ACTEMRA Significantly Reduced Signs, Symptoms Of Rheumatoid Arthritis
Data from two Phase III studies showed that patients who suffer from the debilitating and painful effects of rheumatoid arthritis (RA) achieved significant improvements in signs and symptoms when treated with ACTEMRA (tocilizumab) alone or in combination with methotrexate compared with methotrexate alone.
Results of the RADIATE study, which evaluated difficult-to-treat patients who failed to respond to prior anti-tumor necrosis factor (TNF)-alpha therapies, demonstrated that half of patients treated with ACTEMRA (8 mg/kg) in combination with methotrexate achieved a 20 percent reduction (ACR20)(1) in RA signs and symptoms, compared with 10 percent of patients treated with methotrexate alone.
"Despite treatment with existing therapies, many patients with RA continue to experience symptoms of joint pain and stiffness," said Mark Genovese, M.D., Professor of Medicine at Stanford University School of Medicine. "The compelling results of these studies further support the efficacy and safety of ACTEMRA as a potential new treatment option for managing the chronic signs and symptoms of this debilitating disease."
The AMBITION study, which examined the effects of ACTEMRA (8 mg/kg) as monotherapy, showed that 70 percent of patients receiving ACTEMRA achieved a 20 percent improvement in their signs and symptoms (ACR20), compared with 53 percent of patients receiving methotrexate alone. The study not only successfully met its primary endpoint of non-inferiority in patients with moderate to severe RA, but also demonstrated superiority over the standard effective dose regimen of methotrexate alone.
In both studies, nearly one-third of all ACTEMRA (8 mg/kg) patients achieved disease remission (as defined by DAS28 <2.6(2)) and ACTEMRA was generally well-tolerated compared with existing therapies.
About the RADIATE Study
RADIATE (RheumAtoiD ArthritIs Study in Anti-TNF FailurEs), a three-arm, randomized, double-blind, placebo-controlled study, was designed to evaluate the safety and efficacy of ACTEMRA plus methotrexate compared with placebo plus methotrexate in patients who failed to adequately respond to anti-TNF-alpha medications alone.? Between 13-17 percent of the study population experienced three or more prior anti-TNF-alpha failures. Patients were randomized to receive either ACTEMRA intravenously (4 mg/kg or 8 mg/kg) plus methotrexate every four weeks or placebo infusions plus methotrexate weekly for 24 weeks. The study included nearly 500 patients from 128 sites in 13 countries, including the United States.
In the study, 50 percent, 29 percent and 12 percent of RA patients treated with ACTEMRA 8 mg/kg plus methotrexate achieved ACR20, ACR50 and ACR70, respectively, and 30 percent, 17 percent and 5 percent of patients in the ACTEMRA 4 mg/kg arm achieved these ACR scores, respectively. In contrast, 10 percent, 4 percent and 1 percent of patients in the control group achieved ACR20, ACR50 and ACR70, respectively. Furthermore, disease remission (DAS28 <2.6) was demonstrated in 30 percent and 8 percent of patients treated with ACTEMRA 8 mg/kg and 4 mg/kg, respectively, compared with 1.6 percent of patients in the control group.
Treatment with ACTEMRA and methotrexate showed significant clinical benefits even in the subgroup analysis of difficult-to-treat patients who received up to three anti-TNF-alpha therapies that failed.
The most common adverse reactions reported most frequently in the ACTEMRA arms of the RADIATE study were diarrhea, upper abdominal pain, rash and dizziness.