UK gains confidence with TNF inhibitors

[Guest guest]

Rheumawire

May 6, 2004

UK gains confidence with TNF inhibitors

Edinburgh, UK - The subject of how both rheumatologists and patients are

faring with the TNF inhibitors was high on the agenda at the recent

British Society of Rheumatology (BSR) meeting in Edinburgh.

In March 2002, the UK drug watchdogthe National Institute of Clinical

Excellence (NICE)together with the BSR issued guidelines on who would be

eligible for TNF inhibitors funded by the state. Only those with severe

RA qualify for the new drugs, and although as many as 10% of RA patients

in the UK fulfill these criteria, not all of these people are yet

receiving the agents.

Delegates heard that although rheumatologists are still nervous about

TNF inhibitors, they are gaining confidence in using the drugs, and the

results seen in trials seem to be translating into clinical practice.

And while access is still patchy, the patients who are receiving the

drugs report positive effects, although problems with unrealistic

expectations of treatment remain.

One of the most important sources of information about TNF inhibitor use

in the UK is the BSR Biologics Register, which was launched on October

1, 2001 and plans to continue recruitment and follow-up for a minimum of

5 years.

Prof Deborah Symmons (Arthritis Research Campaign Epidemiology Unit,

University of Manchester, UK) told the meeting that, so far, the

register has proved a success [1]. " It shows that the people who are

getting [TNF inhibitors] are the ones recommended to get them, " she told

rheumawire.

The register now has a total of 7000 patients recruited, the vast

majority of whom (>80%) remain on TNF inhibitors more than 6 months

after starting them. Around 10% of patients discontinued therapy due to

adverse events, and others stopped because of inefficacy. Around 20% of

those taking the new drugs obtained a good EULAR response and a further

60% had a moderate response.

More work is needed, however, to track serious adverse events, she said.

As the baseline risk of many serious adverse events is already increased

in patients with RA, the plan is to recruit 500 RA patients not

receiving biologics as a comparison cohort. " We hope to do a really

proper analysis of this by the end of 2005, " she noted.

Symmons told rheumawire that her general feeling about TNF inhibitors is

that " rheumatologists are gaining in confidence using the drugs, and

they are slowly beginning to prescribe them to those with less severe

disease. " However, " they are still nervous, particularly about

infections, " she says. " I sense that anxiety, and that is precisely why

we need this registry. "

Other countries, too, have registries tracking use of TNF inhibitors,

and once or twice a year, a meeting is arranged of all the registries,

to exchange information. Sweden and Germany have the largest registries,

and there are also a lot of smaller ones, she explained.

A variety of other presentations at the BSR meeting covered biologics in

clinical practice and the patients' experience of the new agents [see

sidebar].

Dr RN Jois (Norfolk and Norwich Hospital, Norwich, UK) and colleagues

described their experience with 217 patients begun on anti-TNF therapy

[2], which they said " represents one of the largest clinical experiences

of biologic agents in the UK outside clinical trials. " They reported

that the percentage of patients still on treatment at 3.5 years is

" higher than expected " and side effects lower.

Dr TC (Royal Liverpool University Hospital, UK) and coworkers

reported an audit of 167 patients [3], which showed that, generally,

" all 3 anti-TNF drugs are equivalent at inducing an adequate response. "

However, " infliximab is significantly worse at inducing remission

compared with etanercept (p=0.006), " they noted. But if patients fail to

respond to the first anti-TNF drug, " they are likely to have an adequate

response to the second. "

And Dr M Koutantji (Imperial College, London, UK) and colleagues looked

at the impact of anti-TNF agents on quality of life and mood [4]. " We

observed significant improvements in disease activity and self-reported

measures of pain, general health status, and depression at 3 months from

baseline, which were largely maintained at 6 months. " Preliminary

findings " suggest the positive effects of anti-TNF treatments on disease

activity and symptoms in RA observed in clinical trials largely

translate into routine clinical practice in a UK setting. Furthermore,

there seem to be improvements in most aspects of quality of life and

mood for a subsample of patients. "

The patients' view

Doctors from Newcastle Upon Tyne Hospitals NHS Trust

described the use of small focus groups to gain information about

patients' experience of TNF inhibitors [5]. Seven patients treated with

infliximab and 10 using etanercept were quizzed on the effects of the

treatment on quality of life, their views on being entered into the BSR

biologics registry, and their expectations of the new drugs.

" Overall, the response to anti-TNF therapy was

positive, with high levels of satisfaction, " the doctors reported.

" Prior to treatment the patients had high expectations of the drugs . .

gained from media sources. This led to unrealistic expectations that

inevitably would not be met, highlighting the fact that realistic

expectations need to be given and reinforced during treatment. "

The patients had not been involved in a continual

assessment process before with a national registry, they noted, but

" overall they were not daunted; instead, there was an eagerness to help

others. " However, all of the patients felt that the drug should be

available to patients at earlier stages of the disease, the doctors

noted, " especially if this meant long-term savings in health and social

care. "

Nainggolan

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org