The innovative new rheumatoid arthritis drug Actemra (tocilizumab) has been shown to significantly improve the signs and symptoms of rheumatoid arthritis (RA) in patients who failed to achieve an adequate response to traditional disease modifying agents (DMARDs). Exciting new data from the TOWARD1 study, being presented as a late breaker, at the American College of Rheumatology (ACR) Annual Scientific Meeting in Boston, November 6-11, reinforce the benefit of tackling RA through the inhibition of the IL-6 pathway.
In the TOWARD trial, 61% of patients in the Actemra plus DMARD group achieved a 20% reduction in RA symptoms (ACR202 response) compared with only 25% of patients in the control group. Around one in three patients achieved clinical remission in the Actemra group, as assessed using DAS28 <2.63 .These results are consistent with the results of another Actemra trial, the OPTION4 study, which were previously reported and which will be the subject of further presentations at ACR. The OPTION study showed that 59% of patients in the Actemra treatment arm experienced a 20% reduction in RA symptoms (ACR20 response) versus only 27% of patients in the control group.
"We are very encouraged by the findings of this new TOWARD data which suggest that Actemra plus DMARDs demonstrates significant improvement in RA symptoms compared with DMARDs alone," said Mark C. Genovese, M.D., lead study investigator of the TOWARD trial and associate Professor of Medicine at Stanford University School of Medicine. "These data further establish the efficacy of Actemra and confirm that inhibiting the interleukin-6 (IL-6) receptor is a novel method of reducing RA symptoms."
"These results show that remission rates achieved with Actemra compare favourably with current RA therapies indicating the medicine's potential to become a very effective new treatment option," said Dr. Urs Schleuniger, Head of Inflammatory Diseases, Roche. "Findings from the TOWARD and OPTION studies will be part of the application to Regulatory Authorities that we intend to submit by the end of the year."
About TOWARD Study
Patients were randomized to receive either Actemra intravenously (8mg/kg) every four weeks plus DMARDs weekly or placebo infusions plus DMARDs weekly. The multicentre study treated 1,216 patients at 130 trial sites in 18 countries, including the U.S. At 24 weeks significantly more patients achieved a 20%, 50% and 70% (ACR20, ACR50 and ACR70) reduction of symptoms with Actemra plus DMARDs compared to the control group. The ACR20, ACR50 and ACR70 was achieved in 61%, 38% and 21%, respectively, of Actemra plus DMARDs patients versus 25%, 9% and 3%, respectively, in the placebo plus DMARDs arm. Disease remission was demonstrated in 30% of Actemra patients (DAS28 <2.6) compared with 3% of patients treated with only DMARDs.
About OPTION Study
In the OPTION trial, 623 patients were randomized to receive Actemra intravenously (either 4mg/kg or 8mg/kg) every four weeks plus methotrexate weekly or placebo infusions plus methotrexate weekly. The study was conducted in 73 trial sites in 17 countries, outside the United States. At 24 weeks significantly more patients achieved a 20%, 50% and 70% (ACR20, ACR50 and ACR70) reduction of symptoms with Actemra plus methotrexate compared to the control arm. Fifty nine per cent, 44% and 22%, respectively, of patients treated with Actemra (8mg/kg) plus methotrexate achieved ACR20, ACR50 and ACR70 compared with 27%, 11% and 2%, respectively, in the control group. Disease remission was demonstrated in 28% of Actemra patients (DAS28 <2.6) compared with 1% of patients treated with methotrexate alone.
Other parameters measured in both studies included levels of C-reactive protein (CRP), a marker of inflammation, fatigue and haemoglobin. Patients on Actemra showed a rapid normalisation of the CPR levels within two weeks and a rapid improvement in haemoglobin levels. According to both studies, patients treated with Actemra plus DMARDs experienced greater improvements in quality of life and function measures, including fatigue and physical and mental functions compared to placebo plus DMARDs.
Actemra generally well tolerated in both TOWARD and OPTION
Actemra was generally well tolerated in both studies. The most common adverse events reported more frequently in the Actemra arm were upper respiratory tract infections, headache, nasopharyngitis and hypertension. As with other disease modifying anti-rheumatic drugs, serious infections have been reported in some patients treated with Actemra.
Actemra is the first humanised interleukin-6 (IL-6) receptor inhibiting monoclonal antibody and represents a novel mechanism of action to treat RA, a disease with a high unmet medical need. The overall safety profile observed in the global studies of Actemra is consistent and Actemra is generally well tolerated.
About rheumatoid arthritis
Rheumatoid arthritis is a progressive, systemic autoimmune disease characterized by chronic inflammation of multiple joints and fatigue as well as the possibility of osteoporosis, anaemia, and lung, skin and liver effects.
All trademarks used or mentioned in this release are protected by law.
Roche & Autoimmune diseases: www.roche.com/med_events_mb1106
1. TOWARD refers to Tocilizumab in cOmbination With traditional DMARD therapy
2. The ACR response is a standard assessment used to measure patients' responses to anti-rheumatic therapies, devised by the American College of Rheumatology (ACR). It requires a patient to have a defined percentage reduction in a number of symptoms and measures of their disease. For example, a 20%, 50% or 70% level of reduction (the percentage of reduction of RA symptoms) is represented as ACR20, ACR50 or ACR70. An ACR70 response is exceptional for existing treatments and represents a significant improvement in a patient's condition.
3. The Disease Activity Score (DAS)28 is a combined index that measures disease activity in patients with RA. It combines information 28 tender and swollen joints (range0-28), erythrocyte sedimentation rate, and a general health assessment on a visual analog scale. The level of disease activity is interpreted as low (DAS28¡Ü3.2), moderate (3.2 4. OPTION refers to the TOcilizumab Pivotal Trial in Methotrexate Inadequate respONders
4. OPTION refers to the TOcilizumab Pivotal Trial in Methotrexate Inadequate respONders