NORTH CHICAGO, Ill.,
June 1, 2020 /PRNewswire/ -- AbbVie
(NYSE: ABBV), a research-based global biopharmaceutical company,
today announced that it has submitted applications for a new
indication to the U.S. Food and Drug Administration (FDA) and
European Medicines Agency (EMA) for RINVOQ™ (upadacitinib; 15 mg,
once daily), a selective and reversible JAK inhibitor, for the
treatment of adult patients with active psoriatic arthritis.
"Psoriatic arthritis is a complex heterogeneous disease with
manifestations across multiple domains, including joints and skin,
causing daily pain, fatigue and stiffness," said Michael Severino, M.D., vice chairman and
president, AbbVie. "We look forward to working with regulatory
authorities and hope to bring RINVOQ to people living with this
debilitating disease as quickly as possible."
The applications are supported by data from two Phase 3 studies
across a broad range of more than 2,000 patients with active
psoriatic arthritis.1,2 In both studies, RINVOQ met the
primary endpoint of ACR20 response at week 12 versus
placebo.1,2 RINVOQ 15 mg also achieved non-inferiority
versus adalimumab in terms of ACR20 response at week
12.1 Patients receiving RINVOQ also experienced greater
improvements in physical function (HAQ-DI) and skin symptoms (PASI
75), and a greater proportion achieved minimal disease
activity.*,1,2 Overall, the safety profile of RINVOQ in
psoriatic arthritis was consistent with previously reported results
across the Phase 3 rheumatoid arthritis clinical trial program,
with no new significant safety risks detected.1-3
*Physical function was measured by the Health Assessment
Questionnaire Disability Index (HAQ-DI). Skin symptoms were
measured by a 75 percent improvement in the Psoriasis Area Severity
Index (PASI 75). Minimal disease activity is defined as the
fulfillment of five of seven outcome measures: Tender joint count
≤1; swollen joint count ≤1; PASI ≤1 or body surface area-psoriasis
≤3 percent; Patient's Assessment of Pain Numerical Rating Scale
(NRS) ≤1.5; Patient Global Assessment-Disease Activity NRS ≤2.0;
HAQ-DI score ≤0.5; and Leeds Enthesitis Index ≤1.
About RINVOQ™ (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a
selective and reversible JAK inhibitor that is being studied in
several immune-mediated inflammatory diseases.1,2,4-10
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. In December
2019, RINVOQ was 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.
The approved dose for RINVOQ in rheumatoid arthritis is 15 mg.
Phase 3 trials of RINVOQ in psoriatic arthritis, rheumatoid
arthritis, axial spondyloarthritis, Crohn's disease, atopic
dermatitis, ulcerative colitis and giant cell arteritis are
ongoing.1,2,4-10 Use of RINVOQ in psoriatic arthritis is
not approved and its safety and efficacy have not been established
by regulatory authorities.
Important Safety Information about RINVOQ
(upadacitinib)11
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 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.
Important EU Safety Information about RINVOQ
(upadacitinib)12
RINVOQ is contraindicated in patients hypersensitive to the
active substance or to any of the excipients, in patients with
active tuberculosis (TB) or active serious infections, in patients
with severe hepatic impairment, and during pregnancy.
Use in combination with other potent immunosuppressants is not
recommended.
Serious and sometimes fatal infections have been reported in
patients receiving upadacitinib. The most frequent serious
infections reported included pneumonia and cellulitis. Cases of
bacterial meningitis have been reported. Among opportunistic
infections, TB, multidermatomal herpes zoster, oral/oesophageal
candidiasis, and cryptococcosis have been reported with
upadacitinib. Prior to initiating upadacitinib, consider the risks
and benefits of treatment in patients with chronic or recurrent
infection or with a history of a serious or opportunistic
infection, in patients who have been exposed to TB or have resided
or travelled in areas of endemic TB or endemic mycoses, and in
patients with underlying conditions that may predispose them to
infection. Upadacitinib therapy should be interrupted if a patient
develops a serious or opportunistic infection. As there is a higher
incidence of infections in patients ≥75 years of age, caution
should be used when treating this population.
Patients should be screened for TB before starting upadacitinib
therapy. Anti-TB therapy should be considered prior to initiation
of upadacitinib in patients with previously untreated latent TB or
in patients with risk factors for TB infection.
Viral reactivation, including cases of herpes zoster, were
reported in clinical studies. Consider interruption of therapy if a
patient develops herpes zoster until the episode resolves.
Screening for viral hepatitis and monitoring for reactivation
should be performed before starting and during therapy with
upadacitinib.
The use of live, attenuated vaccines during, or immediately
prior to therapy is not recommended. It is recommended that
patients be brought up to date with all immunizations, including
prophylactic zoster vaccinations, prior to initiating upadacitinib,
in agreement with current immunization guidelines.
The risk of malignancies, including lymphoma is increased in
patients with rheumatoid arthritis (RA). Immunomodulatory medicinal
products may increase the risk of malignancies, including lymphoma.
The clinical data are currently limited and long-term studies are
ongoing. Malignancies, including non-melanoma skin cancer (NMSC),
have been reported in patients treated with upadacitinib. Consider
the risks and benefits of upadacitinib treatment prior to
initiating therapy in patients with a known malignancy other than a
successfully treated NMSC or when considering continuing
upadacitinib therapy in patients who develop a
malignancy. Periodic skin examination is recommended for
patients who are at increased risk for skin cancer.
Absolute neutrophil count <1000 cells/mm3,
absolute lymphocyte count <500 cells/mm3, or
haemoglobin levels <8 g/dL were reported in <1% of
patients in clinical trials. Treatment should not be initiated, or
should be temporarily interrupted, in patients with these
haematological abnormalities observed during routine patient
management.
RA patients have an increased risk for cardiovascular disorders.
Patients treated with upadacitinib should have risk factors (e.g.,
hypertension, hyperlipidaemia) managed as part of usual standard of
care.
Upadacitinib treatment was associated with increases in lipid
parameters, including total cholesterol, low-density lipoprotein
cholesterol, and high-density lipoprotein cholesterol. The effect
of these lipid parameter elevations on cardiovascular morbidity and
mortality has not been determined.
Treatment with upadacitinib was associated with an increased
incidence of liver enzyme elevation compared to placebo. If
increases in ALT or AST are observed during routine patient
management and drug-induced liver injury is suspected, upadacitinib
therapy should be interrupted until this diagnosis is excluded.
Events of deep vein thrombosis (DVT) and pulmonary embolism (PE)
have been reported in patients receiving JAK inhibitors, including
upadacitinib. Upadacitinib should be used with caution in patients
at high risk for DVT/PE. Risk factors that should be considered in
determining the patient's risk for DVT/PE include older age,
obesity, a medical history of DVT/PE, patients undergoing major
surgery, and prolonged immobilisation. If clinical features of
DVT/PE occur, upadacitinib treatment should be discontinued and
patients should be evaluated promptly, followed by appropriate
treatment.
The most commonly reported adverse drug reactions are upper
respiratory tract infections (13.5%), nausea (3.5%), increased
blood creatine phosphokinase (2.5%), and cough (2.2%). The most
common serious adverse reactions were serious infections.
Please see the full SmPC for complete prescribing information at
www.EMA.europa.eu. Globally, prescribing information varies;
refer to the individual country product label for complete
information.
About AbbVie in Rheumatology
For more than 20 years, AbbVie has been dedicated to improving
care for people living with rheumatic diseases. Our longstanding
commitment to discovering and delivering transformative therapies
is underscored by our pursuit of cutting-edge science that improves
our understanding of promising new pathways and targets in order to
help more people living with rheumatic diseases reach their
treatment goals. For more information on AbbVie in rheumatology,
visit
https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/rheumatology.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, the possibility
that the proposed acquisition of Allergan will not be pursued,
failure to obtain necessary regulatory approvals or required
financing or to satisfy any of the other conditions to the proposed
acquisition, failure to realize the expected benefits of the
proposed acquisition, failure to promptly and effectively integrate
Allergan's businesses, significant transaction costs and/or unknown
or inestimable liabilities, potential litigation associated with
the proposed acquisition, challenges to intellectual property,
competition from other products, 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 (SEC). 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. Efficacy and Safety of Upadacitinib Versus
Placebo and Adalimumab in Patients With Active Psoriatic Arthritis
and Inadequate Response to Non-Biologic Disease-Modifying
Anti-Rheumatic Drugs (SELECT-PsA-1): a Double-Blind, Randomized
Controlled Phase 3 Trial. 2020 EULAR E-Congress; LB0001.
- Genovese MC, et al. Efficacy and Safety of Upadacitinib in
Patients With Active Psoriatic Arthritis and Inadequate Response to
Biologic Disease-Modifying Anti-Rheumatic Drugs (SELECT-PsA-2): a
Double-Blind, Randomized Controlled Phase 3 Trial. 2020 EULAR
E-Congress; OP0223.
- Cohen S., et al. Safety profile of upadacitinib in Rheumatoid
Arthritis: Integrated analysis from the SELECT Phase 3 Clinical
Program. EULAR 2019; THU0167.
- Pipeline – Our Science | AbbVie. AbbVie. 2019. Available at:
https://www.abbvie.com/our-science/pipeline.html. Accessed on
May 8, 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 May 8, 2020.
- Evaluation of Upadacitinib in Adolescent and Adult Patients
With Moderate to Severe Atopic Dermatitis (Eczema)- Measure Up 1.
ClinicalTrials.gov. 2020. Available at:
https://clinicaltrials.gov/ct2/show/NCT03569293. Accessed on
May 8, 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 May 8, 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
May 8, 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
May 8, 2020.
- RINVOQ™ (upadacitinib) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
- RINVOQ [Summary of Product Characteristics]. AbbVie Deutschland
GmbH & Co. KG; March 2020.
Available at:
https://www.ema.europa.eu/en/documents/product-information/rinvoq-epar-product-information_en.pdf.
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