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

A. Hernandez Camba1, L. Arranz1, I. Vera2, D. Carpio3, M. Calafat Sard4, A. Lucendo5, C. Taxonera6, S. Marín7, M.J. Garcia8, G. Suris Marín9, E. Sánchez Rodríguez10, A.Y. Carbajo11, M.L. De Castro12, M. Iborra13, A. Martin-Cardona14, I. Rodríguez Lago15, D. Busquets16, F. Bertoletti17, M. Sierra Ausín18, C. Tardillo1, J. Huguet Malaves19, L. Bujanda20, A. Castaño21, O. Merino22, E. Domènch23, L. Ramos24, ENEIDA Project of GETECCU

1Hosp. Universitario Nuestra Señora de la Candelaria, Gastroenterology, Santa Cruz de Tenerife, Spain, 2Hospital Universitario Puerta de Hierro, Gastroenterology, Madrid, Spain, 3Complexo Hospitalario Universitario de Pontevedra, Gastroenterology, Pontevedra, Spain, 4Hospital Universitario Germans Trias i Pujol, Gastroenterology, Badalona, Spain, 5Hospital General de Tomelloso, Gastroenterology, Tomelloso, Spain, 6Hospital Clínico San Carlos, Gastroenterology, Madrid, Spain, 7Hospital Reina Sofía, Gastroenterology, Córdoba, Spain, 8Hospital Universitario Marqués de Valdecilla, Gastroenterology, Santander, Spain, 9Hospital Universitari de Bellvitge, Gastroenterology, Barcelona, Spain, 10Hospital Universitario Ramón y Cajal, Gastroenterology, Madrid, Spain, 11Hospital Universitario Río Hortega, Gastroenterology, Valladolid, Spain, 12Complexo H. Universitario de Vigo, Gastroenterology, Vigo, Spain, 13Hospital Universitari La Fe de Valencia and CIBEREHD, Gastroenterology, Valencia, Spain, 14Hospital Universitari Mútua Terrassa and CIBEREHD, Gastroenterology, Barcelona, Spain, 15Hospital de Galdakao, Gastroenterology, Galdakao, Spain, 16Hospital Universitari de Girona, Gastroenterology, Girona, Spain, 17Hospital de la Sta Creu i Sant Pau, Gastroenterology, Barcelona, Spain, 18Complejo Asistencial Universitario de León, Gastroenterology, León, Spain, 19Hospital General Universitario de Valencia, Gastroenterology, Valencia, Spain, 20Hospital Universitario de Donostia- Instituto Biodonostia- Universidad del País Vasco UPV/EHU- and CIBEREHD, Gastroenterology, Donostia, Spain, 21Hospital Universitario Central de Asturias, Gastroenterology, Oviedo, Spain, 22Hospital de Cruces, Gastroenterology, Barakaldo, Spain, 23Hospital Universitario Germans Trias i Pujol and CIBEREHD, Gastroenterology, Badalona, Spain, 24Hospital Universitario de Canarias, Gastroenterology, La Laguna, Spain

Background

Mycophenolate mofetil (MMF) is an immunomodulatory drug that inhibits T and B cells, through a reversible inhibition of inositol monophosphate dehydrogenase. MMF is commonly used for prophylaxis of organ rejection after transplant. Studies to evaluate its use in inflammatory bowel disease (IBD) are limited especially after the appearance of biological treatments (BT). The aim of this study was to evaluate the efficacy and safety of MMF in IBD.

Methods

IBD patients who had received MMF were identified in the ENEIDA registry (prospective database of GETECCU). Patients with Crohn′s disease (CD) or Ulcerative colitis (UC) in whom oral MMF was prescribed for this condition were evaluated. Demographic and IBD clinical data were collected. Clinical activity was assessed through Harvey‐Bradshaw Index (HBI) and partial Mayo score (pMS); C-reactive protein (CRP) and faecal calprotectin (FC) were reviewed at baseline (at MMF starting), 3 and 6 months and at the end of follow-up (at MMF stopping or the last visit while on MMF). Adverse events (AEs) during MMF treatment were documented. Statistical analyses were performed by descriptive statistics and non-parametric tests.

Results

Between June 1999 and November 2018 a total of 83 patients received MMF (mean age 36.4 (SD12.3) years; 52F/31M; 66 CD and 17 UC). Indication for MMF use was maintenance of remission (50%), induction of remission (44%) and post-surgical prophylaxis (6%). Mean MMF dose used was 1269.8 (SD 741) mg/day. In 61% of cases, systemic steroids were administered starting MMF and it was used concomitantly to BT in 27% of patients. In CD, 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) compared with baseline (mean 7.6 (SD 4.3)) were observed. In UC, statistically significant differences in pMS 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 with baseline (mean 4.8 (SD 2.5)) were determined. No significant differences in CRP or CF values during follow-up were observed. Concomitant use of BT was significantly associated with clinical response (OR 1.36 95% CI 1.08–1.73). MMF was maintained for a median time of 28.9 months (IQR 20.4–37.5) and was stopped in 84% of patients due to lack of response (50%), loss of response (17%) and remission (15%). Overall, 23% of patients presented MMF-related AEs (60% abdominal pain). MMF was withdrawn in 11% of patients due to AEs.

Conclusion

MMFshows a clinical benefit in the long term in both CD and UC patients with a favourable safety profile. MMF could be a treatment option alone or in combination with biologics in patients with IBD in clinical practice.