Background: Rapidity of response to treatment in Crohn's disease (CD) is now considered a field of major interest, due to the importance of achieving the highest benefit in the shortest possible time. There are no studies specifically designed to evaluate the rapidity of response to ADA neither other anti-TNF therapies. The aim of this trial was to evaluate the rapidity of onset of clinical response to adalimumab (ADA) therapy.
Methods: Adult anti-TNF naïve patients with active luminal (Harvey-Bradshaw Index (HBI) ≥8) moderate-to-severe CD (excluding penetrating and stricturing disease), with no response to a full and adequate course of therapy with corticosteroids and/or immunosuppressants, were enrolled in this interventional, prospective, open label, single arm and multicenter clinical trial. Patients received standardized ADA treatment (160 mg – 80 mg – 40 mg eow).
The HBI was evaluated to determine the response at day 4 and week 1; and clinical remission at weeks 2, 4 and 12. Response was defined as a decrease of, at least, 3 points in the HBI global score and remission was defined as HBI global score <5.
CRP (C Reactive Protein) and fecal calprotectin (FC) were analyzed at baseline, day 4, week 1, 2, 4, 12.
The modified intention to treat (mITT) population was the primary population for efficacy analysis and consisted of those patients enrolled in the study who had received at least one dose of ADA.
Treatment-emergent serious adverse events (AEs) were recorded to assess safety throughout the study until 70 days after last treatment dose. All patients who received at least one dose of ADA were included in the safety population.
Statistical analyses were performed by the t-test or the Wilcoxon signed rank test, as applicable. Time to clinical response was analyzed using a Kaplan-Meier survival analysis model.
Results: 80 anti-TNF naïve patients were analyzed. 62.5% and 71.3% of patients experienced a response at day 4 and week 1, respectively. Remission was achieved by 50.0% of patients at week 2, 62.5% at week 4 and 42.5% at week 12. The median time to obtain response was 4.0 days (95% confidence interval (CI): 1.0, 4.0) and the median time to remission was 7.0 days (95% CI: 4.0–18.0).
37.50% of the patients suffered from any adverse event (AE) during the study. Only 1 patient (1.25%) showed a serious AE.
Conclusions: ADA produces rapid clinical remission and response since day 4 in patients with moderate-to-severe CD unresponsive to therapy with corticosteroids and/or immunosuppressants.