RESUMO
BACKGROUND AND AIMS: We aimed to assess cost-effectiveness of increasing adalimumab dose intervals compared to the conventional dosing interval in patients with Crohn's disease [CD] in stable clinical and biochemical remission. DESIGN: We conducted a pragmatic, open-label, randomized controlled non-inferiority trial, comparing increased adalimumab intervals with the 2-weekly interval in adult CD patients in clinical remission. Quality of life was measured with the EQ-5D-5L. Costs were measured from a societal perspective. Results are shown as differences and incremental net monetary benefit [iNMB] at relevant willingness to accept [WTA] levels. RESULTS: We randomized 174 patients to the intervention [nâ =â 113] and control [nâ =â 61] groups. No difference was found in utility (difference: -0.017, 95% confidence interval [-0.044; 0.004]) and total costs (-943, [-2226; 1367]) over the 48-week study period between the two groups. Medication costs per patient were lower (-2545, [-2780; -2192]) in the intervention group, but non-medication healthcare (+474, [+149; +952]) and patient costs (+365 [+92; 1058]) were higher. Cost-utility analysis showed that the iNMB was 594 [-2099; 2050], 69 [-2908; 1965] and -455 [-4,096; 1984] at WTA levels of 20 000, 50 000 and 80 000, respectively. Increasing adalimumab dose intervals was more likely to be cost-effective at WTA levels below 53 960 per quality-adjusted life year. Above 53 960 continuing the conventional dose interval was more likely to be cost-effective. CONCLUSION: When the loss of a quality-adjusted life year is valued at less than 53 960, increasing the adalimumab dose interval is a cost-effective strategy in CD patients in stable clinical and biochemical remission. CLINICAL TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, number NCT03172377.