From the standpoint of patients and clinicians, selecting among immunomodulator monotherapy, anti-TNF-alpha monotherapy and combination therapy is a common clinical dilemma. It is my pleasure to report that AGA has released a new decision support tool (gastro.org/crohnsdecisiontool) and guideline on the relative positioning of immunomodulators and anti-TNF-alpha biologic agents in inducing and maintaining clinical remission in patients with inflammatory (luminal) Crohn’s disease. The technical review is also available for review, which offers an in-depth analysis of the existing research informing the clinical recommendations.
Recommendations for the induction of remission:
1. We suggest against using thiopurine monotherapy to induce remission in patients with moderately severe Crohn’s disease (weak recommendation, moderate-quality evidence).
2. We suggest against using methotrexate to induce remission in patients with moderately severe Crohn’s disease (weak recommendation, low-quality evidence).
3. We recommend using anti-TNF-alpha drugs to induce remission in patients with moderately severe Crohn’s disease (strong recommendation, moderate-quality evidence).
4. We recommend using anti-TNF-alpha monotherapy over thiopurine monotherapy to induce remission in patients who have moderately severe Crohn’s disease (strong recommendation, moderate-quality evidence).
5. We recommend using anti-TNF-alpha drugs in combination with thiopurines over thiopurine monotherapy to induce remission in patients who have moderately severe Crohn’s disease (strong recommendation, high-quality evidence).
6. We suggest using anti-TNF-alpha drugs in combination with thiopurines over anti-TNF-alpha drug monotherapy to induce remission in patients who have moderately severe Crohn’s disease (weak recommendation, moderate-quality evidence).
Recommendations for maintenance of remission:
1. We recommend using thiopurines over no immunomodulator therapy to maintain a steroid-induced remission in patients with Crohn’s disease (strong recommendation, moderate-quality evidence).
2. We suggest using methotrexate over no immunomodulator therapy to maintain a steroid-induced remission in patients with Crohn’s disease (weak recommendation, low-quality evidence).
3. We recommend using anti-TNF-alpha drugs over no anti-TNF-alpha drugs to maintain a steroid or anti-TNF-alpha drug-induced remission in patients with Crohn’s disease (strong recommendation, high-quality evidence).
4. We make no recommendation for or against the combination of an anti-TNF-alpha drug and a thiopurine versus an anti-TNF-alpha drug alone to maintain remission induced by a combination of these drugs in patients with Crohn’s disease (no recommendation, low-quality evidence).
Published in the December issue of Gastroenterology, this guideline was developed under AGA’s new clinical guideline development process that employs the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. GRADE has been adopted by several national and international societies, including the AGA, and is becoming the common methodology for the streamlined and rigorous development of clear, transparent and actionable guidelines.
Dr. Weinberg is chair, department of medicine, Fox Chase Cancer Center and chair of the AGA Institute Clinical Practice and Quality Management Committee.