Abstract
Background
Data on the effectiveness of anti–tumour necrosis factor medications in patients with Crohn’s disease with poor prognostic factors are scarce. This study aimed to generate real-world evidence on the effect of early (≤24 months after diagnosis) versus delayed (>24 months) initiation of adalimumab on the 26-week remission rate (Harvey-Bradshaw Index ≤4) in these patients.
Methods
This multicentre, retrospective, chart-review study performed in 10 Greek hospitals enrolled adult patients with moderate to severe Crohn’s disease (Harvey-Bradshaw Index ≥8) with ≥3 poor prognosis factors who were initiated on adalimumab ≥12 months before enrolment. A sample size of 164 patients (early:delayed cohort allocation ratio, 30:70) was required to address the primary endpoint.
Results
Eligible patients (n=171) were consecutively enrolled. In the early versus delayed cohorts, the 26-week remission rates (off steroids) using the last-observation-carried-forward imputation method were 60.7% (37/61) versus 47.2% (50/106), respectively (Δ=13.5%, p=0.044). The respective remission rates were 61.2% versus 42.4% among anti–tumour necrosis factor–naive patients (p=0.023) and 58.3% versus 53.2% among anti–tumour necrosis factor–experienced patients (p=0.374). The 52-week remission rates using as-observed data were 78.8% and 60.3%, and the intestinal resection rates were 6.5% and 11.9% in the early versus delayed ADL cohorts, respectively.
Conclusions
Patients with Crohn’s disease with poor prognostic factors who received early versus delayed treatment with adalimumab achieved higher clinical response and remission rates. This effect was more pronounced in those patients who were bio-naive and steroid-dependent/refractory with concurrent extraintestinal manifestations than those who were not.
The effect of early versus delayed initiation of adalimumab on remission rates in patients with Crohn’s disease with poor prognostic factors: The MODIFY study
