BSRBR|Newsletter - The British Society for Rheumatology

BSRBR|Newsletter
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economic analyses. This applies to first-line use of the drugs and even more so
to sequential use following the failure of a first anti-TNF.
BSRBR has produced a wealth of observational data on real-life use of anti-TNF
in the NHS. BSRBR patients tend to have long disease duration with
well-established disease, failing on many conventional DMARDs (usually many
more than the two required by NICE). As such, they may not be ideal to study
efficacy. NICE health economic analyses are driven by the change in Health
Assessment Questionnaire (HAQ), and in patients with established disease, this
is governed by factors other than disease activity, such as damage to joints.
Therefore the ability of anti-TNF to influence the HAQ in the BSRBR population
is much less than in patients with a more recent onset of RA. We have used this
as an argument to show that as time has gone by, rheumatologists are using
biological drugs in patients with earlier disease that is proving resistant to
conventional DMARDs, and where data shows that these patients will respond
better than the BSRBR patients.
Colleagues at the arc Epidemiology Unit in Manchester have performed helpful
analyses, sometimes at short notice with tight NICE timetables with occasional
late-night telephone calls before Appraisal Committee meetings. With health
economists in Sheffield, they have performed analyses with change in DAS28 as
the driver of the model, suggesting that anti-TNF was cost-effective in treating
RA, despite the limitations of the BSRBR data. This alternative approach to a
health economic analysis, as well as other evidence, was instrumental in
producing sufficient doubt in the veracity of the original NICE health economic
models to allow access to a first anti-TNF.
University of
Manchester update
Cohort recruitment update
BSRBR recruitment to the anti-TNF and the comparison
cohort for patients with RA is complete, with an overall
total of over 16,000 patients. More importantly, we are
extending the follow-up and will continue to collect data
from you and the UK national registers for cancer and
deaths for all of these patients until at least
September 2013.
Rituximab (RTX) recruitment is increasing and by end of
August we had registered 442 people. We aim to recruit
1,100 RTX treated patients to allow us to thoroughly
analyse the risk of serious infection so please continue
to register any new rituximab patients with us. Other cohorts
that remain “open” are the anakinra cohort and
patients who have a diagnosis other than RA, PsA or AS
starting any anti-TNF therapy.
Figure 1: Rituximab recruitment prediction
(cohort requirement: n = 1100)
BSRBR data showed that a second anti-TNF is effective in patients who have had
an unsatisfactory response to the first anti-TNF, and given some insights into
which sub-populations of patients may gain the best benefits from a second
anti-TNF. This evidence will be used in ongoing negotiations over access to
sequential anti-TNF therapy.
The NICE approach to health economic modelling is to map the change in HAQ
onto a quality of life score, and then calculate cost effectiveness from this.
BSRBR analyses have shown that this approach may underestimate
improvements in quality of life when they are measured directly in RA patients,
and this observation supports the need to improve current NICE modelling.
One of the greatest concerns over current access to anti-TNF expressed by
patients and professionals is the hurdle of a DAS28 of >5.1 in order to have
access to anti-TNF. There are many clinical situations in which this is
inappropriately high, such as in patients who need oral steroids to maintain
disease control. An analysis of BSRBR data, performed with the considerable
assistance of Kimme Hyrich, Mark Lunt, and Deborah Symmons, showed that
patients with a baseline DAS of less than 5.1 did just as well as those with a
DAS28 of >5.1, suggesting that it would be just as cost-effective to use the
drugs in patients with less active disease than is currently the case.
I am pleased to be given the opportunity to show colleagues that as well as the
obvious triumphs of the BSRBR, there is other activity that helps to support
ongoing negotiations with NICE. I have always found my colleagues in
Manchester to be extremely helpful in assisting our efforts to ensure that the
most appropriate RA patients will get access to biological therapies. I am
confident that they would be equally helpful with other colleagues who may
have ideas for analyses of BSRBR data.
Dr Chris Deighton
BSRBR Steering
Committee vacancies 2009
The BSRBR Steering Committee oversees the
operation of the Register and is directly responsible
to the BSR Executive. It meets four times a year,
normally in London. The Committee has
responsibility in particular for:
• safeguarding patient safety
• ensuring financial and contractual obligations
are met; and
• ensuring research objectives are being met.
There is a vacancy for a consultant representative
on the committee for a three-year term from
November 2009. The representative would be
expected to have a particular interest in the scientific
output (analyses and publications) of the register.
Applications for membership (on a nomination form)
are considered by current members of the Steering
Committee which makes nominations to the BSR
Executive for appointment.
To find out more or request a nomination form,
please contact BSRBR Co-ordinator Nia Taylor
(DL: 020 8742 0905, ntaylor@rheumatology.org.uk).
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