Study probes predictors of response to vedolizumab

 

LAS VEGAS – Crohn’s patients with a history of smoking and/or elevated C-reactive protein (CRP) level at initiation of vedolizumab were less likely respond to the drug, a small, single-center study showed.

“Right now there are a variety of medications to treat Crohn’s disease, but there isn’t a set criteria [for] what [drug] works for which kind of patient,” Adam A. Dhedhi, MD, said in an interview at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “We’re trying to figure out if we can find a predictor of response to vedolizumab.” Manufactured by Millennium Pharmaceuticals, vedolizumab is a gut-selective monoclonal antibody to alpha4beta7 integrin that prevents transportation of leukocytes into gastrointestinal mucosa.

Dr. Dhedhi, a third-year resident in the division of gastroenterology-hepatology at the University of Iowa Hospitals and Clinics, Iowa City, and his associates retrospectively reviewed the medical records of 45 Crohn’s patients who were treated with vedolizumab during 2014-2017. The researchers gathered demographic data including age, disease duration, and disease location, as well as prior and concurrent medications; the Harvey Bradshaw index; total white blood cell count; neutrophil, lymphocyte, monocyte, and eosinophil counts; hemoglobin and platelet levels; erythrocyte sedimentation rate and CRP levels; and endoscopic disease activity. All clinical data was analyzed at the time of initiation, at 8-12 weeks of follow-up, and at 6-12 months of follow-up.

He and his associates reported that a low CRP value at time of initiation (a mean of 6.6 mg/L) was found to be a positive predictor of both response and remission (odds ratio, 0.3045; P = .001), while the mean CRP value for nonresponders was 29.9 mg/L. In addition, any smoking history was a predictor of poor response to vedolizumab (OR, 0.0008; P = .009). “That was surprising and useful information to carry forward,” Dr. Dhedhi said. “If you’re making a decision between an anti-TNF [tumor necrosis factor] agent and vedolizumab, [and] if the patient is a smoker or has a higher active disease state, that may help tip the scales one way or the other.” In their abstract, the researchers noted that cigarette smoke “has been found to be involved in beta-2 integrin activation and neutrophil migration in lung tissue and may play a similar role in the gut” (Respiratory Research 2011;12[1]:75). Dr. Dhedhi and his associates also found that more than half of patients who had previously used two or more anti-TNF therapies (58%) achieved remission, compared with 47% who had used one prior anti-TNF drug and 43% who were anti-TNF naive.

He acknowledged certain limitations of the study, including its retrospective design and small sample size. Dr. Dhedhi reported having no financial disclosures.

*This story was updated on 3/26.

[email protected]

SOURCE: Dhedhi AA et al. Crohn’s & Colitis Congress, Poster 207.

 

LAS VEGAS – Crohn’s patients with a history of smoking and/or elevated C-reactive protein (CRP) level at initiation of vedolizumab were less likely respond to the drug, a small, single-center study showed.

“Right now there are a variety of medications to treat Crohn’s disease, but there isn’t a set criteria [for] what [drug] works for which kind of patient,” Adam A. Dhedhi, MD, said in an interview at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “We’re trying to figure out if we can find a predictor of response to vedolizumab.” Manufactured by Millennium Pharmaceuticals, vedolizumab is a gut-selective monoclonal antibody to alpha4beta7 integrin that prevents transportation of leukocytes into gastrointestinal mucosa.

Dr. Dhedhi, a third-year resident in the division of gastroenterology-hepatology at the University of Iowa Hospitals and Clinics, Iowa City, and his associates retrospectively reviewed the medical records of 45 Crohn’s patients who were treated with vedolizumab during 2014-2017. The researchers gathered demographic data including age, disease duration, and disease location, as well as prior and concurrent medications; the Harvey Bradshaw index; total white blood cell count; neutrophil, lymphocyte, monocyte, and eosinophil counts; hemoglobin and platelet levels; erythrocyte sedimentation rate and CRP levels; and endoscopic disease activity. All clinical data was analyzed at the time of initiation, at 8-12 weeks of follow-up, and at 6-12 months of follow-up.

He and his associates reported that a low CRP value at time of initiation (a mean of 6.6 mg/L) was found to be a positive predictor of both response and remission (odds ratio, 0.3045; P = .001), while the mean CRP value for nonresponders was 29.9 mg/L. In addition, any smoking history was a predictor of poor response to vedolizumab (OR, 0.0008; P = .009). “That was surprising and useful information to carry forward,” Dr. Dhedhi said. “If you’re making a decision between an anti-TNF [tumor necrosis factor] agent and vedolizumab, [and] if the patient is a smoker or has a higher active disease state, that may help tip the scales one way or the other.” In their abstract, the researchers noted that cigarette smoke “has been found to be involved in beta-2 integrin activation and neutrophil migration in lung tissue and may play a similar role in the gut” (Respiratory Research 2011;12[1]:75). Dr. Dhedhi and his associates also found that more than half of patients who had previously used two or more anti-TNF therapies (58%) achieved remission, compared with 47% who had used one prior anti-TNF drug and 43% who were anti-TNF naive.

He acknowledged certain limitations of the study, including its retrospective design and small sample size. Dr. Dhedhi reported having no financial disclosures.

*This story was updated on 3/26.

[email protected]

SOURCE: Dhedhi AA et al. Crohn’s & Colitis Congress, Poster 207.

 

LAS VEGAS – Crohn’s patients with a history of smoking and/or elevated C-reactive protein (CRP) level at initiation of vedolizumab were less likely respond to the drug, a small, single-center study showed.

“Right now there are a variety of medications to treat Crohn’s disease, but there isn’t a set criteria [for] what [drug] works for which kind of patient,” Adam A. Dhedhi, MD, said in an interview at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “We’re trying to figure out if we can find a predictor of response to vedolizumab.” Manufactured by Millennium Pharmaceuticals, vedolizumab is a gut-selective monoclonal antibody to alpha4beta7 integrin that prevents transportation of leukocytes into gastrointestinal mucosa.

Dr. Dhedhi, a third-year resident in the division of gastroenterology-hepatology at the University of Iowa Hospitals and Clinics, Iowa City, and his associates retrospectively reviewed the medical records of 45 Crohn’s patients who were treated with vedolizumab during 2014-2017. The researchers gathered demographic data including age, disease duration, and disease location, as well as prior and concurrent medications; the Harvey Bradshaw index; total white blood cell count; neutrophil, lymphocyte, monocyte, and eosinophil counts; hemoglobin and platelet levels; erythrocyte sedimentation rate and CRP levels; and endoscopic disease activity. All clinical data was analyzed at the time of initiation, at 8-12 weeks of follow-up, and at 6-12 months of follow-up.

He and his associates reported that a low CRP value at time of initiation (a mean of 6.6 mg/L) was found to be a positive predictor of both response and remission (odds ratio, 0.3045; P = .001), while the mean CRP value for nonresponders was 29.9 mg/L. In addition, any smoking history was a predictor of poor response to vedolizumab (OR, 0.0008; P = .009). “That was surprising and useful information to carry forward,” Dr. Dhedhi said. “If you’re making a decision between an anti-TNF [tumor necrosis factor] agent and vedolizumab, [and] if the patient is a smoker or has a higher active disease state, that may help tip the scales one way or the other.” In their abstract, the researchers noted that cigarette smoke “has been found to be involved in beta-2 integrin activation and neutrophil migration in lung tissue and may play a similar role in the gut” (Respiratory Research 2011;12[1]:75). Dr. Dhedhi and his associates also found that more than half of patients who had previously used two or more anti-TNF therapies (58%) achieved remission, compared with 47% who had used one prior anti-TNF drug and 43% who were anti-TNF naive.

He acknowledged certain limitations of the study, including its retrospective design and small sample size. Dr. Dhedhi reported having no financial disclosures.

*This story was updated on 3/26.

[email protected]

SOURCE: Dhedhi AA et al. Crohn’s & Colitis Congress, Poster 207.