P584 Use of mycophenolate mofetil in inflammatory bowel disease: results from the ENEIDA registry

Abstract

Introduction: Mycophenolate mofetil (MMF) is an immunomodulatory drug that inhibits T and B cells, by reversible inhibition of inositol monophosphate dehydrogenase. MMF is commonly used for prophylaxis of organ rejection however studies to evaluate its use in inflammatory bowel disease (IBD) are limited especially after the appearance of biological treatments. The aim of this study was to evaluate the efficacy and safety in IBD patients. Aims & Methods: Based on the ENEIDA registry (a large, prospectively maintained database of the Spanish Working Group in IBD-GETECCU), IBD patients that had received MMF were identified. Only IBD patients with an established diagnosis of Crohn's disease (CD) or Ulcerative colitis (UC) in whom oral MMF was prescribed for this condition (except for perianal disease) were evaluated. Demographic and IBD clinical data (time from diagnosis, IBD type and extension, concomitant treatments, steroids use) were collected. Clinical activity for Harvey-Bradshaw Index (HBI) and partial Mayo score (pMS), endoscopic activity, C reactive protein (CRP) and faecal calprotectin (FC) were reviewed at baseline (at MMF starting) , 3 and 6 months and at final follow-up (at MMF stopping or last visit using MMF). Adverse events (AEs), surgeries and hospitalizations during MMF treatment were documented. Statistical analysis were performed by descriptive statistics and non-parametric tests. Result(s): Between June 1999 and November 2018 a total of 83 patients received MMF for IBD treatment (mean age 36.4 (+/-12.3) years; 52F/31M; 66 CD(L1 17,2%; L2 21,9%;L3 48,4%) and 17 UC ( E1 11,8%; E2 29,4%; E3 58,8%)). Indication for MMF use were maintenance of remission (50%), induction of remission (43,6%) and postsurgical prophylaxis (6,4%). MMF therapy was initiated before 2010 in 59% of patients. Mean MMF dosis used was 1269.8 (+/-741) mg/day. In 61% of cases, systemic steroids were administrated starting MMF and it was used concomitantly to biologic agents in 27.3% of patients (16 Infliximab/ 3 Adalimumab/ 1 Vedolizumab/ 1 Ustekinumab). In CD patients, statistically significant differences in HBI at 6 months (mean 5.9 (SD 4.8), p = 0.04) and at the end of follow-up(mean 5.7 (SD 5), p = 0.014) compare with baseline (mean 7.6 (SD 4.3)) were observed. Alike in UC patients, statistically significant differences in pMayo score at 6 months (mean 2.1 (SD 2.7), p = 0.018) and at the end of follow-up(mean 1.8 (SD 2.6), p = 0.003) compared tto baseline ( mean 4.8 (SD 2.5)) were determinated. No significant diferences in PCR or CF values during follow-up were observed . Concomitant use of biologics was significantly associated with clinical response (OR 1.36 95% CI 1.08-1.73). Survival curve showing maintenance of MMF treatment ( Figure 1). The drug was maintained for a median time of 28.9 months (20.4-37.5). MMF was stopped in 84% (68/83) of patients (50% due to lack of response, 16,7 % for loss of response and 15,3% for remission) and required hospitalization or surgery, during MMF treatment, in 26% and 9.9% of patients, respectively. A total of 22.8% (19/83) patients developed adverse events related to the MMF (60% abdominal pain). In 10.8% (9/83), these adverse events resulted in drug withdrawal. Conclusion(s): Mycophenolate mofetil-MMF shows a clinical benefit in the long term both in UC and CD patients with a good safety profile. MMF could be a treatment option alone or in combination with biologics in patients with IBD in clinical practice.