NORTH CHICAGO, Ill.,
Aug. 4, 2021 /PRNewswire/
-- AbbVie (NYSE: ABBV) today announced that JAMA
Dermatology has published 24-week results from the Phase
3b Heads Up study evaluating the
efficacy and safety of RINVOQ® (upadacitinib, 30 mg,
once daily) versus DUPIXENT® (dupilumab, 300 mg, every
other week) – both as monotherapy treatments – in adults with
moderate to severe atopic dermatitis who were candidates for
systemic therapy.
The publication expands upon previously announced topline
results and showed upadacitinib (30 mg, once daily) achieved
superiority compared to dupilumab for the primary endpoint, the
proportion of patients with at least a 75 percent improvement in
the Eczema Severity Index (EASI 75) at week 16.1 Of
those treated with upadacitinib, 71 percent achieved EASI 75 at
week 16 compared to 61 percent of those treated with
dupilumab.1 Additionally, upadacitinib demonstrated
statistically significant greater efficacy across all ranked
secondary endpoints compared to dupilumab through week 16,
including early reduction in itch and rates of skin clearance
improvement.1
"In this study, upadacitinib 30 mg demonstrated a more rapid
onset of action compared to dupilumab, with patients experiencing a
reduction in itch at one week and skin clearance improvements at
two weeks. In addition, more upadacitinib-treated patients achieved
high levels of skin clearance, such as EASI 90 and 100, by 16 weeks
of treatment," said Andrew Blauvelt,
MD, MBA, lead investigator for the Heads Up study and president of
Oregon Medical Research Center in Portland, Oregon. "The results from this
important comparative study will help inform how physicians work
with their patients to set treatment goals for atopic
dermatitis."
Results for select ranked secondary endpoints include:
- After one week of treatment, the upadacitinib 30 mg treatment
group had a 31 percent reduction in itch (as measured by Worst
Pruritus Numerical Rating Scale [NRS]) compared to 9 percent in the
dupilumab group (p<0.001).1
- After two weeks of treatment, 44 percent receiving upadacitinib
achieved EASI 75 versus 18 percent receiving dupilumab
(p<0.001). 1
- At 16 weeks, 28 percent of people treated with upadacitinib
achieved clear skin (EASI 100; p<0.001) and 61 percent achieved
almost clear skin (EASI 90; p<0.001), compared to 8 percent and
39 percent, respectively, of those treated with
dupilumab.1
The safety profile of upadacitinib was consistent with what was
observed in the Phase 3 pivotal studies, Measure Up 1, Measure Up 2
and AD Up.1-3 Through week 16, the most common adverse
events were acne for the upadacitinib group and conjunctivitis for
the dupilumab group.1 Serious adverse events occurred in
2.9 percent of those receiving upadacitinib and 1.2 percent of
those receiving dupilumab.1 Serious infections were
reported infrequently in both treatment groups (1.1 percent in
those who received upadacitinib and 0.6 percent in those who
received dupilumab).1 One treatment-emergent death due
to bronchopneumonia associated with influenza A occurred in a
patient who received upadacitinib.1 No malignancies were
reported in the upadacitinib group; one non-melanoma skin cancer
was reported in the dupilumab group.1 No major adverse
cardiac events or venous thromboembolic events were reported in
either treatment group.1
About Heads Up1
Heads Up is a
Phase 3b multicenter, randomized, double-blind,
double-dummy, active comparator-controlled study in adults with
moderate to severe atopic dermatitis. Patients were randomized
to receive upadacitinib (30 mg, once daily, orally administered) or
dupilumab (300 mg, every other week, subcutaneous injection) for 24
weeks. Patients who received dupilumab received an initial dose of
600 mg at the baseline visit followed by 300 mg every other week.
All patients received placebo of the other treatment as part of the
Heads Up double-dummy study design.
The primary endpoint was the proportion of patients achieving
EASI 75 at week 16. Ranked secondary endpoints were percent change
from baseline in Worst Pruritus NRS (weekly average) at weeks 1, 4
and 16; proportion of patients achieving EASI 100 and EASI 90 at
week 16; proportion of patients achieving EASI 75 at week 2; and
Worst Pruritus NRS (weekly average) improvement ≥4 at week 16.
Additional endpoints at week 24 included EASI 75, EASI 90, EASI 100
and improvement from baseline Worst Pruritus NRS (weekly
average). More information on this trial can be found
at www.clinicaltrials.gov (NCT03738397).
About Upadacitinib
(RINVOQ®)4
Discovered and developed by
AbbVie scientists, RINVOQ is a selective and reversible JAK
inhibitor that is being studied in several immune-mediated
inflammatory diseases. In human cellular assays, RINVOQ
preferentially inhibits signaling by JAK1 or JAK1/3 with functional
selectivity over cytokine receptors that signal via pairs of JAK2.
RINVOQ 15 mg is approved by the U.S. Food and Drug Administration
(FDA) for adults with moderately to severely active rheumatoid
arthritis. RINVOQ 15 mg also is approved by the European Medicines
Agency (EMA) for adults with moderate to severe active rheumatoid
arthritis, adults with active psoriatic arthritis (PsA) and adults
with active ankylosing spondylitis (AS).
Use of RINVOQ in moderate to severe atopic dermatitis is not
approved and its safety and efficacy are under evaluation by the
U.S. FDA and the EMA. In June 2021,
the EMA's Committee for Medicinal Products for Human Use (CHMP)
adopted a positive opinion recommending the approval of RINVOQ for
the treatment of moderate to severe atopic dermatitis.
Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic
dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's
disease, ulcerative colitis, giant cell arteritis and Takayasu
arteritis are ongoing.5-12
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.
Please see the Full Prescribing Information, including
the Medication Guide, for RINVOQ.
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
more.
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, LinkedIn or Instagram.
Forward-Looking Statement
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 2020 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:
- Blauvelt, A., et. al. A Phase 3 Trial of Upadacitinib Versus
Dupilumab in Atopic Dermatitis. JAMA Dermatology doi:
10.1001/jamadermatol.2021.3023
- Guttman-Yassky E., et al.
Once-daily upadacitinib versus placebo in adolescents and adults
with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure
Up 2): results from two replicate, double-blind, randomized
controlled phase 3 studies. Lancet.
doi:10.1016/s0140-6736(21)00588-2.
- Reich K., et al. Safety and efficacy of upadacitinib in
combination with topical corticosteroids in adolescents and adults
with moderate-to-severe atopic dermatitis (AD Up): results from a
randomized, double-blind, placebo-controlled phase 3 trial. Lancet.
doi:10.1016/s0140-6736(21)00589-4.
- RINVOQ® (upadacitinib) [Package Insert].
North Chicago, Ill.: AbbVie
Inc.
- Pipeline – Our Science | AbbVie. AbbVie. 2019. Available at:
https://www.abbvie.com/our-science/pipeline.html. Accessed on
August 17, 2020.
- Burmester G.R., et al. Safety and efficacy of upadacitinib in
patients with rheumatoid arthritis and inadequate response to
conventional synthetic disease-modifying anti-rheumatic drugs
(SELECT-NEXT): a randomised, double-blind, placebo-controlled phase
3 trial. Lancet. 2018 Jun 23;391(10139):2503-2512. doi:
10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 18.
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled
Study of ABT-494 for the Induction of Symptomatic and Endoscopic
Remission in Subjects With Moderately to Severely Active Crohn's
Disease Who Have Inadequately Responded to or Are Intolerant to
Immunomodulators or Anti-TNF Therapy. ClinicalTrials.gov. 2020.
Available at: https://clinicaltrials.gov/ct2/show/NCT02365649.
Accessed on August 17, 2020
- A Study to Evaluate the Safety and Efficacy of ABT-494 for
Induction and Maintenance Therapy in Subjects With Moderately to
Severely Active Ulcerative Colitis. ClinicalTrials.gov. 2020.
Available at: https://clinicaltrials.gov/ct2/show/NCT02819635.
Accessed on August 17, 2020.
- A Study Evaluating the Safety and Efficacy of Upadacitinib in
Subjects With Active Ankylosing Spondylitis (SELECT Axis 1).
ClinicalTrials.gov. 2020. Available at:
https://clinicaltrials.gov/ct2/show/study/NCT03178487. Accessed on
August 17, 2020.
- A Study to Evaluate the Safety and Efficacy of Upadacitinib in
Participants With Giant Cell Arteritis (SELECT-GCA).
ClinicalTrials.gov. 2020. Available at:
https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed on
August 17, 2020.
- A Study to Evaluate Upadacitinib in Adolescent and Adult
Subjects With Moderate to Severe Atopic Dermatitis.
ClinicalTrials.gov. 2020. Available at:
https://clinicaltrials.gov/ct2/show/record/NCT03607422. Accessed on
August 17, 2020.
- A Study Comparing Upadacitinib (ABT-494) to Placebo and to
Adalimumab in Participants With Psoriatic Arthritis Who Have an
Inadequate Response to at Least One Non-Biologic Disease Modifying
Anti-Rheumatic Drug (SELECT - PsA 1). ClinicalTrials.gov. 2020.
Available at: https://clinicaltrials.gov/ct2/show/NCT03104400.
Accessed on August 17, 2020.
View original
content:https://www.prnewswire.com/news-releases/jama-dermatology-publishes-data-showing-rinvoq-upadacitinib-achieved-superiority-versus-dupixent-dupilumab-for-primary-and-all-ranked-secondary-endpoints-in-phase-3b-head-to-head-study-in-adults-with-atopic-dermatitis-301348484.html
SOURCE AbbVie