical-remission-and-mucosal-healing-at-week-52-in-patients-with-ulcerative-colitis/

About author

Related Articles