P012 Long-term real life efficacy of infliximab in Crohn's disease: Brazilian initial experience since 1999
Authors: Arceu Scanavini Neto , Natália Queiroz , Marcelo Borba , Carlos Sobrado , Magaly Teixeira , Edesio Silva-Fillho , Sergio Nahas , Ivan Cecconello 
Published: July 2019

BACKGROUND:
Anti-TNF agents emerged as an option for the approach of patients with inflammatory bowel diseases (IBD) 20 years ago. Infliximab (IFX) is an effective induction and maintenance option for patients with Crohn's disease.1,2 The purpose of this study is to present the long term efficacy observed with IFX use in a real life setting comparing it with data from the beginning of our experience, previously published.3

METHODS:
The first 60 IFX treated Crohn's disease patients were prospectively followed at the IBD unit of the Colorectal Surgery Division of the Clinics Hospital of the Sao Paulo University from July 1999 to January 2006. Data was then reviewed from January 2006 to January 2018 based on medical records. Clinical response was defined by physician's global assessment (PGA) after first infusion. Clinical remission was defined by drug continuation rate after week 52. Patients were stratified according to disease duration and previous operation. The reason for discontinuation of IFX was determined according to the following criteria: primary non-response, secondary loss of response and intolerance (discontinuation due to side effects, including infusion reactions).

RESULTS:
Demographics and clinical characteristics are described in Table 1. All patients were anti-TNF naive and started treatment between 1999 and 2006. Clinical response rate was 78%. No statistical significant difference of clinical response rates was observed among different groups according to disease duration (68% for patients with up to 5 years from diagnose, 90% for those between 6–10 years and 84% for those with >10 years). At last follow-up, the mean duration of treatment was 23 months (0–146). Clinical remission defined by drug continuation at week 52 was observed in 30/53 (56%) of patients with data available. Drug continuation at week 104 was 21/53 (39%). At the last follow-up, corresponding to a mean duration of 97 (5–188) months, 47 patients have discontinued drug. Reasons for discontinuation were primary non-response in 19%, secondary loss of response 14% and intolerance in 40% of patients. After induction of IFX, 12 patients were submitted to 13 surgical procedures (5 perianal, 6 colectomies and 2 enterectomies). Mean duration of treatment in this population was 29 months (40 and 21 months respectively for patients who performed perianal and abdominal procedures).

CONCLUSION(S):
This data reflects the initial experience with anti-TNF agents in our Center, the tertiary referral one with the largest and longer followed cohort in IBD in Brazil. Patient's baseline characteristics (mainly long disease duration and complicated disease since our background as a reference Center for complex cases) and short experience with IFX therapy at that time can explain the low continuation rate at week 52 and the high rate of intolerance assumed (in some cases the drug was suspended due to events not surely related to anti-TNF effects). Data collection of anti-TNF drug usage after 2010 will accurately reflect the real-life experience with this class of medication and should be presented shortly after.