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7 IBD Studies Presented at ACG 2015
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HONOLULU — A number of advances in treatment and therapeutic drug monitoring in inflammatory bowel disease were recently presented at the American College of Gastroenterology Annual Scientific Meeting in Honolulu.
Here are seven key highlights of IBD research covered by Healio Gastroenterology at this year’s meeting.
1. GEMINI: Entyvio maintenance unaffected if immunosuppression stopped
Brian Feagan
Discontinuation of immunosuppressants did not significantly impact the efficacy of Entyvio maintenance therapy in patients with IBD, according to post hoc analyses of the GEMINI 1 and 2 trials.
“Discontinued immunosuppressant use upon response to vedolizumab induction did not appear to substantially affect the efficacy of vedolizumab maintenance therapy in patients with UC,” Brian Feagan, MD, from Robarts Research Institute, University of Western Ontario, said during his presentation. Read more
2. UNITI-2 trial: Stelara effective for treating Crohn’s disease
In the UNITI-2 clinical trial, the results of which were also presented by Feagan, researchers found Stelara to be a safe and effective therapy for Crohn’s disease.
“Both IV ustekinumab induction regimens were well-tolerated, without higher rates of key safety events observed over IV placebo,” Feagan said. Read more
3. Remicade first trough levels at week 2 helps predict outcomes in UC
The first trough level of Remicade at week 2 was found to be predictive of short- and long-term response in patients with ulcerative colitis.
“These results may suggest the usefulness of trough level in early decision making and also may justify the dose intensification strategy, especially if [clinical activity index] is 5 or above at week 2,” Taku Kobayashi, MD, from the Center for Advanced IBD Research and Treatment, Kitasato University, Tokyo, said during his presentation. Read more
4. TOUCHSTONE: Ozanimod provides long-term benefit in moderate-to-severe UC
Stephen B. Hanauer
The long-term safety and efficacy of ozanimod for moderate-to-severe ulcerative colitis was confirmed by data from the maintenance period of the TOUCHSTONE study.
“Ozanimod was well tolerated with a favorable benefit-risk profile, which supports the planned phase 3 trial in ulcerative colitis and the phase 2 trial in Crohn’s disease,” Stephen B. Hanauer, MD, Clifford Joseph Barborka professor in medicine-gastroenterology and hepatology, Northwestern University Feinberg School of Medicine, Chicago, said during his presentation. Read more
5. Radiological response predicts outcomes in small bowel Crohn’s disease
Radiological response to medical therapy was found to be associated with reduced long-term risk for hospitalization, surgery and corticosteroid use in patients with small bowel Crohn’s disease, suggesting its utility as a potential treatment target.
“These findings suggest the significance of radiological response as a treatment target and a component of risk stratification models,” Parakkal Deepak, MBBS, from the division of gastroenterology at the Mayo Clinic, said during his presentation. Read more
6. Researchers find anti-TNFs, thiopurines generally safe in pregnancy
Brindusa Truta
Anti-TNFs and thiopurines were safe during pregnancy for the treatment of inflammatory bowel disease, but in combination with steroids may cause complications for both patients with and without IBD.
“The use of anti-TNFs and thiopurines in pregnancy is generally safe; however, combination therapy and the chronic use of conventional steroids increases the risk for pregnancy complications and severe acute respiratory infections in the babies’ first year of life,” Brindusa Truta, MD, assistant professor of medicine, Johns Hopkins University School of Medicine, said during her presentation. Read more
7. Commercial, clinical trial assays for Remicade show strong agreement
Commercially available assays for determining Remicade concentrations and antibodies were found to have strong agreement with assays used by Janssen in the clinical development of Remicade for inflammatory bowel disease.
“The strong agreement reported here between the comparator assays and the Janssen drug-tolerant assay provides support to clinicians in their use of these commercial assays, and for understanding their patients’ [infliximab] and [antibodies to infliximab] results relative to published data from clinical studies of Remicade,” the researchers wrote. Read more