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 per cent less damage to their joints compared to those treated with MTX, the current standard therapy, alone. 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 studies 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 three-year period, from 27 per cent at 24 weeks to 62 per cent 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:
Patients with no previous biologic therapy: After 96 weeks (1.8 years) of treatment with Actemra, close to 50 per cent of the patients had one or less swollen joint Patients with inadequate response to one or more tumour necrosis factor (TNF) inhibitors: Among those patients 34 per cent had one or less swollen joint after treatment with Actemra Patients who were MTX-naive and were treated with Actemra as monotherapy: 55 per cent had one or less swollen joint and 35 per cent had one or less tender joints after 96 weeks."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.
Actemra is the result of research collaboration by Chugai and is being co-developed globally with Chugai.