Spondyloarthritis (SpA) and Rheumatoid arthritis (RA) are among the most common chronic inflammatory rheumatic diseases. Introduction of Tumor Necrosis Factor alpha inhibitors (TNFi) to the therapeutic strategy improved acute inflammation and pain, but a significant percentage of patients develop severe adverse events or are still non responders or incomplete responders to these expensive treatments. There is an urgent need to identify new predictors of biological therapy response. It has been described the role of microbiota in some rheumatic diseases, however, clinical trials are scarce. We hypothesized that microbiota or their metabolites may play a role in therapeutic response to TNFi.
Thus, this project aimed to evaluate the influence of oral and gut microbiota in the therapeutic response to biologic therapies, in 60 patients. It is expected to enrolled 30 SpA and 30 RA patients and 30 controls, crossed by gender, age and diet profile. Oral and fecal microbiota will be characterized before TNFi therapeutic. Patients will have an additional microbiota and metabolic profile characterization 14 weeks late after. This will allow to identify specific profiles of oral and gut microbiome and/or specific biochemical patterns in these patients. At week 14 it will be possible to identify changes induced by TNFi. In addition, it will be possible to identify microbiota pattern associated clinical therapeutic TNFi response vs non-response. This will allow to predict isolate microbe or microbes patterns at baseline associated to clinical response obtained at week 14. These results may additionally contribute to clinical decision and a better evidenced-based treatment.
Study Type
OBSERVATIONAL
Enrollment
90
bDMARD therapy (TNF inhibitors), according to the Portuguese recommendations for the use of biological therapies in patients with axSpA and RA
Centro Hospitalar Baixo Vouga - Hospital Infante D. Pedro
Aveiro, Portugal
NOT_YET_RECRUITINGHospital de Braga, E.P.E.
Braga, Portugal
NOT_YET_RECRUITINGHospital Sousa Martins - Unidade de Saúde Local da Guarda
Guarda, Portugal
NOT_YET_RECRUITINGCentro Hospitalar Lisboa Ocidental - Hospital Egas Moniz
Lisbon, Portugal
RECRUITINGCentro Hospitalar Universitário de Lisboa Norte - Hospital Santa Maria
Lisbon, Portugal
NOT_YET_RECRUITINGInstituto Português de Reumatologia
Lisbon, Portugal
NOT_YET_RECRUITINGUnidade Local de Saúde do Alto Minho, Hospital Conde de Bertiandos
Ponte de Lima, Portugal
NOT_YET_RECRUITINGCentro Hospitalar Universitário São João
Porto, Portugal
NOT_YET_RECRUITINGCentro Hospitalar de Médio Tejo - Hospital Rainha Santa Isabel - Torres Novas
Torres Novas, Portugal
NOT_YET_RECRUITINGCentro Hospitalar de Vila Nova da Gaia/Espinho
Vila Nova de Gaia, Portugal
NOT_YET_RECRUITINGOral and gut microbiota characterization in axSpA and RA patients at baseline
Time frame: Before bDMARD
Oral and gut microbiota characterization in axSpA and RA patients at week 14
Time frame: 14 weeks after start bDMARD
Disease activity measured by ASAS20 in axSpA and ACR20 in RA
Time frame: 14 weeks after start bDMARD
Changes in Erythrocyte Sedimentation Rate (ESR, measured in mm/h)
Time frame: Before bDMARD and 14-week after start bDMARD
Changes in High-sensitivity C-reactive protein (hsCRP, measured in mg/dL)
Time frame: Before bDMARD and 14-week after start bDMARD
Disease activity characterization using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in axSpA
Scale from 0 (worse outcome) to 10 (better outcome)
Time frame: Before bDMARD and 14-week after start bDMARD
Disease activity characterization using Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS-CRP) in axSpA
\< 1.3 Inactive disease; \> 3.5 Very high disease activity
Time frame: Before bDMARD and 14-week after start bDMARD
Disease activity characterization using Disease Activity Score-28 for Rheumatoid Arthritis with C-Reactive Protein (DAS28-CRP) for RA
Score greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission
Time frame: Before bDMARD and 14-week after start bDMARD
Quality of life evaluation with Short form 36 (SF36) at baseline and week 14
Score from 0 (worse outcome) to 100 (better outcome)
Time frame: Before bDMARD and 14-week after start bDMARD
Quality of life evaluation with Ankylosing Spondylitis Quality of Life (ASQOL) at baseline and week 14
Range from 0 -18 - High scores indicate worse quality of life
Time frame: Before bDMARD and 14-week after start bDMARD
Quality of life evaluation with Health Assessment Questionnaire (HAQ) at baseline and week 14
Scores of 0 to 1 are generally considered to represent mild to moderate difficulty, 1 to 2 moderate to severe disability, and 2 to 3 severe to very severe disability
Time frame: Before bDMARD and 14-week after start bDMARD
Quality of life evaluation regarding depression and anxiety using Hospital Anxiety and Depression Scale (HADS) at baseline and week 14
Scores of less than 7 indicate non-cases; 8-10 Mild; 11-14 Moderate;15-21 Severe
Time frame: Before bDMARD and 14-week after start bDMARD
Fatigue evaluation at baseline and week 14
Visual analogic scale (0-10)
Time frame: Before bDMARD and 14-week after start bDMARD
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.