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P303. Certolizumab pegol in patients with inflammatory or fistulizing Crohn's disease: A long term update of compassionate use

F. Mocciaro, S. Renna, A. Orlando, M. Olivo, E. Sinagra, M. Cottone

Department of Medicine Pneumology and Physiology of Nutrition, Palermo University, Palermo, Italy

Aim: Certolizumab pegol (CP) is a pegylated Fab' fragment of a humanized anti-TNFα monoclonal-antibody, effective in the treatment of Crohn's disease (CD). It can be useful in patients who had previously received and responded to infliximab, but who no longer have a sustained response and/or tolerance to infliximab. We report a long term update, from a referral centre for Inflammatory Bowel Diseases, concerning the efficacy, the safety and the final outcomes of compassionate use of CP in patients with moderate to severe CD (Harvey Bradshaw Index – HBI score >4).

Materials and Methods: Ten patients (5 with intolerance and 5 with loss of response to infliximab) were treated from 2007. Patients received 400 mg of CP subcutaneously at week 0, 2, 4 (induction phase). Responders maintained a scheduled regimen of 400 mg every 4 weeks. Remission was defined as HBI≤4 or a complete fistulas closure; response was defined as a reduction of HBI≥3 or a reduction of at least 50% of drainage trough the fistulas.

Results: Five males/5 females (mean age 40.7 years, range 18–56) were enrolled with a mean disease duration of 14.3 years (range 4–22). The median baseline HBI score was 9.5 (range 7–16). Involved intestinal areas were: ileum (2 patients), colon (3), ileum-colon (5). Three patients were treated with CP for fistulizing CD (evaluated with MRI) and 7 for inflammatory CD. At week 6 the overall clinical benefit was higher in patients treated for inflammatory CD than fistulizing CD (6/7 [86%] vs 0/3 [0%]) but the efficacy gradually decreased trough the follow-up. At month 6 and 12 only 50% and 33% of patients maintained a clinical benefit. The last 2 patients relapsed after 30 months from the first dose and discontinued CP. At the end of the follow up (October 2010): among patients treated for inflammatory CD all experienced a clinical recurrence and 2 of them underwent surgery for fistulas development; among patients treated for fistulizing CD all underwent surgery for severe perianal disease. Five patients experienced adverse events: 2 patients (both with fistulizing CD) developed an abdominal abscess, 1 developed a skin rash after the first dose, 1 a paradoxical development of psoriasis after 9th injection, and 1 an oral lichen planus probably as paradoxical effect due to CP.

Conclusion: In our experience, CP was effective in inducing clinical response and remission in patients with moderate to severe inflammatory CD previously treated with infliximab. Unfortunately the efficacy decreases slowly through the follow-up and all patients experienced a clinical relapse. For fistulas healing CP was ineffective. CP was quite safe but abscesses developed in 2 patients with fistulas, suggesting an accurate radiological and surgical screening for perianal sepsis before starting therapy.