- ACCENT I (A CD clinical trial evaluating infliximab in a new long-term teatment regimen).6
This trial clearly demonstrated that scheduled treatment was more effective than episodic treatment in inducing and maintaining remission and mucosal healing.
It also provided useful evidence that clinical response can be achieved by increasing the infliximab dosage in patients who are no longer responding to standard infliximab therapy.
- Present DH, Rutgeerts P, Targan S, et al. Infliximab for the treatment of fistulas in patients with Crohn's disease. N Engl J Med 1999; 340: 1398-405.7
This study showed that infliximab was highly effective in fistulising CD, with a response rate of 68 per cent compared with 26 per cent in the placebo group.
This study randomised immunomodulator naive patients to receive AZA, infliximab or both.
The trial demonstrated that infliximab (monotherapy or combination with AZA) was more effective than AZA alone. It also demonstrated the benefit of initiating infliximab early in the treatment of CD.
The incidence of serious infections was not increased in patients receiving infliximab and AZA combination therapy.
- British Society of Gastroenterology guidelines.
Mowat C, Cole A, Windsor A, et al. Guidelines for the management of inflammatory bowel disease in adults. Gut 2011; doi: 10.1136/gut. 2010.224154.
- Dignass A, Van Assche G, Lindsay JO, et al.
The second European evidence-based consensus on the diagnosis and management of Crohn's disease: current management. J Crohns Colitis 2010: 4: 28-62.
- NICE. Infliximab (review) and adalimumab for the treatment of Crohn's disease. TA187. London, NICE, 2010.
The previous 2002 guidance was too restrictive, allowing the use of infliximab in patients with severe active CD but not in patients with fistulising disease alone.
The new 2010 NICE guidance suggests a scheduled course of treatment of one year is the most cost-effective therapy, after which a full reassessment of disease is required.
The guidance also allows for the use of infliximab for fistulising disease and in paediatric patients. The new guidance refers to the licensed indications which involve failure of steroids and/or immune suppressants, raising the option of using biologics earlier in the disease course.
- Feldman M, Friedman LS, Brandt LJ. Sleisenger and Fordtran's Gastrointestinal and Liver Disease (9th edition). Philadelphia, Saunders, 2010. A comprehensive overview of CD.