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Epitope-specific immunotherapy of rheumatoid arthritis: Clinical responsiveness occurs with immune deviation and relies on the expression of a cluster of molecules associated with T cell tolerance in a double-blind, placebo-controlled, pilot phase II trial
Arthritis & Rheumatism, 11/06/09

Koffeman EC et al. – Tolerization to dnaJP1 leads to immune deviation and a trend toward clinical efficacy. Susceptibility to treatment relies on the coexpression of molecules that can down-regulate adaptive immunity.

Methods

Pilot phase II trial
160 patients with active RA and immunologic reactivity to dnaJP1

Results

dnaJP1 peptide safe and well-tolerated
Significant reduction in percentage of T cells producing tumor necrosis factor and corresponding trend toward increased percentage of T cells producing interleukin-10
Coexpression of cluster of molecules (programmed death 1 and its ligands) associated with T cell regulation also found to be a prerequisite for successful tolerization in clinical responders
Analysis of primary efficacy end point (meeting the American College of Rheumatology 20% improvement criteria at least once on day 112, 140, or 168) showed difference between treatment groups that became significant in post hoc analysis using generalized estimating equations
Differences in clinical responses also found between treatment groups on day 140 and followup
Post hoc analysis showed that combination of dnaJP1 and hydroxychloroquine (HCQ) was superior to combination of HCQ and placebo

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