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Decrease of Disease Activity Under Ineffective Therapy in DMARD-Naive Patients with Early Rheumatoid Arthritis: Role of Antibody Profiles and Carriage of the HLA Shared Epitope in Predicting Decrease of Disease Activity

BERT VANDER CRUYSSEN, ANDRÉ M.M. MILTENBURG, FILIP Van den BOSCH, JOS G.A. HOUBIERS, RUTH WITTOEK, ANNEMIEKE M.H. BOOTS, and FILIP De KEYSER

ABSTRACT.

Objective. To evaluate whether the baseline presence of rheumatoid arthritis (RA)-associated biomarkers could define subgroups of patients that are more prone to show a spontaneous decrease of RA disease activity. In a previous placebo-controlled phase II trial that failed to show any superiority of the experimental compound versus placebo, a remarkable decrease of such disease activity was observed despite the lack of effective treatment.

Methods. A subgroup of 83 disease modifying antirheumatic drug-naive RA patients with disease duration < 3 years was analyzed. Rheumatoid factor (RF), anti-citrullinated protein/peptide antibodies (ACPA), and HLA shared epitope (SE) were determined at baseline.

Results. RF-positive patients tended to have higher levels of disease activity at baseline compared to RF-negative patients [Disease Activity Score (DAS) 6.12 vs 5.65, p = 0.02 at screening], but the decrease in disease activity was similar in both subgroups (DAS –1.23 vs –1.07). In contrast, ACPA-positive patients showed similar baseline disease activity scores compared to ACPA-negative patients, but tended to show a smaller decrease of disease activity than patients without ACPA ( DAS –1.53 vs –0.79, p = 0.013). Presence of the HLA-SE seemed not to have any effect on the baseline DAS or on the spontaneous decrease of DAS.

Conclusion. The predictive value of baseline RA-associated biomarkers for spontaneous decrease of disease activity under placebo or ineffective treatment is limited. Yet the data analyzed here might be useful for the design of future placebo-controlled trials in RA. (J Rheumatol 2007;34:1992-6)

Key Indexing Terms:

RHEUMATOID ARTHRITIS
DISEASE ACTIVITY
ANTIBODIES
HLA SHARED EPITOPE

From Ghent University, Gent, Belgium; and Organon NV, Oss, The Netherlands.

Supported by Organon NV, Oss, The Netherlands.

B. Vander Cruyssen, MD, PhD; F. Van den Bosch, MD, PhD; R. Wittoek, MD; F. De Keyser, MD, PhD, Ghent University; A.M.M. Miltenburg, PhD; J.G.A. Houbiers, PhD; A.M.H. Boots, PhD, Organon NV.

Address reprint requests to Dr. B. Vander Cruyssen, Department of Rheumatology, Ghent University Hospital, De Pintelaan 185, 90000 Gent, Belgium. E-mail: Bert.VanderCruyssen@Ugent.be

Accepted for publication June 25, 2007.