BSRBR 10th Anniversary brochure - The British Society for ...

Professor Deborah Symmons, director of the Arthritis Research UK
Epidemiology Unit, describes how data from BSRBR has encouraged
vigilance in some areas and offered reassurance in others.
The most significant difference BSRBR has
made to the way clinicians treat patients is
that it has helped to clarify which patients
are most at risk of infectious diseases when
taking anti-TNF drugs and when they are
most likely to develop them.
Because of TNFs’ role in the immune system,
we knew that in theory biologics carried an
increased risk of infectious diseases. Data
from BSRBR has confirmed a small but
significant risk of serious infections and,
more importantly, that it is at its greatest
within the first six months of starting anti-TNF
treatments then declines. This knowledge is
helpful for clinicians, as it encourages
vigilance in looking for symptoms of
infectious diseases and emphasises the
importance of educating patients about
how best to avoid complications.
Tuberculosis is one disease of concern,
although it is unusual in that the background
risk is low; chest and skin infections make
up the majority of illnesses associated with
anti-TNFs. Since the risk of contracting TB
was confirmed, all patients are now screened
before starting treatment with biologics, a
step that has brought down the rate of
infection. There is also an increased risk of
patients developing TB after they stop taking
anti-TNFs, however, and clinicians should be
alert to that possibility.
Research based on BSRBR data has allowed
us to draw comparisons between drugs.
The risk of developing TB on Etanercept, for
example, is much lower than on the
monoclonal antibodies Infliximab or
Adalimumab. This is useful ammunition for
a clinician trying to secure funding for
treatment with Etanercept from an NHS trust.
While the Register has been an important
tool in identifying risks and helping clinicians
to minimise them, it has also produced some
reassuring publications. No signals for an
increase in malignancy have been detected,
for example, although that was a concern
when anti-TNF therapies were first
introduced.
Data from BSRBR also indicates that
patients who respond to anti-TNFs have
fewer heart attacks in the first six months of
treatment than expected. The drugs appear
to stabilise the lesions that cause heart
attacks. No long-term certainty regarding
the reduced risk of heart attacks can be
confirmed, but in the short term this is a
positive development.
Information from BSRBR has also influenced
decisions made by NICE, in particular its
guidelines on sequential therapy for patients
failing a first anti-TNF. Usually, if a patient
fails to respond to a first anti-TNF, they are
prescribed rituximab and methotrexate.
NICE’s guideline means clinicians can now
prescribe an alternative anti-TNF. Since
cost-effectiveness is an important part of
NICE’s decision-making process, this is an
important development for clinicians.
It is worth noting, too, that without the
Register, NICE would have to rely on data
from other countries when preparing
guidelines. Most UK clinicians would view
that as less than satisfactory because it
would not represent the patients they
treat on a daily basis.
The team in Manchester does not operate
in isolation. We receive many queries from
clinicians seeking advice on particular
problems that prompt us to look into areas
we have not previously considered. In some
instances, we are able to offer reassurance
that the problem is unlikely to be caused by
the drugs. In others, their concerns have led
us to undertake a proper analysis and
opened up new avenues of research.
Ultimately, the Register gives a collective
experience for rheumatologists. Clinicians
contribute data to it and get information out
of it that can only benefit their patients.
www.rheumatology.org.uk/BSRBR | 7