Rheumatoid arthritis (RA) is a systemic disabling inflammatory disease, of autoimmune origin
characterized by chronic synovial inflammation resulting in joint damage. Treg cell function
in patients with active RA is assumed to be impaired, a trend that seems to be reversed by
TNFalpha antagonist therapy. Remission is the current treatment goal in RA.
An increasing number of patients in clinical trials achieve this goal raising the question
whether patients who have been in remission for a prolonged period (sustained remission)
still need medication indefinitely. From a decade TNF-blocker therapy have represented a new
treatment option for RA patients non responders to conventional DMARDs and some evidence are
now available showing that sustainable remission can be maintained achieved after withdrawal
of TNF blocker. Objectives: to verify whether in RA patients in prolonged clinical and
instrumental remission the percentages of CD4+CD25highCD127low/- T cells could represent a
reliable marker of immunological remission and, even more relevant, if the pharmacological
reconstitution of this "immune-modulator" Tcell population could contribute to better
identify patients with a low risk of relapse after cessation of TNF-blocker therapy. Methods:
in RA patients, who fulfilled the 1987 ACR revised criteria, with disease duration ! 5 years,
clinical [Disease Activity Score on 28 joints-DAS28 0.56 ×√(TJC28) + 0.28×√(SJC28) +
0.70×ln(ESR) + 0.014×GH.TJC= Tender Joints Count (from 0 to 28); SJC= Swollen Joints Count
(from 0 to 28) ESR=Erythrocyte Sedimentation Rate GH= patient's assessment of general health
(VAS range from 0 to 100 mm); disease's flare was considered if: DAS44 >=2.4/DAS28 >=3.2.)],
instrumental (joint ultrasonography: sites to be explored wrists are II-III
metacarpophalangeal joint bilaterally using Power Doppler signal (grading 0-3); any other
joint will be studied if symptomatic) and immunological (circulating
CD4+CD25highCD127low/-Tcells and inflammatory cytokines levels) examination will be performed
in order to asses, at different levels, disease activity status. Expected results: to
identify in RA patients treated with anti-TNF an "exit-strategy" from these drugs based on
clinical, imaging and immunologic features indicative of a sustained remission and to verify
whether such conditions are able to predict a low incidence of relapse.