Objective: To compare the efficacy of step-up and top-down infliximab therapy on patients with Crohn's disease (CD).
Methods: A prospective and open-label study was performed by the First Affiliated Hospital of SUN Yat-sen University during September 2007 to December 2010. Active CD patients who were refractory to steroid/immunomodulator or who were steroid-dependent were enrolled into step-up group. Active CD patients who had no steroid or immunomodulator therapy before were enrolled into top-down group. All patients were intravenously infused with infliximab of 5 mg/kg body weight in an induction regimen of 3 doses at week 0, 2 and 6, followed by maintenance dosing every 8 weeks beginning at week 14. The clinical and endoscopic follow up lasted 30 weeks. Clinical symptoms and mucosal healing status under endoscopy were evaluated by follow-up at week 10 and 30.
Results: Forty-one CD patients were enrolled, with 24 in step-up group and 17 in top-down group. There were significant differences in disease duration (P = 0.006), combination therapy (P < 0.001) and severity of disease (P = 0.011) in baseline between step-up and top-down groups. At week 10 and 30 during treatment, the clinical remission rates in step-up group were 45.8% (11/24) and 58.3% (14/24) respectively; the mucosal healing rates in step-up group were 33.3% (8/24) and 54.2% (13/24) respectively; the clinical remission rates in top-down group were 70.6% (12/17) and 82.4% (14/17) respectively; and the mucosal healing rates in top-down group were 35.3% (6/17) and 52.9% (9/17) respectively. No significant differences in clinical remission and mucosal healing rates at both week 10 and 30 were observed between the two groups. The prevalences of adverse events in step-up and top-down group were 41.7% (10/24) and 29.4% (5/17) respectively (P = 0.422).
Conclusion: Both step-up and top-down infliximab therapy can induce remission in more than half of CD patients, while top-down therapy might be more beneficiary to symptom and endoscopic remission.