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P613 Mycophenolate mofetil is a valid option in patients with inflammatory bowel disease resistant to TNF-alpha inhibitors and conventional immunosuppressants

Macaluso F.S.*1, Maida M.2, Renna S.1, Orlando E.1, Affronti M.1, Sapienza C.1, Dimarco M.1, Orlando R.1, Rizzuto G.1, Cottone M.1, Orlando A.1

1Division of Internal Medicine, “Villa Sofia-Cervello” Hospital, Palermo, Italy 2Gastroenterology and Endoscopy Unit, “Villa Sofia-Cervello” Hospital, Palermo, Italy

Background

Few studies evaluated the role of mycophenolate mofetil (MMF) in inflammatory bowel disease (IBD), and none of them had specifically focused on patients with previous multiple intolerances and/or nonresponses to conventional immunosuppressants and TNF-alpha inhibitors. The aim of this study was to evaluate efficacy and tolerability profile of MMF in patients with IBD and limited medical treatment options.

Methods

All consecutive patients with previous multiple intolerances and/or nonresponses to conventional immunosuppressants and TNF-alpha inhibitors who started an off-label treatment with MMF from January 2014 to February 2016 were entered in a prospectively maintained database. The steroid-free remission and the clinical response, this latter defined as a clear clinical improvement with a concomitant reduction of steroid dosage compared with baseline or discontinuation, were set as clinical end points.

Results

Baseline features of the study population (n=24) are summarized in Table 1.

Table 1. Baseline characteristics of patients

VariableN=24
Age (years), mean ± SD/Male gender, n (%)41.4±12.5/10 (41.7%)
Smokers, n (%) Never/Current/Ex18 (75.0%)/2 (8.3%)/4 (16.7%)
Type of Disease, n (%) CD/UC13 (54.2%)/11 (45.8%)
CD, n (%) Ileal/Ileocolic/Colic/UpperGI/Perianal2 (15.4%)/9 (76.9%)/1 (7.7%)/
1 (7.7%)/5 (41.7%)
UC, n (%) Proctitis/Left-sided/Extensive0 (0.0%)/7 (63.6%)/4 (36.4%)
Behavior(CD), n(%) Inflammatory/Stricturing/Fistulizing3 (21.3%)/5 (38.3%)/5 (38.3%)
Previous resections (CD), n (%)10 (76.9%)
Extraintestinal manifestations, n (%)8 (33.3%)
Concurrent drugs, n (%) Prednisone/5-ASA/Biologics21 (87.5%)/9 (37.5%)/4 (16.7%)

All patients had at least one previous nonresponse to IM or biologics. In particular, 15 (62.5%) were non responders to at least one IM, and 22 (91.7%) to at least one biologic agent; 12 (50.0%) were not responder to at least one IM plus at least one biologic. In addition, 20 (83.3%) had a previous intolerance to at least one IM, and 13 (54.2%) to at least one biologic. The median duration of total follow-up was 32 weeks (range 12–124). Four weeks after initiation of MMF therapy, a steroid-free remission was achieved in 4 patients (16.7%), while a clinical response in 13 (54.1%). At the end of follow- up, 12 patients (50.0%) remained on MMF. Six achieved and maintained steroid-free remission throughout the study period (25.0% of total), and a further 6 patients (25.0%) achieved a clinical response with complete discontinuation of steroids. Twelve patients (50.0%) were considered as treatment failure, and five of them underwent surgery. There was a trend towards a higher efficacy in patients with ulcerative colitis compared with Crohn's disease (63.6% vs. 38.5%, Figure 1), but this was not significant (p=0.20).

Figure 1. Time to treatment failure on mycophenolate mofetil among patients with Crohn's disease and ulcerative colitis (log-rank: p=0.410).

Conclusion

This is the first experience reporting a good efficacy and tolerability of MMF in patients with IBD and multiple previous failures to conventional immunosuppressants and/or TNF-alpha inhibitors.