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

Monitoring the use of biologics has spread from rheumatoid arthritis to other musculoskeletal
diseases, and in 2012 recruitment will begin for BSR’s new ankylosing spondylitis register.
Professor Gary Macfarlane, leader of the team that runs the new
BSRBR-AS register, outlines the aims and ambitions for it.
Rheumatologists in Scotland have a history
of working together, so when I moved from
Manchester to Aberdeen in 2005 it wasn’t
long before I was approached about doing a
research project. Ankylosing spondylitis soon
emerged at the top of the agenda, so we set
up the Scotland and Ireland Registry for AS
(SIRAS), which quickly attracted funding
from the pharmaceutical companies.
When BSR proposed to set up an AS register
to run parallel to BSRBR-RA, we were keen
to get involved, because it seemed a natural
progression to expand our work into England
since we already had links with some English
centres.
SIRAS has approximately 1,400 patients
registered. It covers everyone with a clinical
diagnosis of AS, regardless of the therapies
they are on. The BSRBR-AS will be slightly
different as it will aim to recruit an initial
cohort of 650 AS patients being treated with
biologics and a similarly sized comparison
cohort who are not on biologics.
Twenty centres in England and Wales have
expressed an interest in taking part, so we
should have 33 centres including the 13
already in SIRAS.
Although BSRBR-AS is a separate
undertaking, it will have strong links with
Manchester as the unit there will collect
safety data on any adverse events that occur
to AS patients on biologics. Their expertise
in this field meant it seemed silly for us to
try and collect this information separately,
although we will analyse the data they
collect.
Efficacy is another area we will look at;
do patients on biologics fare better than
patients not on these treatments? Because
clinicians put patients on biologics for
specific reasons, for example, if their
condition is deteriorating, and because
patients have the right to choose not to go
on biologics, it is a challenge to compare
efficacy between one treatment and another.
We have models that allow us to take the
register’s observations of what happens and
use them as the basis for making
comparisons between similar groups
of people.
Other important questions occur, too.
For example, when people go on biologic
therapies, why do some fare better than
others? If we can understand that, it can
help us to make informed decisions on
treatments in the future.
What takes time, though, is setting
everything up, obtaining the funding and
support of drug companies and the
participation of regional centres. Then there
is the technical part of designing the
database and finalising the data sheets.
For this, it is important to look at similar data
collections, so we have set up a committee
that includes representatives from Europe,
North America and Australia to look at what
other countries are doing and how we can
collaborate with them.
There are bureaucratic hurdles, too. Before
a study can take place, an NHS ethics
committee has to give its approval. It will
assess whether the overall balance of risk
to benefit is acceptable, check through all
issues of indemnity and ensure that patients
are provided with enough information and
given enough time to make an informed
decision when they are approached to
participate.
Setting up BSRBR-AS has involved a lot of
planning and preparation. The hope is that
it will make a valuable contribution both to
our knowledge and to the wellbeing of our
patients.
www.rheumatology.org.uk/BSRBR | 11