NORTH CHICAGO, Ill.,
April 1, 2021 /PRNewswire/ -- AbbVie
(NYSE: ABBV) today announced that the New England Journal of
Medicine has published 24-week results from the Phase 3
SELECT-PsA 1 trial evaluating
RINVOQ™ (upadacitinib, 15 mg and 30 mg) in
adults with active psoriatic arthritis who had responded
inadequately or were intolerant to one or more non-biologic disease
modifying anti-rheumatic drugs (DMARDs).1 These
data build on previously announced Phase 3 topline results
showing that upadacitinib 15 mg and 30 mg met the primary endpoint
of ACR20 response at week 12 versus placebo as well as key
secondary endpoints.1
"These data show upadacitinib's potential to improve clinical
and radiographic outcomes for people with psoriatic arthritis, a
complex and progressive autoimmune disease," said Thomas Hudson, MD, senior vice president,
research and development, chief scientific officer, AbbVie.
"Ultimately, our goal is to help more patients achieve disease
control and relief from their most bothersome joint and skin
symptoms that can impact their daily lives."
Recently, the European Commission (EC) approved RINVOQ (15 mg)
for use in adults with active psoriatic arthritis. Use of RINVOQ in
psoriatic arthritis is not approved and its safety and efficacy are
under evaluation by regulatory authorities in the United States.
Efficacy results for ranked secondary endpoints not previously
reported include:1*
- A significantly higher percentage of patients taking
upadacitinib 15 mg and 30 mg (54 and 58 percent, respectively)
achieved resolution of enthesitis (Leeds Enthesitis Index (LEI)=0)
compared to those taking placebo (32 percent) at week 24
(p<0.001 for both doses); 47 percent of patients achieved
resolution of enthesitis in the adalimumab group.
- Patients taking upadacitinib 15 mg and 30 mg (6.3 and 7.1 mean
change from baseline, respectively) saw an improvement in fatigue
compared to patients taking placebo (2.8) at week 12 (p<0.001
for both doses), as measured by the Functional Assessment of
Chronic Illness Therapy-Fatigue (FACIT-F) scale, which continued to
improve through week 24; patients in the adalimumab group saw an
improvement (5.7) at week 12.
- At week 16, significantly more patients achieved a score of 0
or 1 and at least a 2-point improvement in the static Investigator
Global Assessment of psoriasis (sIGA) with the 15 mg and 30 mg
doses of upadacitinib (42 and 54 percent, respectively) versus
placebo (11 percent, p<0.001 for both doses); 39 percent of
patients in the adalimumab group.
- Inhibition of radiographic progression, as measured by the
modified total Sharp/van der Heijde Score (mTSS) at week 24, was
observed with both doses of upadacitinib (-0.04 for the 15 mg dose,
p<0.001, and 0.03 for the 30 mg dose, p=0.007), compared to
placebo, which showed an increase of 0.25; 0.01 was observed in the
adalimumab group.
- At week 24, 77 percent and 80 percent of patients taking 15 mg
and 30 mg of upadacitinib, respectively, achieved resolution of
dactylitis (Leeds Dactylitis Index (LDI)=0) compared to 40 percent
of patients taking placebo (nominal p-values <0.001; comparison
not multiplicity controlled); 74 percent of patients achieved
resolution of dactylitis in the adalimumab group.
* Comparison to adalimumab for these endpoints was
not multiplicity-controlled.
"Psoriatic arthritis is a chronic, painful autoimmune disease,"
said Iain McInnes, Professor of
Medicine and Versus Arthritis Professor of Rheumatology at
University of Glasgow, UK, and the lead
study author. "I am encouraged by these results showing that
upadacitinib can improve outcomes for people living with psoriatic
arthritis who are facing the potentially debilitating impact of
joint and skin symptoms, along with other debilitating challenges
like fatigue."
The safety profile of upadacitinib was generally similar to
results reported previously in rheumatoid arthritis
trials.1,2 Through 24 weeks,
rates of treatment-emergent adverse events (AEs) and serious AEs
were similar between 15 mg of upadacitinib and 40 mg of adalimumab,
but were more frequent with upadacitinib 30 mg. The most common AE
was upper respiratory tract infection. Rates of serious infections
were 0.9 percent (placebo), 0.7 percent (adalimumab), 1.2 percent
(upadacitinib 15 mg) and 2.6 percent (upadacitinib 30 mg). Herpes
zoster were reported in three (0.7 percent), zero, four (0.9
percent) and five (1.2 percent) cases for the placebo, adalimumab,
upadacitinib 15 mg and upadacitinib 30 mg arms, respectively.
Malignancy was reported in all treatment arms with one case in the
placebo and upadacitinib 15 mg arms (0.2 percent) and three cases
in the adalimumab and upadacitinib 30 mg arms (0.7 percent).
Adjudicated venous thrombotic events included one event of deep
vein thrombosis in the placebo group (0.2 percent), two events of
deep vein thrombosis in the adalimumab group (0.5 percent), and one
event of pulmonary embolism in the upadacitinib 30 mg group (0.2
percent); no thrombotic events were reported in the upadacitinib 15
mg group. No major adverse cardiovascular events (MACE) and deaths
were reported with upadacitinib
treatment.1
About SELECT-PsA 11,3
SELECT-PsA 1 is a
Phase 3, multicenter, randomized, double-blind, parallel-group,
active and placebo-controlled study designed to evaluate the safety
and efficacy of upadacitinib compared to placebo and adalimumab in
adult patients with active psoriatic arthritis who have a history
of inadequate response to at least one non-biologic DMARD. Patients
were randomized to upadacitinib 15 mg, upadacitinib 30 mg,
adalimumab 40 mg EOW, or placebo followed by either upadacitinib 15
mg or upadacitinib 30 mg at week 24.
The primary endpoint was the percentage of subjects receiving
upadacitinib 15 mg or 30 mg who achieved an ACR20 response after 12
weeks of treatment versus placebo. Ranked secondary endpoints
included percentage of patients achieving a static Investigator
Global Assessment (sIGA) of psoriasis of 0 or 1 and at least a
2-point improvement from baseline at week 16; percentage of
patients achieving PASI 75 response at week 16; inhibition of
radiographic progression at week 24 per the modified total
Sharp/van der Heijde Score; the percentage of patients
achieving MDA at week 24; percentage of participants with
resolution of enthesitis at week 24; change in Functional
Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
questionnaire at week 12; and percentage of patients with
resolution of dactylitis at week 24 versus placebo. The long-term
extension of the trial is ongoing. More information on this trial
can be found at www.clinicaltrials.gov (NCT03104400).
About RINVOQ™ (upadacitinib)
Discovered and developed
by AbbVie scientists, RINVOQ is a JAK inhibitor that is being
studied in several immune-mediated inflammatory
diseases.2-12 In August
2019, RINVOQ received U.S. FDA approval for adult patients
with moderately to severely active rheumatoid arthritis who have
had an inadequate response or intolerance to methotrexate. RINVOQ
is approved 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; for the treatment of
active psoriatic arthritis (PsA) in adult patients who have
responded inadequately to, or who are intolerant to one or more
DMARDs; and for the treatment of active ankylosing spondylitis (AS)
in adult patients who have responded inadequately to conventional
therapy. The approved dose for RINVOQ in rheumatoid arthritis is 15
mg. 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.2-5,7-12 Use of RINVOQ in
psoriatic arthritis is not approved and its safety and efficacy are
under evaluation by regulatory authorities.
RINVOQ U.S. Use and Important Safety
Information13
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 HUMIRA (adalimumab) in the U.S.
Uses14
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, with methotrexate, or with certain other
medicines.
- 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 Crohn's disease (CD) and to achieve
and maintain clinical remission in adults who have not responded
well to certain other medications. HUMIRA is also used to reduce
signs and symptoms and to achieve clinical remission in these
adults who have lost response to or are unable to tolerate
infliximab.
- Moderate to severe Crohn's disease (CD) and to
achieve and maintain clinical remission in children 6 years of age
and older when certain other treatments have not worked well
enough.
- Moderate to severe hidradenitis suppurativa (HS) in
people 12 years and older.
- In adults, to help get moderate to severe ulcerative colitis
(UC) under control (induce remission) and keep it under control
(sustain remission) when certain other medicines have not worked
well enough. 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
HUMIRA is a TNF blocker
medicine that affects the immune system and can lower the body's
ability to fight infections. 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. People should be tested for TB
before HUMIRA use and monitored for signs and symptoms of TB during
therapy, even if their TB test was negative. People at risk of TB
may be treated with medicine for TB. Treatment with HUMIRA should
not be started in a person with an active infection, unless
approved by a doctor. HUMIRA should be stopped if a person develops
a serious infection. People should tell their doctor if they live
in or have been to a region where certain fungal infections are
common, as these infections may happen or become more severe if
people use HUMIRA. People should tell their doctor if they have had
TB or hepatitis B, are prone to infections, or have symptoms such
as fever, fatigue, cough, or sores.
For people taking TNF blockers, including HUMIRA, the chance of
getting lymphoma or other cancers may increase. 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, the chance of getting two types of skin
cancer (basal cell and squamous cell) may increase. These types are
generally not life-threatening if treated.
Other possible serious side effects with HUMIRA include
hepatitis B infection in carriers of the virus; allergic reactions;
nervous system problems; blood problems; certain immune reactions,
including a lupus-like syndrome; liver problems; and new or
worsening heart failure or psoriasis. The use of HUMIRA with
anakinra or abatacept is not recommended. People using HUMIRA
should not receive live vaccines. Children should be brought up to
date on all vaccines before starting HUMIRA.
Common side effects of HUMIRA include injection site reactions
(redness, rash, swelling, itching, or bruising), upper respiratory
infections (including sinus infections), headaches, rash, and
nausea.
HUMIRA is given by injection under the skin.
The benefits and risks of HUMIRA should be carefully considered
before starting therapy.
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 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
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 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 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:
- McInnes I, et al. Trial of Upadacitinib and Adalimumab for
Psoriatic Arthritis. New England Journal of Medicine. 2021
April 1;384:1227-1239. doi:
10.1056/NEJMoa2022516.
- Burmester GR, 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 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 November 30, 2020.
- A Study Comparing Upadacitinib (ABT-494) to Placebo in
Participants With Active Psoriatic Arthritis Who Have a History of
Inadequate Response to at Least One Biologic Disease Modifying
Anti-Rheumatic Drug (SELECT-PsA 2). Clinicaltrials.gov. 2020.
Available at: https://clinicaltrials.gov/ct2/show/NCT03104374.
Accessed on November 30, 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 November 30, 2020.
- Pipeline – Our Science | AbbVie. AbbVie. 2019. Available
at: https://www.abbvie.com/our-science/pipeline.html. Accessed
on November 30, 2020.
- 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 November 30, 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 November 30, 2020.
- A Study to Compare Safety and Efficacy of Upadacitinib to
Dupilumab in Adult Participants With Moderate to Severe Atopic
Dermatitis (Heads Up). ClinicalTrials.gov. 2020. Available
at: https://clinicaltrials.gov/ct2/show/NCT03738397. Accessed
on November 30, 2020.
- A Study to Evaluate Efficacy and Safety of Upadacitinib in
Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2).
ClinicalTrials.gov. 2020. Available
at: https://clinicaltrials.gov/ct2/show/NCT04169373. Accessed
on November 30, 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 November 30, 2020.
- A Study to Evaluate the Efficacy and Safety of Upadacitinib in
Subjects With Takayasu Arteritis (SELECT-TAK). ClinicalTrials.gov.
2020. Available
at https://clinicaltrials.gov/ct2/show/record/NCT04161898.
Accessed on November 30, 2020.
- RINVOQ™ (upadacitinib) [Package Insert]. North
Chicago, Ill.: AbbVie Inc.
- HUMIRA Injection [Package Insert]. North Chicago, Ill.: AbbVie Inc.
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