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The treatment of IBD has evolved significantly over the past 15 years. Historically, steroids and immunosuppressive drugs, such as methotrexate (MTX), azathioprine (AZA) and 6-mercaptopurine (6-MP) had been the mainstay of therapy. When infliximab (IFX) was approved for the treatment of Crohn's disease, it began the era of trying to understand how best to optimise our available treatment options. Initially, antitumour necrosis factor (anti-TNF) agents were used after immunosuppressives failed. Then, evidence showed that using AZA together with IFX early in the disease course was more effective than the typical sequential treatment algorithm.1 With the addition of newer anti-TNF drugs and development of different treatment regimens,2–5 there are still significant questions related to the most effective therapeutic strategy. Perhaps the most controversial of these questions is when to use anti-TNF monotherapy versus combination therapy with 6-MP, AZA or MTX.
When considering patients with rheumatoid arthritis, where anti-TNF therapy also has a demonstrated efficacy, it is clear from randomised controlled trials (RCT) that the use of combination therapy improves clinical outcomes.6 Although it is logical that a similar benefit should exist in IBD, the evidence base upon which to make decisions is less robust, leading to patient and provider concerns regarding the balance between efficacy and toxicity. Providers have two sources of data to rely upon when addressing this concern with IBD patients, RCTs and observational data. RCTs are more rigorous, generally have better patient follow-up, and more often include prospective measurement of study end-points using well-accepted and often validated outcome measures. For this reason, RCTs result in a relatively robust assessment of key outcome measures such as clinical response, remission and mucosal healing. Although the data from RCTs may not directly translate to the ‘real world’,7 whatever generalisability is lost due to the application of strict inclusion …