Antibiotic prophylaxis results in lower risk of infectious complications before ERCP in patients with biliary obstruction

A recent study suggests that incidence of postendoscopic retrograde cholangiopancreatography (ERCP) infections was significantly lower with antibiotic prophylaxis in patients with biliary obstruction. The study's findings were published in The American Journal of Gastroenterology.

This double-blind, placebo-controlled, randomized trial included 378 patients who were randomly assigned in a 1:1 ratio to receive either a single dose of 1 g intravenous cefoxitin (n=189) or normal saline (n=189; placebo), 30 minutes before undergoing ERCP. The incidence of infectious complications after ERCP comprised the primary outcome of this trial.

At the end of the study, it was found that the risk of infectious complications after ERCP was 2.8% and 9.8% in the antibiotic prophylaxis group and placebo group, respectively. The incidence rates of bacteremia in the antibiotic prophylaxis and placebo groups were 2.3% and 6.4%, respectively. Finally, the incidence rate of cholangitis was 1.7% in the antibiotic prophylaxis group and 6.4% in the placebo group.

Based on the above results, it can be concluded that before ERCP, antibiotic prophylaxis resulted in a significantly lower risk of infectious complications, especially cholangitis, in patients with biliary obstruction.

Risankizumab is safe and effective in patients with Crohn's disease

A recent study found that risankizumab, an anti-interleukin-23 antibody is safe and effective in patients with moderate-to-severe Crohn’s disease. This study’s findings were published in the Journal of Gastroenterology and Hepatology.

This was a post hoc sub analysis of the global phase 3 ADVANCE, MOTIVATE, and FORTIFY studies. ADVANCE and MOTIVATE were double-blind, placebo-controlled, phase 3 induction studies that included a total of 198 patients who had previously experienced intolerance or inadequate response to biologic (MOTIVATE) or a conventional therapy (ADVANCE). The participants were randomized to receive intravenous risankizumab (600 or 1200 mg) or placebo at weeks 0, 4, and 8. The clinical responders to risankizumab entered the placebo-controlled maintenance withdrawal study (FORTIFY). Patients were re-randomized to receive subcutaneous risankizumab (180 or 360 mg) or placebo (withdrawal) every 8 weeks for 52 weeks.

Among 198 patients in the induction studies, the rates of clinical remission and endoscopic response at week 12 were achieved by 61.4% and 40.0% of patients in the risankizumab 600 mg group, 59.5% and 35.8% of patients in the risankizumab 1200 mg group, and 27.3% and 9.1% of patients in the placebo group, respectively. At week 52, among 67 patients who entered the maintenance study, clinical remission and endoscopic response rates were achieved by 57.1% and 52.4% of patients in the risankizumab 180 mg group, 75.0% and 40.0% of patients in the risankizumab 360 mg group, and 53.8% and 34.6% of patients in the placebo (withdrawal) group. Additionally, it was observed that fistula closure was observed in 28.6% (induction) and 57.1% (maintenance) of patients with risankizumab treatment.

Based on the above findings, it may be concluded that risankizumab was effective and well tolerated in patients with Crohn's disease.

Efficacy of botulinum toxin type A (BoNTA) injections for the treatment of faecal incontinence

A recent study suggests that intrarectal botulinum toxin type A (BoNTA) injections are an efficacious treatment for urge faecal incontinence. This study was published in the journal, The Lancet. Gastroenterology & Hepatology.

This phase 3 study was a double-blind, multicentre, randomized trial that included 200 adult patients who had experienced a failure of conservative or surgical treatment or had at least one urgency or faecal incontinence episode per week for a minimum of 3 months. After withdrawals, the patients were randomly assigned in a 1:1 ratio to receive either 200 units of BoNTA (n=96) or an equivalent volume of saline or placebo (n=95) injections. Three months after treatment, the number of episodes of faecal incontinence and urgency recorded in 21-day patient bowel diaries served as the primary endpoint. For the primary analysis, a modified intention-to-treat (mITT) approach was utilized, with adjustment for baseline faecal incontinence and urgency episodes.

At the end of the study, it was observed that in the BoNTA group, the mean number of faecal incontinence and urgency episodes per day, decreased from 1·9 at baseline to 0.8 at 3 months after the injections were administered while in the placebo group, it decreased from 1.4 to 1.0. The trial did not report any serious treatment-related adverse events. The non-serious adverse event (treatment-related or not) that was frequently seen was constipation, seen in 68 patients in the BoNTA group and 38 patients in the placebo group. From the above results, it can be concluded that BoNTA injections are an efficacious treatment for urge faecal incontinence in adult patients.