U.S. Food and Drug Administration has approved the use of the monoclonal
antibody mepolizumab for an autoimmune disease called eosinophilic
granulomatosis with polyangiitis (EGPA).
- Mepolizumab is a
monoclonal antibody used in eosinophilic asthma that has now been approved
for eosinophilic granulomatosis with polyangiitis
- It appears to
increase the total duration of remission as well as the number of patients
who achieve remission, thereby reducing the required dose of
- It may, however,
not be effective in all individuals with the disease.
It was earlier approved
as an additional maintenance treatment for adults and children over 12 years of
age for eosinophilic asthma.
The benefits of mepolizumab
in EGPA were earlier demonstrated in
a study published in the New England
Journal of Medicine
. In the 52-week trial, 136 individuals with relapsing
EPGA or EPGA that was not responding to treatment were administered either 300
mg mepolizumab by subcutaneous injection every four weeks or placebo. All the
patients had a previous history of eosinophilic asthma
receiving daily oral corticosteroids with or without immunosuppressant drugs.
The study scientists found that:
- The treatment with mepolizumab was associated with a
longer total disease-free duration.
The percentage of patients who were free from the disease within 24 weeks
was higher (28%) in the mepolizumab group as compared to those who
received placebo (3%).
- A higher
percentage of individuals on mepolizumab achieved remission at week 36 and
week 48 of the trial as compared to placebo.
- Almost half the
patients (44%) in the mepolizumab group and 81% in the placebo group did
not achieve remission. Thus, though
the above numbers depict an advantage of mepolizumab over placebo, it is
possible that a large number of individuals treated with the drug may not
respond to it.
- Treatment with
mepolizumab allowed the reduction of the corticosteroid dose. Only around
7% patients on placebo could reduce their prednisone or prednisolone dose
to 4 mg or less per day between 48 and 52 weeks of treatment; in contrast,
this was achieved by 44% patients in the mepolizumab group. A lower dose
of corticosteroid translates into lesser side effects caused by its
- The adverse
effects reported in the study included headache, upper respiratory tract
infection, injection-site reaction and worsening asthma.
Mepolizumab is an
anti-interleukin 5 monoclonal antibody. Interleukin 5 controls the
proliferation, maturation and differentiation of white blood cells called
eosinophils, which play an important role in allergic reactions. Mepolizumab
reduces the number of eosinophils in
the patient, which explains its effectiveness in eosinophilic asthma where it
is used in a dose of 100 mg. The approved dose for eosinophilic granulomatosis
with polyangiitis is a subcutaneous injection of 300 mg once every four weeks
into the upper arm, thigh or abdomen.
‘Mepolizumab has been approved by the US FDA for the treatment of eosinophilic granulomatosis with polyangiitis, thereby providing a treatment option for patients with the autoimmune disorder.’
Mepolizumab is contraindicated
in patients with acute bronchospasm, status asthmaticus or serious allergic
reactions. Prior to starting treatment, the patients should receive treatment
for worm infestation and possibly vaccination against herpes zoster infection.
Eosinophilic Granulomatosis with Polyangiitis
granulomatosis with polyangiitis
(EGPA), previously called Churg-Strauss
syndrome, is a rare autoimmune disease that results in inflammation of
small-to-medium blood vessels, adult-onset asthma and high levels of
eosinophils in the blood. It can affect the nasal sinuses, skin, heart,
digestive tract and the nervous system. Frequent relapses can lead to organ
damage. It is usually treated with corticosteroids, sometimes with additional
- FDA approves first drug for Eosinophilic Granulomatosis with Polyangiitis, a rare disease formerly known as the Churg-Strauss Syndrome - (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm588594.htm)
- Wechsler ME et al. Mepolizumab or Placebo for Eosinophilic Granulomatosis with Polyangiitis. N Engl J Med 2017; 376:1921-193. DOI: 10.1056/NEJMoa1702079