In an exploratory, randomized trial, fecal microbiota transplantation (FMT) was evaluated as a treatment for patients with active peripheral psoriatic arthritis (PsA) who were on methotrexate. While the microbiota transplantation appeared safe, initial results suggest that disease activity reduction from FMT is inferior to the placebo. The study was published in Annals of the Rheumatic Diseases.
Lead author, Maja Skov Kragsnaes, MD, PhD, summed up the findings of the study as such, “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.”
Researchers randomly allocated 31 adult patients with active peripheral PsA, defined as three or more swollen joints, despite methotrexate treatment to either one gastroscopic-guided FMT group, or a sham transplantation group. The primary efficacy endpoint was the proportion of participants failing treatment—defined as needing treatment intensification—through 26 weeks. Secondary endpoints included change in Health Assessment Questionnaire Disability Index (HAQ-DI) and American College of Rheumatology (ACR20) response at week 26.
Thirty patients completed the 26-week study. Researchers observed that intense treatment was needed in nine patients (60%) in the FMT group compared to three in the sham group (19%) (risk ratio = 3.20; 95% CI 1.06 to 9.62; p = 0.018). Improvement in HAQ-DI score was 0.23 points higher in the sham group (95% CI 0.02 to 0.44; p=0.031). There was no difference in the proportion of ACR20 responders between groups (7 of 15 (47%) vs 8 of 16 (50%)). No serious adverse events were observed.
The study’s proof-of-concept results suggest that FMT potentially worsens PsA, but still indicates a role of the intestinal microbiota in downstream immune effects of PsA, according to the authors. They ended their report calling for “larger, randomized trials of FMT where a sufficient number of participants will be included combined with exploration of immunological effects and in-depth analyses of the composition and functional potential of the microbiota in donor and recipients” to continue investigating the potential benefits of treatments targeting the gut–joint axis in immune-mediated arthritis.
Source: Annals of the Rheumatic Diseases