Ulcerative colitis is a long-term condition where the
colon and rectum become inflamed. Small ulcers can
develop on the colon’s lining and can bleed and produce
pus.
The main symptoms of ulcerative colitis are recurring diarrhoea,
which may contain blood, mucus or pus, stomach pain and increased
stool frequency. Patients may also experience extreme tiredness
(fatigue), loss of appetite and weight loss.
Beach, MHRA Interim Executive
Director, Healthcare Quality and Access, said:
Keeping patients safe and enabling their access to high quality,
safe and effective medical products are key priorities for
us.
We’re assured that the appropriate regulatory standards for the
approval of this medicine have been met.
As with all products, we will keep its safety under close
review.”
Etrasimod is a long-term prescription medicine and treatment
should only be started under the supervision of a doctor who is
experienced in treating ulcerative colitis.
The recommended dose of etrasimod is one 2 mg tablet taken once
daily. Etrasimod should be taken with food for the first 3 days.
After this, etrasimod can be taken each day with or without
food.
Etrasimod prevents lymphocytes (a type of white blood cell) from
travelling from the lymph nodes (part of the body’s immune system
that contains lymphocytes) into the blood. These Iymphocytes are
involved in the immune response and inflammation that is linked
to the development of ulcerative colitis. By reducing the
number of lymphocytes circulating in the blood surrounding the
large intestine, etrasimod helps to reduce bowel inflammation and
the symptoms associated with the disease.
This regulatory approval is supported by evidence from two
randomised, double-blind, placebo-controlled clinical studies
(ELEVATE UC 52 and ELEVATE UC 12) involving 743 patients aged 16
years and over for whom standard treatment or other treatments
did not work well enough or could not be used.
Taken together, the results from the two studies showed that,
after 12 weeks of treatment, 26% (129 out of 496) of those who
received etrasimod had achieved clinical remission compared with
11% (27 out of 247) of those who received placebo.
One of these studies also looked at the longer-term effect of
treatment and found that 32% (88 out of 274) of people taking
etrasimod achieved clinical remission after 52 weeks compared
with 7% (9 out of 135) for those receiving placebo.
The most common side effects of the medicine are bradycardia
(slow heart rate), hypertension (high blood pressure), urinary
tract infection (infection of parts of the body that collect and
pass out urine) and lower respiratory tract infection (infection
of the lower airways or lungs).
As with any medicine, the MHRA will keep the safety and
effectiveness of etrasimod under close review. Anyone who
suspects they are having a side effect from this medicine are
encouraged to talk to their doctor, pharmacist or nurse and
report it directly to the MHRA Yellow Card scheme, either through
the website (https://yellowcard.mhra.gov.uk/)
or by searching the Google Play or Apple App stores for MHRA
Yellow Card.
Notes to editors
- The new marketing authorisation was granted on 11 March 2024
to Pfizer
- More information can be found in the Summary of Product
Characteristics and Patient Information leaflets which will be
published on the MHRA Products
website within 7 days of approval.
- This was a randomised, double-blind clinical trial, where
neither the participants nor the staff on the trial were aware of
were aware of what each participant was taking. For more
information about the studies, see the Summary of Product
Characteristics.
- For more information about ulcerative colitis, visit:
https://www.nhs.uk/conditions/ulcerative-colitis/
