RESEARCH - Selective co-stimulation modulation using Orencia in RA patients receiving Enbrel

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Ann Rheum Dis. 2006 Aug 25; [Epub ahead of print]

Selective co-stimulation modulation using abatacept in patients with active

rheumatoid arthritis while receiving etanercept: a randomized clinical

trial.

Weinblatt ME, Schiff MH, Goldman A, Kremer JM, Luggen M, Li T, Chen D,

Becker JC.

Brigham & Womens Hospital, Boston, MA, United States.

OBJECTIVE: To investigate the efficacy and safety of abatacept in

combination with etanercept in patients with active rheumatoid arthritis

(RA) during a 1-year, randomized, placebo-controlled, double-blind (DB)

phase, followed by an open-label, long-term extension (LTE). METHODS:

Patients continued etanercept (25 mg biweekly) and were randomized to

receive abatacept 2 mg/kg (n=85) or placebo (n=36). Since the effective dose

of abatacept was established as 10 mg/kg in a separate trial, all patients

received abatacept 10 mg/kg and etanercept during the LTE. RESULTS: A total

of 121 patients were randomized; 80 completed DB therapy and entered the

LTE. During DB treatment, the difference in the percentage of patients

achieving the primary endpoint (modified American College of Rheumatology

[ACR] 0 response at 6 months) was not significant between groups (48.2%

versus 30.6%; p=0.072). At 1 year, no notable changes in modified ACR

responses were observed. Subsequent to the dosing change, similar modified

ACR responses were seen during the LTE. Significant improvements in quality

of life were observed with abatacept/etanercept versus placebo/etanercept in

five of the eight Short Form-36 (SF-36) subscales at 1 year. More abatacept

plus etanercept-treated patients experienced serious adverse events (SAEs)

at 1 year than patients receiving placebo plus etanercept (16.5% vs 2.8%),

with 3.5% vs 0% experiencing serious infections.

CONCLUSION: The combination of abatacept (dosed at 2 mg/kg during the DB

phase and 10 mg/kg during the LTE) plus etanercept was associated with an

increase in SAEs, including serious infections, with limited clinical

effect. Based on the limited efficacy findings and safety concerns,

abatacept in combination with etanercept should not be used for RA therapy.

PMID: 16935912

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_uids=1\

6935912

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