Early data do not show fecal microbiota transplantation benefit in peripheral PsA
medwireNews: Findings from a proof-of-concept study suggest that fecal microbiota transplantation (FMT) may not be a suitable option for patients with active peripheral psoriatic arthritis (PsA) but further investigation is still needed.
Although FMT “has demonstrated local therapeutic immune-modulating abilities in patients with chronic inflammatory bowel disease,” the researchers say that “[i]n this first preliminary, randomised controlled trial of FMT in immune-mediated arthritis, transfer of donor microbiota was safe, but appeared inferior to sham in reducing disease activity in patients with active peripheral PsA concomitantly treated with methotrexate.”
Nevertheless, they suggest: “Larger, randomised trials of FMT […] should be undertaken to further investigate the safety and potential benefits of therapeutic targeting of the gut–joint axis in immune-mediated arthritis.”
Fifteen patients who had active peripheral PsA despite taking the maximum tolerable dose of methotrexate were randomly assigned to undergo gastroscopic-guided FMT involving one stool transplant from a single donor into the duodenum, while their 16 counterparts were allocated to receive sham transplantation.
Within 26 weeks of undergoing FMT or sham transplantation, a respective 60% and 19% of patients experienced treatment failure, defined as needing more than one intra-articular glucocorticoid injection or a biologic or non-methotrexate conventional DMARD (leflunomide, sulfasalazin, or ciclosporin).
Overall, as reported in the Annals of the Rheumatic Diseases, the risk for treatment failure was a significant 4.87-fold higher among patients who had FMT instead of sham transplantation.
Accordingly, greater improvements in physical function were reported in the sham versus FMT group, as indicated by a least squares mean improvement in HAQ-DI score of 0.30 versus 0.07 points. But there was no significant between-group difference in disease activity, with approximately half of each group achieving an ACR20 response.
“Most importantly, one FMT appeared to be safe in this patient population,” report the study investigators, who add that the adverse events (AEs) that did occur were “mainly related to the gastrointestinal tract.”
In total, 93% of FMT and 88% of sham transplantation patients had an AE, with nausea (60 vs 44%), reflux (53 vs 50%), high white blood cell count (>8.80×109/L; 33 vs 38%), and vomiting (40 vs 6%) the most common AEs associated with FMT.
None of the AEs were considered serious nor did they lead to patient withdrawal from the trial or death, the team notes.
“Although no firm conclusions can be drawn […] our findings indicate that FMT may lead to worsening of PsA, suggesting a role of the intestinal microbiota in downstream immune effects of this disease,” write Torkell Ellingsen (Odense University Hospital, Denmark) and co-investigators.
They continue: “Whether microbial dysbiosis or specific bacteria are common or decisive mediators of disease activity in PsA and whether this proposed relation can be modified without exacerbating the disease will be crucial to clarify to determine the future role of microbiota-targeted interventions in the management of PsA.”
The researchers also caution that their trial involved “primarily adults with active, polyarticular PsA, which is a relatively rare condition in clinical practice,” and consequently, “the ability to generalize our findings to the majority of patients with PsA is limited.”
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