RoActemra is the result of a research collaboration by Chugai and is being co-developed globally with Chugai. RoActemra is the first humanized interleukin-6 receptor-inhibiting monoclonal antibodies. Actemra was approved in Japan, and launched by Chugai in June 2005 as a therapy for Castleman’s disease, in April 2008, additional indications for rheumatoid arthritis , polyarticular juvenile idiopathic arthritis and systemic-onset arthritis juvenile idiopathic arthritis were also approved in Japan. RoActemra has been approved in the EU in January 2009 for the treatment of rheumatoid arthritis in patients who have responded inadequately to two, or are intolerant to previous treatment with one or more disease-modifying anti-rheumatic drugs or tumor necrosis factor . It is also approved for use in over 90 countries, including India, Brazil, Switzerland and Australia. Actemra was approved in the U.S. in January 2010 for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have had an inadequate response to one or more TNF inhibitors. Additionally, Actemra was approved in the United States and Mexico for the treatment of patients with SJIA active in two or more years. The safety and efficacy of RoActemra in RA has been established in a large clinical development program, including five Phase III clinical trial enrolled more than 4,000 people with rheumatoid arthritis in 41 countries, including the United States. The overall safety profile of RoActemra is consistent in all clinical trials. Serious adverse events reported in clinical studies include serious infections RoActemra, gastrointestinal perforations and hypersensitivity reactions, including. The most common adverse events reported in clinical studies were upper respiratory tract infection, nasopharyngitis, increased ALT. The increase in liver enzymes were seen in some patients, these increases were generally mild and reversible. Treatments that suppress the immune system, such RoActemra, may cause an increased risk of malignancies.ACT-ray is a phase IIIb, double-blind two-year study to assess the efficacy and safety of adding RoActemra MTX MTX alone in switching from MTX RoActemra inadequate response , biological na ve, adult patients moderately to severely active RA. 556 patients with an inadequate response to MTX received RoActemra and were randomized to remain on a stable dose of methotrexate , or to receive a dose of matching placebo with 92 % completed the first 24 weeks. The primary endpoint of the study was to obtain the DAS28 remission has shown that monotherapy had similar efficacy to RoActemra RoActemra clinical MTX in patients with rheumatoid arthritis who had an inadequate response to MTX.
‘The results of the ACT-RAY further evidence of significant benefits alone RoActemra. RoActemra is approved for people with rheumatoid arthritis who do not respond or are unable to tolerate the side effects associated with methotrexate, a drug commonly used to the disease, ‘said Hal Barron, MD, Head of Roche Global Development and Medical Director. RoActemra is the first of a new class of treatments for rheumatoid arthritis targeting receptors of interleukin-6. It ‘is currently approved in Europe for the treatment of rheumatoid arthritis in people who have responded inadequately to two, or were intolerant to previous treatment with one or more DMARDs or tumor necrosis factor . The results of the ACT-ray on the basis of a previous phase III study which showed that, compared with MTX-treated patients achieved only RoActemra a greater reduction of signs and symptoms of rheumatoid arthritis in six months and almost three times as many patients with DAS28 remission. RoActemra is the first biological agent and the only one to have demonstrated superiority over MTX alone.
Methotrexate, a disease-modifying antirheumatic drugs , is widely prescribed for people with rheumatoid arthritis. However, up to 40 percent of those given MTX has not responded adequately to treatment or experience adverse events and require more drugs to control inflammation. The study data showed that the ACT-RAY RoActemra provided a clinical benefit, regardless of whether it was administered in combination with MTX or monotherapy.1
Roche has announced new data from the ACT-RAY, presented at the European League Against Rheumatism Congress. The results showed that in people with , RoActemra alone had comparable efficacy in clinical trials RoActemra in combination with methotrexate . The safety profile of RoActemra is consistent with previous clinical studies.
– The rapid onset of action of RoActemra has been maintained. 18.1 % and 15.
2 % of patients achieved remission in eight weeks in the combination of the monotherapy groups, respectively