Abatacept (CTLA4Ig) treatment increases the remission rate in rheumatoid arthritis patients refractory to methotrexate treatment

R Westhovens¹, P van Riel², J Sibilia³, G Vratsanos⁴, I Nuamah⁴ and JC Becker⁴

¹Department of Rheumatology, Universitaire Ziekenhuizen Leuven, Leuven, Belgium

²Department of Rheumatology, University Medical Center Nijmegen, Nijmegen, The Netherlands

³Department of Rheumatology, Strasbourg University Hospital, Strasbourg, France

⁴Bristol-Myers Squibb Pharmaceutical Research Institute, Princeton, NJ, USA

from 24th European Workshop for Rheumatology Research
Berlin, Germany. 26–29 February 2004

Arthritis Res Ther 2004, 6(Suppl 1):86doi:10.1186/ar1128

Received:	16 January 2004
Published:	24 February 2004

Background

Effective amelioration of symptoms and induction of remission are goals in treatment of rheumatoid arthritis (RA).

Objectives

Data from a Phase II study for RA treatment with abatacept, a selective co-stimulation modulator, showing induction of remission (DAS-28 score < 2.6) are presented.

Methods

Patients on background methotrexate (MTX) who met ACR criteria for active RA with ≥ 10 swollen joints (66 joint count) and ≥ 12 tender joints (68 joint count) were randomly assigned to receive 10 mg/kg abatacept (n = 115) or placebo (n = 119) treatment for 1 year. DAS-28 scores and serum cytokine levels were assessed at days 1, 90, 180 and 360.

Results

Abatacept-treated patients showed a progressive increase in remission rates up to 1 year (analysis not prespecified) compared with placebo (P < 0.001; Fig. 1). Abatacept treatment also decreased serum levels of proinflammatory cytokines. In particular, levels of serum IL-6, a multifunctional cytokine that contributes both to acute phase response and to pathological B cell activation, were reduced by 67% at 180 days and by 73% at 360 days (P < 0.05). Placebo-treated patients showed no reduction. Abatacept was generally safe and well tolerated.

Figure 1. Abatacept increases the remission rate in RA patients refractory to MTX treatment. Means and 95% confidence intervals are shown.

Conclusions

In patients with active RA who were receiving MTX, abatacept treatment significantly improved RA symptoms and produced a progressive increase in remission rates for over one-third of the treatment group, which was sustained at 1 year. In addition, abatacept decreased serum IL-6 levels. The results of this phase II study suggest that abatacept may have potential as therapy for patients with active RA despite MTX treatment.

Acknowledgement

Study supported by Bristol-Myers Squibb.

This article is part of the supplement: 24th European Workshop for Rheumatology Research