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

  • R Westhovens1,

    Affiliated with

    • P van Riel2,

      Affiliated with

      • J Sibilia3,

        Affiliated with

        • G Vratsanos4,

          Affiliated with

          • I Nuamah4 and

            Affiliated with

            • JC Becker4

              Affiliated with

              Arthritis Res Ther20046(Suppl 1):86

              DOI: 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.
              http://static-content.springer.com/image/art%3A10.1186%2Far1128/MediaObjects/13075_2004_Article_1118_Fig1_HTML.jpg
              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.

              Declarations

              Acknowledgement

              Study supported by Bristol-Myers Squibb.

              Authors’ Affiliations

              (1)
              Department of Rheumatology, Universitaire Ziekenhuizen Leuven
              (2)
              Department of Rheumatology, University Medical Center Nijmegen
              (3)
              Department of Rheumatology, Strasbourg University Hospital
              (4)
              Bristol-Myers Squibb Pharmaceutical Research Institute

              Copyright

              © BioMed Central Ltd 2004

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