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Evaluation of abatacept in biologic-naïve patients with active rheumatoid arthritis

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Abstract

This article reviews the efficacy, safety, and tolerability of abatacept plus methotrexate in patients with active rheumatoid arthritis (RA) and an inadequate response to methotrexate who are naïve to biologic disease-modifying antirheumatic drugs (DMARDs). Data from the randomized, double-blind, placebo-controlled Abatacept in Inadequate Responders to Methotrexate, Abatacept or Infliximab vs Placebo, a Trial for Tolerability, Efficacy, and Safety in Treating Rheumatoid Arthritis, and phase IIb dose-finding trials and their long-term extensions are reviewed. Abatacept plus methotrexate significantly improved clinical responses, physical function, and health-related quality of life compared with methotrexate alone. More patients receiving abatacept plus methotrexate than methotrexate monotherapy achieved a low disease activity state or remission. Radiographic progression of the disease was significantly slowed in the abatacept plus methotrexate arms. Abatacept plus methotrexate was generally well tolerated with no clinically significant safety issues identified. The beneficial effects of abatacept plus methotrexate were sustained long term in extension studies, and no new tolerability or safety issues were evident. Abatacept in combination with methotrexate is an effective, safe, and well-tolerated long-term therapy in biologic-naïve patients with active RA and an inadequate response to methotrexate. Abatacept could be considered as a first-line biologic DMARD in the treatment of RA.

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Acknowledgement

The authors thank Janet Manfre of Wolters Kluwer for editorial assistance in the preparation of this manuscript.

Disclosures

Michael Schiff serves as a consultant for and receives grant support from UCB Pharma.

Louis Bessette serves as an investigator in clinical studies for and receives honorariums for talks and consultant (AdBoard) from Bristol-Myers Squibb.

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Correspondence to Michael Schiff.

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Support for this paper was provided by Bristol-Myers Squibb Canada Co.

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Schiff, M., Bessette, L. Evaluation of abatacept in biologic-naïve patients with active rheumatoid arthritis. Clin Rheumatol 29, 583–591 (2010). https://doi.org/10.1007/s10067-009-1363-0

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