Despite increasing use of anti–tumor necrosis factor (TNF) medications in recent years and a low rate of proctectomy, there has been no decline in stoma incidence among Crohn’s disease (CD) patients, according to a new retrospective analysis of a Swedish population database.
The overall 5-year stoma incidence was 2.5%, and there was no significant difference between calendar periods, wrote Åsa H Everhov, MD, PhD, of the Karolinska Institutet, Stockholm, and colleagues. Their report is in Inflammatory Bowel Diseases. Previous population studies looking at temporal trends have found mixed results with respect to stoma formation. However, many previous studies analyzed cohorts from referral centers that included patients with more severe disease. Others had small sample sizes.
“This is somewhat surprising as the rate of overall surgery for Crohn’s has decreased with the advent of biologic therapies,” said Miguel Regueiro, MD, who was asked to comment on the study. He is chair of the Digestive Disease and Surgery Institute, and professor of medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University.
Regueiro pointed out that the rate of stoma creation was quite low, and characteristics of the disease may explain the lack of a trend. For example, anorectal disease, especially when accompanied by fistula and strictures, is often medication refractory. “Although the study could not delineate this, it is my clinical practice experience that some patients present with destructive anorectal disease early, and that despite medications the ‘damage is too far gone’ to reverse,” said Regueiro. Also, the anorectum does not allow for an anastomosis since there is no region to connect to that isn’t damaged, he added.
The findings shouldn’t affect patient management or counseling, according to Stephen Hanauer, MD, professor of medicine at Northwestern University, Chicago, who was not involved in the study. “The indications for surgery in Crohn’s disease have not changed with the advent of newer therapies. Complications such as strictures and abscesses are still treated with similar surgeries. It is hopeful that the future course after surgery can be modified by effective biologic therapies,” he said.
The study authors noted that the findings are consistent with previous studies suggesting that the rate of abdominal surgery had begun to decline before anti-TNF drugs were introduced. The Swedish National Patient Register used in the current work includes only inpatient data previous to 2001, preventing a broader analysis prior to 1999, when infliximab gained approval in Sweden. But the researchers looked at time from first surgery to stoma, and found a decline in stoma formation between 1994 and 1997. A similar analysis found no decrease in the 2000s.
The researchers pointed out that anti-TNF inhibitor use would be expected to reduce the rate of stomas by inducing remission, although temporary stomas may be placed to relieve symptoms while waiting for the medication to take effect. But anti-TNF agents could also encourage patients and physicians to postpone surgery. The delay could raise the chance of surgical complications, which in turn could lead to creation of a temporary stoma. Permanent stomas are typically created in cases of severe perianal CD.
The study could come as a disappointment to some patients and physicians, according to the authors. “The more active and early use of anti-TNF (therapeutics), in combination with the decreasing incidence of abdominal surgery in general for CD, has raised hopes of decreased incidence of stoma formation, but this was not observed in the present study,” the authors wrote.
But the news wasn’t all bad. The study found a lower cumulative stoma incidence than had previous studies, and the incidence of permanent stoma was just 0.8% at 5 years, “which should be reassuring for patients,” according to the authors.
CD patients often fear that a stoma will become necessary, but a stoma can be quite beneficial, allowing patients to regain some control over their lives. That can lead to more work participation and social activity. Qualitative studies showed that both patients and clinicians described outcomes of stoma placement as beating expectations, with a key factor being support from other inflammatory bowel disease patients with stomas. The authors encouraged clinicians to discuss the possibility of a stoma early on in the treatment process, and to avoid referring to it as a “last resort.”
The study also suggests that patients with anal and anorectal Crohn’s disease should receive biologics early, and a multidisciplinary approach involving both the gastroenterologist and surgeon is important. And patients should be counseled on the impact of disease on diet and psychological health, according to Regueiro.
The new study analyzed data between 2003 and 2014, from 18,815 Crohn’s disease patients who had not undergone previous surgery. The median age was 39 years, 53% were women, and 12% were pediatric patients.
After a median follow-up of 9.6 years, 9.5% of patients had perianal disease. Overall, 36% of patients had been treated with immunomodulators, and 17% with anti-TNF agents; 3.5% had stoma surgery, and just 0.05% underwent proctectomy.
Among those who had a stoma placed, the median age at diagnosis was 47 years, and 53% were men. In all, 12.6% had perianal disease at diagnosis, and 24.5% had perianal disease by the end of follow-up; 43% had received immunomodulators, and 26% anti-TNF agents. Among stomas, 64% were ileostomies, and 44% were temporary, with 88% of removals performed within 2 years of surgery.
The calendar periods of CD onset (2003-2006, 2007-2010, and 2011-2014) had similar rates of cumulative stoma placement (log rank test, P = .61). Overall, the 1-year cumulative incidence of stoma was 1.3%, the 3-year incidence was 1.9%, and the 5-year incidence was 2.5%.
The cumulative incidence of ever-use of anti-TNF agents increased with each successive calendar period (P < .001), but there was no significant difference in cumulative stoma incidence (P = .07).
One limitation of the study is the lack of detailed patient characteristics, and another is the short follow-up for patients diagnosed during 2011-2014.
The study authors have received funding and consulted for various pharmaceutical companies. Regueiro has received grants from and has consulted or been on a scientific advisory board for Abbvie, UCB, and Janssen. Hanauer has no relevant financial disclosures.
This article originally appeared on MDedge.com, part of the Medscape Professional Network.
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