Adalimumab for maintenance treatment of Crohn’s disease: results of the CLASSIC II trial

By W. Sandborn, S. B. Hanauer, P. Rutgeerts, R. Fedorak, M. Lukas, G. Macintosh, R. Panaccione, D. Wolf, B. B. J D Kent, J. Li and 23 more. Gut, 2007

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Loss of Response to Anti-TNFs: Definition, Epidemiology, and Management (2016, background): “Between 20–40% of patients included in clinical trials for all TNFα antagonists do not show clinical response to therapy.(3,13,20,39) Reasons for non-response include symptoms other than active inflammation, non-TNFα-mediated inflammation, or early immunogenicity.”
Guidelines for the management of inflammatory bowel disease in adults (2011, result): “There was no statistical difference in GAIN between those failing IFX due to intolerance or as primary non-responders. The efficacy of maintenance therapy has been conclusively demonstrated by the CLASSIC-II and CHARM studies.”
Adalimumab Induction Therapy for Crohn Disease Previously Treated with Infliximab: A Randomized Trial (2008, background): “Adverse events 121 (73) 91 (57) Adverse events occurring in 5% of any treatment group Abdominal pain 12 (7) 9 (6) Arthralgia 3 (2) 9 (6) Headache 12 (7) 8 (5) Injection-site irritation 7 (4) 8 (5) Fatigue 9 (5) 7 (4) Crohn disease 15 (9) 2 (1) Patients with any type of injection-site reactions 17 (1”