NORTH CHICAGO, Ill.,
Feb. 24, 2021 /PRNewswire/ -- AbbVie
(NYSE: ABBV) today announced that the U.S. Food and Drug
Administration (FDA) approved HUMIRA® (adalimumab) for
the treatment of moderately to severely active ulcerative colitis
in pediatric patients 5 years of age and older. In clinical trials,
HUMIRA induced clinical remission at Week 8 and maintained
remission at Week 52 in patients who responded at Week
8.1,2
"Ulcerative colitis can have a profound effect on children and
for too long, treatment options for pediatric patients have been
limited," said Brandee Pappalardo,
vice president and head of U.S. immunology medical affairs, AbbVie.
"This approval provides the first and only subcutaneous biologic
for pediatric patients with ulcerative colitis that can be
administered at home. This new indication for HUMIRA demonstrates
AbbVie's commitment to patients with inflammatory bowel diseases
and reinforces our goal of reducing the burden of this disease for
patients."
This approval is based on results from the pivotal Phase 3
ENVISION I study, which showed that HUMIRA achieved the co-primary
endpoints of clinical remission per Partial Mayo Score (PMS) at
Week 8 and, among those who responded at Week 8, clinical remission
per Full Mayo Score (FMS) at one year (52 weeks).1,2
Clinical remission was defined as a PMS or as a FMS less than or
equal to two and no individual sub-score greater than
one.1,2
"Ulcerative colitis is unpredictable and affects everyone,
especially children, in different ways," said Marla Dubinsky, M.D., chief, Division of
Pediatric Gastroenterology for the Mount Sinai Health System and
co-director of the Susan and Leonard Feinstein IBD Center at Mount
Sinai.* "In the ENVISION I study, HUMIRA provided clinical response
as early as Week 8, and many who achieved partial Mayo score
response at Week 8 achieved clinical remission at Week 52, per FMS.
As a clinician, I am excited to have a new treatment option
available and am encouraged by these positive results, which have
the potential to help pediatric patients and their caregivers
manage their disease."
Ulcerative colitis is characterized by inflammation of the large
intestine with symptoms ranging from mild to severe bowel urgency
and bowel incontinence as well as weight loss and
fatigue.3,4 It remains a lifelong condition that is not
adequately controlled in many patients, underscoring the need for
more treatment options.3,4 Significant unmet needs
remain in moderate to severe pediatric ulcerative colitis, compared
to adults, as pediatric patients tend to have more extensive
disease often causing significant morbidity in
children.4,5
About the ENVISION I Phase 3 Study1,2,6
The ENVISION I study was a Phase 3, randomized, double-blind,
multicenter study designed to evaluate the efficacy, safety and the
pharmacokinetics of HUMIRA in pediatric patients (ages 4-17) with
moderate to severe ulcerative colitis (defined as a FMS of 6 to 12
with endoscopy subscore of 2 to 3 points, confirmed by centrally
read endoscopy), administered subcutaneously.
Through Week 8, patients in both dosage groups received 2.4
mg/kg (maximum of 160 mg) at Week 0, 1.2 mg/kg (maximum of 80 mg)
at Week 2, and 0.6 mg/kg (maximum of 40 mg) at Weeks 4 and 6. The
higher dosage group also received an additional dosage of 2.4 mg/kg
(maximum of 160 mg) at Week 1. Between Week 8 and Week 52, patients
received double-blind placebo, HUMIRA 0.6 mg/kg (maximum of 40 mg)
every other week, or every week. The co-primary endpoints of the
study were clinical remission per PMS (defined as PMS ≤ 2 and no
individual subscore > 1) at Week 8, and clinical remission per
the Mayo Score (defined as Mayo Score ≤ 2 and no individual
subscore > 1) at Week 52 in patients who achieved clinical
response per PMS at Week 8.
Study results demonstrated 60 percent [28/47] of patients taking
the higher dosage of HUMIRA achieved clinical remission per PMS, at
the end of the 8-week induction period and 43 percent [13/30] of
patients in the lower dosage group. At Week 52, among Week 8 PMS
responders, 45 percent [14/31] of patients receiving the higher
dosage of HUMIRA achieved remission per FMS and 29 percent [9/31]
of patients taking the lower dosage of HUMIRA and 33 percent [4/12]
of those randomized to placebo. There are limitations to the
interpretability of the placebo data due to the small sample
size.
Approved dosing for HUMIRA will be determined based on the
child's weight, as follows1:
Pediatric
Weight
|
Recommended
Dosage
|
|
Days 1 –
15
|
Starting on Day
29
|
20 kg (44
lbs) to < 40
kg (88 lbs)
|
- Day 1: 80
mg
- Day 8: 40
mg
- Day 15: 40
mg
|
Or
|
≥ 40 kg (88
lbs)
|
- Day 1: 160 mg (as
single
dose or split over two
consecutive days)
- Day 8: 80
mg
- Day 15: 80
mg
|
Or
|
It is recommended to continue the recommended pediatric dosage
in patients who turn 18 years of age and who are well-controlled on
their HUMIRA regimen.
In the ENVISION I study, no new safety signals for HUMIRA were
observed.1,2 Throughout any HUMIRA exposure in the
study, 22.6 percent of patients experienced a serious adverse
event.1,2 The most frequently reported (greater than or
equal to 5 percent) treatment-emergent adverse events during
induction and maintenance periods were headache and worsening of
ulcerative colitis.6 No deaths, malignancies, active
tuberculosis or demyelinating disease were observed in this
study.1,2
More information on this trial can be found at
www.clinicaltrials.gov (NCT02065557).
*Marla Dubinsky, M.D. is a
consultant and advisor for AbbVie.
About HUMIRA (adalimumab) in the U.S.
Uses
HUMIRA is a prescription medicine used:
- To reduce the signs and symptoms of:
-
- Moderate to severe rheumatoid arthritis (RA) in adults.
HUMIRA can be used alone, with methotrexate, or with certain other
medicines. HUMIRA may prevent further damage to your bones and
joints and may help your ability to perform daily activities.
- Moderate to severe polyarticular juvenile idiopathic
arthritis (JIA) in children 2 years of age and older. HUMIRA
can be used alone or with methotrexate.
- Psoriatic arthritis (PsA) in adults. HUMIRA can be used
alone or with certain other medicines. HUMIRA may prevent further
damage to your bones and joints and may help your ability to
perform daily activities.
- Ankylosing spondylitis (AS) in adults.
- Moderate to severe hidradenitis suppurativa (HS) in
people 12 years and older.
- To treat moderate to severe Crohn's disease (CD) in adults
and children 6 years of age and older.
- To treat moderate to severe ulcerative colitis (UC) in
adults and children 5 years of age and older. It is not known
if HUMIRA is effective in people who stopped responding to or could
not tolerate anti-TNF medicines.
- To treat moderate to severe chronic plaque psoriasis (Ps) in
adults who are ready for systemic therapy or phototherapy, and
are under the care of a doctor who will decide if other systemic
therapies are less appropriate.
- To treat non-infectious intermediate (middle part of the
eye), posterior (back of the eye), and panuveitis
(all parts of the eye) in adults and children 2 years of age and
older.
Important Safety Information About
HUMIRA® (adalimumab)
What is the most important information I should know about
HUMIRA?
You should discuss the potential benefits and risks
of HUMIRA with your doctor. HUMIRA is a TNF blocker medicine that
can lower the ability of your immune system to fight infections.
You should not start taking HUMIRA if you have any kind of
infection unless your doctor says it is okay.
- Serious infections have happened in people taking HUMIRA.
These serious infections include tuberculosis (TB) and infections
caused by viruses, fungi, or bacteria that have spread throughout
the body. Some people have died from these infections. Your
doctor should test you for TB before starting HUMIRA, and check you
closely for signs and symptoms of TB during treatment with HUMIRA,
even if your TB test was negative. If your doctor feels you are at
risk, you may be treated with medicine for TB.
- Cancer. For children and adults taking TNF blockers,
including HUMIRA, the chance of getting lymphoma or other cancers
may increase. There have been cases of unusual cancers in children,
teenagers, and young adults using TNF blockers. Some people have
developed a rare type of cancer called hepatosplenic T-cell
lymphoma. This type of cancer often results in death. If using TNF
blockers including HUMIRA, your chance of getting two types of skin
cancer (basal cell and squamous cell) may increase. These types are
generally not life-threatening if treated; tell your doctor if you
have a bump or open sore that doesn't heal.
What should I tell my doctor BEFORE starting
HUMIRA?
Tell your doctor about all of your health
conditions, including if you:
- Have an infection, are being treated for infection, or have
symptoms of an infection
- Get a lot of infections or infections that keep coming
back
- Have diabetes
- Have TB or have been in close contact with someone with TB, or
were born in, lived in, or traveled where there is more risk for
getting TB
- Live or have lived in an area (such as the Ohio and Mississippi River valleys) where
there is an increased risk for getting certain kinds of fungal
infections, such as histoplasmosis, coccidioidomycosis, or
blastomycosis. These infections may happen or become more severe if
you use HUMIRA. Ask your doctor if you are unsure if you have lived
in these areas
- Have or have had hepatitis B
- Are scheduled for major surgery
- Have or have had cancer
- Have numbness or tingling or a nervous system disease such as
multiple sclerosis or Guillain-Barré syndrome
- Have or had heart failure
- Have recently received or are scheduled to receive a vaccine.
HUMIRA patients may receive vaccines, except for live vaccines.
Children should be brought up to date on all vaccines before
starting HUMIRA
- Are allergic to rubber, latex, or any HUMIRA ingredients
- Are pregnant, planning to become pregnant, breastfeeding, or
planning to breastfeed
- Have a baby and you were using HUMIRA during your pregnancy.
Tell your baby's doctor before your baby receives any vaccines
Also tell your doctor about all the medicines you take.
You should not take HUMIRA with ORENCIA® (abatacept),
KINERET® (anakinra), REMICADE® (infliximab),
ENBREL® (etanercept), CIMZIA® (certolizumab
pegol), or SIMPONI® (golimumab). Tell your doctor if you
have ever used RITUXAN® (rituximab), IMURAN®
(azathioprine), or PURINETHOL® (mercaptopurine,
6-MP).®
What should I watch for AFTER starting
HUMIRA?
HUMIRA can cause serious side effects,
including:
- Serious infections. These include TB and infections
caused by viruses, fungi, or bacteria. Symptoms related to TB
include a cough, low-grade fever, weight loss, or loss of body fat
and muscle.
- Hepatitis B infection in carriers of the virus. Symptoms
include muscle aches, feeling very tired, dark urine, skin or eyes
that look yellow, little or no appetite, vomiting, clay-colored
bowel movements, fever, chills, stomach discomfort, and skin
rash.
- Allergic reactions. Symptoms of a serious allergic
reaction include hives, trouble breathing, and swelling of your
face, eyes, lips, or mouth.
- Nervous system problems. Signs and symptoms include
numbness or tingling, problems with your vision, weakness in your
arms or legs, and dizziness.
- Blood problems (decreased blood cells that help fight
infections or stop bleeding). Symptoms include a fever that does
not go away, bruising or bleeding very easily, or looking very
pale.
- Heart failure (new or worsening). Symptoms include
shortness of breath, swelling of your ankles or feet, and sudden
weight gain.
- Immune reactions including a lupus-like syndrome.
Symptoms include chest discomfort or pain that does not go away,
shortness of breath, joint pain, or rash on your cheeks or arms
that gets worse in the sun.
- Liver problems. Symptoms include feeling very tired,
skin or eyes that look yellow, poor appetite or vomiting, and pain
on the right side of your stomach (abdomen). These problems can
lead to liver failure and death.
- Psoriasis (new or worsening). Symptoms include red scaly
patches or raised bumps that are filled with pus.
Call your doctor or get medical care right away if you
develop any of the above symptoms.
Common side effects of HUMIRA include injection site
reactions (pain, redness, rash, swelling, itching, or
bruising), upper respiratory infections (sinus infections),
headaches, rash, and nausea. These are not all of the
possible side effects with HUMIRA. Tell your doctor if you have any
side effect that bothers you or that does not go away.
Remember, tell your doctor right away if you have an
infection or symptoms of an infection, including:
- Fever, sweats or chills
- Muscle aches
- Cough
- Shortness of breath
- Blood in phlegm
- Weight loss
- Warm, red or painful skin sores on your body
- Diarrhea or stomach pain
- Burning when you urinate
- Urinating more often than normal
- Feeling very tired
HUMIRA is given by injection under the skin.
This is the most important information to know about HUMIRA.
For more information, talk to your health care provider.
Please click here for the Full Prescribing
Information and Medication Guide.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or
call 1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie
may be able to help. Visit AbbVie.com/myAbbVieAssist to learn
more.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
About AbbVie in Gastroenterology
AbbVie has focused on improving care in gastroenterology for
more than 10 years. With a robust clinical trial program in
inflammatory bowel disease (IBD), we are committed to cutting-edge
research to drive exciting discoveries and developments in Crohn's
disease and ulcerative colitis. By innovating, learning, and
adapting, AbbVie aspires to eliminate the burden of IBD and make a
long-term impact on the lives of people with IBD. For more
information on AbbVie in gastroenterology, visit
https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/gastroenterology.html.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
that solve serious health issues today and address the medical
challenges of tomorrow. We strive to have a remarkable impact on
people's lives across several key therapeutic areas: immunology,
oncology, neuroscience, eye care, virology, women's health and
gastroenterology, in addition to products and services across its
Allergan Aesthetics portfolio. For more information about AbbVie,
please visit us at www.abbvie.com. Follow
@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statements
Some statements in this news release are, or may be
considered, forward-looking statements for purposes of the Private
Securities Litigation Reform Act of 1995. The words "believe,"
"expect," "anticipate," "project" and similar expressions, among
others, generally identify forward-looking statements. AbbVie
cautions that these forward-looking statements are subject to risks
and uncertainties that may cause actual results to differ
materially from those indicated in the forward-looking statements.
Such risks and uncertainties include, but are not limited to,
failure to realize the expected benefits from AbbVie's acquisition
of Allergan plc ("Allergan"), failure to promptly and effectively
integrate Allergan's businesses, competition from other products,
challenges to intellectual property, difficulties inherent in the
research and development process, adverse litigation or government
action, changes to laws and regulations applicable to our industry
and the impact of public health outbreaks, epidemics or pandemics,
such as COVID-19. Additional information about the economic,
competitive, governmental, technological and other factors that may
affect AbbVie's operations is set forth in Item 1A, "Risk Factors,"
of AbbVie's 2019 Annual Report on Form 10-K, which has been filed
with the Securities and Exchange Commission, as updated by its
subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no
obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
References:
- HUMIRA Prescribing Information.
https://www.rxabbvie.com/pdf/humira.pdf.
- Croft N.M., et al. Efficacy and safety of adalimumab in
pediatric patients with moderate to severe ulcerative colitis:
results of a randomized-controlled phase 3 study. UEGJ.
2020;8(8S):98-99.
- The Economic Costs of Crohn's Disease and Ulcerative Colitis.
Access Economics Pty Limited. 2007. Available at:
https://www.crohnsandcolitis.com.au/site/wp-content/uploads/Deloitte-Access-Economics-Report.pdf.
- Romano, C., et al., Management of Acute Severe Colitis in
Children With Ulcerative Colitis in the Biologics Era. Pediatrics.
2016;137(5):e20151184.
- Jakobsen C., et al. Differences in phenotype and disease course
in adult and paediatric inflammatory bowel disease—a
population-based study. Aliment Pharmacol Ther.
2011;34(10):1217–1224pmid:21981762.
- Efficacy and Safety of Adalimumab in Pediatric Subjects With
Moderate to Severe Ulcerative Colitis. ClinicalTrials.gov. 2020.
Available at:
https://clinicaltrials.gov/ct2/show/record/NCT02065557. Accessed on
October 6, 2020.
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