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Faecal microbiota transplantation not effective in active peripheral PsA

Presented By
Dr Maja Skov Kragsnaes , University of Southern Denmark, Denmark
EULAR 2021
Faecal microbiota transplantation (FMT) as an add-on therapy to methotrexate was inferior in the treatment of active peripheral psoriatic arthritis (PsA) in the proof-of-concept, randomised, sham-controlled FLORA trial [1].

The exploratory FLORA study (NCT03058900) investigated the safety and efficacy of a single-donor FMT in 31 adult patients with active peripheral PsA (≥3 swollen joints). In addition to methotrexate treatment, participants were randomised to FMT (n=15, mean age 48.9) or sham transplantation (n=16, mean age 52.4). Primary endpoint was the proportion of patients with treatment failure (i.e., needing treatment intensification) at 26 weeks of therapy, based on shared decision-making between patient and physician. Safety was assessed by comparing the number of treatment-induced serious adverse events (AEs).

The results demonstrated that treatment failure at 26 weeks of therapy had occurred more often in the FMT group (60%) than in the sham group (19%; HR 4.87; 95% CI 1.31–18.18; P=0.018). Components of treatment failure included patients starting biologic DMARD treatment (FMT 53% vs sham 19%), receiving intra-articular glucocorticoid injection(s) (FMT 13% vs sham 6%), or starting non-methotrexate conventional synthetic DMARD therapy (FMT 0% vs sham 6%). Compared with baseline, Health Assessment Questionnaire Disability Index (HAQ-DI) scores, a key secondary efficacy endpoint, had decreased significantly more in the sham group (-0.30) than in the FMT group (-0.07) (difference between groups 0.23; 95% CI 0.02–0.44;  P=0.031). A similar difference was observed for the SPARCC Enthesitis Index score (FMT -1.9 vs sham -4.3). American College of Rheumatology (ACR)20 response was reached in 47% (FMT) and 50% (placebo). The number of AEs was similar across groups (FMT 57 vs placebo 53). Infections were reported in 9 patients (FMT 3 vs placebo 6). The infections that occurred in the FMT group were pneumonia, cystitis, and diverticulitis. No serious AEs were detected with FMT therapy in the safety analysis.

Although FMT was inferior to sham in this trial, Dr Maja Skov Kragsnaes (University of Southern Denmark, Denmark) argued that other trials should investigate the efficacy and safety of FMT. “The most important finding of this study is the feasibility of FMT. There are no preliminary safety issues and patients reacted positively to the application of this therapy. We have to learn more about the immunological effects of FMT and thoroughly analyse the composition of microbiota in donors and recipients to find the right donor for each patient.”

  1. Skov Kragsnaes M, et al. Safety and efficacy of faecal microbiota transplantation for active peripheral psoriatic arthritis: an exploratory randomised placebo-controlled trial. OP0010, EULAR 2021 Virtual Congress, 2–5 June.


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