M Matar et al. Inflamm Bowel Dis 2020; 26: 1627-1635. Free full text link: Combination Therapy of Adalimumab With an Immunomodulator Is Not More Effective Than Adalimumab Monotherapy in Children With Crohn’s Disease: A Post Hoc Analysis of the PAILOT Randomized Controlled Trial
Methods: Participants (n=78, ages 6-17 years) in this study were part of the PAILOT trial; they were naïve to biologic therapy with moderate to severe Crohn’s disease. This was a randomized controlled trial aimed to evaluate proactive vs reactive therapeutic drug monitoring in children with Crohn’s disease (CD) treated with adalimumab.
- There was no significant difference in the rates of sustained corticosteroid-free clinical remission (25/34, 73%, vs 28/44, 63%; P = 0.35) or sustained composite outcome of clinical remission, C-reactive protein ≤0.5 mg/dL, and calprotectin ≤150 µg/g (10/34, 29%, vs 14/44, 32%; P = 0.77) between the combination group and the monotherapy group, respectively.
- Adalimumab trough concentrations and immunogenicity were not significantly different between groups. The rate of serious adverse events was not significantly different between groups but was numerically higher in the monotherapy group. The monotherapy group had three patients undergo ileo-cecal resection.
The discussion reviews a number of studies that have compared combination and monotherapy. One key point is that this study enrolled children who were naïve to biologic therapy; thus, combination therapy may be more useful in those who have failed a previous biologic, particularly if the loss of response was immune-mediated.
My take: This study indicates that combination therapy is likely not routinely needed in children who start adalimumab and who are naïve to biologic therapy. Another finding of interest is the relatively low sustained composite outcome of clinical remission, approximately 30; this outcome combined clinical remission with biological markers. ~30%