The first Phase III study involving the use of Actemra in the treatment of rheumatoid arthritis has revealed that it is superior to conventional treatment modality that uses disease modifying anti-rheumatic drugs (DMARDs to inhibit joint destruction. It has also been found to provide symptomatic relief and improve sensation of pain.
Rheumatoid arthritis is a debilitating autoimmune disease in which the lining of the joints becomes inflamed causing irreversible joint damage and destruction. Actemra (tocilizumab) is a humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody. A monoclonal antibody is used to denote antibodies derived from genetically identical group of cells, a clone. The novel mechanism of action of the antibody can eventually pave way for a new therapeutic option for the treatment of RA.
Nearly 306 patients with early aggressive rheumatoid patients were taken up for the study and were randomized to receive either Actemra as monotherapy or traditional treatment. Actemra was administered at 8 mg/kg I.V for every three weeks while the other group underwent treatment for 52 weeks. The administration of anti-TNF agents and leflunomide were restricted in the control group.
At the end of the study, the results were compared which revealed that there was a substantial reduction in the progression of joint damage over a 1-year period. Actemra was superior to DMARDs in preventing both erosion and joint space narrowing. Furthermore, the results are more promising in patients with early, aggressive disease.
The tolerability of the monotherapy was comparatively much higher in the Actemra group. Although there was a slight increase in the cholesterol level initially, it soon stabilized around the upper limit of normal. There was no incidence of tuberculosis in the group studied.
Similar clinical trials are being conducted in Europe and US to determine the efficacy and safety of Actemra in combination with other anti-rheumatoid medications. Head of Global Pharma Development, Roche, expressed his hope regarding the outcome of the clinical trials, expected to be released in the near future.