Appropriateness of therapy for active Crohn's disease: Results of a multidisciplinary international expert panel—EPACT II
Received 13 March 2009; received in revised form 22 May 2009; accepted 22 May 2009. published online 16 July 2009.
Abstract
The increasing number of trials testing management strategies for luminal Crohn's disease (CD) has not filled all the gaps in our knowledge and thus, in clinical practice, many decisions for CD patients have to be taken without the benefit of high-quality evidence.
Methods
A multidisciplinary European expert panel used the RAND Appropriateness Method to develop and rate explicit criteria for the management of individual patients with active, steroid-dependent (ST-D) and steroid-refractory (ST-R) CD.
Results
Overall, 296 indications pertaining to mild-to-moderate, severe, ST-D, and ST-R CD were rated. In anti-TNF naïve patients, budesonide and prednisone were found to be appropriate for mild-moderate CD, and infliximab (IFX) was appropriate when these had previously failed or had not been tolerated. In patients with a prior successful treatment by IFX, this drug, with or without co-administration of a thiopurine analog, was favoured. Other anti-TNFs were appropriate in the presence of intolerance or resistance to IFX. High-dose steroids, IFX or adalimumab were appropriate in severe active CD. For the 105 indications for ST-D or ST-R disease, the panel considered the thiopurine analogs, methotrexate, IFX, adalimumab, and surgery for limited resection, to be appropriate, depending on the outcome of prior therapies. Anti-TNFs were generally considered appropriate in ST-R.
Conclusion
Steroids, including budesonide for mild-to-moderate CD, remain the first-line therapy for active luminal CD. Anti-TNFs, in particular IFX as shown by the amount of available evidence, remain the second-line therapy for most indications. Thiopurine analogs, methotrexate and anti-TNFs are favoured in ST-D patients and ST-R patients.
dDepartment of Internal Medicine I, Robert-Bosch-Krankenhaus, Stuttgart, Germany
eHealthcare Evaluation Unit, Institute of Social & Preventive Medicine (IUMSP), Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland
fDepartment of Gastroenterology, University of Basle, Basle, Switzerland
Corresponding author. Department of Gastroenterology and Hepatology, Centre Hospitalier Universitaire Vaudois, Rue du Bugnon 46, CH-1011 Lausanne, Switzerland. Tel.: +41 21 314 0690; fax: +41 21 314 0707.
1 The EPACT II Study Group (in alphabetical order): Erika Angelucci (Italy), Willem Bemelman (The Netherlands), Miquel Gassull (Spain), Franz Josef Heil (Germany), Marc Lémann (France), Tom Öresland (Norway), Colm O'Morain (Ireland), Yves Panis (France), Frank Seibold (Switzerland), Eduard Stange (Germany), Reinhold Stockbrügger (The Netherlands) and Boris Vucelic (Croatia).