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Addition of Etanercept to Anakinra Offers No Added Benefit But More Toxicity in Patients With Rheumatoid Arthritis

There is no evidence that etanercept provides added benefit when combined to anakinra for the treatment of patients with active rheumatoid arthritis despite the use of methotrexate.

"These results suggest that use of combination treatment with anakinra and etanercept is not justified in patients with rheumatoid arthritis (RA)," write Mark C. Genovese, MD, and colleagues, Stanford University, California, United States.

The researchers enrolled 244 patients with active rheumatoid arthritis that did not respond to methotrexate therapy and randomly assigned them in a 1:1:1 ratio to receive 25 mg of etanercept twice weekly plus placebo once daily, 25 mg of etanercept once weekly plus 100 mg anakinra daily, or 25 mg of etanercept twice weekly plus 100 mg of anakinra once daily.

Most patients were women with long-standing and very active disease. The primary end point was the proportion of patients achieving an American College of Rheumatology (ACR) response of 50% (ACR50) at week 24.

Patients were considered ACR50 responders if they had at least a 50% reduction in the number of tender and swollen joints and in 3 of the following 5 measures: patient's assessment of disease activity by visual analogue scale (VAS), physician's assessment of disease activity by VAS, patient's assessment of pain by VAS, disability score as measured by the Health Assessment Questionnaire, and acute phase reactants (C-reactive protein or erythrocyte sedimentation rate).

Safety assessment data were collected regularly at every visit. The primary comparison was the full dosage etanercept plus anakinra group against the etanercept-only group.

Patients in all treatment groups showed improvement from baseline at week 24. Therapy in the etanercept-only group resulted in an ACR50 of 41%, compared with 31% in the full-dosage etanercept plus anakinra group (P = .914). Evaluation of the ACR20 and ACR70 response rates confirmed that combination therapy was not superior to etanercept alone.

The proportion of patients reporting adverse events was similar for each treatment group (90%-95%). However, combination therapy with anakinra and etanercept was associated with a higher incidence of serious adverse events, events causing patient withdrawal from study, and injection-site reactions.

"Combination therapy with etanercept plus anakinra provided no treatment benefit over etanercept alone, regardless of the regimen, but was associated with increased safety risk," the authors conclude.
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"

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