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P254. Adalimumab treatment in Crohn's disease patients previously non-responders or intolerant both to infliximab and certolizumab pegol: A referral centre experience

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

Division of Internal Medicine “Villa Sofia-V. Cervello” Hospital, Palermo University, Palermo, Italy

Aim: Inhibitors of tumor necrosis factor-alpha (TNF-alpha) as infliximab (IFX), adalimumab (ADA) and certolizumab pegol (CP), represent important treatment advances in Crohn's disease (CD). There are some data about the treatment with a second anti-TNF-alpha but it is still unclear which is the role of a third anti-TNF-alpha course when 2 had previously failed. The aim of this study is to report the experience of a tertiary referral centre concerning the treatment with ADA in CD patients previously non-responders or intolerant both to IFX and CP.

Materials and Methods: Between May 2008 and October 2010, 8 CD patients, all previously treated both to IFX and CP, received an induction dose of ADA (160/80 mg [3 patients] or 80/40 mg [5 patients] subcutaneously at week 0 and 2); responders received a maintaining dose of 40 mg eow. Screening for sepsis, tuberculosis, hepatitis, and malignancy was negative. We evaluated the efficacy and safety of ADA at the end of the induction phase (week 6), and at 6, 12, and 24 months.

Results: Five male and 3 female patients (mean age of 44.62±12.6 years), all with previous bowel resection history, were treated with ADA: 6 (75%) were intolerant to IFX and 2 (25%) were non-responders while 2 (25%) were intolerant to CP and 6 (75%) were non-responders. Five patients had an ileo-colonic CD, 2 ileal, and 1 colonic. Five patients (62.5%) received ADA for steroid-dependent CD, and 3 (37.5%) for fistulizing CD. The mean CDAI score was 167.6±11.1. At week 6, among the steroid-dependent patients, 5/5 (100%) achieved a clinical response (3 were in complete free-steroid clinical remission); in fistulizing patients, 1/3 (33%) achieved a complete fistulas closure while 2/3 were non-responders (but 1 of them received only one dose because of acute reaction). At 6 months 100% of responders after the induction phase achieved and maintained the clinical remission. At 12 months 4/6 responder patients (66.6%) were in clinical remission (2 patients had a follow-up of 10 months). At 24 months, 3 out of 4 patients with an adequate follow-up were in complete clinical remission while 1 out of 4 experienced a disease recurrence. Only 1 patient discontinued the treatment for skin rash. The 2 patients with fistulas, non-responders after the induction, underwent surgery for severe perianal disease.

Conclusion: In our experience ADA was more effective in inducing clinical remission than fistulas closure in patients with steroid-dependent or fistulizing CD previously intolerant or non-responder both to IFX and CP. This efficacy was confirmed at 6, 12, and 24 months. ADA was safe through the follow-up. Further placebo-controlled trials will definitively address the role of a third anti-TNF-alpha course when 2 TNF-alpha inhibitors previously failed in CD patients.