Mono vs combo therapy

In January 2009, the BRIDGe group assembled as a RAND appropriateness panel to methodologically study the controversial topic of the use of anti-TNF monotherapy versus anti-TNF with immunomodulator combination therapy for the treatment of Crohn’s disease. The RAND/UCLA appropriateness method employs a modified Delphi panel approach, which is an iterative, evidence-based process that combines the best available scientific data with the collective judgment of experts to determine the “appropriateness” of processes of care in medicine. This approach is now widely used to develop quality indicators and establish appropriateness of care across all areas of medicine.

The question

The panel assumed that all patients were candidates to receive anti-TNF therapy. The question then addressed was the appropriateness of using an immunomodulator in addition to the anti-TNF agent for the treatment of Crohn’s disease. Five different patient types were considered along with six different disease variables to develop 134 unique patient scenarios. The panel carefully considered each of these scenarios before making recommendations.

Definition of appropriate

An immunomodulator (6-mercaptopurine, azathioprine) was considered APPROPRIATE when the expected health benefits exceeded negative health consequences by a sufficiently wide margin to justify prescribing the immunomodulator. An immunomodulator was considered INAPPROPRIATE when the expected or potential health risks outweighed anticipated health benefits. The use of an immunomodulator was deemed UNCERTAIN when panelists were unable to rate a given scenario as appropriate or inappropriate. Unless otherwise noted in the results, there was statistical agreement amongst the panel for the recommendations presented.