Oral Health Assessment in Rheumatoid Arthritis and Other Autoimmune Diseases-- Anti- TNF Substudy

20 subjects with RA, who are starting TNF inhibitors based on the decision of their treating
rheumatologist, will be recruited only from the existing clinic population who receive
ongoing clinical care at the Johns Hopkins Arthritis Center. No patients from outside the
clinic will be recruited. No medications will be supplied through the study.

Study duration and numbers of visits: Patients will be followed through 14-16 weeks after
the initiation of TNF inhibitor. Each patient will be seen for 4 visits: a screening visit,
a baseline visit, a follow up visit between 6-8 weeks after TNF inhibitor initiation, and a
final visit at weeks 14-16 after TNF inhibitor initiation. At each visit the procedures
noted below will be performed. Should a patient discontinue the TNF inhibitor for any
reason, a final assessment at the time of stopping will be requested.

Rheumatology Assessments: Subjects will complete standard clinical assessment questionnaires
with age, race, demographic status, past medical and surgical history, co-morbid diseases,
signs and symptoms of arthritis,. Multi-dimensional Health Assessment Questionnaire (MD-HAQ)
and SF-36. Baseline joint counts for swollen, tender, and deformed or operated joints will
be recorded. A Schirmer test to measure conjunctival tear production will be performed.

Oral Health and Periodontal Evaluation: Subjects will have a comprehensive oral health and
periodontal evaluation. Subjects will complete standardized oral health questionnaires to
assess dental health (including caries, tooth loss, periodontitis, dry mouth, and TMD)
dental hygiene practices, prior dental procedures, , smoking, and access to dental care.
Subjects will undergo a comprehensive dental evaluation including oral mucosal assessment,
including plaque, gingivitis, and periodontal indices recorded at 6 sites per tooth, as well
as an evaluation for xerostomia and temporomandibular joint (TMJ) function. Gingival
crevicular fluid will be collected on paperpoints placed into the periodontal sulcus of the
2 most severely affected teeth and 2 sites with the least amount of periodontal
inflammation. Unstimulated saliva will be collected over 5 minutes following GCF collection.

Laboratory Assessments: At each visit we will obtain blood to be assayed for CRP and other
biomarkers. These will include the evaluation of a panel of inflammatory cytokines that will
be tested in the blood, saliva, and GCF, to determine how these may change over time in
response to TNF antagonist therapy for RA. .

Withdrawal Criteria: Patients may withdraw consent at any time and no longer participate in
the oral examinations or other assessments. Patients who discontinue TNF agents for reasons
of tolerability or lack of efficacy will be asked to return for a study termination visit
for a follow up oral examination.

INCLUSION CRITERIA:

- Adult patients age 18-75, able to provide written informed consent

- Diagnosis of RA by 2010 ACR/EULAR Criteria

- Patients will not be required to be taking MTX unless they are being prescribed
infliximab or golimumab as per approved indications. If taking background MTX, dose
must be stable in 4 weeks and be expected to continue at the same dose for 3 months.
Patients taking other nonbiological DMARDS will be excluded (leflunomide,
hydroxychloroquine, sulfasalazine)

- Prednisone greater than or equal to 10 mg/day

- No prior treatment with a TNF inhibitor or other biological DMARD

- Starting anti-TNF agents with documented insurance authorization for coverage. The
decision to start TNF agent and choice of particular agent will be based on the
opinion of the treating rheumatologist.

- Standard starting dosing of agents will be:

- Infliximab (Remicade) 3 mg/kg IV; baseline, 2 wk, 6 wk, then q 8 wk

- Golimumab (Simponi) 50 mg SC q month

- Etanercept (Enbrel) 50 mg SC q week

- Adalimumab (Humira) 40 mg SC q every other week

- Certolizumab (Cimzia) 400 mg SQ baseline, 2 wk, 4 week, then 200 mg q every other
week or 400 mg q month.

- If it has been decided to use any other dosing regimen than those above, the patient
will be excluded from participation.

- At least 14 teeth in the functional dentition

- Willing to practice contraception for the duration of the study period (as would be
recommended to most patients starting these medications including MTX).

- Are considered eligible for a TNF inhibitor according to the following tuberculosis
(TB) screening criteria:

- Have no history of latent or active TB prior to screening.

- Have no signs or symptoms suggestive of active TB upon medical history and/or
physical examination.

- Have had no recent close contact with a person with active TB.

- Have a negative (greater than 5mm induration) PPD test within 6 weeks. Patients with
a positive PPD will not be allowed to enroll regardless of exposure history or
receipt of BCG.

EXCLUSION CRITERIA:

- Taking other nonbiological DMARD unless discontinued for at least 1 month:
(sulfasalazine, hydroxychloroquine, leflunomide).

- Used systemic or oral topical antibiotics (inc. tetracyclines) within 30 d of
enrollment.

- Taken phenytoin, cyclosporine, or coumadin within 3 months

- Known bleeding diathesis or coagulopathy

- Subjects with valvular heart disease, joint prosthesis, or other condition requiring
routine antibiotic prophylaxis for dental procedures will not necessarily be excluded
unless they are not willing to receive standard appropriate antibiotic prophylaxis
before dental evaluations.

- No planned elective surgery within 4 months

- Comorbid condition that in the opinion of the investigator would preclude
administration of a TNF inhibitor or the performance of oral examinations

- History of latent or active granulomatous infection, including tuberculosis,
histoplasmosis, or coccidiomycosis prior to screening.

- History of positive PPD or other TB exclusions noted above.

- History of persistently indeterminate on repeat exams, Quantiferon TB Gold or other
gamma-interferon releasing TB assays.