New Real-World Data Analyses Support the Long-Term Use of Entyvio® (vedolizumab) in Bio-Naïve Patients for the Treatment of Moderate to Severe Ulcerative Colitis or Crohn's Disease

DEERFIELD, Ill., Oct. 8, 2018 /PRNewswire/ -- Takeda Pharmaceuticals U.S.A., Inc., ("Takeda") today announced the presentation of new long-term efficacy real-world data analyses for Entyvio^® (vedolizumab) at ACG 2018 in Philadelphia, PA. Studies of note include a retrospective multicentre cohort study of biologic-naïve adults with ulcerative colitis (UC) and Crohn's disease (CD), two systematic reviews and meta-analyses of real-world treatment persistence and mucosal healing, and a time-trend analysis of Entyvio utilization and outcomes across the United States (U.S.). A total of 10 Entyvio abstracts were accepted for presentation at the meeting.

The retrospective cohort study included 249 patients (UC: 166; CD: 83) with no prior exposure to biologic drugs for the treatment of UC or CD who initiated Entyvio treatment. Cumulative probability of clinical outcomes and treatment persistence were analyzed by Kaplan Meier method. At 18 months, 78.6% of UC and 74.8% of CD patients persisted on Entyvio treatment, and at 24 months, 76.9% of UC and 74.8% of CD patients persisted. High rates of treatment persistence (≥75%), clinical response, clinical remission and mucosal healing are observed in bio-naïve Entyvio patients after 18 months.

The abstract featuring a systematic review of treatment persistence showed similar trends in persistence rates. This meta-analysis identified 16 studies that reported Entyvio persistence or discontinuation rates in UC and CD patients. At 12 months, approximately three-quarters and nearly two-thirds of UC and CD patients, respectively, persisted with Entyvio treatment despite utilization in largely biologic-refractory patients. Higher Entyvio persistence was seen in bio-naïve patients. These results will need to be confirmed with a larger cohort.

"Treatment persistence rates are important indicators of the long-term effectiveness and tolerability of a therapy, and these results suggest positive patient response with Entyvio among those who had not previously taken a biologic," said Karen Lasch, M.D., Medical Head, GI Specialty, U.S. Medical Office, Takeda. "The high rates of treatment persistence, clinical response and remission observed with Entyvio in real-world settings are important considerations for physicians as they evaluate biologic options and when to prescribe them for patients with ulcerative colitis and Crohn's disease."

The mucosal healing systematic review analysed 26 studies that reported mucosal healing and/or endoscopic improvement rates in patients with moderate to severe CD taking Entyvio. The most common definition of mucosal healing was the absence of all ulcers and/or erosions. Twenty-six percent of CD patients at six months and 37 percent at 12 months achieved mucosal healing with Entyvio, despite utilization in largely bio-refractory patients. Higher mucosal healing rates were observed in patients naïve to biologic therapy.

An additional Takeda-sponsored poster presented at ACG includes a time trend analysis examining outcomes associated with shifts in Entyvio utilization across the U.S. The analysis included a comparison of real-world outcomes from Entyvio treatment during the first 12 months following its U.S. availability in May 2014 versus the subsequent 24 months. Results showed a shift in positioning Entyvio during the past three years toward use in less refractory patients with a more pronounced shift toward earlier use in the treatment paradigm in UC compared to CD. The shift was also accompanied by lower rates of IBD-related hospitalization and surgery for UC. A significant shift in IBD-related hospitalizations and surgery was not observed for CD. Further studies are needed to understand if earlier use in CD impacts disease-related complications.

"The cumulative real-world evidence presented at ACG this year further supports the long-term effectiveness of Entyvio for patients with moderate to severe ulcerative colitis or Crohn's disease, particularly as a first-line biologic treatment option in bio-naïve patients" said Uthra Sundaram, SVP, Specialty Business Unit, Takeda. "Takeda is committed to supporting the GI community through scientific exchange and improving patient outcomes, and we are pleased to present this new information about the only biologic with a gut-selective mechanism of action for treatment of moderate to severe ulcerative colitis and Crohn's disease at ACG."

For a full list of poster titles and authors being presented at ACG, visit https://www.eventscribe.com/2018/ACG/PosterTitles.asp?h=Browse%20by%20Title.

About Entyvio^® (vedolizumab)

Vedolizumab is a gut-selective biologic. It is a humanized monoclonal antibody that is designed to specifically antagonize the alpha4beta7 integrin, inhibiting the binding of alpha4beta7 integrin to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1) and fibronectin, but not vascular cell adhesion molecule 1 (VCAM-1). MAdCAM-1 is preferentially expressed on blood vessels and lymph nodes of the gastrointestinal tract. The alpha4beta7 integrin is expressed on a subset of circulating white blood cells. These cells have been shown to play a role in mediating the inflammatory process in UC and CD. By inhibiting alpha4beta7 integrin, vedolizumab may limit the ability of certain white blood cells to infiltrate gut tissues. 

About Ulcerative Colitis and Crohn's Disease

Ulcerative colitis (UC) and Crohn's disease (CD) are two of the most common forms of inflammatory bowel disease (IBD). Both UC and CD are chronic, relapsing, remitting, inflammatory conditions of the gastrointestinal (GI) tract that are often progressive in nature. UC only involves the large intestine as opposed to CD which can affect any part of the GI tract from mouth to anus. CD can also affect the entire thickness of the bowel wall, while UC only involves the innermost lining of the large intestine. UC commonly presents with symptoms of abdominal discomfort, loose bowel movements, including blood or pus. CD commonly presents with symptoms of abdominal pain, diarrhea, and weight loss. The cause of UC or CD is not fully understood; however, recent research suggests hereditary, genetics, environmental factors, and/or an abnormal immune response to microbial antigens in genetically predisposed individuals can lead to UC or CD.

INDICATIONS: ENTYVIO (vedolizumab)

Adult Ulcerative Colitis (UC)

ENTYVIO (vedolizumab) is indicated in adult patients with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids for inducing and maintaining clinical response, inducing and maintaining clinical remission, improving endoscopic appearance of the mucosa, and achieving corticosteroid-free remission.

Adult Crohn's Disease (CD)

ENTYVIO (vedolizumab) is indicated in adult patients with moderately to severely active CD who have had an inadequate response with, lost response to, or were intolerant to a TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids for achieving clinical response, achieving clinical remission, and achieving corticosteroid‐free remission.

IMPORTANT SAFETY INFORMATION

• ENTYVIO (vedolizumab) for injection is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients.

• Infusion-related reactions and hypersensitivity reactions including anaphylaxis have occurred. Allergic reactions including dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate have also been observed. If anaphylaxis or other serious allergic reactions occur, discontinue administration of ENTYVIO immediately and initiate appropriate treatment.

• Patients treated with ENTYVIO are at increased risk for developing infections. Serious infections have been reported in patients treated with ENTYVIO, including anal abscess, sepsis (some fatal), tuberculosis, salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis. ENTYVIO is not recommended in patients with active, severe infections until the infections are controlled. Consider withholding ENTYVIO in patients who develop a severe infection while on treatment with ENTYVIO. Exercise caution in patients with a history of recurring severe infections. Consider screening for tuberculosis (TB) according to the local practice.

• Although no cases of PML have been observed in ENTYVIO clinical trials, JC virus infection resulting in progressive multifocal leukoencephalopathy (PML) and death has occurred in patients treated with another integrin receptor antagonist. A risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms. Typical signs and symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. If PML is suspected, withhold dosing with ENTYVIO and refer to a neurologist; if confirmed, discontinue ENTYVIO dosing permanently.

• There have been reports of elevations of transaminase and/or bilirubin in patients receiving ENTYVIO. ENTYVIO should be discontinued in patients with jaundice or other evidence of significant liver injury.

• Prior to initiating treatment with ENTYVIO, all patients should be brought up to date with all immunizations according to current immunization guidelines. Patients receiving ENTYVIO may receive non-live vaccines and may receive live vaccines if the benefits outweigh the risks.

• Most common adverse reactions (incidence ≥3% and ≥1% higher than placebo): nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities.

Please see the accompanying full Prescribing Information including Medication Guide for ENTYVIO.

More information is available at www.ENTYVIOHCP.com and www.ENTYVIO.com

Takeda's Commitment to Gastroenterology

Gastrointestinal (GI) diseases can be complex, debilitating and life-changing. Recognizing this unmet need, Takeda and our collaboration partners have focused on improving the lives of patients through the delivery of innovative medicines and dedicated patient disease support programs for over 25 years. Takeda aspires to advance how patients manage their disease. Additionally, Takeda is leading in areas of gastroenterology associated with high unmet need, such as inflammatory bowel disease, acid-related diseases and motility disorders. Our GI Research & Development team is also exploring solutions in celiac disease and liver diseases, as well as scientific advancements through microbiome therapies.

About Takeda Pharmaceutical Company Limited

Takeda Pharmaceutical Company Limited (TSE: 4502) is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and neuroscience therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. Innovative products, especially in oncology and gastroenterology, as well as Takeda's presence in emerging markets, are currently fueling the growth of Takeda. Around 30,000 Takeda employees are committed to improving quality of life for patients, working with Takeda's partners in health care in more than 70 countries.

For more information, visit https://www.takeda.com/newsroom/.

Takeda Pharmaceuticals U.S.A., Inc. is located in Deerfield, Ill., and is the U.S. marketing and sales organization of Takeda Pharmaceutical Company Limited.

Additional information about Takeda is available through its corporate website, www.takeda.com, and additional information about Takeda Pharmaceuticals U.S.A., Inc. is available through its website, www.takeda.us.

SOURCE Takeda Pharmaceuticals U.S.A., Inc.