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| |  ACR: Kineret (Anakinra) Beneficial in Treatment of Rheumatoid Arthritis By Bruce Sylvester Special to DG News SAN FRANCISCO, CA -- November 15, 2001 -- Kineret (anakinra) provides clinically significant benefit in rheumatoid arthritis (RA) as characterised by American College of Rheumatology (ACR) scores, time to onset of effect, and duration of response. This finding resulted from a large, placebo-controlled study presented today at the America College of Rheumatology annual meeting in San Francisco, California. Kineret was approved by the Food and Drug Administration (FDA) on November 14, 2001, for marketing in the United States. This double-blind, placebo-controlled, randomised trial was designed primarily to assess radiographically the reduction of disease progression and secondarily ACR scores. The study is ongoing and blinded to the primary end point, thus only the ACR scores are reported. Five-hundred-and-six patients were randomised to Kineret (100 mg/day subcutaneously) plus methotrexate (MTX) or MTX alone in a 1:1 ratio. Patients were over 18 years of age, had active RA for over six months, and radiographic evidence of at least one bone erosion. Prior to randomisation, patients were on stable doses of MTX (10-25 mg/wk), non-steroidal anti-inflammatory drugs (NSAIDs), and/or oral corticosteroids (10 mg/d). The primary analysis was ACR20 at week 24. Secondary analyses were ACR 50, ACR 70, and the proportion of subjects with sustained ACR20 response. Safety end points included adverse events, serious adverse events and infectious events. Five-hundred-and-one patients received at least one dose of study drug. The two treatment groups had similar demographics, disease status, and use of concomitant RA medications. Researchers observed higher response rates in Kineret plus MTX-treated patients compared to MTX alone in ACR 20 (38 percent vs. 22 percent; p<0.001), ACR 50 (17 percent vs. 8 percent; p=0.001) and ACR 70 (6 percent vs. 2 percent; p=0.024). A greater proportion of patients had a sustained ACR 20 response with Kineret plus MTX vs. MTX alone (27 percent vs. 12 percent; p<0.001). Patients treated with Kineret plus MTX vs. MTX alone had a two-fold higher ACR 20 response at week 4 (21 percent vs. 11 percent; p=0.004). Improvements in individual week 24 ACR components were all statistically significant with the exception of swollen joint count. Decreases in C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were five- and three-fold higher, respectively, for patients treated with Kineret plus MTX vs. MTX alone. Patients receiving Kineret plus MTX experienced a 61 percent improvement in the Health Assessment Questionnaire (HAQ) as compared to MTX alone. Kineret was well tolerated. The most frequent adverse event was the incidence of injection site reactions in patients treated with Kineret plus MTX as compared to MTX alone -- 65 percent vs. 24 percent. There were 8.4 percent of patients on anakinra plus MTX vs. 0.8 percent on MTX alone who withdrew due to injection site reactions (ISRs). Injection site reactions were characterised as mild to moderate and transient. Patients treated with kineret plus MTX vs. MTX alone have similar profiles of serious adverse events (4.4 vs. 3.2 percent; p=0.477), while serious infectious events occurred at equal frequency of 0.8 percent with no opportunistic infections. This study was supported by a grant from Amgen Inc.
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