This study evaluates the intestinal microbiome and disease activity in patients with rheumatoid arthritis receiving immunosuppressive therapy. Patients will be analysed at two time points in reference to two predefined primary endpoints: * Changes in intestinal microbiome * Response to therapy The investigators want to evaluate if successful treatment of rheumatoid arthritis coincide with specific changes in the gut flora.
Methotrexate (MTX) and tumor necrosis factor (TNF) -inhibitors are two efficient medications for the treatment of rheumatoid arthritis. In a substantial number of cases however, these medications remain ineffective. At present, the scientific community has limited understanding of why some patients are resistant to these medications. The purpose of this study is to understand if the gut flora may associate with treatment response. Recent studies have associated rheumatoid arthritis with intestinal dysbiosis. Specifically, the bacteria Prevotella copri, has been associated with this disease, an observation that has been supported also by mechanistic studies. In patients receiving methotrexate, normalization of dysbiosis has been associated with successful treatment. This study is of observational character and integrated in the routine clinical care of patients with rheumatoid arthritis at the Rheumatology Clinic, Skane University Hospital, Lund, Sweden. Study participants are asked to deliver blood and fecal sampling at two time-points together with clinical evaluation of disease activity. With an estimated inclusion of 50 patients, at least 20 responders and 20 non-responders are expected to be included and to be compared to each other. If successful treatment response in rheumatoid arthritis is associated with specific alterations of the gut flora, these results may guide future studies on the impact of dysbiosis and probiotics on this disease.
Study Type
OBSERVATIONAL
Enrollment
50
Intestinal gut flora in rheumatoid arthritis
Intestinal gut flora based on DNA-based microbial analysis of fecal samples
Time frame: Analysis made at study start/baseline
Change in gut flora
Change in Dysbiosis Index Score at follow up compared to baseline. The Dysbiosis Index Score measures degree of intestinal dysbiosis on a scale from 1 to 5, where 5 indicates dysbiosis. The Index has been extensively described at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5029765/
Time frame: Change from baseline Dysbiosis Index Score at 6 months
Change in disease activity/treatment response at follow up
Change in Disease Activity Score 28 (DAS-28), an established index of disease activity in rheumatoid arthritis between 0-10, where 10 equals maximum activity.
Time frame: Change from baseline DAS-28 at 6 months
Adherance to immunosuppressive therapy
Is the patient still prescribed the same immunosuppressant compared to baseline?
Time frame: Analysis made at 6 months follow up
Change in intestinal concentration Prevotella
Alterations in intestinal concentrations of Prevotella bacteria according to polymerase chain reaction (PCR)-based analysis
Time frame: Change from baseline concentration at 6 months
Change in intestinal concentration Lactobacillus
Alterations in intestinal concentrations of Lactobacillus bacteria according to PCR-based analysis
Time frame: Change from baseline concentration at 6 months
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Change in intestinal concentration Clostridia
Alterations in intestinal concentrations of Clostridia bacteria according to PCR-based analysis
Time frame: Change from baseline concentration at 6 months