DOP67 First-line infliximab is cost-effective compared to conventional treatment in paediatric Crohn’s Disease – Results from the TISKids study

Abstract

Objectives and Study: First-line infliximab (FL-IFX) induction treatment combined with azathioprine (AZA) is more effective to achieve and maintain clinical remission without treatment escalation at week 52 compared to conventional induction treatment (Exclusive Enteral Nutrition or prednisone) combined with AZA in children with moderate-to-severe Crohn's disease (CD). Data on cost-effectiveness of a FL-IFX strategy in children with CD is still limited. Therefore, our aim is to investigate the costeffectiveness of FL-IFX in comparison with conventional treatment. We hypothesized that the costeffectiveness of a FL-IFX strategy is comparable to conventional treatment strategy in children with newly diagnosed moderate-to-severe CD during the first two years of treatment after diagnosis. Method(s): We included patients from the TISKids international randomized controlled trial where children with moderate-to-severe CD were treated with either FL-IFX (Inflectra, biosimilar of IFX) or conventional treatment.(1) Patients included outside of the Netherlands (n=6) or patients with serious comorbidity unrelated to CD (n=2) were excluded from this analysis. Data on healthcare consumption and costs were obtained per hospital for all included patients until week 104. Direct health-related costs were collected, including outpatient hospital visits, hospital admissions, drug costs, laboratory tests, endoscopies and surgeries. The effectiveness of treatment was assessed by mean weighted paediatric CD activity index (wPCDAI) and faecal calprotectin (fcal) levels (mu g/g) measured over time until week 104. This analysis was performed by a mixed model. Moreover, time to additional or (re)start of anti-tumor necrosis factor-alpha (anti-TNF) treatment up to 104 weeks after inclusion was assessed. In the FL-IFX group, time to additional or re(start) of anti-TNF treatment included IFX interval shortening or dose increase within the first 5 infusions, or continuation or restart of anti-TNF treatment after the first five standard infusions. Result(s): In this analysis, 89 patients were included, 44 in the FL-IFX group and 45 in the conventional treatment group. Interestingly, the mean costs were similar for FL-IFX (34,783) and conventional treatment (34,923) over two years, p=0.97. An overview of the distribution of costs per category is provided in Figure 1. The mean wPCDAI scores over two years were numerically lower for FL-IFX compared to conventional treatment (5.9 vs 10.3, p=0.01), but this difference became smaller over time. Mean fcal levels were lower for FL-IFX compared to conventional treatment over two years (416 vs. 625, p=0.03). Furthermore, the time to additional or (re)start of anti-TNF treatment was significantly longer in the FL-IFX group (median 68 weeks) compared to the conventional treatment group (median 32 weeks) (p=0.02). Conclusion(s): Treatment with FL-IFX has a beneficial effect on the course of disease during the first two years, and costs are equal compared to conventional treatment. FL-IFX is therefore cost-effective compared to conventional treatment in the first two years after diagnosis in children with moderate-tosevere CD.