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FDA Expands Indication for Humira

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Faxwatch © 2004 Abbott Laboratories’ Humira (adalimumab) received approval from the Food and Drug Administration to be used to improve physical function in adult patients with moderately to severely active rheumatoid arthritis. This expanded indication was supported by results from a 52-week, open-label continuation trial that enrolled 457 patients with RA. All of the patients showed an inadequate response to methotrexate and were previously involved in a year-long, lead-in study.

The Health Assessment Questionnaire Disability Index, which assesses a patient’s ability to perform normal everyday activities, and the Short Form 36-item Health Survey, which examines the physical and mental impact of RA on patients, were used to measure improvements in patients' physical function throughout the study. During the trial, patients treated with Humira demonstrated meaningful improvements in physical function that were maintained through two years of treatment. Some patients began showing signs of improved physical function within two weeks of taking the drug.

"Improvement in physical function is an important goal of therapy for RA patients, who often experience disability and loss of function that can greatly reduce quality of life," Abbott said. Humira had already been approved to reduce the signs and symptoms of RA and to inhibit the progression of structural damage in adult patients with moderately to severely active RA who have shown an inadequate response to at least one disease-modifying antirheumatic drug.

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