Scotland article about D2E7 (Adalimumab)

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Breakthrough arthritis drug set to cost Scotland £14m

 

Astonishing improvements reported by chronic sufferers during trials of

revolutionary new treatment

By Naysmith, Science Correspondent

 

A DRUG so new it does not yet have a brand name could provide relief from

chronic arthritis, and may also be able to help sufferers of Crohn's

disease. D2E7 (Adalimumab) -- as it is currently known -- has produced

impressive results in trials, according to its developers at Chicago's

Abbott Laboratories.

Abbott's trial data shows that 30% of rheumatoid arthritis sufferers taking

the drug experienced at least a 50% improvement in their symptoms, and 15%

reported a 70% improvement. The drug is now to be tested to see if it can

help sufferers of Crohn's Disease and juvenile arthritis.

However, it may have side effects, including increased risk of infection ,

and it may not work for everyone. Long-term effects are also unknown.

Rheumatoid arthritis causes inflammation that can destroy bone and

cartilage, resulting in misshapen and deformed joints, pain and loss of

function. The drug works by blocking the actions of an inflammatory protein

called tumour necrosis factor (TNF), which is secreted by the body's immune

system.

It is one of a number of TNF-blocking drugs, but what makes it unique is

that it can be self-administered with a fortnightly injection. Other drugs

such as Remicade and Enbrel require more frequent treatments or inconvenient

visits to hospital .

D2E7 is aimed at patients with moderate to severe forms of rheumatoid

arthritis who have failed to respond to treatment with more traditional

anti-rheumatic drugs. It is currently under review by medicine approval

bodies, but has completed the last stage of its clinical trials in Europe

and America and is expected to go on the market early next year once final

approval is given.

Last week, Abbott Laboratories held a press call where 10 patients testified

to dramatic improvements in their symptoms. One woman's illness was so

debilitating she had been set to move into special housing, but since taking

the drug she has been able to resume hiking, cycling and water aerobics.

Another said: 'In 18 months this drug has turned my life around. I can walk,

run, play golf and lift weights. I could hardly walk, but today I drove two

hours to get here.'

Shirley Caldwell, the first person to receive the drug in Scotland, is

similarly enthusiastic. Caldwell had previously been refused permission to

try another drug because she lives in on and her local Ayrshire and

Arran health board had not authorised it. 'Some people called it postcode

prescribing,' she said. 'To me it seemed they were not prepared to give me

my life back.'

A nurse for 25 years, the last 16 at Crosshouse Hospital in Kilmarnock, she

had been considering giving up her job because of the pain caused by

arthritis. 'Sometimes the pain was bearable but at other times it became

extreme,' she said.

Three weeks ago, her doctor at the Glasgow Royal Infirmary gave her a chance

to try D2E7. 'I saw a difference in just 48 hours,' she said. 'On the Friday

I got the first injection. On Sunday I was able to walk across the room with

no pain.

'Just getting up in the morning and walking without pain is my biggest joy.

And putting my feet on the floor without having to hang on to something. I

have been really getting back my mobility, although I still can't put my

hands behind my back. But I have been able to stop using painkillers.'

The manufacturers are quietly confident the medication will be a success.

More than 3000 patients worldwide have taken part in the trials, and because

results were so promising, Abbott has invested in a £26m state-of-the-art

manufacturing facility at Massachusetts in the US. They hope D2E7 will

generate £640m in annual worldwide sales.

New trials will assess whether the drug can alleviate juvenile rheumatoid

arthritis. This attacks the joints of children under 16, and is more common

in girls than boys. Separate trials will determine whether it is effective

against Crohn's, a debilitating disease of the gastro-intestinal tract.

Results are expected in late 2003.

The crunch for regular patients will come when the drug goes on

prescription. Caldwell's doctor at Glasgow Royal believes the cost in the UK

will be around £10,000 a year. He said: 'Seven thousand patients in Scotland

have rheumatoid arthritis and of these roughly 20% -- 1400 -- would be

candidates for this drug. That would give the ish health service an

additional bill of £14m a year.'

In America, cost is also expected to be an issue with some health insurance

companies likely to baulk at the bills. Caldwell's physician said: 'Society

has an important choice to make. Would you want anything but the very best

medicine for your loved one?'

An Abbott spokesman said: 'You cannot simply measure the cost in terms of

the cost of the medicine. With it, these patients will continue to make a

positive contribution to society. Without it they will become progressively

more and more disabled and the cost of care will soar.'

http://www.sundayherald.com/28593