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P395. Re-induction regimen in Crohn's disease adalimumab failure or disease relapse after a first adalimumab course. A single centre experience

C. Praticò1, P. Gionchetti1, G. Spuri Fornarini1, A. Calafiore1, M. Campieri1, C. Calabrese1, F. Rizzello1, 1Bologna, Clinical Medicine, Bologna, Italy

Background

Adalimumab (ADA) is a fully human monoclonal antibody targeting TNF-alfa with proven efficacy in the treatment of Crohn's disease (CD). We evaluate the efficacy of a second new ADA induction regimen.

Methods

Forty-six CD patients were treated with a second ADA induction regimen (40 patients with 160/80 mg, 6 with 80/40 mg) and maintenance with 40 mg every other week (22 patients) or weekly (24 patients). Patients were divided into 3 groups: moderate CD relapses [Harvey–Bradshaw score (HBI) >8] during ADA maintenance treatment after an initial response were defined as ‘secondary non responders’ (SNR), failures at week 12 of the first induction regimen as ‘primary non responders’ (PNR) and CD recurrences [HBI score >5] within 6 months after the first successful ADA course as ‘early relapses’ (ER). Three of them received azathioprine (AZA) plus ADA. Clinical response or remission were evaluated at week 12 [remission: HBI <4; response: 3-point reduction in the HBI vs baseline].

Results

Of 149 CD patients treated with ADA and followed prospectively, 46 patients [M/F: 24/22; mean age 31.7 years (18–63 years); median disease duration 7 years (0.3–18 years); disease location: 7 ileal, 23 ileo-colonic, 16 colonic; mean HBI at the baseline 11.9 (6–38)] were enrolled. Eighteen patients were SNR (mean first ADA treatment duration: 50 weeks), 14 were PNR (mean first ADA treatment duration:14 weeks) and 14 had an ER (mean first ADA treatment duration:77 weeks). Considering the overall group of patients, at week 12 remission was observed in 24 patients (52.2%), 10 patients (21.7%) had partial response, while 12 patients (26.1%) had no improvement. In the subgroup of SNR, 5 patients (27.8%) regained remission, 5 regained (27.8%) response, while 8 (44.4%) had no response. Seven patients (50.0%) out of the 14 PNR gained remission, 3 patients (21.4%) had a partial response and 4 patients (28.6%) had no response to the second ADA course. The 3 patients treated with ADA plus AZA achieved complete remission around week 24. All of the 14 ER patients responded to the second ADA course: 12 (85.7%) showed new complete remission, 2 patients (14.3%) had partial response.

Conclusion

ADA re-induction regimen seems to be effective in patients who lost response during ADA maintenance treatment (SNR). Dose intensification with a new early induction regimen showed efficacy to gain response in PNR. A new induction regimen with ADA seems to be extremely effective to regain remission in patients with ER and previous ADA-response.