For patients with Crohn’s disease who undergo surgery there is little clinical benefit from routine risk-based prophylactic treatment to prevent postoperative recurrence, new research shows.
Findings from a Dutch study suggest that an approach based on endoscopy-driven step-up treatment would provide similar post-operative outcomes in high risk Crohn’s disease patients and avoid overtreatment with prophylactic treatments such as metronidazole, immunomodulatory drugs and anti-TNF agents.
The study involving 376 patients who underwent an ileocaecal resection with anastomosis, of whom 275 were categorised as high risk and 86 as low risk for postoperative recurrence according to ECCO criteria. Patients received either immediate prophylactic treatment or step-up treatment based on endoscopy within 12 months.
Researchers led by Dr Vincent Joustra of the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centres, showed that while immediate prophylactic treatment reduced endoscopic postoperative recurrence in high risk patients, it had little impact on clinical recurrence rates at three years.
In patients who received immediate prophylactic treatment there were significantly reduced rates of and time to endoscopic postoperative recurrence within one year in the high-risk group (hazard ratio [HR] 0.48, p = 0.04, number needed to treat = 5) but not in the low group low-risk [HR 0.90, p = 0.85].
However no significant differences were observed in rates of clinical postoperative recurrence within three years between prophylactic- and endoscopy-driven low-risk [HR 1.17, p = 0.75] and high-risk patients [HR 1.06, p = 0.82, NNT = 22].
A possible benefit of prophylactic treatment was seen in a subset of high-risk patients with three or more ECCO-defined risk factors, for whom there was a large numerical albeit not statistical significant difference in three-year clinical postoperative recurrence [28.6% vs. 62.5%, p = 0.11].
The study authors said the results suggested a need to rethink the current guidelines for postoperative management in Crohn’s disease, which recommend selecting patients at high risk of endoscopic POR to receive immediate prophylactic treatment.
“The current approach to risk stratification for postoperative recurrence performs poorly in real-world practice and means many patients may receive medication with little concrete benefit.,” they wrote in the Journal of Crohn’s and Colitis (link here).
“Based on our data, we can conclude that the 6-12 months delay of treatment until an early endoscopic evaluation did not alter the probability of clinical postoperative recurrence. In fact, rates of overall endoscopic postoperative recurrence within 1 year [40% vs. 39.2%, respectively] and clinical postoperative recurrence at 3 years of follow-up [43.6% vs. 50%, respectively] were remarkably similar for low- and high-risk patients, questioning the utility of current risk stratification,” they noted.
“Prophylactic therapy seems to reduce endoscopic recurrence but does not meaningfully reduce clinical recurrence within 3 years and there is no appreciable advantage in prophylactically treating the low-risk or even average-risk patient …We therefore suggest [moving] towards the use of early endoscopic evaluation and treatment according to the presence of endoscopic recurrence, reserving prophylactic treatment for carefully selected high-risk patients in order to avoid potential over-treatment,” they concluded.
An accompanying commentary article (link here) said that postoperative management of Crohn’s disease patients was likely to change radically in the future with more personliased approaches possible based on improvements in risk stratification obtained from microbial, immunological and genetic profiling of resection specimens.
Treatment decisions after Crohn’s surgery could also be assisted by emerging non-invasive monitoring strategies such as intestinal ultrasound, the authors suggested.
For the moment, it appears that both the tortoise [endoscopy-driven treatment] and the hare [prophylactic treatment] are still in the running in our collective race to beat postoperative recurrence of Crohn’s disease and modify the disease course,” the authors concluded.