Roche has announced that it has submitted a combined filing to the European health authorities (the European Medicines Agency) for three new indications to extend the label for MabThera to use as a first-line biologic therapy for patients with rheumatoid arthritis (RA).
The new filings are for patients who have not been treated with methotrexate (MTX), the current standard treatment option; those who have had an inadequate response to MTX; and for the prevention of joint damage across all RA patient populations.
Joint damage in RA often begins early in the disease, so it is critical to treat patients as early as possible to reduce symptoms and stop irreversible damage before it occurs. This damage can lead to permanent disability affecting patients' ability to carry out normal everyday activities such as walking or dressing.
MabThera (administered as courses of two infusions of 1000mg, with repeat treatment determined by disease activity) is already a well established therapeutic option when used later in the treatment algorithm. It is currently licensed for patients with moderate-to-severe disease who have not benefited from, or are intolerant to, one or more tumour necrosis factor (TNF) inhibitors. In this population, MabThera is the only RA therapy that has proven to offer the preservation of joint structure for patients, providing additional improvements in the signs and symptoms of RA with each repeat course of treatment.
"This filing represents a significant advance for patients with early rheumatoid arthritis", said Urs Schleuniger, Roche's Global Product Strategy Head, Inflammation/Immunology. "A successful regulatory outcome will mean that clinicians and patients have a new treatment option to tackle the disease early on, allowing patients to carry on with everyday tasks and activities without experiencing the detrimental effects of RA and irreversible damage to their joints."
The combined filing follows positive results from three large clinical trials: IMAGE, SERENE and MIRROR. The studies showed that MabThera, when used as the first biologic in combination with MTX, improves the signs and symptoms of RA in patients, compared to those patients treated with MTX alone. In addition, the IMAGE trial demonstrated that treatment with MabThera (two x 1000mg every 24 weeks), in combination with MTX, can significantly reduce the progression of joint damage including a reduction in bone erosions, where areas of the bone are destroyed.