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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.

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

• 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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