RESEARCH - Safety and efficacy of Orencia in patients with RA receiving background MTX

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J Rheumatol. 2009 Apr;36(4):736-42. Epub 2009 Feb 27.

Safety and Efficacy of the Selective Costimulation Modulator Abatacept

in Patients with Rheumatoid Arthritis Receiving Background

Methotrexate: A 5-year Extended Phase IIB Study.

Westhovens R, Kremer JM, Moreland LW, Emery P, AS, Li T,

Aranda R, Becker JC, Qi K, Dougados M.

Department of Rheumatology, KU Leuven, Herestraat 49, B 3000 Leuven, Belgium.

OBJECTIVE: To evaluate the safety and efficacy of abatacept plus

methotrexate (MTX) over 5 years in patients with rheumatoid arthritis.

METHODS: Patients were randomized to abatacept 10 or 2 mg/kg or

placebo, plus MTX. Patients completing the 1-year, double-blind period

entered the longterm extension, where all patients received a fixed

dose of abatacept ~10 mg/kg. We describe safety analyses for all

patients who received at least 1 dose of abatacept and efficacy

analyses for the original ~10 mg/kg abatacept-treated group, over 5

years.

RESULTS: Of the 235 abatacept- or placebo-treated patients completing

the double-blind period, 219 entered the longterm extension; 130

(59.4%) were continuing at Year 5. No unexpected safety events were

observed during the longterm extension compared with the double-blind

period. Incidence rates of adverse events (AE) and serious AE were

489.7 and 20.0/100 patient-years in Year 1 versus 374.9 and 18.9/100

patient-years in the cumulative period, respectively. Using

exploratory analyses, improvements observed at Year 1 in the 10 mg/kg

group were maintained at Year 5, as assessed by ACR responses (ACR20 =

77.1% vs 82.7%; ACR50 = 53.0% vs 65.4%; ACR70 = 28.9% vs 40.4% at

Years 1 and 5, respectively) and disease activity (Low Disease

Activity State = 48.2% vs 58.5%; Disease Activity Score-28-defined

remission = 25.3% vs 45.3% at Years 1 and 5, respectively).

CONCLUSION: Abatacept maintained the efficacy observed at Year 1 over

5 years of treatment, and demonstrated consistent safety and

tolerability. These data, along with relatively high retention rates,

support the longterm clinical benefit provided by selective T cell

costimulation modulation. Clinical trial registry: ClinicalTrials.gov;

clinical trial registration number: NCT00254293.

PMID: 19273451

http://www.ncbi.nlm.nih.gov/pubmed/19273451

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