ADHERE was largest and most innovative clinical
trial of CIDP patients to date
VYVGART® Hytrulo (efgartigimod alfa and
hyaluronidase-qvfc) demonstrated reduction in disease progression,
reduced risk of relapse and rapid onset of action
VYVGART Hytrulo is first and only neonatal Fc
receptor (FcRn) blocker FDA-approved to treat CIDP
September 19, 2024 – 7:00 am CET
Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq:
ARGX), a global immunology company committed to improving the lives
of people suffering from severe autoimmune diseases, today
announced publication in The Lancet Neurology of the pivotal ADHERE
Study, the largest clinical trial to date in chronic inflammatory
demyelinating polyneuropathy (CIDP). CIDP is a rare, debilitating,
often progressive, immune-mediated neuromuscular disorder of the
peripheral nervous system. This is the first time the ADHERE Study
has been published in a peer-reviewed medical journal. A link to
the full manuscript can be found here.
“Since its approval in June, VYVGART Hytrulo is already
transforming the lives of patients with CIDP,” said Luc Truyen,
M.D., Ph.D., Chief Medical Officer of argenx. “With today’s
publication in The Lancet Neurology, we are also advancing
scientific knowledge of the disease biology underlying CIDP and
thereby helping to progress further innovation with the potential,
like VYVGART Hytrulo, to significantly improve function for
patients while easing the burdens associated with prior
treatments.”
Highlights from the ADHERE study:
- ADHERE met its primary endpoint (p<0.0001) demonstrating a
61% reduction (HR: 0.39 95% CI: 0.25; 0.61) in the risk of relapse
versus placebo
- 69% (221/322) of patients treated with VYVGART Hytrulo,
regardless of prior treatment, demonstrated evidence of clinical
improvement, including improvements in mobility, function and
strength
- 99% of trial participants elected to participate in the ADHERE
open-label extension
- VYVGART Hytrulo was well-tolerated and safety results were
consistent with the known safety profile of VYVGART in previous
clinical studies and real-world use
The ADHERE data demonstrate that VYVGART Hytrulo
has a rapid onset of action, and can reduce CIDP disease
progression and risk of relapse:
- Reduced
risk of relapse: VYVGART Hytrulo reduced the risk of
relapse by 61% as assessed by aINCAT deterioration (Stage B primary
endpoint) versus placebo (HR 0.394 [95% CI 0.253–0.614];
p<0.0001).
- Reduced disease
progression: VYVGART Hytrulo reduced the risk of CIDP
disease progression based on time-to-first ≥4-point decrease in
I-RODS score compared with Stage B baseline (HR 0.537 [95% CI
0.354–0.814]; nominal p=0.0034).
- Rapid onset of
action: In Stage A, time to first improvement on aINCAT,
I-RODS, or grip strength scores among the 25th percentile of
patients was 9.0 days (95% CI 8.0-9.0) after the first dose of
VYVGART Hytrulo; the median estimate was 22.0 days
(15.0-23.0).
In June 2024, the U.S. Food and Drug
Administration approved VYVGART Hytrulo for the treatment of adult
patients with CIDP. VYVGART Hytrulo is also approved for the
treatment of generalized myasthenia gravis (gMG) in adult patients
who are anti-acetylcholine receptor (AChR) antibody positive.
See FDA-approved Important Safety
Information below and full Prescribing Information for VYVGART
Hytrulo for additional information.
What is VYVGART® HYTRULO (efgartigimod
alfa and hyaluronidase-qvfc)?VYVGART HYTRULO is a
prescription medicine used for the treatment of adult patients with
chronic inflammatory demyelinating polyneuropathy (CIDP).
IMPORTANT SAFETY INFORMATIONDo
not use VYVGART HYTRULO if you have a serious allergy to
efgartigimod alfa, hyaluronidase, or any of the other ingredients
in VYVGART HYTRULO. VYVGART HYTRULO can cause serious allergic
reactions and a decrease in blood pressure leading to fainting.
VYVGART HYTRULO may cause serious side
effects, including:Infection. VYVGART HYTRULO may increase
the risk of infection. The most common infections for efgartigimod
alfa-fcab-treated patients were urinary tract and respiratory tract
infections. Signs or symptoms of an infection may include fever,
chills, frequent and/or painful urination, cough, pain and blockage
of nasal passages/sinus, wheezing, shortness of breath, fatigue,
sore throat, excess phlegm, nasal discharge, back pain, and/or
chest pain.
Allergic Reactions (hypersensitivity reactions).
VYVGART HYTRULO can cause allergic reactions such as rashes,
swelling under the skin, and shortness of breath. Hives were also
observed in patients treated with VYVGART HYTRULO. Serious allergic
reactions, such as trouble breathing and decrease in blood pressure
leading to fainting have been reported with efgartigimod
alfa-fcab.
Infusion-Related Reactions. VYVGART HYTRULO can
cause infusion-related reactions. The most frequent symptoms and
signs reported with efgartigimod alfa-fcab were high blood
pressure, chills, shivering, and chest, abdominal, and back
pain.
Tell your doctor if you have signs or symptoms
of an infection, allergic reaction, or infusion-related reaction.
These can happen while you are receiving your VYVGART HYTRULO
treatment or afterward. Your doctor may need to pause or stop your
treatment. Contact your doctor immediately if you have signs or
symptoms of a serious allergic reaction.
Before taking VYVGART HYTRULO, tell your
doctor if you:
- take any medicines, including
prescription and non-prescription medicines, supplements, or herbal
medicines,
- have received or are scheduled to
receive a vaccine (immunization), or
- have any allergies or medical
conditions, including if you are pregnant or planning to become
pregnant, or are breastfeeding.
- What are the common side effects of
VYVGART HYTRULO?
The most common side effects in
efgartigimod-alfa-fcab-treated patients were respiratory tract
infection, headache, and urinary tract infection. Additional common
side effects with VYVGART HYTRULO are injection site reactions,
including rash, redness of the skin, itching sensation, bruising,
pain, and hives.
These are not all the possible side effects of
VYVGART HYTRULO. Call your doctor for medical advice about side
effects. You may report side effects to the US Food and Drug
Administration at 1-800-FDA-1088.
Please see the full Prescribing Information for
VYVGART HYTRULO and talk to your doctor.
About ADHERE Trial Design
The ADHERE trial was a multicenter, randomized,
double-blind, placebo-controlled trial evaluating VYVGART® Hytrulo
(efgartigimod alfa and hyaluronidase-qvfc) for the treatment of
chronic inflammatory demyelinating polyneuropathy (CIDP). ADHERE
enrolled 322 adult patients with CIDP who were treatment naïve (not
on active treatment within the past six months or newly diagnosed)
or being treated with immunoglobulin therapy or corticosteroids.
The trial consisted of an open-label Stage A followed by a
randomized, placebo-controlled Stage B. In order to be eligible for
the trial, the diagnosis of CIDP was confirmed by an independent
panel of experts. Patients entered a run-in stage, where any
ongoing CIDP treatment was stopped and in order to be eligible for
Stage A had to demonstrate active disease, with clinically
meaningful worsening on at least one CIDP clinical assessment tool,
including INCAT, I-RODS, or mean grip strength. Treatment naïve
patients were able to skip the run-in period with proof of recent
worsening. To advance to Stage B, patients needed to demonstrate
evidence of clinical improvement (ECI) with VYVGART Hytrulo. ECI
was achieved through improvement of the INCAT score, or improvement
on I-RODS or mean grip strength if those scales had demonstrated
worsening during the run-in period. In Stage B, patients were
randomized to either VYVGART Hytrulo or placebo for up to 48 weeks.
The primary endpoint was measured once 88 total relapses or events
were achieved in Stage B and was based on the hazard ratio for the
time to first adjusted INCAT deterioration (i.e. relapse). After
Stage B, all patients had the option to roll-over to an open-label
extension study to receive VYVGART Hytrulo.
About VYVGART Hytrulo (efgartigimod alfa
and hyaluronidase-qvfc)
VYVGART Hytrulo is a subcutaneous combination of
efgartigimod alfa, a human IgG1 antibody fragment marketed for
intravenous use as VYVGART, and recombinant human hyaluronidase
PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology to
facilitate subcutaneous injection delivery of biologics. In binding
to the neonatal Fc receptor (FcRn), VYVGART Hytrulo results in the
reduction of circulating IgG. It is the first-and-only approved
FcRn blocker administered by subcutaneous injection.
About Chronic Inflammatory Demyelinating
Polyneuropathy
Chronic inflammatory demyelinating
polyneuropathy (CIDP) is a rare and serious autoimmune disease of
the peripheral nervous system. Although confirmation of disease
pathophysiology is still emerging, there is increasing evidence
that IgG antibodies play a key role in the damage to the peripheral
nerves. People with CIDP experience fatigue, muscle weakness and a
loss of feeling in their arms and legs that can get worse over time
or may come and go. These symptoms can significantly impair a
person’s ability to function in their daily lives. Without
treatment, one-third of people living with CIDP will need a
wheelchair. There are approximately 24,000 patients in the U.S.
currently receiving treatment for CIDP.
About argenx
argenx is a global immunology company committed
to improving the lives of people suffering from severe autoimmune
diseases. Partnering with leading academic researchers through its
Immunology Innovation Program (IIP), argenx aims to translate
immunology breakthroughs into a world-class portfolio of novel
antibody-based medicines. argenx developed and is commercializing
the first approved neonatal Fc receptor (FcRn) blocker in the U.S.,
Japan, Israel, the EU, the UK, Canada and China. The Company is
evaluating efgartigimod in multiple serious autoimmune diseases and
advancing several earlier stage experimental medicines within its
therapeutic franchises. For more information,
visit www.argenx.com and follow us
on LinkedIn, X/Twitter, Instagram, Facebook,
and YouTube.
Contacts
Media:
Ben Petokbpetok@argenx.com
Investors:
Alexandra Roy (US)aroy@argenx.com
Lynn Elton (EU)lelton@argenx.com
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