Oral vancomycin may offer ‘viable option’ for IBD-related primary sclerosing cholangitis
Key takeaways:
- Clinical response was noted in 47.6% of patients treated with oral vancomycin therapy for IBD associated with PSC.
- Vancomycin-resistant enterococci was reported in 8.7% of patients following treatment.
Oral vancomycin therapy resulted in clinical response in nearly half of patients with inflammatory bowel disease associated with primary sclerosing cholangitis, according to a study published in Therapeutic Advances in Gastroenterology.
“There have been case reports and small case series describing the positive effect of oral vancomycin therapy for inducing remission of IBD associated with primary sclerosing cholangitis (PSC),” Badr Al Bawardy, MD, study author and director of the Inflammatory Bowel Disease Program at King Faisal Specialist Hospital and Research Center in Riyadh, Saudi Arabia, told Healio. “We aimed to review the literature regarding the evidence.”
Bawardy and colleagues performed a systematic review of Cochrane Library, Embase, Google Scholar, Medline, PubMed, Scopus and Web of Science databases to identify 21 open-label, noncontrolled studies including 290 patients (median age, 30 years; interquartile range [IQR], 13.5-38 years; 58.3% male) treated with oral vancomycin for IBD associated with PSC.
The primary IBD outcome was clinical response, which the researchers defined as any improvement in IBD-related clinical symptoms; secondary outcomes included clinical, biochemical and endoscopic remission.
Safety outcomes included risk for infection, acute cholangitis, development of cirrhosis, liver decompensation, need for liver transplantation, cholangiocarcinoma and development of vancomycin-resistant enterococci, according to the researchers.
Across all studies, the total daily dose of oral vancomycin used ranged from 250 mg to 1,500 mg, with a median duration of treatment of 32.5 weeks (IQR, 19-83 weeks).
Also, 113 patients were on concomitant treatments while receiving oral vancomycin, which included oral mesalamine (n = 42), steroids (n = 20), advanced therapies (n = 30) and immunosuppressive agents (n = 41).
Median follow-up was 14.4 months (IQR, 6.3-27.4 months).
The researchers observed clinical response in 47.6% of patients, clinical remission in 43.5%, steroid-free clinical remission in 58.3% and endoscopic remission in 39.4%. Based on the available data for 80 patients, the biochemical remission rate was 68.8%.
“Our systematic review of 21 studies including 290 patients revealed that almost half of patients achieved clinical response to oral vancomycin therapy with an overall favorable safety profile,” Al Bawardy told Healio.
When looking exclusively at the eight studies that reported on outcomes among children, the researchers observed a clinical response rate of 51.9% and a clinical remission rate of 64.2%.
Four studies (n = 20) reported no episodes of acute cholangitis while on oral vancomycin therapy, according to the researchers.
Additionally, they noted that five studies (n = 69) reported an incidence rate of 8.7% for vancomycin-resistant enterococci following oral vancomycin therapy.
“Our review highlights that oral vancomycin may be a viable option for some patients with IBD associated with PSC but cannot be universally recommended due to the low quality of supporting data,” Al Bawardy said. “Oral vancomycin therapy may be considered in select patients with IBD associated with PSC who do not respond to conventional and advanced therapies after informed consent of off-label use.”
Al Bawardy and colleagues acknowledged several study limitations, including the fact that many of the studies included in the analysis lacked long-term follow-up, limiting the assessment of safety. They also noted that all of the studies were limited by their small sample size.
“Adequately powered randomized controlled trials are needed to investigate the utility and safety of oral vancomycin therapy for the treatment of IBD associated with PSC,” Al Bawardy told Healio. “Specifically, oral vancomycin therapy appropriate dose, duration of therapy and long-term safety need to be further investigated.”
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