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Findings From a Controlled Clinical Trial
A double-blind, placebo-controlled trial consisting of 899 patients with active rheumatoid arthritis (RA) was performed to assess the efficacy and safety of Kineret®. All patients were receiving regular doses of methotrexate (MTX) for a minimum of 8 weeks prior to study entry. In addition to their regular doses of MTX, patients were randomized to receive 100 mg daily subcutaneous injection of Kineret® or placebo for 24 weeks. Evaluation for improvement in signs and symptoms was performed on the first 501 patients to complete the trial and evaluation for progression of structural damage was performed on the full 899 patients.1 Regular dose ranges of MTX were between 10 and 25 mg per week. All patients had either an erythrocyte sedimentation rate (ESR) of at least 28 mm per hour, or a C-reactive protein (CRP) of at least 1.5 mg per deciliter. All patients had suffered at least 6 swollen or painful joints, and at least 9 tender joints.2 Clinical Efficacy The American College of Rheumatology (ACR) response criteria (ACR 20, ACR 50, and ACR 70) were used to determine the reduction of the symptoms of RA for the duration of the trial. The primary endpoint of the study was the proportion of patients achieving an ACR 20 response at week 24. A higher percentage of patients receiving Kineret® achieved an ACR 20 response than those receiving placebo (see Figure 1).3 Most responses were reached by the twelfth week of treatment, but some patients experienced improvement of RA symptoms as early as the fourth week of treatment.4,5
A completer's analysis showed that many of the patients who completed the first 24 weeks experienced substantial clinical improvement (see Figure 2). The completer subset comprised 77% of the original intent-to-treat population. Most clinical responses occurred within 12 weeks of enrollment in the trial.8
Slowing of Radiographic Progression Total Modified Sharp Score (TMSS) was used to assess the effect of Kineret® on the progression of bone and cartilage erosion and destruction over a 12-month timeline (see Figure 3). The erosion score (ES) and joint space narrowing (JSN) score subcomponents of the TMSS were also analyzed. Radiographs of hand, wrists, and forefeet were administered after 6 and 12 months. Findings were scored by neutral readers blinded to the treatment assignment. A significant difference was found between treatment with Kineret® and placebo for change in TMSS, ES, and JSN scores.11 After 52 weeks of treatment, 50% of patients on Kineret® had no radiographic progression from baseline (TMSS ≤ 0.0 units) (P = 0.018 vs MTX).12
Patient-Reported Outcomes After the first 6 months of the study and every following quarter thereafter, the disability index of the Health Assessment Questionnaire (HAQ) was conducted using participants in the study. Short Form-36 (SF-36) questionnaires were used to measure health outcomes. The physical component summary (PCS) score of the SF-36 demonstrated an improvement in patients using Kineret® versus those using a placebo, where the mental component summary showed no difference.14,15 Patient assessment of disease was found to be 2 times lower after 52 weeks of treatment with Kineret® vs placebo. Patient functionality, as measured by HAQ, also demonstrated a significant improvement over placebo (see Figure 4).16 Persistency in the Real-World A long-term, prospective, multicenter observation at study documents use patterns, effectiveness and safety of disease-modifying antirheumatic drugs (DMARDs) currently used in the management of RA enrolled 4,959 patients. To be enrolled, patients were required to be at least 18 years of age, have a diagnosis of RA by American College of Rheumatology. 191 of these RA patients failed one or more anti-TNF therapies and received Kineret®. At 6 months, 70% of this subset continued using Kineret®.17
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ABOUT KINERET® ABOUT IL-1 PROFESSIONAL RESOURCES REIMBURSEMENT IMPORTANT PRODUCT SAFETY INFORMATION GLOSSARY |
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