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P454 Combo-therapy in infliximab-resistant inflammatory bowel disease patients: data from a tertiary referral centre

S. Renna*, G. Rizzuto, E. Orlando, M. Affronti, M. Cottone, A. Orlando

‘Villa Sofia-Cervello’ Hospital, Division of Internal Medicine, Palermo, Italy


Infliximab (IFX) is effective for induction and maintenance of remission in patients (pts) with inflammatory bowel disease (IBD). The immunogenicity of IFX is an important cause of treatment failure. Combo-therapy with immunosuppressants (IM) is a possible therapeutic option in case of treatment failure. The effectiveness and security of a concomitant use of IM is still questionable. A recent meta-analysis showed that the concomitant use of IM and anti-TNFα is no more effective than anti-TNFα monotherapy in inducing or maintaining remission in patients with Crohn’s disease (CD).1


We report a tertiary referral centre experience on the efficacy of the concomitant use of IM and IFX in a sub-group of patients (pts) who had primary or secondary non-response to IFX monotherapy. Primary non-response was defined as clinical non-response within 12 weeks, and secondary non-response as loss of response after 12 weeks. Pts with CD and ulcerative colitis (UC) treated with IFX from October 2014 to October 2015 were analysed. Pts who did not obtained a clinical remission with IFX monotherapy despite dose optimisation started a concomitant IM.


In total, 150 pts with IBD were treated with IFX during the last year (115 CD and 35 UC). The clinical benefit was obtained in 110 pts (73%); in 25 pts, IFX was discontinued for failure or intolerance (17%). Further, 15 pts added IM to IFX because of monotherapy failure after a mean 17.1+/- 0.8 months: 2 primary failure (CD) and 13 secondary failure (7 CD and 6 UC). All 9 CD pts and only 1 UC patient had been previously treated with adalimumab without clinical benefit. Azathioprine (AZA) was used in 8 pts; 6-mercaptopurine (6-MP) in 2 pts; and methotrexate (MTX) in 5 pts. After a median follow-up of 10.4 months, clinical remission was observed in 10/15 pts (67%): 4 treated with MTX and 6 with AZA/6MP (3 naïve and 3 previously non-responder). The combined treatment was discontinued in 3/15 pts (20%) for side effects, and in 2/15 pts (13%) for non-response.


These preliminary results suggest that IFX monotherapy is effective in a high rate of pts. Combo-therapy with IFX and IM should be reserved only to pts nonresponsive to IFX monotherapy.


[1] Jones JL Kaplan GG, Peyrin-Biroulet L, et al. Effects of concomitant immunomodulator therapy on efficacy and safety of anti-tumor necrosis factor therapy for Crohn’s disease: a meta-analysis of placebo-controlled trials. Clin Gastroenterol Hepatol 2015;13(13):2233–40.