P594. Anti-TNF alpha therapy and mucosal healing: the key to change the story of pediatric Crohn's disease?
F. Nuti1, C. Alessandri1, A. Dilillo1, F. Civitelli1, M. Aloi1, G. Di Nardo1, S. Cucchiara1, F. Viola1, 1Sapienza University, Pediatrics, Gastroenterology and Liver Unit, Rome, Italy
Efforts have been made to optimize the use of available therapies to improve Crohn's disease (CD) outcome, but up to now no therapy changed the natural history of the disease. Mucosal healing (MH) appears as a therapeutic goal able to predict sustained clinical remission. Therapy with anti-TNF α antibodies, Infliximab (IFX) and Adalimumab (ADA), have been proven effective in achieving MH with a more potent and rapid effect compared to immumomodulants (IMM). No pediatric studies evaluating MH as a therapeutic goal are available.
Aim of our study is to assess the efficacy of IFX and ADA in obtaining MH in a pediatric CD cohort. Secondary aim is to evaluate differences in response in children with early (<1 year) or late (>1 year) disease.
CD patients (pts), between 6 and 18 years of age, starting IFX or ADA from January 2009 were enrolled. All pts were naïve to biological therapies but could have been previously treated with corticosteroids, IMM and aminosalycilates.
Pts' characteristics collected at baseline are: age at diagnosis, indication for therapy, age at enrollment, disease duration and location, and concomitant medications. An endoscopic procedure was performed before starting biologics and after 9 to12 months to evaluate MH. Clinical and endoscopic disease activity were assessed by Pediatric Crohn's Disease Activity Index (PCDAI) and Simple Endoscopic Score (SES CD) respectively at time 0 (T0) and at the time of endoscopic follow-up (FU). Pts underwent anti-TNF α therapy with appropriate induction and maintenance therapeutic schemes.
Thirty-one pts (21 IFX and 10 ADA) were enrolled, 18 males. At enrollment mean age was 12.7±2.9 years and mean disease duration was 13±15.3 months. Fifteen pts (6 IFX) were in the early disease group, 16 (15 IFX) in the late disease group. At T0 16 pts (52%) were on IMM, 10 of them were still on IMM at FU. Mean±SD values of PCDAI and SES CD at T0 and FU are 30±17.6 and 11.3±11.5, and 15.5±8.6 and 6.5±7.5 respectively; both values were significantly reduced at FU (p < 0.05). Dividing patients on the basis of disease duration prior to therapy SES CD values decreased significantly at FU both in early and in late disease pts, however more significantly in the first group (p < 0.0001 vs 0.02).
In our cohort biological therapy appears effective in achieving MH, probably more effectively if introduced early in the course of the disease. Larger studies with longer FU will highlight the effect of MH on disease evolution.