medwireNews: Appendectomy is better than standard medical therapy alone in maintaining remission in patients with ulcerative colitis, reports a trial by the ACCURE Study Group.
At 1 year, significantly fewer patients had relapsed in the appendectomy group than the control group, with respective rates of 36% and 56%, and a relative risk of 0.65.
Adverse events were comparable between the appendectomy and control groups, with rates of 11% and 10%, respectively. The most common included temporary self-limiting abdominal pain (3% of the appendectomy group) and skin rash (3% controls).
“Appendicectomy might be an effective and safe option for reducing the relapse rate within 1 year in patients with ulcerative colitis in addition to standard medical therapy, offering a potential addition to standard medical therapies,” write Christianne Buskens (University of Amsterdam, the Netherlands) and colleagues in The Lancet Gastroenterology & Hepatology.
Buskens et al randomly assigned adult patients to receive either appendectomy plus maintenance medical therapy (n=99) or medical therapy alone (n=98). Eligible patients had established ulcerative colitis that was in remission but had received treatment for active disease in the preceding 12 months.
Patients receiving appendectomy underwent the procedure within 9 weeks of randomization and were typically discharged on the same day. Both groups were followed up for 12 months after randomization or appendectomy.
The participants were a mean of 42.2 years old in the appendectomy group and 43.2 years old in the control group, the average disease duration was 5.1 and 5.3 years, respectively, and the mean BMIs were 24.3 kg/m² and 24.8 kg/m². A total of 56.4% of the cohort were women, and the patients most commonly took oral mesalazine (79.7%), topical therapy (22.8%), immunomodulators (9.1%), or no medication (6.6%).
The investigators defined relapse as a total Mayo score of 5 points or more on the 12-point composite measure of disease activity, plus a score of 2 or 3 points on the 4-point endoscopic subscore or, when endoscopy was not feasible, abdominal symptom exacerbation, increased rectal bleeding or elevated fecal calprotectin (>150 µg/g), or the need for treatment escalation beyond mesalazine.
Buskens and colleagues found that the median time to first relapse was unreached for the appendectomy group versus 50.57 weeks in the control group, with a significant hazard ratio for relapse of 0.54.
In those who relapsed, they also observed that relapse occurred once in 81% and 69% of the appendectomy and control groups, respectively, twice in a corresponding 19% and 22%, and three times in 0% and 9%, although the differences in the rates between the groups were not statistically significant.
The mean total Mayo score at 12 months was significantly lower in the appendectomy group than the control group (1.2 vs 1.8), and there were no colectomies performed in either group during follow-up.
Buskens et al found that the use of oral mesalazine decreased significantly in both groups over the 12 months. They also report that significantly fewer patients in the appendectomy group than the control group started taking biologic treatments at 3, 6, 9, and 12 months.
“If this trend were to persist beyond 12 months, even a modest reduction in biologic use could be clinically and economically meaningful,” the authors say, although they caution that the patient numbers were small.
Patients in the appendectomy group showed a significantly greater improvement in quality of life over 12 months relative to the control group, with a difference of 11.0 points in the mean total score change on the Inflammatory Bowel Disease Questionnaire (IBDQ), although this did not meet the minimum clinically important difference of 17.8 points.
Other measures of health-related quality of life including the EQ-5D-3L and EORTC QLQ-C30 showed no significant differences between the groups, which the researchers suggest could be “due to lower sensitivity and weaker correlation of these measures with disease relapse compared with the total IBDQ score.”
A total of 5% of patients undergoing appendectomy had postoperative complications with 2% experiencing major complications, defined as Clavien–Dindo grade III or above. These included an internal herniation requiring laparotomy and an intra-abdominal hematoma. None of the control group had major complications and no deaths were reported.
In a related comment, Offir Ukashi and Shomron Ben-Horin, both at Tel-Aviv University in Israel, say that “[t]he novel findings of the ACCURE trial open new avenues for research and potentially offer practical and tangible benefits for patients with ulcerative colitis.”
Noting a lack of information on corticosteroid dosing and a nonstandard definition of relapse, they say that “refining patient selection and independent corroboration of these intriguing results would be valuable for optimising this approach while balancing the risk of serious complications, albeit small.”
The commentators conclude: “As such, the ACCURE trial is a seminal first step forward in advancing the surgical inflammatory bowel disease field toward the desired goal of genuine holistic surgical–medical treatment.”
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