Study shows MabThera continues to improve patient response in rheumatoid arthritis with multiple courses of treatment
MabThera shown to be effective and well tolerated over the long-term
A study has shown that rheumatoid arthritis patients given multiple courses of MabThera experienced further improvements in their condition with each subsequent treatment course. The patients in the study all suffered from moderate to severe rheumatoid arthritis (RA) and had failed to respond adequately to another class of RA drug known as tumour necrosis factor (TNF) inhibitors, the most commonly prescribed first-line biologic therapy for RA. The continued response seen with MabThera is a particularly important outcome as it highlights durable efficacy over time.
The impressive new data1 presented at the American College of Rheumatology (ACR) annual meeting in San Francisco show that MabThera continues to improve RA symptoms with each subsequent course of treatment, maximising patient response. The number of patients achieving remission from their disease doubled over three successive treatment courses with MabThera (Disease Activity Scores, DASi, increased from 8.8% after the first course to 17.6% after the third course). Additionally, almost twice as many patients achieved a 70% reduction of their symptoms1 after their third course of treatment compared to their first course of treatment (increase in ACR70ii response from 14% to 25.7%).
"Prolonged treatment with MabThera clearly demonstrates an improvement in symptoms for patients with rheumatoid arthritis who do not respond adequately to TNF inhibitor therapy," said Professor Edward Keystone, Rheumatology Department at the University of Toronto, Canada. "These findings confirm that MabThera controls rheumatoid arthritis very effectively, giving patients greater freedom from the disease with repeat courses of treatment."
Long term treatment with MabThera also shown to reduce joint damage
MabThera's effectiveness over the long term is reinforced by further data presented at ACR which demonstrate that the drug continues to significantly inhibit the progression of joint damage caused by RA over a period of two years in those patients who do not respond to TNF inhibitor therapy2. Damage to the structure of joints ultimately causes joint destruction and contributes to joint deformity and loss of mobility. The inhibition of structural damage is therefore a major goal of treatment. In patients who do not respond to TNF inhibitor therapy, MabThera is the first and only therapy to have demonstrated a reduction in joint structural damage.
Data demonstrate long-term safety of MabThera
Six-year follow-up data also presented at the ACR prove that MabThera continues to be well-tolerated over several courses of treatment. The safety profile of MabThera remained consistent with a low rate of adverse events and infections in 2578 patients, receiving multiple treatment courses. These results add to the wealth of data contributing to MabThera's safety profile with 5013 patient-years of follow-up now collected.3
Commenting on the findings, Dr. Ronald van Vollenhoven, Rheumatology Unit at Karolinska University Hospital, Sweden, said, "This data confirms that the excellent safety profile identified with MabThera in clinical trials after one course of therapy is maintained over multiple courses. This is very reassuring for physicians. Given that rheumatoid arthritis is a long-term condition, we want to ensure that treatments for patients are both effective and safe over an extended period of time."
Editor's Notes
About rheumatoid arthritis and MabThera
Rheumatoid arthritis (RA) is an autoimmune disease characterized by inflammation that leads to stiff, swollen and painful joints. This ultimately results in irreversible joint damage and disability. MabThera selectively targets B cells and represents a new highly effective therapeutic approach for RA in addition to existing treatments such as disease-modifying anti-rheumatic drugs (DMARDs) and tumour necrosis factor (TNF) inhibitors.
B cells are known to play a key role in the inflammation associated with RA. As the first and only selective B cell therapy available for the treatment of RA, MabThera represents a proven and truly different alternative for patients who have inadequate response or are not able to tolerate TNF inhibitor therapy. MabThera is the only RA treatment that has demonstrated the ability to preserve joint structure in this patient group and offers an unprecedented duration of response of at least six months with each course. Each course of MabThera also provides the opportunity of sustained or improved relief for patients from the signs and symptoms of their disease.
MabThera is marketed in the US by Genentech and Biogen Idec under the brand name Rituxan.
About Roche in rheumatoid arthritis
One of the most important drivers for growth at Roche over the next few years is expected to be the company's emerging franchise in autoimmune diseases with rheumatoid arthritis as the first indication. Following the launch of MabThera (rituximab) there are a number of projects in development, potentially allowing Roche to build on further opportunities. MabThera is the first and only selective B-cell therapy for RA, providing a fundamentally different treatment approach by targeting B cells, one of the key players in the pathogenesis of RA. Actemra is Roche's second novel medicine and is a humanised monoclonal antibody to the interleukin-6 (IL-6) receptor, inhibiting the activity of IL-6, a protein that plays a major role in the RA inflammation process. Additional projects creating a rich pipeline include compounds in Phase I, II and III clinical trials. Notably, ocrelizumab, a humanised anti-CD20 antibody, has entered phase III development for RA.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 80,000 people. Additional information is available on the Internet at www.roche.com [1].
Links:
[1] http://www.roche.com