Faecal microbiota transplantation (FMT) offers no advantage for patients with active peripheral psoriatic arthritis.
The findings challenge enthusiasm for a relationship between microbial dysbiosis and joint inflammation as per gut inflammation.
The FLORA trial, presented at EULAR 2021, evaluated the effectiveness and safety of single donor FMT versus sham FMT in 31 adult patients with PsA who were stable on at least three months of methotrexate treatment. A single dose of FMT or sham was delivered into the duodenum via gastroscope.
Dr Maja Kragsnaes, from the Research Unit of Rheumatology at the University of Southern Denmark and Odense University Hospital, told the Virtual Congress that significantly more FMT patients than controls experienced treatment failure or required treatment escalation by 26 weeks (60% v 19%; p=0.018).
In particular, more patients in the FMT group started biologic therapy than controls (53% v 19%) and more patients in the FMT group received >1 intraarticular glucocorticoid injection (13% v 6%).
In secondary endpoints, the HAQ-DI score improved more in the sham group indicating better physical function (-0.07 v -0.30; p=0.031).
“Although the FMT intervention did not induce beneficial effects, in the majority of people receiving the intervention the safety profile seemed to be acceptable,” she said.
Common adverse events included nausea and reflux in both patient groups and vomiting in the FMT group. There were no serious adverse events reported.
Infections, such as pneumonia and cystitis, were reported in both groups but more often in the sham group.
Dr Kragsnaes said the small size of the study population was a limitation. As well, the trial was neither large enough nor long enough to evaluate less common serious adverse events and long-term risks.
She concluded that FMT was inferior to sham treatment but FMT did to appear to result in serious adverse events.
“Overall, larger randomised controlled trials of FMT combined with exploration of immunology effects and in-depth analyses of the composition and functional potential of the microbiota in donors and recipient should be undertake to further investigate safety and potential benefits of therapeutic targeting of the gut-joint axis in immune-mediated arthritis.”
The study was also recently published in Annals of Rheumatic Diseases.