Safe but ineffective stool transplantation in PsA trial


The first clinical trial of fecal microbiota transplantation in patients with psoriatic arthritis has found that the procedure is as safe as a simulated procedure, but has not shown any effectiveness in decreasing PsA symptoms for 6 months, according to a team of researchers from Denmark in Annals of rheumatic diseases (2021 Apr 29.10.1136 / annrheumdis-2020-219511).

However, the researchers said the process indicates that fecal microbiota transplantation (FMT) is worth further study.

Dra. Maja Kragsnaes

“Overall, we believe that the results are very interesting and that the viability and safety aspects, as well as the clinical results of the trial, may favor further research on the potential of FMT in the treatment of inflammatory arthritis and may help guide future trials within the field, ”lead author May S. Kragsnaes, MD, PhD, and principal investigator Torkell Ellingsen, MD, PhD, of Odense University Hospital (Denmark), said together in an interview.

Dr. Torkell Ellingsen

“The most important findings from this trial are that FMT appears to be safe in patients with PSA and that patients consider treatment to be acceptable and support future research on the therapeutic potential of FMT in PsA,” they said.

The study evaluated the 6-month outcomes of 31 randomized patients in the FMT and simulated groups. Patients with FMT were three times more likely to experience treatment failure, defined by the need to intensify treatment, with failure rates of 60% versus 20% in the simulated group.

As a secondary endpoint, the study used a 6-month change in the disability assessment of the Health Assessment Questionnaire (HAQ-DI) and a 20% improvement in the criteria of the American College of Rheumatology (ACR20). The simulated group showed a greater decrease in HAQ-DI, indicating better physical function (–0.30 vs. –0.07; Pg = 0.031). The proportion of respondents to ACR20 was similar between both groups: 47% for patients with FMT (7 of 15) and 53% for simulated (8 of 15).

The study included adults between the ages of 18 and 75 with active peripheral disease, defined as three or more swollen joints, who had been taking at least 15 mg. methotrexate one week for at least 3 months before enrolling in the study, with a 12-week wash period (26 weeks for those with biological agents). Four healthy donors provided stool transplants.

In the study, Kragsnaes and Ellingsen acknowledged that FMT has been shown to be safe Clostridioides difficult infection or inflammatory bowel disease when “well-examined stool” is used. “Therefore,” they wrote, “our findings are added to the growing body of tests suggesting an axis of the intestinal joint in the pathogenesis of PsA “.

Kragsnaes and Ellingsen said the factors that may influence the effectiveness of FMT in PSA deserve further investigation. “From FMT trials in active patients ulcerative colitis, a higher dose and repeated administration appear to be effective and safe in inducing remission, ”they said in their joint statement, noting research from China.

“Furthermore,” they added, “the successes of FMT in inflammatory bowel disease appear to have been driven by” superdonors “characterized by the presence or absence of species-specific bacteria.”

They said the effectiveness of FMT in immunity-mediated diseases will continue to be investigated, including how to characterize donors.

“We will perform new randomized trials using different FMT strategies, changing the type of administration, dose and frequency of treatment, to explore whether microbial dysbiosis or specific bacteria are common or decisive mediators of disease activity. in inflammatory diseases and whether this proposed relationship can be modified without exacerbating the disease, ”Kragsnaes and Ellingsen said.

Kragsnaes and Ellingsen had no relevant financial relationships to reveal.

This article originally appeared on, which is part of the Medscape professional network.

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