NORTH CHICAGO, Ill.,
June 18, 2020 /PRNewswire/
-- AbbVie (NYSE: ABBV), a research-based global
biopharmaceutical company, today announced upadacitinib (15 mg and
30 mg, once daily) monotherapy met the co-primary endpoints of at
least a 75 percent improvement in the Eczema Area Severity Index
(EASI 75) and a validated Investigator's Global Assessment for
Atopic Dermatitis (vIGA-AD) of clear or almost clear (0/1) at week
16 in adults and adolescents with moderate to severe atopic
dermatitis who are candidates for systemic
therapy.1 Measure Up 1 is the first
pivotal Phase 3 study to evaluate the efficacy and safety of RINVOQ
for the treatment of moderate to severe atopic dermatitis.
In this study, patients receiving either 15 mg or 30 mg of
upadacitinib monotherapy showed significant improvement in skin
clearance.1 Of patients receiving upadacitinib 15/30 mg,
70/80 percent achieved EASI 75 at week 16, respectively, versus 16
percent in the placebo group (p<0.001).1 Of those
treated with upadacitinib 15/30 mg, 48/62 percent of patients
achieved vIGA-AD 0/1, respectively, versus 8 percent of
patients receiving placebo (p<0.001).1
"People with atopic dermatitis often struggle with relentless
skin and itch symptoms, resulting in a significant unmet need,"
said Michael Severino, M.D., vice
chairman and president, AbbVie. "We're excited by these results,
which show the potential of RINVOQ for individuals living with the
burden of atopic dermatitis."
For both doses, patients experienced an early reduction in itch,
which was maintained through week 16.1 Clinically
meaningful reduction in itch was defined as improvement in Worst
Pruritus Numerical Rating Scale (NRS)≥4,1 which was
achieved by a significantly higher proportion of patients receiving
upadacitinib 15/30 mg at week 16 compared to placebo (52/60
percent, respectively, versus 12 percent, p<0.001).1
Clinically meaningful reductions in itch compared to placebo were
observed as early as one day after the first dose (day 2) for
patients receiving upadacitinib 30 mg (12 percent versus 4 percent,
p<0.001) and two days after the first dose (day 3) for patients
receiving upadacitinib 15 mg (16 percent versus 3 percent,
Measure Up 1
Results at Week 16*,1
Improvement in Worst
endpoints were EASI 75 and vIGA 0/1 at week 16. Co-primary
endpoints achieved p-values of <0.001. Improvement in Worst
Pruritus NRS≥4 at day 2, day 3 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.
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.
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 common, chronic, relapsing, inflammatory
skin disease that can manifest as a recurring cycle of itching and
scratching leading to painful, cracked skin.13,14 It
affects up to an estimated 25 percent of adolescents and 10 percent
of adults at some point in their lifetime.15 Between 20
and 46 percent of adults with atopic dermatitis have moderate to
severe disease.16 The range of symptoms pose significant
physical, psychological and economic burden on individuals impacted
by the disease.13,14
"Both adolescents and adults patients living with moderate to
severe atopic dermatitis often suffer from an enormous burden of
disease that can affect every aspect of their daily life," said
lead investigator Emma
Guttman-Yassky, M.D., Ph.D., professor of dermatology and
immunology, Icahn School of Medicine at Mount Sinai Medical Center.
"It is encouraging to see the high proportion of patients achieving
clear or almost clear skin with upadacitinib, and the meaningful
and rapid reduction in itch with both doses."
No new safety risks were observed compared to the safety profile
observed in patients with rheumatoid arthritis and psoriatic
arthritis receiving RINVOQ.1-5 In Measure Up 1, serious
adverse events occurred in 2.1 percent of patients receiving
upadacitinib 15 mg, 2.8 percent of patients receiving upadacitinib
30 mg, and 2.8 percent of patients receiving placebo at week
16.1 The most common treatment-emergent adverse events
were acne, upper respiratory tract infection and
nasopharyngitis.1 Acne was observed with both doses of
upadacitinib (6.8 percent of patients on 15 mg and 17.2 percent of
patients on 30 mg) versus placebo (2.1 percent of patients) and was
mild to moderate in most cases.1 Eczema herpeticum was
observed in patients receiving upadacitinib 30 mg (1.1 percent of
patients) and placebo (1.4 percent of patients); it was not
observed in patients receiving upadacitinib 15 mg.1
Serious infections were reported infrequently (0.7 percent of
patients receiving upadacitinib 15 mg or 30 mg; none were observed
on placebo).1 No deaths, venous thromboembolic events
(VTE) or major adverse cardiac events (MACE) were
Full results from Measure Up 1 will be presented at a future
medical meeting and published in a peer-reviewed publication. Use
of RINVOQ in atopic dermatitis is not approved and its safety and
efficacy have not been evaluated by regulatory authorities.
About the Measure Up 1 Study1,17
Measure Up 1 is a Phase 3, multicenter, randomized,
double-blind, parallel-group, placebo-controlled study designed to
evaluate the safety and efficacy of upadacitinib in adult and
adolescent (12 years or older) patients with moderate to severe
atopic dermatitis who are candidates for systemic treatment.
Patients were randomized to upadacitinib 15 mg, upadacitinib 30 mg
or placebo, followed by 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 score of 0/1 after 16 weeks of
treatment. Secondary endpoints included Improvement in Worst
Pruritus NRS≥4 at week 16, 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. More information on this trial can be
found at www.clinicaltrials.gov (NCT03569293).
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.1,6-12 It
was engineered to have greater inhibitory potency for JAK1 versus
JAK2, JAK3 and TYK2.2 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.7-12,14 Use of RINVOQ in atopic dermatitis is
not approved and its safety and efficacy have not been evaluated by
Important Safety Information about RINVOQ™
RINVOQ U.S. Use and Important Safety
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
What is the most important information I should know about
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
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
- Weight loss
- Burning when urinating or urinating more often than normal
- Have TB or have been in close contact with someone with
- 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
- 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
- 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
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
- Have any signs or symptoms of blood clots during treatment with
- 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 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
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
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.
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, competition from
other products, challenges to intellectual property, difficulties
inherent in the research and development process, adverse
litigation or government action, and changes to laws and
regulations applicable to our industry. 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. 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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