New anti-rheumatoid drugs bring hope to thousands
Reproduced from Issue 103 of Arthritis Today
Research work into new therapies
for rheumatiod arthritis continues at the Kennedy InstituteThe race is on to bring new treatments to patients with rheumatoid arthritis – as at least two new anti-rheumatoid drugs look set to be available in the UK within the next few months.
Both drugs will probably only be prescribed for patients for whom other drug therapies have failed to work. But, like the male impotence drug Viagra, the cost of the drugs, and whether they will available on the NHS, has yet to be decided.
One of the drugs, Remicade™ (generic name infliximab) will be better known to Arthritis Today readers by its experimental name cA2, which was the first anti-TNF drug to enter clinical trials based on research carried out by arc's flagship Kennedy Institute in west London.
After undergoing extensive trials, and if the results continue to be promising, it could be licensed in the US by the spring, and be available to patients in the UK in the autumn.
The Kennedy, under its director Professor Ravinder Maini, has played a highly significant role in the early development of the anti-TNF drug therapies. The institute's scientists developed the concept and pre-clinical research over a decade before cA2 – a man-made monoclonal antibody – was used to block the activity of a disease-causing molecule TNF (tumour necrosis factor) which causes inflammation of the joints in rheumatoid arthritis.
The American pharmaceutical company Centocor has funded clinical trials in Europe and the USA and are now funding the third phase of its multi-centre clinical trials of Remicade, co-ordinated by Professor Maini at the Kennedy.
Remicade was approved by the Federal Drugs Authority in the US in autumn last year after its efficacy and safety data were perceived in September 1998, and could appear in Britain by 1999.
Prof Ravinder Maini
Meanwhile, while the scientific work on anti-TNF studies continues to run in parallel at the Kennedy, jointly funded by arc and Centocor.
"The commercial development of cA2 is not a Kennedy affair, but we started the whole thing. It was our idea, based on arc-funded work between 1988 and 1992," explained Professor Maini, who is also the chairman of committee co-ordinating the Phase III trials.
Four hundred patients in the US, the UK and Europe have been taking part in the Remicade clinical trials, administered the drug through slow, intravenous drip once a month.
US pharmaceutical company Immunex started its own trials into another anti-TNF drug, Enbrel™ (generic name etanercept) a couple of years after the Centocor trials started, but, in the way of much research, has managed to leapfrog past it. Enbrel, self-injected twice a week, looks set to be available in this country by next summer at the earliest.
The new anti-TNF drugs are proving to be very effective in controlling symptoms of RA patients who do not respond to other drugs.
"As a treatment it has a high efficacy profile, but aside from safety and efficacy, there's a question of price," says Professor Maini. "Both drugs are likely to be expensive, but if you think about the long-term cost of a RA patient over a number of years, it puts the cost into perspective.
Meanwhile, the nuts and bolts research work into new therapies for rheumatoid arthritis continues apace at the Kennedy. "We want to understand the limitations of how these drugs work," explained Professor Maini. "Already we know the anti-TNF therapies are not a cure, and that the disease comes back once the treatment stops.
"The next step is to discover how to go beyond this step, make new discoveries, and produce another agents work in combination with it."
- Two other drugs are currently in clinical trial stage – a third anti-TNF drug developed by scientists in Cambridge, and sponsored by a German company BASF. A new anti-lymphocyte treatment, CD4, a Glaxo Wellcome-sponsored multi-centre trial led by the United Medical Schools of Guys and St Thomas's, which was hoped that ultimately the drug would put patients into complete remission, has been stopped.
