Basel, October 17, 2009
ACTEMRA inhibits progression of joint destruction in RA patients by over 80% compared to methotrexate alone
Long-term data also demonstrate unprecedented remission rates that increase over time
Two-year data from the LITHE study, being presented at the American College of Rheumatology, show that, with long-term use, patients with rheumatoid arthritis treated with ACTEMRA (tocilizumab, known as RoACTEMRA within the EU) plus methotrexate (MTX) suffered 81% less damage to their joints compared to those treated with MTX, the current standard therapy, alone1. For patients, this means that their joint damage is significantly reduced, and that they can therefore continue to enjoy their lives without the evolving disability usually associated with the disease.
Furthermore, data from two long-term extension studies2 also being presented at the meeting demonstrate that the percentage of ACTEMRA patients achieving remission from their disease (DAS28<2.6) increased steadily over a 3-year period, from 27% at 24 weeks to 62% at 180 weeks (3.4 years).
The unprecedented remission rates seen with ACTEMRA were primarily the result of the profound effect on swollen and tender joints across a range of patient populations:
"These data confirm that tocilizumab is very effective at inhibiting the damage to joints which is characteristic of rheumatoid arthritis,” says Professor Josef Smolen, University of Vienna, Austria. “This impressive effect on joints, coupled with the previously shown ability of tocilizumab to provide relief from the signs and symptoms of RA gives it an important role within clinical practice. Successful remission with tocilizumab may help to restore a patient’s sense of freedom, without painful flare-ups or fear of long-term disability."
The long-term safety profile of ACTEMRA is well characterised in 2.4 year data3, being presented at the ACR, from the most comprehensive registration trial programme for any RA biologic, with almost 4,000 patients participating in the programme. Analysis from the Phase III programme (including five pivotal trials and two long-term extension studies) show that adverse events and severe adverse events remained stable over extended periods of time.
About the studies
About the LITHE study
The LITHE study, a randomised, double-blind, placebo-controlled trial was designed to evaluate the efficacy of TCZ plus MTX in preventing structural joint damage and improving physical function over two years. LITHE was an international study, including 15 countries and 1196 patients with moderate to severe RA who had an inadequate response to MTX. In this randomised study, patients received either ACTEMRA (4 mg/kg or 8 mg/kg, one infusion every four weeks) in combination with MTX or MTX alone. Results from the 24-month analysis showed that at 104 weeks, total Genant-modified Sharp Score change from baseline for the ACTEMRA 8mg + MTX, 4mg +MTX, and MTX alone groups were: 0.37, 0.58 and 1.96 respectively.
About the long-term extension studies
Patients participating in the most comprehensive trial programme for any biologic in RA including four pivotal studies (OPTION, TOWARD, RADIATE, AMBITION), were entered into two long-term extension studies (GROWTH95, GROWTH96), which examined safety and efficacy of ACTEMRA across a number of different patient populations: DMARD insufficient response (IR), anti-TNF-IR and monotherapy. Over 3,986 patients were included in the 2.4 year safety, and 3.5 year efficacy analyses. Long-term extension studies have shown low discontinuation rates due to side-effects (5.8/100 patient years).
ACTEMRA is the result of research collaboration by Chugai and is being co-developed globally with Chugai. ACTEMRA is the first humanised interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody. An extensive clinical development programme of five Phase III trials was designed to evaluate clinical findings of ACTEMRA, all of which met their primary endpoints. ACTEMRA was first approved in Japan, and launched by Chugai in June 2005 as a therapy for Castleman's disease; in April 2008, additional indications for RA, juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis were also approved in Japan. ACTEMRA was approved in the European Union in January 2009 for the treatment of RA in patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease modifying anti-rheumatic drugs (DMARDs) or TNF inhibitors. It is also approved for use in several other countries, including India, Brazil, Switzerland and Australia.
The overall safety profile of ACTEMRA is consistent across all global clinical studies. The serious adverse reactions reported in ACTEMRA clinical studies include serious infections, gastrointestinal perforations and hypersensitivity reactions including anaphylaxis. The most common adverse reactions reported in clinical studies were upper respiratory tract infection, nasopharyngitis, headache, hypertension and increased ALT. Increases in liver enzymes (ALT and AST) were seen in some patients; these increases were generally mild and reversible, with no evidence of hepatic injuries or any observed impact on liver function. Laboratory changes, including increases in lipids (total cholesterol, LDL, HDL, triglycerides) and decreases in neutrophils and platelets, were seen in some patients without association with clinical outcomes. Treatments that suppress the immune system, such as ACTEMRA, may cause an increase in the risk of malignancies.
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1. LITHE: Tocilizumab inhibits radiographic progression and improves physical function in rheumatoid arthritis (RA) patients (Pts) at 2 years with increasing clinical efficacy over time. Fleischmann, R et al. Oral presentation at ACR, 18th October 2009
2. Long-term efficacy of tocilizumab in rheumatoid arthritis for up to 3.5 years. Smolen J et al. Oral presentation at ACR, 18th October 2009
3. Long-term safety and tolerability of tocilizumab treatment in patients with rheumatoid arthritis and a mean treatment duration of 2.4 years. Van Vollenhoven, R et al. Poster presentation at ACR, 20th October 2009