NORTH CHICAGO, Ill.,
July 21, 2020 /PRNewswire/ -- AbbVie
(NYSE: ABBV) today announced upadacitinib (15 mg and 30 mg, once
daily) monotherapy met both primary and all secondary endpoints in
Measure Up 2, the second Phase 3 study in individuals with moderate
to severe atopic dermatitis.1 The co-primary endpoints
were at least a 75 percent improvement in the Eczema Area Severity
Index (EASI 75) from baseline and a validated Investigator's Global
Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 (clear or
almost clear) at week 16.1 The Measure Up 2 study
evaluates the efficacy and safety of both doses of upadacitinib
monotherapy versus placebo in adolescents and adults with moderate
to severe atopic dermatitis who are candidates for systemic
therapy.1
Significantly more patients receiving either dose of
upadacitinib monotherapy showed improvement in skin clearance and
reduction in itch compared to placebo at week 16.1 In
the study, 60/73 percent of patients receiving upadacitinib 15/30
mg achieved EASI 75, respectively, versus 13 percent in the placebo
group (p<0.001).1 Of patients treated with
upadacitinib 15/30 mg, 39/52 percent achieved vIGA-AD 0/1,
respectively, versus 5 percent of patients receiving placebo
(p<0.001).1
"We are encouraged by these results that reaffirm the data from
Measure Up 1 and underscore the potential impact RINVOQ could have
for individuals struggling to control their atopic dermatitis,"
said Michael Severino, M.D., vice
chairman and president, AbbVie. "We are committed to delivering on
the needs of people living with atopic dermatitis, many of whom
continue to endure relentless itch and skin symptoms that can
interfere with daily activities."
At week 16, 42/60 percent of patients on upadacitinib 15/30 mg
experienced clinically meaningful reductions in itch, respectively,
defined as improvement in Worst Pruritus Numerical Rating Scale
(NRS) ≥4, versus 9 percent of patients receiving placebo
(p<0.001).1 For both doses, patients experienced an
early reduction in itch, which was maintained through week
16.1 After just one day following the first dose (day
2), reductions in itch compared to placebo were observed for
patients receiving upadacitinib 30 mg (8 percent versus 1 percent,
p<0.001).1 For patients receiving upadacitinib 15 mg,
12 percent experienced a reduction in itch after just two days
following the first dose (day 3) compared to 3 percent of patients
receiving placebo (p<0.001).1
"Atopic dermatitis is more than a rash or itchy skin. Many
people living with moderate to severe forms continue to suffer from
significant physical and emotional burden of the disease," said
Alan Irvine, M.D., D.S.c., professor
of dermatology, Trinity College Dublin,
Ireland and lead study investigator of Measure Up 2. "These
data support our continued efforts to provide additional options
for those living with moderate to severe atopic dermatitis."
Measure Up 2
Results at Week 16*,1
|
|
Upadacitinib 15
mg
(n=276)
|
Upadacitinib 30
mg
(n=282)
|
Placebo
(n=278)
|
EASI
75a
|
60%
|
73%
|
13%
|
vIGA-AD
0/1b
|
39%
|
52%
|
5%
|
Improvement in
Worst Pruritus
NRS≥4c
|
42%
|
60%
|
9%
|
|
* Co-primary
endpoints were EASI 75 and vIGA-AD 0/1 at week 16. Co-primary
endpoints achieved p-values of <0.001. Improvement in Worst
Pruritus NRS≥4 at day 2 (upadacitinib 30 mg), day 3 (upadacitinib
15 mg) and week 16 were secondary endpoints. All secondary
endpoints achieved p-values of <0.001. Not all secondary
endpoints are shown.
|
a EASI 75 is defined as at least a 75
percent reduction in Eczema Area and Severity Index.
|
b vIGA-AD 0/1 is defined as a
validated Investigator Global Assessment for Atopic Dermatitis of
clear or almost clear (0/1) with at least two grades of reduction
from baseline.
|
c Improvement in Worst Pruritus NRS≥4
is defined as an improvement (reduction) in Worst Pruritus NRS≥4.
The endpoint was analyzed for participants with pruritus NRS≥4 at
baseline.
|
Atopic dermatitis is a chronic, relapsing inflammatory condition
characterized by a cycle of intense itching and scratching leading
to cracked, scaly, oozing skin.11,12 It affects up to an
estimated 25 percent of adolescents and 10 percent of adults at
some point in their lifetime.12 Between 20 and 46
percent of adults with atopic dermatitis have moderate to severe
disease.13 The range of symptoms pose significant
physical, psychological and economic burden on individuals impacted
by the disease.12,14
No new safety risks were observed compared to the safety profile
observed in patients with rheumatoid arthritis and psoriatic
arthritis receiving RINVOQ.1,15-18 During the 16-week
placebo-controlled period of Measure Up 2, serious adverse events
(SAEs) occurred in 1.8 percent of patients in the upadacitinib 15
mg and 2.5 percent of patients in the upadacitinib 30 mg compared
to 2.9 percent of patients in the placebo group.1 The
most common AEs for the upadacitinib groups were acne, headache and
upper respiratory tract infection.1 Acne was observed
with both doses of upadacitinib (12.7 percent of patients on 15 mg
and 14.5 percent of patients on 30 mg) versus placebo (2.2 percent
of patients); all events were mild or moderate in severity and
none led to treatment discontinuation.1 Eczema
herpeticum was only observed in patients receiving upadacitinib 15
mg (1.1 percent of patients).1 Serious infections
were reported infrequently (0.7 percent of patients receiving
upadacitinib 30 mg, 0.4 percent of patients receiving upadacitinib
15 mg and 0.7 percent of patients receiving placebo).1
No venous thromboembolic events (VTEs) were observed in the
upadacitinib groups; a pulmonary embolism was reported in a patient
receiving placebo.1 No deaths or major adverse cardiac
events (MACE) were reported in any of the treatment
groups.1
Full results from the Measure Up 2 study will be presented at a
future medical meeting and submitted for publication in a
peer-reviewed journal. Use of RINVOQ in atopic dermatitis is not
approved and its safety and efficacy have not been evaluated by
regulatory authorities.
About Measure Up 2 Study1,10
Measure Up 2 is a Phase 3, multicenter, randomized,
double-blind, parallel-group, placebo-controlled study designed to
evaluate the safety and efficacy of upadacitinib in adults and
adolescents (ages 12 to 18 or older) with moderate to severe atopic
dermatitis who are candidates for systemic treatment. Patients were
randomized to upadacitinib 15 mg, upadacitinib 30 mg or placebo.
Placebo patients were switched to either upadacitinib 15 mg or
upadacitinib 30 mg at week 16.
The co-primary endpoints were the percentage of patients
achieving EASI 75 and a vIGA-AD of 0/1 after 16 weeks of treatment.
Secondary endpoints included improvement in Worst Pruritus NRS≥4,
EASI 90, percent change in Worst Pruritus NRS, percent change in
EASI at week 16, as well as improvement in Worst Pruritus NRS≥4 at
day 2 (one day after the first dose) for patients receiving
upadacitinib 30 mg and improvement in Worst Pruritus NRS≥4 at day 3
(two days after the first dose) for patients receiving upadacitinib
15 mg. The trial is ongoing, and the long-term extension period
remains blinded to investigators and patients, to evaluate the
long-term safety, tolerability and efficacy of the two once-daily
doses (15 mg and 30 mg) of upadacitinib in patients who have
completed the placebo-controlled period. Top-line results from the
replicate Phase 3 study, Measure Up 1, were announced in
June 2020.
More information on this trial can be found at
www.clinicaltrials.gov (NCT03607422).
About RINVOQ (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is an
oral, once-daily, selective and reversible JAK inhibitor studied in
several immune-mediated inflammatory diseases.1,3-10 It
was engineered to have greater inhibitory potency for JAK1 versus
JAK2, JAK3 and TYK2.15 In August
2019, RINVOQ received U.S. Food and Drug Administration
approval for adult patients with moderately to severely active
rheumatoid arthritis who have had an inadequate response or
intolerance to methotrexate. In December
2019, RINVOQ also received approval by the European
Commission for the treatment of adult patients with moderate to
severe active rheumatoid arthritis who have responded inadequately
to, or who are intolerant to one or more disease-modifying
anti-rheumatic drugs. The approved dose for RINVOQ in rheumatoid
arthritis is 15 mg. Phase 3 trials of RINVOQ in atopic dermatitis,
rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis,
Crohn's disease, ulcerative colitis and giant cell arteritis are
ongoing.5-10 Use of RINVOQ in atopic dermatitis is not
approved and its safety and efficacy have not been evaluated by
regulatory authorities.
Important Safety Information about RINVOQ™
(upadacitinib)
RINVOQ U.S. Use and Important Safety
Information
RINVOQ is a prescription medicine used to treat
adults with moderate to severe rheumatoid arthritis in whom
methotrexate did not work well or could not be tolerated. It is not
known if RINVOQ is safe and effective in children under 18 years of
age.
What is the most important information I should know about
RINVOQ?
RINVOQ is a medicine that can lower the ability of
your immune system to fight infections. You should not start taking
RINVOQ if you have any kind of infection unless your healthcare
provider (HCP) tells you it is okay.
- Serious infections have happened in some people taking
RINVOQ, including tuberculosis (TB) and infections caused by
bacteria, fungi, or viruses that can spread throughout the body.
Some people have died from these infections. Your HCP should
test you for TB before starting RINVOQ and check you closely for
signs and symptoms of TB during treatment with RINVOQ. You may be
at higher risk of developing shingles (herpes zoster).
- Lymphoma and other cancers, including skin cancers, can
happen in people taking RINVOQ.
- Blood clots in the veins of the legs or lungs and arteries
are possible in some people taking RINVOQ. This may be
life-threatening and cause death.
- Tears in the stomach or intestines and changes in certain
laboratory tests can happen. Your HCP should do blood tests before
you start taking RINVOQ and while you take it. Your HCP may stop
your RINVOQ treatment for a period of time if needed because of
changes in these blood test results.
What should I tell my HCP BEFORE starting RINVOQ?
Tell
your HCP if you:
- Are being treated for an infection, have an infection that
won't go away or keeps coming back, or have symptoms of an
infection such as:
-
- Fever, sweating, or chills
- Shortness of breath
- Warm, red, or painful skin or sores on your body
- Muscle aches
- Feeling tired
- Blood in phlegm
- Diarrhea or stomach pain
- Cough
- Weight loss
- Burning when urinating or urinating more often than normal
- Have TB or have been in close contact with someone with
TB.
- Have had any type of cancer, hepatitis B or C, shingles (herpes
zoster), or blood clots in the veins of your legs or lungs,
diverticulitis (inflammation in parts of the large intestine), or
ulcers in your stomach or intestines.
- Have other medical conditions including liver problems, low
blood cell counts, diabetes, chronic lung disease, HIV, or a weak
immune system.
- Live, have lived, or have traveled to parts of the country that
increase your risk of getting certain kinds of fungal infections,
such as the Ohio and Mississippi
River valleys and the Southwest. If you are unsure if you've been
to these areas, ask your HCP.
- Have recently received or are scheduled to receive a vaccine.
People who take RINVOQ should not receive live vaccines.
- Are pregnant or plan to become pregnant. Based on animal
studies, RINVOQ may harm your unborn baby. Your HCP will check
whether or not you are pregnant before you start RINVOQ. You should
use effective birth control (contraception) to avoid becoming
pregnant while taking RINVOQ and for at least 4 weeks after your
last dose.
- Are breastfeeding or plan to breastfeed. RINVOQ may pass into
your breast milk. You should not breastfeed while taking RINVOQ and
for at least 6 days after your last dose.
Tell your HCP about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal
supplements. RINVOQ and other medicines may affect each other,
causing side effects.
Especially tell your HCP if you take:
- Medicines for fungal or bacterial infections
- Rifampicin or phenytoin
- Medicines that affect your immune system
Ask your HCP or pharmacist if you are not sure if you are taking
any of these medicines.
What should I tell my HCP AFTER starting RINVOQ?
Tell
your HCP right away if you:
- Have any symptoms of an infection. RINVOQ can make you more
likely to get infections or make any infections you have
worse.
- Have any signs or symptoms of blood clots during treatment with
RINVOQ, including:
-
- Swelling
- Sudden unexplained chest pain
- Pain or tenderness in the leg
- Shortness of breath
- Have a fever or stomach-area pain that does not go away, and a
change in your bowel habits.
What are the common side effects of RINVOQ?
These
include: upper respiratory tract infections (common cold, sinus
infections), nausea, cough, and fever. These are not all the
possible side effects of RINVOQ.
RINVOQ is taken once a day with or without food. Do not split,
break, crush, or chew the tablet. Take RINVOQ exactly as your HCP
tells you to use it.
This is the most important information to know about RINVOQ.
For more information, talk to your HCP. 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.
Please click here for the Full Prescribing
Information and Medication Guide.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
About AbbVie in Dermatology
For more than a decade, AbbVie has worked to uncover new
solutions and improve care for people with serious skin diseases,
including psoriasis, psoriatic arthritis, hidradenitis suppurativa
and atopic dermatitis. With a broad clinical trial program, we
continue to actively research and adapt to the evolving needs of
the dermatology community and advance our pipeline to help people
achieve their treatment goals and live beyond their skin disease.
For more information on AbbVie in dermatology, visit
https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/dermatology.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.
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