Fecal microbiota transplantation (FMT) as an add-on therapy to methotrexate was inferior in the treatment of active peripheral psoriatic arthritis (PsA) compared with sham in the proof-of-concept, randomized, placebo-controlled FLORA trial.
The exploratory FLORA study (NCT03058900) investigated the safety and efficacy of a single-donor FMT in active peripheral PsA patients (n=31). In addition to methotrexate treatment, participants were randomized to FMT (n=15) or sham (n=16). Primary endpoint was the proportion of patients with treatment failure at 26 weeks of therapy. 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%). 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). A similar difference was observed for the SPARCC Enthesitis Index score (FMT -1.9 vs sham -4.3).
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 analyze the composition of microbiota in donors and recipients to find the right donor for each patient.”
Source:
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.