Roche Holding AG announced that the European Commission has approved the use of MabThera (rituximab) in Europe for patients with RA. The European Commission also approved the drug as maintenance therapy for patients with Non-Hodgkin’s Lymphoma. In its press release, Roche states that MabThera has been used to treat 730,000 patients over a seven-year period with no major safety concerns.
The FDA approved rituximab for use in the U.S. in February 2006. Genentech, Inc. and Biogen Idec, Inc. market it in the U.S. under the brand name Rituxan. Roche holds a majority ownership of Genentech, Inc.
MabThera/Rituxan kills B-cells, white blood cell made in the bone marrow that releases antibodies in an immune system response. The typical course of treatment is two infusions, lasting for 3-6 hours, spaced two weeks apart. It is typically used in combination with methotrexate to treat adult patients with severe arthritis who have not responded or do not tolerate other treatment options including one or more TNF-inhibitor drugs such as Humira.
Phase III clinical trials are currently in progress to investigate potential clinical benefits to treating patients with RA in its early stages. Approval in the U.S. and EU was based on the results of a different Phase III study called REFLEX. In that study, patients were treated with a combination of MabThera/Rituxan and a steady dose of methotrexate. Patients received two infusions of MabThera in two 1000mg doses, two weeks apart.
The study showed that patients who received this treatment showed more significant improvement after 24 weeks than patients who received placebos. Roche claims that one-year data recently presented in Europe shows that MabThera significantly inhibits the structural damage to joints caused by RA. The study also showed that patients who received a second course of treatment at 6-12 months experienced further improvements and doubled the likelihood of remission (13% versus the 6% who received one course of treatment).