Combination therapy with Enbrel and Kineret in RA

[Guest guest]

Arthritis Rheum. 2004 May;50(5):1412-9.

Combination therapy with etanercept and anakinra in the treatment of

patients with rheumatoid arthritis who have been treated unsuccessfully

with methotrexate.

Genovese MC, Cohen S, Moreland L, Lium D, Robbins S, Newmark R, Bekker

P; 20000223 Study Group.

Stanford University, 1000 Welch Road, Suite 203, Palo Alto, CA 94304,

USA. genovese@...

OBJECTIVE: To determine the potential for additive or synergistic

effects of combination therapy with the selective anti-tumor necrosis

factor alpha agent etanercept and the anti-interleukin-1 agent anakinra.

METHODS: Two hundred forty-four patients in whom rheumatoid arthritis

(RA) was active despite methotrexate therapy were treated with

subcutaneous etanercept only (25 mg twice weekly), full-dosage

etanercept (25 mg twice weekly) plus anakinra (100 mg/day), or

half-dosage etanercept (25 mg once weekly) plus anakinra (100 mg/day)

for 6 months in a double-blind study at 41 centers in the US. Patients

had never previously received anticytokine therapy. Patient response was

measured with the American College of Rheumatology (ACR) core set

criteria, a health-related quality-of-life questionnaire, and the

Disease Activity Score. Safety was assessed by the number of adverse

events and clinical laboratory values. Plasma concentrations of both

agents and antibody formation against both agents were also assessed.

RESULTS: Combination therapy with etanercept plus anakinra provided no

treatment benefit over etanercept alone, regardless of the regimen, but

was associated with an increased safety risk. Thirty-one percent of the

patients treated with full-dosage etanercept plus anakinra achieved an

ACR 50% response, compared with 41% of the patients treated with

etanercept only. This result was not statistically significant (P =

0.914). The incidence of serious infections (0% for etanercept alone,

3.7-7.4% for combination therapy), injection-site reactions, and

neutropenia was increased with combination therapy. Combination therapy

had no effect on the pharmacokinetics or immunogenicity of either agent.

CONCLUSION: Combination therapy with etanercept and anakinra provides no

added benefit and an increased risk compared with etanercept alone and

is not recommended for the treatment of patients with RA.

PMID: 15146410

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org