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Efficacy of Kineret® (anakinra) in patients with Rheumatoid Arthritis
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The efficacy and safety of Kineret® (anakinra) at a dosage of 100 mg/day in combination with methotrexate (MTX) in patients with rheumatoid arthritis (RA) has been assessed in a large, randomised, double-blind, placebo-controlled trial (Confirmatory Efficacy Study).1-3
In total, 906 patients met the American College of Rheumatology (ACR) criteria for entry,4 with features typical of active disease, and radiographic evidence of at least one bone erosion in the hands, wrists or feet. Patients had been receiving continuous MTX treatment for >6 months, with a stable weekly dosage of 15 to 25 mg for >3 months prior to enrolment. The primary endpoint of the study was the modified Sharp score at 52 weeks. However, an initial analysis was performed on the first 501 patients entering the trial who completed 24 weeks of treatment to provide additional data confirming the efficacy of Kineret® (anakinra) with respect to the signs and symptoms of RA.1-3
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24-week data for the first 501 patients in the Confirmatory Efficacy Study confirm the beneficial efficacy of Kineret® ( anakinra) with respect to signs and symptoms of RA
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Significantly more patients receiving Kineret® in combination with MTX achieved an ACR20 response compared with patients receiving placebo plus MTX (38% versus 22%, respectively; P <0.001). Furthermore, the response rate was significantly greater with Kineret® (anakinra) at each of the 4-weekly assessments (Figure 1). Twice as many patients treated with Kineret® as with placebo achieved an ACR50 or ACR70 response (Figure 2).1,3
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Figure 1. Percentage of patients achieving an ACR20 response over time (intent to treat analysis with non-responder imputation)1,3
Figure 2. Percentage of patients achieving an ACR50 or ACR70 response at week 24 (intent to treat analysis with non-responder imputation)1,3
Effects of Kineret® (anakinra) on Patient-Reported Outcomes
Kineret® (anakinra) produced significant improvements in a range of patient-reported outcomes (Table 1).1,3 Patients receiving Kineret® (anakinra) 100 mg/day experienced a 61% greater improvement in Heath Assessment Questionnaire disease index compared with patients receiving placebo (P <0.05). The change from baseline at 24 weeks with Kineret® (anakinra) was considered to be clinically meaningful (change greater than 0.22) (Figure 3).1,3 Kineret® (anakinra) also produced significantly greater improvements over time in patient global assessment of disease activity (P <0.001 at 24 weeks) and patient assessment of pain (P <0.01 at 24 weeks) compared with placebo (Figures 4 and 5).
Table 1. Kineret® (anakinra) produced significant improvements in patient-reported outcomes1,3
Figure 3. Change in HAQ disease index over time1,2
Figure 4. Change in global patient assessment of disease activity over time1,3
Figure 5. Change in patient assessment of pain over time1,3
Effects of Kineret® (anakinra) on Markers of Inflammation
Kineret® (anakinra) produced rapid and sustained decreases in C-reactive protein (CRP) levels and erythrocyte sedimentation rate (ESR) over time (Figures 6 and 7)1,3
Figure 6. Median change in CRP level over time1,3
Figure 7. Mean change in ESR over time1,3
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