Response to biologic therapy in Crohn's disease is improved with early treatment: an analysis of health claims data

Inflamm Bowel Dis. 2012 Dec;18(12):2225-31. doi: 10.1002/ibd.22925. Epub 2012 Feb 22.


Background: Anti-tumor necrosis factor (TNF) therapy is an important treatment option for management of active Crohn's disease (CD) and is labeled for use after failure of conventional therapy (step-up). However, there is debate on the introduction of anti-TNF agents earlier in the treatment strategy (top-down) to potentially improve clinical outcomes. The aim of this study was to determine if a top-down approach with anti-TNF therapy is associated with improved outcomes for patients with active CD.

Methods: Claims data were from adult patients with CD with continuous enrollment in the same health plan for ≥ 6 months prior to the initial diagnostic claim for CD, ≥ 12 months after their initial anti-TNF claim, and with ≥ 1 anti-TNF claims after their initial diagnosis for CD.

Results: Three patient groups were identified: The Step-Up group used 5-aminosalicylates and/or corticosteroids prior to anti-TNF; the immunosuppression (IS)-to-TNF inhibitor group used IS prior to anti-TNF therapy; the Early-TNF group initiated anti-TNF therapy within 30 days of the first prescription for CD. Response to anti-TNF therapy was determined up to 24 months following anti-TNF initiation by concomitant corticosteroid use, CD surgery, anti-TNF dose escalation, and anti-TNF discontinuation/switch. A top-down approach to anti-TNF therapy was associated with a lower risk of concomitant corticosteroid use, anti-TNF dose escalation, discontinuation/switch of anti-TNF, and CD-related surgery compared with the step-up and IS-to-TNF therapy approaches.

Conclusions: These "real-world" data show that a top-down approach to anti-TNF therapy in CD is associated with reductions in loss of response and fewer surgeries than conventional step-wise management.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adalimumab
  • Adult
  • Anti-Inflammatory Agents / therapeutic use
  • Antibodies, Monoclonal / therapeutic use*
  • Antibodies, Monoclonal, Humanized / therapeutic use*
  • Certolizumab Pegol
  • Crohn Disease / drug therapy*
  • Female
  • Humans
  • Immunoglobulin Fab Fragments / therapeutic use*
  • Immunosuppressive Agents / therapeutic use
  • Infliximab
  • Insurance Claim Review
  • Male
  • Middle Aged
  • Polyethylene Glycols / therapeutic use*
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors*
  • Young Adult


  • Anti-Inflammatory Agents
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Immunoglobulin Fab Fragments
  • Immunosuppressive Agents
  • Tumor Necrosis Factor-alpha
  • Polyethylene Glycols
  • Infliximab
  • Adalimumab
  • Certolizumab Pegol