The importance of The Arthritis Advisory Committee
The Arthritis Advisory Committee is often assembled upon the request of the FDA to evaluate and review the efficacy and safety data of products and therapies that have been developed to treat arthritis. The FDA is not legally bound to follow the recommendation of the committee, but does trust their authority when considering therapies for approval.
The Arthritis Advisory Committee considered the safety and efficacy data of sirukumab from a Phase 3 clinical program that included five separate studies and overall involved more than 3,000 patients with RA. All of RA patients included in the study had been unsuccessful in finding alternative therapies that were effective and/or tolerable in the treatment of moderately to severely active RA.
Studied at 50 mg and 100 mg doses every two and four weeks, sirukumab was successful in demonstrating its efficacy in the treatment of RA. Sirukumab improved all of the signs and symptoms of RA, showing inhibition in the progression of structural damage. Sirukumab was also noted to improve patient's lives when reported in a patient-reported outcome, including factors such as quality of life, physical function, fatigue, and pain.
The data revealed that the most common adverse events in the clinical development phases of sirukumab included upper respiratory tract infections, colds, and laboratory abnormalities. Other common adverse events involved the injection of the drug and included swelling, pain, and redness at the site of injection. Less common but more serious adverse events included gastrointestinal perforations, lipid elevations, low platelets, hypersensitivity reactions, osteomyelitis, sepsis, abscess, cellulitis, and pneumonia. Also reported were malignancies, cardiovascular issues, and death as related to the clinical studies of sirukumab.