Breaking News
January 17, 2019 - Effects of linoleic acid on the body are largely dependent on genes, shows study
January 17, 2019 - Pre-injury exercise reduces damage to both muscles and nerves, study finds
January 17, 2019 - Minimizing Antibody Size to Maximize Research Potential
January 17, 2019 - Research finds large genome in tiny forest defoliator
January 17, 2019 - Technology helps reduce the yearning for unhealthy food
January 17, 2019 - New Drug Application for Insomnia Disorder Treatment Lemborexant Submitted in the United States
January 17, 2019 - What you should know about teeth whitening
January 17, 2019 - Why Older Adults Should Eat More Protein (And Not Overdo Protein Shakes)
January 17, 2019 - Colorectal cancer mortality rates predicted to increase globally
January 17, 2019 - Scientists discover mutational signatures of tumor hypoxia
January 17, 2019 - New evidence shows how fever alters immune cells
January 17, 2019 - Researchers find new class of blood pressure-regulating peptides in vampire bat venom
January 17, 2019 - Promega to exhibit new Maxwell RSC48 platform at 2019 Festival of Genomics
January 17, 2019 - Study pinpoints immune cells that could be key to tackling hypertension
January 17, 2019 - Couples Intervention May Aid Partners of Diabetes Patients
January 17, 2019 - Your weight history may predict your heart failure risk
January 17, 2019 - Explore a cornucopia of accomplishments in prematurity research
January 17, 2019 - New study identifies four characteristics that predict severity of postpartum depression
January 17, 2019 - New, scalpel-free treatment for reducing Parkinson’s tremor gets FDA approval
January 17, 2019 - Neurobiologists uncover key component of how the human brain marks time
January 17, 2019 - LifeTime receives fund to develop a plan to embed its vision for healthier future
January 17, 2019 - WTC first responders at higher risk for head and neck cancers, study finds
January 17, 2019 - New NSF funded study may help physicians decrease brain injury deaths
January 17, 2019 - Ham bones contain peptides that could have cardioprotective effects
January 17, 2019 - Research finds how Candida albicans adapt to low oxygen levels to cause infection
January 17, 2019 - Cobra Biologics announces appointment of Dr Darrell Sleep as Director of Innovation
January 17, 2019 - Cellular protein that interacts with viruses appears to enable infection process of Zika virus
January 17, 2019 - Opioids Now More Deadly for Americans Than Traffic Accidents
January 17, 2019 - Women who start periods early are at greater risk of cardiovascular problems
January 17, 2019 - The brain-circuitry clash that keeps you from diving into that plate of ribs when you’re dining with royalty
January 17, 2019 - Poo transplant can successfully treat patients with ulcerative colitis
January 17, 2019 - Study suggests key role for glial cells in Parkinson’s disease
January 17, 2019 - Educational videos in clinical settings increase HPV vaccination rates among adolescents
January 17, 2019 - Better understanding of aggressive brain tumour
January 17, 2019 - Why is life expectancy in the U.S. going down? A Q&A
January 17, 2019 - The Electronics Industry Sees Money In Your Health
January 17, 2019 - Hypertension drug may improve effectiveness of ovarian cancer treatment
January 17, 2019 - Scientists reveal key mechanism in worms that controls cell’s response to stress
January 17, 2019 - How Patch Clamp Technology Can Benefit Ion Channel Research
January 16, 2019 - Researchers cultivate organoids that perfectly mimic blood vessels
January 16, 2019 - Sound Pharmaceuticals Advances Phase 2 Hearing Loss Clinical Trial in Cystic Fibrosis
January 16, 2019 - Unraveling the genetic causes of skin cancer
January 16, 2019 - Higher percentages of saturated fat in low-carb diets may not harm cholesterol levels, new analysis suggests
January 16, 2019 - Using bottled or tap water impacts health benefits of green tea
January 16, 2019 - Best trained alert dogs have potential to improve Type 1 diabetes patients’ quality of life
January 16, 2019 - States with lower incidence of melanoma have higher mortality rates
January 16, 2019 - Pollution on the London Underground found to be dangerously high
January 16, 2019 - Breast cancer cells in mice coaxed to turn into harmless fat cells
January 16, 2019 - Study connects the genetic background of autistic spectrum disorders with stem cell dysfunction
January 16, 2019 - When activated, ‘social’ brain circuits inhibit feeding behavior in mice | News Center
January 16, 2019 - How Exercise May Help Keep Our Memory Sharp
January 16, 2019 - Researchers identify a key regulator that stops excessive inflammation
January 16, 2019 - TGF-beta signaling pathway in uterine cells protects against cancer
January 16, 2019 - MD Anderson Cancer Center collaborates with Dragonfly for new immunotherapy drug clinical trials
January 16, 2019 - Drug Repurposing May Provide More Psychiatric Tx Options
January 16, 2019 - A new brain imaging study challenges the dominant theoretical model of autism spectrum disorders
January 16, 2019 - GoFundMe CEO: ‘Gigantic Gaps’ In Health System Showing Up In Crowdfunding
January 16, 2019 - Induced neuronal cells derived from fibroblasts are similar to neurons in the brain
January 16, 2019 - New study finds link between childhood abuse and suicide in later life
January 16, 2019 - Lifestyle and health factors that are good for the heart can also prevent diabetes
January 16, 2019 - Scientists take another step in understanding bacteria that cause Salmonella epidemic
January 16, 2019 - Look to Your Aunts, Uncles and Parents for Clues to Your Longevity
January 16, 2019 - Study finds ADHD drugs are unlikely to cause cardiac damage in children who take them
January 16, 2019 - Call The Midwife! (If The Doctor Doesn’t Object)
January 16, 2019 - Changes in hippocampal structural connectivity differentiate responders of electroconvulsive therapy
January 16, 2019 - Study sheds light on the deadly venom of Mojave rattlesnakes
January 16, 2019 - University of Nebraska to develop new drugs that prevent and counteract effects of radiation exposure
January 16, 2019 - Sugar-based stent makes precarious sewing process easier
January 16, 2019 - FDA-approved drug hampers cancer metastasis in animal model, shows study
January 16, 2019 - Memories of past meals influence future food intake in rats
January 16, 2019 - Low-level cannabis use can change the adolescent brain
January 16, 2019 - MTC in Rouen acquires Robocath’s R-One robot for future healthcare practitioner training
January 16, 2019 - OSSIO granted FDA 510(k) market clearance for OSSIOfiber Bone Pin Family
January 16, 2019 - Childhood body composition may play a role in future respiratory health
January 16, 2019 - Outdated commissioning methods are failing mental health services in the UK, reveals report
January 16, 2019 - Unconventional immune cells trigger disturbed cytokine production in human spondyloarthritis
January 16, 2019 - Patients Turn To GoFundMe When Money And Hope Run Out
January 16, 2019 - Researchers develop novel viral identification method
January 16, 2019 - Study proposes improvements in pharmacological study of cognitive function enhancers in schizophrenia
January 16, 2019 - Study points to potential new biomarker and drug target for amyotrophic lateral sclerosis
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