NORTH CHICAGO, Ill.,
July 28, 2020 /PRNewswire/ -- AbbVie
(NYSE: ABBV) today announced upadacitinib (15 mg and 30 mg, once
daily) plus topical corticosteroids (TCS) met the co-primary
endpoints and all secondary endpoints in AD Up, the third pivotal
Phase 3 study of RINVOQ in atopic dermatitis.1 AD Up
evaluated the efficacy and safety of both doses of upadacitinib
therapy versus placebo in adults and adolescents with moderate to
severe atopic dermatitis; all treatment groups, including placebo,
received concomitant TCS.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
Significantly more patients receiving either dose of
upadacitinib plus TCS showed improvement in skin clearance compared
to placebo plus TCS at week 16.1 In the study,
65/77 percent of patients receiving upadacitinib 15/30 mg plus TCS
achieved EASI 75, respectively, versus 26 percent receiving placebo
plus TCS (p<0.001).1 Of patients treated with
upadacitinib 15/30 mg plus TCS, 40/59 percent achieved vIGA-AD 0/1,
respectively, versus 11 percent of patients receiving placebo plus
"These data build on the positive results from our previous
studies in atopic dermatitis, now with additional perspective on
the efficacy of RINVOQ used with a mainstay treatment for people
living with the disease – topical steroids," said Tom Hudson, M.D., senior vice president of
R&D and chief scientific officer, AbbVie. "With our deep
heritage in serious skin diseases, we look forward to advancing
research with RINVOQ as part of our ultimate goal to address unmet
needs and improve care for people living with the relentless itch
and skin symptoms of atopic dermatitis."
Additionally, more patients treated with upadacitinib plus TCS
experienced a clinically meaningful reduction in itch, defined as
improvement in Worst Pruritus Numerical Rating Scale (NRS)≥4,
compared to patients treated with placebo plus TCS.1 At
week 16, 52/64 percent of patients receiving upadacitinib 15/30 mg
plus TCS achieved this endpoint compared to 15 percent of patients
receiving placebo plus TCS (p<0.001).1
In a pre-specified additional analysis, treatment with either
dose of upadacitinib also led to a higher mean number of topical
corticosteroid-free days (TCS-free days) up to week 16 versus
placebo.1 A TCS-free day is defined by a response of
EASI 75 or greater without the use of
TCS.1 Patients treated with upadacitinib 15/30 mg
had a mean of 34/47 TCS-free days while maintaining EASI 75,
respectively, compared with a mean of 8 days for those treated with
placebo plus TCS (nominal p<0.001).1
"These results are encouraging, including the analysis showing
some patients in the upadacitinib treatment groups were able to
control their skin symptoms without topical corticosteroids," said
Kristian Reich, M.D., professor of
translational research in inflammatory skin diseases at the
University Medical Center Hamburg Eppendorf, and Skinflammation
Center, Hamburg, Germany and
principal investigator. "Many of the current treatment options rely
on patients to self-manage their condition, often with multiple
applications of topicals. Patients could benefit from more
therapeutic options that can help control symptoms without the
constant need for concomitant topicals, as they strive for relief
from this life-long, chronic disease."
AD Up Results at
Placebo plus TCS
Improvement in Worst
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 week 16 was a secondary endpoint. 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
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
Atopic dermatitis is a chronic, relapsing inflammatory condition
characterized by a cycle of intense itching and scratching leading
to cracked, scaly, oozing skin.12,13 It affects up to an
estimated 25 percent of adolescents and 10 percent of adults at
some point in their lifetime.13 Between 20 and 46
percent of adults with atopic dermatitis have moderate to severe
disease.14 The range of symptoms pose significant
physical, psychological and economic burden on individuals impacted
by the disease.13,15
Safety results were consistent with the two previously reported
Phase 3 studies in atopic dermatitis, with no new safety risks
observed during the 16-week placebo-controlled
period.1-3 Serious adverse events (SAEs) occurred in 2.3
percent of patients in the upadacitinib 15 mg plus TCS group and
1.3 percent of patients in the upadacitinib 30 mg plus TCS group
compared to 3.0 percent of patients in the placebo plus TCS
group.1 The most common AEs for the upadacitinib groups
were nasopharyngitis, acne and upper respiratory tract
infection.1 Acne was observed at higher rates in the 15
mg and 30 mg upadacitinib plus TCS groups (10.0 percent and 13.8
percent, respectively) versus placebo plus TCS group (2.0 percent);
all events were mild or moderate in severity and none led to
treatment discontinuation.1 Eczema herpeticum was
observed in 1.0 percent of patients on upadacitinib 15 mg plus TCS
and 1.3 percent of patients on upadacitinib 30 mg plus TCS; none
were reported in patients on placebo plus TCS.1 Serious
infections were reported infrequently (1.0 percent in the
upadacitinib 15 mg plus TCS group, 1.0 percent in the placebo plus
TCS group; none were reported in the upadacitinib 30 mg plus TCS
group).1 One event of arterial thrombosis occurred in a
patient on placebo plus TCS.1 No deaths, major adverse
cardiac events or venous thromboembolic events were reported in any
of the treatment groups.1
Full results from the AD Up 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
About AD Up1,11
AD Up, together with Measure Up 1 and Measure Up 2 (top-line
results announced in June and July
2020), make up AbbVie's Phase 3 pivotal trial program
evaluating RINVOQ for the treatment of individuals with moderate to
severe atopic dermatitis (ages 12 and older) who are candidates for
AD Up is a Phase 3, multicenter, randomized, double-blind,
parallel-group, placebo-controlled study. Patients were randomized
to upadacitinib 15 mg, upadacitinib 30 mg or placebo, all in
combination with TCS. Patients receiving placebo plus TCS were
switched to either upadacitinib 15 mg or upadacitinib 30 mg plus
TCS 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. 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 plus TCS in patients
who have completed the placebo-controlled period. More information
on this trial can be found at www.clinicaltrials.gov
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.1,4-11 It
was engineered to have greater inhibitory potency for JAK1 versus
JAK2, JAK3 and TYK2.16 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.5-11 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 RINVOQ?
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 RINVOQ?
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?
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
If you are having difficulty paying for your medicine, AbbVie
may be able to help. Visit AbbVie.com/myAbbVieAssist to
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,
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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