Consequences of Anti-interleukin 6 Immunotherapy Treatment for Rheumatoid Arthritis on Periodontium

Study Overview
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Brief Summary
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Rheumatoid arthritis and periodontitis are two inflammatory diseases that share many pathophysiological similarities as some inflammatory mediators like TNF-alpha, IL-1, Il-6, Il-17, Il-12 et Il-17, RANK-L, or OPG The most severe or progressive forms of rheumatoid arthritis require in 10-30% of cases, the use of biotherapies such as anti-TNF-alpha, anti CD-20 and anti-lL-6. All these treatments results in, among other things, an increased risk of infection, both viral and bacterial. These new biotherapies could have an impact on periodontal status either by favouring sub gingival colonization of root surfaces by periodontal pathogenic bacteria and initiate periodontitis or exacerbate pre-existing periodontitis, or a positive modulation of the host response by inhibiting bone resorption of the alveolar process. To date, very few studies have been conducted on this subject which is really a translational research, involving several medical specialties.

Official Title
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Multicenter, Prospective Study, on the Consequences of Anti-interleukin 6 Immunotherapy Treatment for Rheumatoid Arthritis on: - Healthy and Pathological Periodontium - The Level of Expression of Some Markers of Inflammation and Periodontal Pathogenic Bacteria in Periodontal Sulci and Periodontal Pockets

Conditions
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Rheumatoid Arthritis, Periodontitis

Intervention / Treatment
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* Other: oral exam and


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient over 18 years presenting a rheumatoid arthritis and for which an anti IL6 biotherapy treatment is prescribed. At least 18 permanent teeth in the mouth at least 3 teeth with a healthy periodontal status Having expressed their written free and informed consent Exclusion Criteria: Hypersensitivity to any of the following components : tocilizumab, saccharose, polysorbate 80, phosphate disodique dodécahydrate, phosphate monosodique dehydrate Severe or active infections Systemic Pathology affecting the immune system including Sjögren's syndrome Surgery in the previous month HIV positive Alcoholic Toxicoman Antibiotic treatment in the last 2 months Legally protected patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: patient with parodontitis<br>Patient with rheumatoid arthritis and pparodontitis. | Other: oral exam and<br>* The study will be conducted with patient presenting a rheumatoid arthritis and for which an anti IL6 biotherapy treatment is planned. Each patient will benefit a record oral exam that will evaluate his periodontal status and on a possible periodontitis associated. Bacterial samples and cytokine will be realized (in defined periodontal pocket or in the most affected periodontal pocket depending of the periodontal status of patients) before the IL6 biotherapy and 6 month after. A periodontal charting will be realized at the same time.<br>|
| Other: Patient without parodontitis<br>Patient with rheumatoid arthritis but periodontally healthy | Other: oral exam and<br>* The study will be conducted with patient presenting a rheumatoid arthritis and for which an anti IL6 biotherapy treatment is planned. Each patient will benefit a record oral exam that will evaluate his periodontal status and on a possible periodontitis associated. Bacterial samples and cytokine will be realized (in defined periodontal pocket or in the most affected periodontal pocket depending of the periodontal status of patients) before the IL6 biotherapy and 6 month after. A periodontal charting will be realized at the same time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical attachment level | Gain or loss obtained by periodontal probing. | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of periodontopathogenic germs | Detection of periodontopathogenic germs by RT - PCR - Q wich the bacterial samples will be made at the outset of the study and 6 month after the beginning of anti IL6 treatment. | 6 month | 
| Quantification of periodontopathogenic germs | Quantification of periodontopathogenic germs by RT - PCR - Q wich the bacterial samples will be made at the outset of the study and 6 month after the beginning of anti IL6 treatment. | 6 month | 
| Detection of inflammation markers in the gingival fluid | Detection and quantification of inflammation markers in the gingival fluid : IL-1, IL-6, IL-8, IL-10, IL-12, IL-15, IL-17, TGF- beta, TNF-alpha, IL-4 et IFn-gamma. | 6 month | 
| Quantification of inflammation markers in the gingival fluid | Quantification of inflammation markers in the gingival fluid : IL-1, IL-6, IL-8, IL-10, IL-12, IL-15, IL-17, TGF- beta, TNF-alpha, IL-4 et IFn-gamma. | 6 month | 
| Assessment of inflammation | Assessment of inflammation through Bleeding On Probing | 6 month | 
| Assessment of oral hygiene level | Assessment of oral hygiene level with plaque Index | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontitis, rheumatoid arthritis, anti-interleukin 6, immunotherapy, inflammation, bacteria, periodontal sulci, periodontal pockets