Is the Natural History of Crohnʼs Disease Altered by Immune Suppressant or Biologic Drug Use?: 2010 ACG/Centocor IBD Abstract Award

Abstract

Purpose: Recent studies have demonstrated superior outcomes of early biologic therapy with or without concomitant immune-suppressants (IS) compared to standard step up therapy. The purpose of this study is to evaluate differences in disease course among patients in clinical practice who are treated with early biologic therapy in comparison to those treated with initial IS with or without escalation to biologic therapy. Methods: All patients with Crohn's disease (CD) evaluated from July 2004 to January 2010 at a tertiary referral center were included. Demographic data was obtained from a prospectively maintained clinical database. Each patient was categorized into one of two groups. Patients treated with early biologic therapy (with or without concomitant IS) were denoted as Early Bio group; patients treated with initial IS with or without escalation to biologics were denoted as Step Up group. The Short Form Inflammatory Bowel Disease Questionnaire (SIBDQ) and the Harvey Bradshaw Index (HBI) were used to assess disease-specific quality of life and disease activity, respectively. Further, we collected information on physician global assessment of disease activity (PGA), use of steroids, and number of hospitalizations and surgeries after initiation of above therapy. Results: 136 CD patients met inclusion criteria; 73 (54%) in the Step Up group and 62 (46%) in the Early Bio group. There was no significant difference in gender, race, smoking status, presence of extraintestinal manifestations, disease location, disease phenotype, perianal involvement or age at diagnosis between groups. Mean HBI and SIBDQ scores at 3, 6, and 12 months were not different between groups. Response rates as defined by the PGA were similar between groups at 3, 6, and 12 months. The proportion of patients on steroids was not significantly different at each time point. Early Bio patients had a greater number of surgeries at 1 year in comparison to Step Up patients (0.4 vs. 0.2, p=0.01). The number of hospitalizations did not differ between groups (0.5 vs. 0.4, p=0.63). Conclusion: In clinical practice, early biologic therapy did not improve disease activity or quality of life and did not decrease the need for steroids or hospitalizations one year after initiation of therapy. However, the need for surgical intervention was higher in the early biologic group. The latter is likely explained by the aggressive use of exam under anesthesia in our practice for patients with perianal disease. Our results suggest that clinical outcomes are not worsened in patients who undergo Step Up therapy. Therefore, an accelerated Step up approach for most patients seems reasonable. Further research is needed to evaluate outcomes at later time points. Disclosure: Dr Raymond Cross - Consultation for Abbott Pharmaceuticals; grant support from Centocor and Abbott Pharmaceuticals. Dr Mark Flasar - grant support from Procter and Gamble.