As alluded to in a previous post (CCFA Conference Notes 2014 (part 2) | gutsandgrowth), there has been increasing discussion and efforts aimed at mucosal healing (MH) because it is associated with improved clinical outcomes in patient’s with Crohn’s disease (CD). Even before its print publication, this study (Clin Gastroenterol Hepatol 2014; 12: 978-85) by William Sandborn’s group has influenced the discussion.
This retrospective study analyzed 67 patients with CD (2011-2012). These 67 were selected from a population of 510 patients seen at UCSD who had at least several endoscopies and ulcers seen at the initial procedure. In this cohort of 67 patients, the median disease duration was 9.8 years. Only 26 (38.8%) were naive to both immunosuppressives and biologics at referral.
- Only half of the patients achieved MH. “After a median follow-up of 62 weeks, 50.7% had MH and 61.1% had endoscopic improvement.” 79% of those who underwent adjustments achieved MH.
- Clinical symptoms do not correlate with MH. “40.9% of patients experienced clinical symptoms despite MH and 18.8% of patients without clinical symptoms had significant endoscopic lesions.”
- Biomarkers may be effective at predicting MH. “None of the patients with MH had an increased concentration of CRP.”
- Adjusting treatment is needed if abnormal endoscopy; this is inherent in the philosophy of treating-to-target.
The authors conclude that “serial endoscopic procedures to guide treatment to the goal of MH is feasible in clinical practice.” Ultimately the goal is to influence the natural history of Crohn’s disease.
- retrospective study
- small number of highly-selected patients
- lack of randomization
- definition of MH remains debated
- no cost data
- lack of data on stool biomarkers (e.g. calprotectin) which could serve as alternative
- no answer to the question of what to do for the patient without MH who is receiving ‘maximal medical treatment’
From Dr. Sandborn: (from Healio Gastro summary):
“Evidence has accumulated that the complications of Crohn’s disease [CD] … are due to chronic inflammation that has not been fully treated,” William J. Sandborn, MD, chief of the gastroenterology division and director at the University of California, San Diego, IBD Center, told Healio.com. “This in turn has led to the concept of ‘treat to target’ in which patients are assessed with endoscopy for active inflammation prior to making important changes in therapy, and then reassessed with endoscopy within 4 to 6 months to ensure that the therapy change healed the bowel and resolved the inflammation.
“If active disease persists at endoscopy, even in the absence of clinical symptoms, then therapy is intensified and this cycle is repeated until mucosal healing (MH) is achieved.”
Take-home message: This study is one of many that are likely to influence the practice of clinicians to prove that the treatment is exerting a biologic effect and not solely improvement in clinical scoring indices. With the emergence of multiple modalities to assess improvement, including biomarkers and imaging, it is not clear that repeated endoscopy will be the best assessment tool.
Related blog post: EXTEND & MUSIC: Optimizing Crohn Disease Care …
Clin Gastroenterol Hepatol 2014; 12: 986-94. “Association Between Telephone Activity and Features of Patients with Inflammatory Bowel Disease.” The authors found that 15% of patients were responsible for half of all telephone calls. These patients were more likely to be seen in ED and hospitalized.
Clin Gastroenterol Hepatol 2014; 12: 929-34. “Histologic Remission: The Ultimate Therapeutic Goal in Ulcerative Colitis?” This article reviews definitions for histologic remission and highlights questions that need to be addressed before histologic remission is used more widely as a clinical endpoint in trials and in practice.
So good to hear that there is discussion going on about end points. As a patient I have to say it was disappointing to hear ‘you do not poo much, therefore my work is done’ when feeling like I could only participate in 30% of what I call life. Seems like the endpoint is low budget remission.
Also great to have a doctor talking about lived experience of clinical life and giving us an insight of processes and developments rather than simplified patient-talk. Thanks for sharing.
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