News & Events

Published On: 5/23/2021

Target RWE Research Presented at DDW 2021 Shows High Rates of Biologic Combination Therapy and Previous Biologic Exposure in IBD Population

Poster of Distinction Award Granted to TARGET-IBD Research

DURHAM, N.C., May 23, 2021 /PRNewswire/ -- Research presented today at Digestive Disease Week (DDW) 2021 evaluated the prevalence and predictors of immunomodulator use as concomitant therapy with two commonly prescribed biologics, vedolizumab (Entyvio) or ustekinumab (Stelara), in patients with inflammatory bowel disease (IBD). Data from Target RWE's TARGET-IBD large longitudinal cohort Immunomodulators are Commonly Used as Concomitant Therapy with Vedolizumab or Ustekinumab: TARGET-IBD Real World Cohort was selected for the Poster of Distinction Award.

Global IBD prevalence has risen substantially over the past 30 years.1 Biologics neutralize proteins in the body that cause inflammation; however, not all biologics work in the same way. Newer biologics, such as ustekinumab and vedolizumab, have been associated with lower risk of infection than anti-tumor necrosis factor agents (anti-TNFs). The addition of an immunomodulator in combination therapy may limit this potential benefit, especially in those over age 65, without reducing immunogenicity.

"Immunogenicity occurs when a treatment provokes an immune response against itself. It is a serious limitation of biologic therapy used to treat inflammatory bowel disease such as Crohn's disease (CD) or ulcerative colitis (UC)," said Megan Lutz, MD, Fellow at the University of Wisconsin School of Medicine and Public Health and lead author. "We need to further research efficacy and safety of using an immunomodulator in conjunction with newer biologic therapies such as ustekinumab or vedolizumab to decrease immunogenicity in patients with IBD, since we could avoid unnecessary risks with otherwise generally safe therapies."

Key findings include:

  • Among patients with CD on vedolizumab or ustekinumab at enrollment, and patients with UC on vedolizumab at enrollment, combination therapy was used in 28.2% and 19.0% of patients, respectively.
  • High rates of previous biologic exposure: 73.8% of patients treated with vedolizumab had previous anti-TNF exposure, and 89.6% of patients treated with ustekinumab had anti-TNF exposure, of whom 30.8% also had vedolizumab exposure.
  • In patients with CD on ustekinumab at enrollment, combination therapy was more common at community sites and in patients younger than 65 years old.


A separate study from TARGET-IBD, Biologic-naïve Patients with Crohn's Disease are More Likely to Achieve Mucosal Healing than Biologic-experienced Patients: TARGET-IBD Real World Cohort, found that, consistent with observations from clinical trials, biologic-naive patients in a real-world CD cohort were significantly more likely to achieve mucosal healing than biologic-experienced patients.

TARGET-IBD is a study of patients with IBD receiving usual care at community and academic practices in the U.S. Clinical data from secured electronic medical records was analyzed for patients enrolled July 2017 to November 2020.

About Target RWE

Target RWE is a leading health evidence solutions company that generates innovative real-world evidence (RWE) and provides scientific intelligence tools and solutions for pharmaceutical, biotechnology, and other healthcare partners. Specifically designed to address the complexities of the natural history of disease, the drug development process and treatments in real-world settings, Target RWE builds regulatory-grade clinical data sets and applies state of the science epidemiologic methods to produce RWE about patients with specific conditions, symptoms, and therapies used in usual clinical practice.

Target RWE's regulatory-grade data sets and evidence, modern epidemiological methods, and sound scientific principles rendered as software can be utilized to better health outcomes, inform patient health guidelines, and improve overall quality of care. For more information, visit www.targetrwe.com.

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