Abstract | AIM OF THE STUDY: To retrospectively evaluate the efficacy, the duration of response, and the tolerance of Remicade in anoperineal Crohn's disease. METHODS: 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. RESULTS: 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 abscess 16 weeks (range: 4-32) after the first infusion. CONCLUSION:
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.
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Authors | A Ouraghi, S Nieuviarts, J L Mougenel, M Allez, M Barthet, F Carbonnel, J Cosnes, J P Gendre, B Flourié, J J Meurisse, P Quandalle, O Ernst, M Lemann, A Cortot, R Modigliani, J F Colombel |
Journal | Gastroenterologie clinique et biologique
(Gastroenterol Clin Biol)
Vol. 25
Issue 11
Pg. 949-56
(Nov 2001)
ISSN: 0399-8320 [Print] France |
Vernacular Title | Traitement par anticorps anti-TNF alpha (infliximab, Remicade) des lésions anopérinéales de la maladie de Crohn. |
PMID | 11845044
(Publication Type: Clinical Trial, English Abstract, Journal Article, Multicenter Study)
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Chemical References |
- Antibodies, Monoclonal
- Gastrointestinal Agents
- Tumor Necrosis Factor-alpha
- Infliximab
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Topics |
- Abscess
(epidemiology)
- Adolescent
- Adult
- Aged
- Antibodies, Monoclonal
(adverse effects, therapeutic use)
- Anus Diseases
(drug therapy, etiology)
- Crohn Disease
(complications)
- Female
- Fissure in Ano
(drug therapy, etiology)
- Gastrointestinal Agents
(adverse effects, therapeutic use)
- Humans
- Infliximab
- Male
- Middle Aged
- Perineum
- Rectal Fistula
(drug therapy, etiology)
- Recurrence
- Retrospective Studies
- Time Factors
- Treatment Outcome
- Tumor Necrosis Factor-alpha
(immunology)
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