IBD- IXE trials data
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Hello, my name is
Professor Dennis McGonagle.
In this video, I am going to be
discussing the association
between immune-mediated diseases
including psoriatic arthritis, psoriasis,
and ankylosing spondylitis,
and how these sister diseases are
linked to inflammatory bowel disease.
First, it’s important to understand
the heightened risk of IBD
in such patients generally.
Data pooled from epidemiological
studies across several countries
suggests that the risk is higher
for patients with psoriasis,
with psoriatic arthritis,
and ankylosing spondylitis.
So, IBD has been described
as a co-morbidity of
psoriasis, psoriatic arthritis,
and is considered an
extra-articular manifestation
of ankylosing spondylitis.
Looking at pooled data from
ixekizumab psoriasis trials,
there is data from
over 5800 patients available.
In this were 29 patients
had new-onset IBD
or experienced exacerbations
of IBD symptoms.
The incidence rate falls within
the reported background rates
for a psoriasis population.
So moving on to the SPIRIT program
of ixekizumab in psoriatic arthritis
data is available
in over 1,400 patients.
3 patients had new-onset IBD.
And what about the incidence
of IBD in patients with axial SpA
under ixekizumab therapy?
Data is available in 929 patients.
We see an incidence
rate of around 1%,
which aligns with the typical rates
for the ankylosing
spondylitis population.
A total of 13 patients
had new-onset IBD
or experienced an
exacerbation of IBD symptoms.
In pediatric patients, Crohn’s disease
is more commonly diagnosed
than ulcerative colitis.
However, a similar pattern
is seen in the incidence rates
to that of adult population.
The numbers are small
and there is only data available
in 196 patients in total
with 253 patient years of exposure.
The data is currently less robust
due to the smaller
sample size, obviously,
and clearly there’s a heightened
sensitivity around pediatric disease.
Thus far, there is
an incidence rate of 1.6
reported in the pediatric
population treated with ixekizumab.
There is also data
on over 7,000 patients
treated with another IL-17A
inhibitor, namely secukinumab.
Schreiber and colleagues
reported a very similar pattern
of IBD incidence across
psoriasis, psoriatic arthritis,
and ankylosing spondylitis.
There is now initial
real-world evidence emerging,
and it is recapitulating
what has been found in the trials.
So, data from this
2019 meta-analysis
suggests that IBD patients
receiving IL-17 blockade;
it’s rare to see IBD
in this population.
So in summary,
across the ixekizumab
clinical development programs
for adult psoriasis, psoriatic
arthritis, and axial spondyloarthritis,
we have seen the overall
exposure-adjusted incidence rates
of Crohn’s disease and
colitis per 100 patient-years
are comparable
to the background ranges
reported for the populations
affected by these conditions.
In pediatric patients,
we will continue to gather new data
and look for emerging trends.
So, with that I would like
to thank you for your time.
Thank you.