Researchers Explore Unmet Needs for IBD Patients

May 12, 2021
Kenny Walter

Kenny Walter is an editor with HCPLive. Prior to joining MJH Life Sciences in 2019, he worked as a digital reporter covering nanotechnology, life sciences, material science and more with R&D Magazine. He graduated with a degree in journalism from Temple University in 2008 and began his career as a local reporter for a chain of weekly newspapers based on the Jersey shore. When not working, he enjoys going to the beach and enjoying the shore in the summer and watching North Carolina Tar Heel basketball in the winter.

MD Net Guide Newsletter, MD Net Guide® - May 2021,

The presence of extra-intestinal manifestations in biologic-naïve anti-TNF patients with Crohn’s disease was a predictor of disease severity.

New research may give clinicians a better understanding of the unmet needs of biologically-naïve patients with inflammatory bowel disease (IBD).

A team, led by Romina di Giuseppe, Kompetenznetz Darmerkrankungen, characterized the profile of Crohn’s disease or ulcerative colitis biologic-naïve patients starting a new therapy with vedolizumab or TNFα-antagonists, baseline disease activity predictors, and the perception of the quality of life.

In the VEDOIBD-Study, the researchers compared vedolizumab with other biologics as induction and maintenance therapies for Crohn’s disease (n = 627) and ulcerative colitis (n = 546) enrolled from IBD-experienced centers in Germany.

Biologic-Naïve Patients

For biologic-naïve patients—vedolizumab (n = 397) and anti-TNF (n = 359)—the researchers analyzed disease severity and perception of quality of life predictors with logistic regression.

A first biological therapy with vedolizumab was considered for older Crohn’s disease when compared to biologicals-naïve anti-TNF patients, including those with a less complicated, but longer disease course and a history of comorbidities. There were no differences in unmet needs observed among the ulcerative colitis patient group.

The presence of extra-intestinal manifestations in biologic-naïve anti-TNF patients with Crohn’s disease (OR, 3.83; 95% CI, 1.69-8.68), as well as both biologic-naïve patient groups with ulcerative colitis, stool frequency (OR, 2.00; 95% CI, 1.25–3.19); OR, 1.82; 95% CI, 1.10–3.02), respectively) and rectal bleeding (OR, 2.24; 95% CI, 1.20–4.18); OR, 1.92; 95% CI, 1.19–3.11), respectively) emerged as the most important predictors of disease severity. This was significantly linked to a worse perception of quality of life.

“This study highlights the existence of unmet medical needs of patients with CD or UC, for whom a new biological therapy is planned as part of the VEDOIBD-Study, which considerably impacts their HRQoL,” the authors wrote.


A recent study found that maintaining ulcerative colitis (UC) remission was significantly more common in patients who continued treatment with infliximab, compared to those who discontinued treatment.

The use of anti-tumor necrosis factor (TNF) agents is common in the treatment of refractory UC, but the long-term use of anti-TNF therapy can increase the risk of malignancy or infection.

No previous study trial has evaluated the safety of anti-TNF agent discontinuation in patients with UC in remission.

Of the 122 patients screened, a total of 95 were randomly assigned to the infliximab-continued group (n = 48) and the infliximab-discontinued group (n = 47). The final analysis included 92 patients, with 46 in each group.

In the infliximab-continued group, 37 of 46 patients (80.4%) were in remission at week 48.

In the infliximab-discontinued group, 25 of 46 patients (54.3%) were in remission at week 48.

Adverse events were found in 8 (17%) patients in the infliximab-continued group, including a patient who experienced an infusion reaction. This is compared to 6 (13%) in the infliximab-discontinued group, with 2 patients experiencing psoriatic skin lesions.

The study, “Profile of patients with inflammatory bowel disease in conjunction with unmet needs and decision-making for choosing a new biologic therapy: a baseline analysis of the VEDOIBD-Study,” was published online in the International Journal of Colorectal Disease.

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