Background: The optimal treatment strategy for patients with Crohn's disease who have loss of response to the anti–tumor necrosis factor α medication infliximab is uncertain. Natalizumab has an alternative mechanism of action, but its use has been limited by the risk of progressive multifocal leukoencephalopathy. In this study, we performed a decision analysis assessing the impact of JC virus (JCV) antibody testing and natalizumab utilization for loss of response to infliximab.
Methods: We constructed a Markov model to assess the difference between unscreened natalizumab use (option 1), JCV antibody testing with natalizumab when appropriate (option 2), and second anti–tumor necrosis factor α use (option 3). The base case was a 35-year-old man with severe Crohn's disease with loss of response to infliximab. The time horizon was 3 years. Results are reported in quality-adjusted life years (QALYs). Deterministic and probabilistic analyses were conducted. Markov analysis using a cohort of 5000 individuals was performed. The impact of JCV antibody status on outcomes in this model was assessed.
Results: Option 2 was the preferred strategy (2.0880 QALYs), followed by option 1 (2.0875 QALYs) and option 3 (2.0808 QALYs). Patients in option 2 required fewer surgeries compared with option 3. Previous JCV infection was associated with reduced QALYs with all options that allowed for natalizumab use.
Conclusions: JCV antibody testing and subsequent treatment selection yield improved outcomes over natalizumab without testing or using only a second anti–tumor necrosis factor α in all patients.
Article first published online 8 October 2013
*Division of Gastroenterology, University of Pennsylvania, Philadelphia, Pennsylvania;
†Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania;
‡Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; and
§Division of Gastroenterology and Nutrition, Department of Paediatrics, Anna Meyer Children's Hospital, University of Florence, Florence, Italy.
Reprints: Frank I. Scott MD, MSCE, Division of Gastroenterology, Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, 1 Convention Avenue, Penn Tower, 9th Floor, Philadelphia, PA 19104 (e-mail: firstname.lastname@example.org).
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Grant Support through NIH: T32-DK007066-36, K08-DK095951-01, and K24-DK078228.
The authors have no conflicts of interest to disclose.
Received July 19, 2013
Accepted August 26, 2013