Drug Updates September 2006
Taken from NRAS magazine, Autumn 2006
New Type of Biologic Treatment Launched
MabThera works by directly targeting cells in the immune system, called B-cells, which are known to play a key role in the development and progression of RA. This new therapy offers a unique approach to the treatment of severe active adult RA.
Professor Paul Emery, arc Professor of Rheumatology, Leeds Teaching Hospitals NHS Trust, comments, "This is a very exciting time – with the launch of MabThera we have a new approach that has the ability to provide long lasting clinical benefits for patients who do not receive relief from existing treatments."
MabThera in combination with methotrexate is licensed for the treatment of severe active rheumatoid arthritis in adult patients who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARDS) including one or more anti-TNF therapies. It is given as a short course of therapy, just two infusions two weeks apart, with six to twelve months before further treatment.
MabThera already has a well-established safety profile because it has been prescribed to over 730,000 patients worldwide with non-Hodgkin’s lymphoma (NHL) over the last eight years.
New Two-year Orencia® (abatacept) Data Presented At Annual EULAR Congress
Data was presented at the 2006 European League Against Rheumatism (EULAR) annual congress in June on Orencia® (abatacept), the new biologic treatment for RA in development by Bristol-Meyers Squibb. Orencia is already licensed in the States and is administered as a 30-minute intravenous infusion at a fixed dose based on weight. The data included patient-reported outcomes, through two years of treatment in RA patients who had an inadequate response to methotrexate.
In the group treated with Orencia and methotrexate for two years, approximately 80 percent of people achieved ACR 20 responses; 56 percent achieved ACR 50 responses and 34 percent achieved ACR 70 responses. These results are similar to those following one year of treatment. (See our Winter 2005 Newsletter for details of ACR 20, 50 and 70.)
Another Licence for Humira® (adalimumab)
Some NRAS Members will be being treated with Humira® (adalimumab) for their rheumatoid arthritis. Now Humira has been licensed for use in ankylosing spondylitis (AS) too. This is good news for people with AS and also reaffirms the important role that Humira has to play in the management of rheumatic diseases including rheumatoid arthritis and psoriatic arthritis for which Humira was already licensed.
Commenting on the new licence, Professor Paul Wordsworth, Professor of Rheumatology at the Nuffield Orthopaedic Centre, said, "Ankylosing spondylitis is a disease that can go undetected for years, and can eventually rob patients of even the semblance of normal life. The approval of adalimumab is a major step forward in providing physicians with effective treatment options to manage this devastating, but little-known disease. Patients with rheumatoid arthritis and psoriatic arthritis in the UK already benefit from treatment with adalimumab, and with the addition of ankylosing spondylitis, adalimumab continues to reaffirm its potential as an effective option for the treatment of many inflammatory diseases."
New Four-year Enbrel® (etanercept) Data
In June, at the EULAR Congress, new data was presented from an extension of a big international trial called TEMPO. It showed that the safety profile and clinical efficacy of Enbrel and methotrexate combination therapy were sustained at four years of treatment.
In the first three years of the TEMPO study some patients received just Enbrel, some received just methotrexate and some received the combination of the two drugs. But in the fourth year all 227 people participating received Enbrel and methotrexate. Half of the people who had been taking Enbrel and methotrexate for four years achieved clinical remission based on a DAS of less than 1.6. DAS stands for Disease Activity Score and is a combined index to measure disease activity in rheumatoid arthritis patients, it is a system of measurement used in clinical trials.
Professor Robert Moots, Professor of Rheumatology at the University of the Liverpool, said: "These latest data show for the first time that the efficacy of combination treatment with methotrexate and Enbrel can be sustained for up to four years. This is encouraging news for rheumatoid arthritis patients who are currently on this regimen, or for patients who are discussing potential treatment choices with their consultant."
More Information on Remicade® (infliximab) in Early Rheumatoid Arthritis Presented at EULAR
Three year results were presented of a study aimed to describe the clinical course of people with early rheumatoid arthritis, who after initial treatment with Remicade plus methotrexate, discontinued Remicade because of low disease activity.
It was concluded that three years after starting treatment with Remicade plus methotrexate, just over half (53%) of the people with early RA had discontinued Remicade and still had persistent low disease activity. Remarkably, 17 of the 64 (27%) patients who could permanently discontinue Remicade stopped all anti-rheumatic drugs and remained in clinical remission. These findings suggest that initial treatment with Remicade plus methotrexate may alter the course of early rheumatoid arthritis.
Tolerability of Arava® (leflunomide) and Methotrexate Combined Therapy Examined
In May, at the BSR Meeting, a poster was presented to determine if Arava and methotrexate therapy is tolerated in routine clinical practice. The background to this work is that combination therapy is increasingly accepted as essential in inducing clinical, functional and radiographic improvement in inflammatory arthritis when single drug therapy fails. Arava and methotrexate co-therapy is efficacious and compelling reasons exist for using both together because their actions are complementary.
The study involved reviewing the case notes of 38 people with rheumatoid arthritis or psoriatic arthritis. The conclusions were that this combination is an acceptable option in the management of inflammatory arthritis. The study also concluded that when treatment was stopped it was more commonly because of side effects rather that lack of effectiveness. The main reported side effects were related to the gastrointestinal tract, for example nausea and diarrhoea.