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P177. Adalimumab for patients with Crohn's disease and secondary loss of response or severe allergy to infliximab

E. Archavlis, K. Papamichael, D. Tzivras, I. Theodoropoulos, A. Smyrnidis, P. Konstantopoulos, N. Kanellopoulos, I. Drougas, D. Tsironikos, N. Kyriakos, G. Agalos, N. Raptis, G.J. Mantzaris

A' Gastroenterology Clinic, Evaggelismos Hospital, Athens, Greece

Background: In the GAIN study a considerable proportion of patients who had lost response to infliximab (IFX) and received adalimumab (ADA) induction and then scheduled maintenance therapy were able to re-capture response to anti-TNFα therapy.

Aim: In a single center, one-year trial we aimed at assessing the efficacy of adalimumab to restore response to anti-TNFα therapy in Crohn's disease (CD) patients who had gradually lost response to IFX (LOR-I) or had developed allergic reactions precluding further treatment with IFX (AR-I).

Patients and Methods: Patients aged 18–72 years with clinical (CDAI > 220), serological (elevated WBCs, platelet counts, and C-Reacting protein (CRP) and endoscopic (Short Endoscopy Score of CD, SES-CD, higher than 4) activity of CD and AR-I or LOR-I despite treatment with 10 mg/kg IFX every 4 weeks (LOR-I) were eligible for the study. Patients received ADA induction (160/80 mg at weeks 0, 2) and then scheduled maintenance (40 mg every 2 weeks) for one year. Patients unresponsive until week 12–16 were excluded. Patients losing response during maintenance treatment received 40 mg ADA every week. Disease activity was assessed at monthly intervals clinically (using the CDAI) and serologically (full blood count, ESR, CRP) whereas endoscopy to assess mucosal healing was performed between 6 and 12 months.

Results: Twenty-three patients received ADA, 14 for LOR-I and 7 for AR-I. The male:female ratio was 17:6, mean age (range) was 29 (18–55) years, the baseline median CDAI was 285 (range 230–420), 5 patients had perianal fistulae. Two patients (8.7%) failed to respond by week 16. At 4 weeks, 7/23 (30.4%) were in clinical and serological remission (CDAI < 150) whereas 14/24 (60.9%) had responded clinically to ADA (drop in CDAI score >100 over baseline, yet >150). At 12 months, 12/23 (52.2%) patients were in clinical remission, 5/23 (21.7%) were clinical responders and 4/23 (17.4%) who initially responded had stopped treatment [two patients for secondary loss of response to ADA, one adverse event (s. Guillain-Barre) and one for fibrostenotic obstruction]. Overall, 3 of 5 patients had prolonged remission of perianal fistulating disease. The dose of ADA was escalated to 40 mg weekly in 12/23 patients (52%). Ileocolonoscopy was performed in 18/23 (78.2%) patients and revealed complete (no ulcers) or near complete (occasional aphthae compared to baseline endoscopy) mucosal healing in 12/18 (66.7%) and partial healing (residual ulcers and/or some cobble-stoning but significant improvement over baseline) in 6 (33.3%) patients.

Conclusion: In this single-centre one-year study ADA re-captured almost three quarters of patients who had failed IFX because of LOR-I or AR-I and induced mucosal healing in a significant proportion of these patients.