IBD Roundup: DDW research reveals targets to personalize treatment

WASHINGTON — After sorting the vast and varied research presented at Digestive Disease Week 2015, experts in IBD from the Gastrointestinal Health Foundation advisory board honed in several high-impact abstracts they believe showcase the push for personalized and precision medicine.

Panel member and director of the Jill Roberts Center for Inflammatory Bowel Disease at Sanford I. Weill College of Cornell University-New York Presbyterian Hospital, Ellen J. Scherl, MD, FACP, FACG, AGAF, FASGE, shared some of these “highlights” and her views on data covered online at Healio.com/Gastroenterology and in the print publication Healio Gastroenterology.

Ellen J. Scherl

Evaluating specific anti-IL-23 antibody MEDI2070 in active Crohn’s disease and failed anti-tumor necrosis factor therapy

This is a phase 2a study, randomized and controlled, and the researchers’ conclusion was that primary end point was met. The clinical remission was 27.1% in the study drug vs. 15% in placebo, and the clinical response was 45.8% in the study drug vs. 25% in placebo. This is a new and exciting target over a 12-week period of time. MEDI2070 shows clinical effect in patients with active Crohn’s disease failed anti-TNF therapy and a favorable profile over 12 weeks.
Read more in Meeting News Coverage

TOUCHSTONE: Efficacy and safety of oral S1P receptor modulator RPC1063 in moderate to severe ulcerative colitis

This is a randomized, double-blind, placebo-controlled induction trial. Focusing on clinical remission at week 8, in 1 mg of the study drug it was 16.4% of patients and in .5 mg it was 13.8% of patients compared to placebo, which was only 6.2% of patients. The critical response rates were higher, upwards of 50%, in both doses ranging the study, than the placebo, with a clinical response rate of 36.9%. This is a novel and exciting concept for modulation of S1P receptors in moderate to severe alternate colitis.
Read more in Meeting News Coverage

Analyzing rare variants identified by whole exome sequence in very early onset IBD patients under autosomal recessive model of transmission

The researchers concluded that autosomal recessive inheritance involving pathways not previously associated with IBD may be important for a subset of patients with very early onset IBD. It’s likely that for some of these patients with very early onset IBD, additional defects in the same pathway, which involves both B and T cells, result in the specific phenotype of their disease.

This is important because it gives us new potential targets and because it shifts our focus from T cells to B cells, and we’ve learned in the evolving field of immunology that it’s not just T cells it’s going to be dendritic cells. It’s important to know that there’s a rare variant in IL17R, which was detected in heterozygosity in one of the patients in the sample. That becomes important because we may have an IL17 target, and while that won’t work for everybody, it may work for a very select group.
Read more in our In the Journals summary

PIANO: Detecting biologic agents in breast milk and implications for infants born to women with IBD

This study is looking at the role of biologic agents and breast milk and the implications for infection and growth. The conclusion is that infliximab is detected in breast milk within 48 hours of dosing, but the amounts are miniscule and much lower than that found in serum. Both adalimumab and certolizumab were not actually detected in breast milk at 48 hours. The breast milk fed infants of mothers who were on biologics, immunomodulators or confirmation therapy showed similar rates of growth and milestone achievement as well as similar risks of infection compared to unexposed infants. This study is still ongoing.
Read more in HGI’s Cover Story

References:
Sands BE, et al. Abstract 830.
Sandborn W, et al. Abstract 445.
Kelsen JR, et al. Abstract 319.
Matro R, et al. Abstract 747.

Disclosure: Scherl reports grant/research support from Abbott (AbbVie), AstraZeneca, CCFA, Elan, Janssen Research & Development, Johns Hopkins University, Mesoblast (formerly Osiris Therapeutics), Millennium Pharmaceuticals, National Institute of Diabetes and Digestive and Kidney (NIDDK), National Institute of Health (NIH), New York Crohn’s Foundation, Osiris Therapeutics, Pfizer, Prometheus Laboratories, Salix, UCB, UCSF–CCFA Clinical Research Alliance; consultant/advisory board roles with: AbbVie, Crohn’s and Colitis Foundation of America (CCFA), Entera Health, Evidera, GI Health Foundation, Janssen, NPS Pharmaceutical, Prometheus, Protagonist Therapeutics, Salix, Seres Health, Shire, SUN FZE, Takeda Pharmaceuticals, UCB; holding stock in Gilead; and receiving honoraria from GIHealth Foundation for non-branded speaker’s bureau, Janssen for non-branded speaker’s bureau, ClearView Healthcare Partners for market research.