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Clinical Trial
. 2011 Nov;70(11):2003-7.
doi: 10.1136/annrheumdis-2011-200316. Epub 2011 Sep 12.

Clinical response and tolerability to abatacept in patients with rheumatoid arthritis previously treated with infliximab or abatacept: open-label extension of the ATTEST Study

Michael Schiff  1 , Mauro Keiserman, Christine Codding, Suthin Songcharoen, Alberto Berman, Sauithree Nayiager, Cristina Saldate, Richard Aranda, Jean-Claude Becker, Marleen Nys, Manuela le Bars, Diane Moniz Reed, Coralie Poncet, Maxime Dougados
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Free PMC article
Clinical Trial

Clinical response and tolerability to abatacept in patients with rheumatoid arthritis previously treated with infliximab or abatacept: open-label extension of the ATTEST Study

Michael Schiff et al. Ann Rheum Dis. 2011 Nov.
Free PMC article

Abstract

Objective: To assess the efficacy and safety of abatacept in biological-naive patients with rheumatoid arthritis and an inadequate response to methotrexate treated in the long-term extension (LTE) of the ATTEST trial.

Methods: Patients randomly assigned to abatacept, placebo or infliximab completing the 1-year double-blind period were eligible to receive abatacept ∼10 mg/kg in the open-label LTE. Efficacy to year 2 is presented for patients randomly assigned to abatacept or infliximab who switched to open-label abatacept. Safety data are presented for all patients entering LTE regardless of double-blind treatment.

Results: Of 431 patients randomly assigned, 79.8% remained on abatacept at year 2. At years 1 and 2, 19.7% and 26.1% of abatacept and 13.3% and 28.6% of infliximab-to-abatacept patients achieved disease activity score 28-defined remission (<2.6). Safety with abatacept during the cumulative study period was consistent with the double-blind experience, with no increase in adverse event incidence following the switch to abatacept.

Conclusion: In methotrexate-inadequate responders, abatacept efficacy was maintained over 2 years. For infliximab-to-abatacept patients, efficacy improvements were seen in year 2 after patients switched to abatacept. Switching directly from infliximab to abatacept was well tolerated. These data demonstrate that abatacept provides sustained responses and consistent safety, suggesting that switching from infliximab to abatacept is a viable treatment option.

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Conflict of interest statement

Competing interests MS, MD and MK have received grant support and consulting fees from Bristol-Myers Squibb. SS has received grant support from Bristol-Myers Squibb. RA, J-CB, MN, MlB and DMR are employees and stock-holders of Bristol-Myers Squibb. CC, AB, SN and CS have no conflict of interest to declare.

Figures

Figure 1
Figure 1
Data are for patients originally assigned to abatacept or infliximab and switched to abatacept at year 1. Original placebo group is not shown. (A). Percentage (95% CI) of patients in DAS28 (ESR) LDAS and remission. At year 1, 37.0 (95% CI: 28.6 to 45.4) vs 23.0% (15.9 to 30.1) of abatacept- versus infliximab-treated patients, respectively, achieved LDAS, and 19.7 (12.8 to 26.6) versus 13.3% (7.6 to 19.1) achieved remission. At year 2, 41.7 (95% CI: 32.7 to 50.8) versus 45.2% (36.5 to 53.9) of original abatacept versus infliximab-to-abatacept switch patients, respectively, achieved LDAS, and 26.1 (18.1 to 34.1) versus 28.6% (20.7 to 36.5) achieved remission. (B). Percentage (95% CI) of patients in SDAI LDA and remission. At year 1, 56.2 (95% CI: 47.6 to 64.7) versus 38.5% (30.3 to 46.7) of abatacept- vs infliximab-treated patients, respectively, achieved LDA, and 13.1 (7.3 to 18.9) versus 11.9% (6.4 to 17.3) achieved remission. At year 2, 63.5 (95% CI: 54.7 to 72.3) versus 65.1% (56.8 to 73.4) of original abatacept vs infliximab-to-abatacept switch patients, respectively, achieved LDA, and 21.7 (14.2 to 29.3) versus 24.6% (17.1 to 32.1) achieved remission.
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References

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