Roche Pharmaceuticals is all set to address the unmet need in rheumatology by developing therapies that help patients achieve the ultimate goal of remission. This move is expected to benefit several patients who fail to respond effectively to the current treatments.
As part of this initiative, for the treatment of rheumatoid arthritis (RA) the company has introduced its auto-immune franchise Actemra (tocilizumab), the first IL-6 receptor inhibitor in the world, in India. Roche received the approval to market Actemra (tocilizumab) in the country recently.
Actemra is indicated for treatment of patients with rheumatoid arthritis, poly-articular active juvenile idiopathic arthritis and systemic juvenile idiopathic disease. Actemra is also indicated in patients affected with castlemans disease for improvement in the symptoms and laboratory findings associated with the disease.
Actemra is a 'first-in-class' medicine that has undergone a comprehensive and extensive development programmes. It has been co-developed globally with Roche's partner in Japan, Chugai. More than 4,000 RA patients in 41 countries, including Europe and US, were enrolled in Roche's largest phase III programme to date.
Actemra is a humanised monoclonal antibody that blocks the activity of interleukin 6 (lL-6), the master cytokine that plays a major role in the inflammation process associated with RA. Studies have shown that overproduction of IL-6 and the IL-6 receptor leads to inflammation, swelling, joint damage and destruction, and many systemic symptoms associated with the disease. By blocking the action of IL-6, Actemra rapidly improves the signs and symptoms of RA by reducing inflammation both in the joints and throughout the body, thereby helping more patients to achieve the ultimate goal of remission.
The first two of these global phase III trials, OPTION and TOWARD, showed 28 per cent and 30 per cent of patients (respectively) treated with Actemra achieved the ultimate goal of remission (DAS28 2.6) with rapid improvements in the signs and symptoms of RA.
Two further multinational phase III studies - RADIATE and AMBITION - were also undertaken. RADIATE examined the safety and efficacy of Actemra in combination with methotrexate in patients who had an inadequate response to anti-tumour necrosis factor therapy (antiTNFs). AMBITION examined the safety and efficacy of Actemra monotherapy against a standard, effective regimen of methotrexate in patients with active RA, including a high proportion of patients with early disease. Both these studies have also been successful.
The company's broad autoimmune disease portfolio and strong pipeline contain clinically differentiated compounds. MabThera, the first selective B cell therapy, is also the first licensed product within the company's autoimmune franchise for the treatment of RA.