In data presented during the annual ACG meeting, investigators show vedolizumab can be safe and effective for treating pediatric patients with IBD who have failed anti-TNF therapy.
Harry Sarles Jr., MD
There may be a new option emerging for pediatric patients with inflammatory bowel disease (IBD) who have failed anti-tumor necrosis factor (anti-TNF) therapy, a patient population currently with a dearth of treatment options.
In research presented as a poster at the American College of Gastroenterology’s Annual Scientific Meeting (ACG 2019), a team of investigators, led by Harry Sarles Jr., MD, Medical Director for the DHAT Research Institute, presented data from a retrospective study of pediatric IBD patients who received vedolizumab (VZD) for at least 12 months.
While vedolizumab has proven safe and effective for adults with refractory IBD, the long-term outcomes for pediatric IBD patients are not well known.
The study included 29 pediatric IBD patients treated with vedolizumab since the medication gained US Food and Drug Administration approval in 2014. At baseline, the mean age was age 14±3.2 years, with 17 male patients (59%), 16 (55%) suffering from Crohn’s disease (CD) and 13 (45%) having ulcerative colitis (UC).
All 29 patients were previously treated with an anti-TNF agent. The median vedolizumab duration of treatment was 21.3 months and the drug was discontinued in 5 patients for primary non-response (less than 6 months) and in 5 patients for secondary non-response (12-24 months).
Efficacy data is presented for 24 patients treated with the medication for 1 year and for 14 patients for 2 years.
In the study, the investigators collected data on demographics, disease characteristics, therapy, and adverse events. They assessed disease activity scores at baseline and after 14 weeks and 6,12, and 24 months using the short pediatric Crohn’s disease activity index (shPCDAI) and pediatric ulcerative colitis activity index (PUCAI).
Clinical remission was defined by shPCDAI score less than 15 or a PUCAI score less than 10.
“Significant reductions in shPCDAI and PUCAI scores compared to baseline were observed at all time points,” the authors wrote. “Clinical remission was achieved at 1 year in 8 of 13 (62%) CD [patients] and 5 of 11 (45%) UC [patients]. Remission was sustained at 2 years in 8 of 9 (89%) CD [patients] and 3 of 5 (60%) UC [patients].”
The most common adverse events that occurred were headache and fatigue with no drug discontinuations occurring because of adverse events. There was also only 1 IBD-related emergency department visit and 3 IBD-related hospitalizations, with 2 resulting in surgeries.
“Our data suggest that VDZ is effective in achieving clinical remission in pediatric IBD [patients] with prior anti-TNF failure, with minimal safety concerns,” the authors said. “We observed early and sustained remission rates in both UC and CD [patients], with CD [patients]Vide experiencing higher rates than previously reported in literature.”
The investigators said additional studies are needed to determine the role of vedolizumab in the treatment of pediatric IBD.
The poster, “Long-Term Efficacy of Vedolizumab in Pediatric Inflammatory Bowel Disease,” was presented Monday, October 28, 2019, at the American College of Gastroenterology Annual Scientific Meeting (ACG 2019) in San Antonio, Texas.