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Step Up Versus Early Biologic Therapy for Crohn's Disease in Clinical Practice

Ghazi, Leyla J. MD*,†; Patil, Seema A. MD*; Rustgi, Ankur MBBS*; Flasar, Mark H. MD, MS*,†; Razeghi, Sanam MD; Cross, Raymond K. MD, MS*,†

doi: 10.1097/MIB.0b013e318281337d
Original Clinical Article

Background: Recent studies have demonstrated superior outcomes of early biologic therapy. Our purpose was to evaluate differences in disease course among patients in clinical practice treated with early biologic therapy compared with those receiving conventional Step Up therapy.

Methods: Patients with Crohn's disease evaluated from July 2004 to November 2010 at a tertiary referral center were included. Demographic data were obtained from a prospectively maintained database. Patients were categorized into 1 of 2 groups: Early Bio group (with or without concomitant immune suppressants) or Step Up group (initial immune suppressants with or without escalation to biologic). Disease activity, quality of life, use of steroids, and number of hospitalizations, and surgeries were assessed.

Results: Ninety-three patients with Crohn's disease met inclusion criteria: 39 (45%) in the Step Up group and 54 (58%) in the Early Bio group. There was no significant difference in demographic and clinical variables between groups. Mean Harvey–Bradshaw index and Short Inflammatory Bowel Disease Questionnaire scores at 3, 6, and 12 months were not different between groups. Response rates were higher in the Step Up group compared with the Early Bio group only at 3 months. Early Bio patients had a greater number of hospitalizations at 1 year (P = 0.04).

Conclusions: In clinical practice, early biologic therapy did not improve disease activity or quality of life and did not decrease the need for steroids or surgeries 1 year after therapy. Our results suggest that clinical outcomes are not worsened using the conventional approach. Therefore, an accelerated Step Up approach for most patients seems reasonable.

Article first published online 17 April 2013

*Division of Gastroenterology and Hepatology, Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland;

Department of Medicine, Veterans Affairs, Maryland Heath Care System, Baltimore, Maryland; and

Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland.

Reprints: Leyla Ghazi, MD, 100 North Greene Street, Lower Level, Baltimore, MD 21201 (e-mail:

R. K. Cross has received educational grants from Abbott Laboratories, Janssen, and UCB, Inc., and research grants from Abbott Laboratories. And he has received income from consulting and round table discussions from Abbott Laboratories and has participated in advisory boards for Abbott Laboratories, Janssen, and UCB, Inc., M. H. Flasar has received research grants from Janssen and he has participated in advisory boards for Janssen, Prometheus, and Abbott Laboratories.

The other authors have no relevant conflicts of interest to disclose.

Received September 24, 2012

Accepted September 25, 2012

© Crohn's & Colitis Foundation of America, Inc.
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