G Horneff et al. J Pediatr 2018; 201: 166-75. This industry-funded analysis of 577 pediatric patients who received adalimumab (1440 patient-years) identified no new safety signals. The most common serious infection was pneumonia (0.6 events per 100 patient-years). The most common adverse events were respiratory tract infections/nasopharyngitis. Serious infections were more common in the subset of patients with Crohn’s disease (CD), (n=189), occurring in 13%.
PS Dulai et al. Gastroenterol 2018; 155: 687-95. This study, using data from GEMINI 2 phase 3 trial with 814 patients, developed a clinical prediction tool for determining the likelihood of a clinical response to vedolizumab. Common predictors for response:
- No prior bowel surgery
- No prior anti-TNF exposure
- No prior fistulizing disease
- Higher baseline albumin
- Lower baseline CRP
R Matro et al. Gastroenterol 2018; 155: 696-704. The authors performed a prospective study of women with IBD and their infants (n=72). They “detected low concentrations of infliximab, adalimumab, certolizumab, natalizumab, and ustekinumab in breast milk samples. We found breastfed intants of mothers on biologics, immunomodulators, or combination therapies to have similar risks of infection …compared to non-breastfed infants or infants unexposed to these drugs.”