T-cell Subsets in Rheumatoid Arthritis Patients on Long-term Anti-TNF or IL6-receptor-blocker Therapy

Szeged University122 enrolled

Overview

Data on the impact of biological therapies, especially of IL6-blocker treatment, on the T-cell phenotype in rheumatoid arthritis (RA) are limited, inconclusive, and mainly involve short-term follow-up. Here, the investigator prospectively measure the percentages of 15 circulating T-cell subtypes using flow cytometry. The investigators aim to obtained transversal and longitudinal data in 30 anti-TNF responders, 19 secondary anti-TNF-non-responders, 43 IL6R-antagonist-responders before, 8 weeks and, after, at least, 6 months of biological therapy. These are then compared with results obtained in early, untreated RA patients and gender-and-age matched healthy controls.

Study Type

OBSERVATIONAL

Enrollment

122

Conditions

Rheumatoid Arthritis

Interventions

No interventionOTHER

Observational study

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria for patients: * Diagnosis of rheumatoid arthritis classified according to the 2010 ACR/EULAR classification criteria for RA * Biological treatment with anti-TNF therapy (adalimumab or certolizumab pegol or etanercept or infliximab or golimumab) or anti-IL-6R agent (tocilizumab) Inclusion Criteria for healthy controls: * negative history of RA symptoms * negative status upon detailed physical and laboratory examination including normal CRP and ESR values Exclusion Criteria: * other autoimmune comorbidity * lack of informed consent

Outcomes

Primary Outcomes

Flow cytometry for the assessment of change in T cell subtypes

The percentages of 15 circulating T-cell subtypes were measured using flow cytometry.

Time frame: Before, after 8 weeks and after at least 6 months of the initiation of biological therapy.