• Press Release

Monitoring Crohn’s Disease Using Inflammation Biomarkers and Symptoms Led to Better Patient Outcomes Than Using Symptoms Alone, Mount Sinai Researchers Report

46 percent of patients experienced mucosal healing vs. 30 percent using standard therapeutic strategies

  • New York, NY
  • (October 31, 2017)

An efficacy and safety study of two treatment models for patients with Crohn’s disease has found that monitoring both inflammation biomarkers and symptoms led to superior outcomes compared to clinical management of symptoms alone.

Mount Sinai researchers found that 46 percent of patients randomly assigned to a “tight control” (TC) protocol of biomarker and symptom monitoring experienced mucosal healing—the complete absence of all ulcerative lesions in all segments of the gut after 48 weeks—compared with 30 percent of patients randomized to clinical management (CM). In addition, a significantly higher proportion of patients in the TC group achieved deep remission and steroid-free remission compared with the CM group.

The trial, known as CALM, “Open-Label, Multi Center, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease” is the first study to demonstrate that monitoring inflammation biomarkers, including C-reactive protein (CRP) and fecal calprotectin, along with clinical symptoms led to superior patient outcomes while using anti-tumor necrosis factor (TNF) therapy (adalimumab/Humira®) compared with symptom-driven decisions alone.

The results of the study will be published online in The Lancet on Tuesday, October 31, at 8:01 pm EDT and will be presented at the United European Gastroenterology Week meeting in Barcelona.

“With this study, we have implemented a new concept of ‘tight control’ of Crohn’s disease, which will change the way that patients will be followed in clinical practice,” said the paper’s lead author, Jean–Frederic Colombel, MD, Director of The Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center at The Mount Sinai Hospital and Professor of Medicine and Gastroenterology at the Icahn School of Medicine at Mount Sinai. “Treatment   should be based on objective markers of inflammation and not only on symptoms. A patient with Crohn’s disease may do well clinically, but if biomarkers for the disease remain high, we still need to escalate interventions including drugs. This study shows tight control led to more patients experiencing clinical remission, which will ultimately improve their long-term outcomes.”

In the phase 3, multi-center clinical trial, 244 patients with moderate to severe Crohn’s disease were randomly assigned in equal numbers to TC or CM groups after eight weeks of prednisone induction therapy, or earlier if they had active disease. In both groups, treatment was escalated in a stepwise from no treatment to adalimumab induction every other week, to every week and finally to both adalimumab and azathioprine every week. The presence of CRP in blood and fecal calprotectin in stool was monitored in the TC group: In the TC group, drugs were escalated to the next step  when CRP rose above 5mg/L or fecal calprotectin above250 ìg. In both groups, drugs were also escalated to the next step when patients reported increases in clinical symptoms.

According to Dr. Colombel, further research is needed to demonstrate the long-term effects of the TC approach on Crohn’s disease as measured by shorter hospitalizations, fewer surgeries and complications, and less disability.

“When patients with Crohn’s disease are making therapeutic decisions about starting a drug, or escalating or de-escalating a drug, they can’t base these decisions on symptoms alone,” said Dr. Colombel. “They need objective data including biomarkers and endoscopy results. Ultimately this will disable their disease from progressing.”

This study was supported by NIH NCT01235689. AbbVie, the maker of Humira, funded the study, contributed to design, and participated in the collection, analysis, and interpretation of the data and in preparation and approval of this report. All authors had access to study data, reviewed and approved the final report, and take full responsibility for the accuracy of the data and statistical analysis. The corresponding author had full access to study data and had final responsibility for the decision to submit for publication.

About the Mount Sinai Health System

Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 43,000 employees working across eight hospitals, over 400 outpatient practices, nearly 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time — discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it.

Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients’ medical and emotional needs at the center of all treatment. The Health System includes approximately 7,300 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics and top 20 in Cardiology/Heart Surgery, Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report’s “Best Children’s Hospitals” ranks Mount Sinai Kravis Children's Hospital among the country’s best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is one of three medical schools that have earned distinction by multiple indicators: It is consistently ranked in the top 20 by U.S. News & World Report's "Best Medical Schools," aligned with a U.S. News & World Report "Honor Roll" Hospital, and top 20 in the nation for National Institutes of Health funding and top 5 in the nation for numerous basic and clinical research areas. Newsweek’s “The World’s Best Smart Hospitals” ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.

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