Peter D.R. Higgins MD, PhD, MSc

Dr. Higgins is an Assistant Professor in the Division of Gastroenterology at the University of Michigan. Dr. Higgins attended Duke University where he majored in Chemistry and Molecular Biology, and received his M.D. and Ph.D. in Molecular Cancer Biology. He received training in Internal Medicine at Duke University, and completed a master’s degree in Clinical Research Design and Statistical Analysis at the University of Michigan School of Public Health.

Dr. Higgins is a diplomate of the American Board of Internal Medicine with subspecialty certification in Gastroenterology. An author of over 60 papers and numerous book chapters, Dr. Higgins’ research has focused on mechanisms of intestinal fibrosis in animal models, therapeutics for intestinal fibrosis, measurement of ulcerative colitis, measurement of intestinal fibrosis with ultrasound elastography, and microbiota in IBD. He has received research funding from the CCFA, the AGA, the NIH, and industry clinical trials. He serves as the IBD editor for the American Journal of Gastroenterology, and on the CCFA Senior Research Award Review committee. He was the recipient of the 2004 AGA-Centocor Excellence in IBD Clinical Research Award.

Research Interests:
Mechanisms of Intestinal Fibrosis
Treatment or Prevention of Intestinal Fibrosis
Machine Learning to Improve Diagnosis and Treatment
Measurement of Ulcerative Colitis
Biomarkers in IBD
Ultrasound Measurement of Intestinal Fibrosis
Microbiota in IBD
Prognosis of IBD

News:
Dr. Higgins was named to the 2010-2011 Best Doctors in America list.

The Division of Gastroenterology is one of the largest gastroenterology practices in the country and is a leader in the prevention, diagnosis, and treatment of diseases of the gastrointestinal tract and liver. 40-plus physicians are experts in the diagnosis and treatment of all diseases of the gastrointestinal system, from simple to complex, including those of the esophagus, stomach, small intestine, colon, rectum, liver, gallbladder, pancreas, and biliary tract.

In addition to being leaders in the clinic, the faculty are also leaders in their respective areas of research, which span such varied interests as the role of peptides in the brain-gut interactions in functional bowel diseases to innovative treatments of viral hepatitis and liver cancer.

 The human gut microbiome: current knowledge, challenges, and future directions.

  Ultrasound Elasticity Imaging (UEI) to Measure Fibrosis in Crohn's disease (HUM 12895)
PI: Peter Higgins, MD, PhD, MSc

This pilot study, for which we have applied for NIH funding, is investigating whether ultrasound through the skin of the abdomen can measure how stiff the intestine is in a narrowed area. We have preliminary data from rats that shows that UEI can measure intestinal stiffness, and that this measures the progressive scarring of the intestine. We are testing this ultrasound approach on patients who are going to surgery for intestinal narrowing due to CD, and comparing the ultrasound results to the findings of scarring in the removed intestine. If this is successful, we will have a way to measure whether people are developing intestinal scarring before they have a blockage, and perhaps institute therapy to slow the progress or reverse the scarring, before an intestinal obstruction occurs.

 CD Patient Reported Outcomes (PRO) and UC PRO (HUM 33866)
PI: Peter Higgins, MD, PhD, MSc

These companion projects, sponsored by Genentech, are designed to produce new and more accurate ways to measure the impact of IBD disease activity on patients with UC and CD. We will conduct patient focus groups at 4 around the US, followed by several one-on-one interviews, and use this information to develop and test PRO measures for UC and CD.

 A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Unduction Therapy, Administered Subcuntaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis (C0524T17) (HUM 32062)
PI: Peter Higgins, MD, PhD, MSc

This study will test whether an anti-TNF antibody medication, Golimumab, injected under the skin can control the symptoms of UC. Throughout the 6-week long study, the study medication will be given twice. Centocor is the study sponsor.

To qualify for this study, patients must:
• Be 18 years old with moderate to severe ulcerative colitis, determined at screening
• Have active disease despite treatment with at least 1 of the following conventional therapies: oral 5 aminosalicylates (5-ASA), oral corticosteroids (OCS), the
immunomodulator azathioprine (AZA), or 6 mercaptopurine (6-MP)
• Have no prior treatment with biologic therapy targeted at TNF (i.e., infliximab/Remicade, etanercept/Enbrel, certolizumab/ CimziaÂ, adalimumab/Humira)
• Have negative TB tests
• Not be pregnant or planning to become pregnant, or have a history of persistent infection or cancer
Study duration: 5 or 6 visits over at least 6 weeks, including screening, 2 drug administration visits, and 2 follow-up visits. Patients who complete the Golimumab induction study will be eligible to enter a maintenance study (T18), which will offer possible extended access to Golimumab for up to three years. Patients will be followed until week 6 in T17 if they choose to enroll in T18. If they choose not enroll, patients in the induction study will undergo one final follow-up evaluation at week 18.

 A Phase 3 Multicenter, randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis (C0524T18) (HUM 33258)
PI: Peter Higgins, MD, PhD, MSc

To qualify for this study: Once eligibility is reconfirmed, subjects will be assigned a treatment group based on their participation in the induction study. Treatment will be administered subcutaneously every four weeks for up to 52 weeks as follows:

• Patients in clinical response to Golimumab in the induction study will be re-randomized to receive Golimumab or placebo during the maintenance study
• Patients who are not in clinical response in the induction study will receive Golimumab during the maintenance study
• Patients in clinical response to placebo in the induction study will continue to receive placebo during the maintenance study
• Patients who lose clinical response to either Golimumab or placebo during the maintenance study will be eligible for a dose adjustment with Golimumab

Study duration: The maintenance portion will consist of 16 visits over 54 weeks, which includes 14 drug administrations and 2 safety visits. The study extension will consist of 42 visits over an additional 172 weeks, totaling 228 weeks, with drug administration every 4 weeks.

 UC Patient Reported Outcomes (PRO) and CD PRO (HUM 28223)
PI: Peter Higgins, MD, PhD, MSc

Description: These companion projects, sponsored by Genentech, are designed to produce new and more accurate ways to measure the impact of IBD disease activity on patients with UC and CD. We will conduct patient focus groups at 4 around the US, followed by several one-on-one interviews, and use this information to develop and test Patient Reported Outcome (PRO) measures for UC and CD. We hope to get these measures approved by the FDA for use in judging whether new therapies have important beneficial impact on patients' lives.

 UPCOMING STUDIES:

Methotrexate Response In Treatment of Ulcerative colitis (MERIT-UC) (HUM 38636)
PI: Peter Higgins, MD, PhD, MSc
Description: This study will test whether methotrexate is effective for maintenance therapy in UC. Eligible patients must have active UC. All subjects will receive methotrexate simultaneously with a steroid taper covered by the study, and responders will be randomized to continue methotrexate or a placebo, and monitored on a regular basis to determine whether they need continued therapy.

 Novel Biomarkers of Intestinal Inflammation and Fibrosis in Crohn's Disease (HUM 32452)
PI: Peter Higgins, MD, PhD, MSc

The hypothesis of this study is to determine if blood-based biomarkers of intestine specific fibrogenesis and fibrosis will identify and quantify fibrostenotic intestinal damage, providing prognostic value for complications of CD. The specific aims of this study are three-fold: To determine if levels of novel markers of IF discovered by proteomic analysis correlate with the presence and burden of fibrostenotic disease in patients with CD, to determine if identified biomarkers of fibrosis predict the long-term development of fibrosis and recurrent intestinal fibrostenotic disease in post-operative patients, and finally to determine if identified biomarkers of IF provide unique prognostic and predictive disease monitoring information compared to other biomarkers of disease activity including erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), fecal calprotectin, and lactoferrin.Patients with CD who have active disease, intestinal narrowing, and are scheduled for surgical resection will be recruited for this study.

 Seton Study
PI: Peter Higgins, MD, PhD, MSc

Description: This study will test whether a new type of seton (a length of suture material looped through the fistula which keeps it open and allows infected material to drain) can completely heal perianal fistulas in CD. Eligible patients must have CD and an existing perianal fistula.

 Trial Comparing Remicade and Placebo in the Prevention of Relapse in CD Patients Undergoing Surgical Resection (SURGE Study)
PI: Peter Higgins, MD, PhD, MSc

This study will test whether an FDA approved anti-TNF antibody, Remicade, after surgery for CD can prevent recurrence of disease symptoms. Eligible patients may be able to enroll in maintenance and extension phases that can provide medication for up to 4 years.Centocor is the study sponsor.