Infliximab (Remicade®) has been shown to be an efficacious treatment for fistulae in patients with Crohn's disease, but its long term efficacy remains uncertain.
Aim of the study
To retrospectively evaluate the efficacy, the duration of response, and the tolerance of Remicade® in anoperineal Crohn's disease.
Fifty patients with severe symptomatic and refractory anoperineal Crohn's lesions (38 fistulae and 29 cavitating ulcers and superficial fissures) were treated with 3 intravenous infusions of Remicade® (5 mg/kg) at weeks 0, 2 and 6. Efficacy was assessed using Allan's functional score and proctologic examination at 8 weeks (W8) and 24 weeks (W24) after the first infusion.
At W8, a response was noted for 71% (27/38) of fistulae and 79% (23/29) of ulcers and fissures. Healing rates were 39% and 49%, respectively. Efficacy of Remicade® at W8 did not vary according to sex, number and type of fistulae and other treatments. At W24, 58% (15/26) of patients with fistulae and 63% (10/16) of patients with ulcers or fissures had a response. The response rate at W24 was higher in patients having anoperineal Crohn's lesions for less than one year: 77% vs 32% (P = 0.004). Median Allan's score significantly decreased from 3.9 before treatment to 1.7 at W2 (P < 0.001), 1.3 at W6 and 0.8 at W8. Median duration of response was 9.5 months (range: 0.5-12.5) after last infusion and was not influenced by associated treatments including immunomodulators. The relapse rate at 1 year was 64% for the responders followed at least one year (n = 21). Minor adverse events occurred during 12% of all infusions. Eight patients had an infection, including one pneumonia. Eight patients developed a perineal abcess 16 weeks (range: 4-32) after the first infusion.
Remicade® is rapidly effective and well tolerated in anoperineal Crohn's lesions, but the high relapse rate stresses the need for long term therapeutic strategies in these patients.
© 2001 Elsevier Masson SAS. Tous droits réservés.