NORTH CHICAGO, Ill.,
Oct. 28, 2020 /PRNewswire/ -- AbbVie
(NYSE: ABBV), a research-based global biopharmaceutical company,
today announced the presentation of new data on RINVOQ™
(upadacitinib) and HUMIRA® (adalimumab) across multiple rheumatic
diseases at the American College of Rheumatology's annual meeting
(ACR Convergence 2020), to be held virtually November 5-9. A total of 38 abstracts, including
seven oral presentations, will be presented from a broad range of
studies in rheumatoid arthritis, psoriatic arthritis and ankylosing
spondylitis.
"At AbbVie, we have a focused vision of improving the care and
advancing treatment options for people living with rheumatic
diseases, which is illustrated by the body of research that will be
presented at this year's ACR meeting," said Marek Honczarenko M.D., Ph.D., vice president,
global immunology development, AbbVie. "These data underscore the
potential for RINVOQ and HUMIRA to help more people living with
rheumatic diseases reach their goals."
Data evaluating the long-term safety and efficacy of RINVOQ in
rheumatoid arthritis will be presented, including:
- 84-week data on RINVOQ as a monotherapy in patients with
inadequate response to methotrexate
- 72-week RINVOQ monotherapy data in methotrexate-naïve
patients
- 72-week data comparing RINVOQ versus HUMIRA in patients with
inadequate response to methotrexate
- An integrated safety update reflecting up to three years of
treatment with RINVOQ
Oral presentations will also highlight the safety and efficacy
of RINVOQ in the treatment of psoriatic arthritis (through 24
weeks) and ankylosing spondylitis (through 64 weeks), while a
poster presentation will provide a new integrated safety analysis
from two Phase 3 trials evaluating the safety profile of RINVOQ in
psoriatic arthritis.
Further, several presentations will show patient-reported
outcomes for RINVOQ in the treatment of rheumatoid arthritis,
psoriatic arthritis and ankylosing spondylitis, including its
impact on pain reduction and physical function.
Key AbbVie rheumatology abstracts in the ACR Convergence 2020
program include:
Rheumatoid Arthritis
- Safety Profile of Upadacitinib up to 3 Years of Exposure in
Patients with Rheumatoid Arthritis. SB Cohen, et al. Abstract
Number: 0237; Poster Session: Friday,
November 6, 9 – 11 a.m.
EST
- Long-Term Safety and Effectiveness of Upadacitinib or
Adalimumab in Patients with Rheumatoid Arthritis: Results at 72
Weeks. R Fleischmann, et al. Abstract Number: 0212; Poster
Session: Friday, November 6, 9 –
11 a.m. EST
- Upadacitinib as Monotherapy in Patients with Rheumatoid
Arthritis and Prior Inadequate Response to Methotrexate: Results at
84 Weeks. JS Smolen, et al. Abstract Number: 0209; Poster
Session: Friday, November 6, 9 –
11 a.m. EST
- Incidence and Risk of Venous Thromboembolic Events Among
Patients with Rheumatoid Arthritis Enrolled in the Upadacitinib
Clinical Trial Program. E Choy, et al. Abstract Number: 0215;
Poster Session: Friday, November 6, 9
– 11 a.m. EST
- Upadacitinib Monotherapy in Methotrexate-naïve Patients with
Rheumatoid Arthritis: Results at 72 Weeks. R van Vollenhoven,
et al. Abstract Number: 0207; Poster Session: Friday, November 6, 9 – 11
a.m. EST
- Impact of Upadacitinib or Adalimumab as Initial Therapy on
the Achievement of 48-week Treatment Goals in Patients with
Rheumatoid Arthritis and Inadequate Response to Methotrexate: Post
Hoc Analysis of a Phase 3 Study. E Mysler, et al. Abstract
Number: 0228; Poster Session: Friday,
November 6, 9 – 11 a.m.
EST
- Radiographic Outcomes in Patients with Rheumatoid Arthritis
Receiving Upadacitinib as Monotherapy or in Combination with
Methotrexate: Results at 2 Years. CG Peterfy, et al. Abstract
Number: 1231; Poster Session: Sunday,
November 8, 9 – 11 a.m.
EST
- Patient-Reported Outcomes of Upadacitinib versus Abatacept
in Patients with Rheumatoid Arthritis and an Inadequate Response to
Biologic Disease-Modifying Antirheumatic Drugs: 12-Week Results of
a Phase 3 Study. M Bergman, et al. Abstract Number: 1728;
Poster Session: Monday, November 9, 9
– 11 a.m. EST
- Evaluation of Response to Pneumococcal Vaccination in
Patients with Rheumatoid Arthritis Receiving Upadacitinib: Results
from a Phase 2 Open-Label Extension Study. K Winthrop, et al.
Abstract Number: 1996; Oral Presentation: Monday, November 9, 10 – 10:50 a.m. EST
- Incidence and Risk Factors for Herpes Zoster in Rheumatoid
Arthritis Patients Receiving Upadacitinib. K Winthrop, et al.
Abstract Number: 2002; Oral Presentation: Monday, November 9, 3 – 3:50 p.m. EST
Psoriatic Arthritis
- Efficacy and Safety of Upadacitinib in Patients with Active
Psoriatic Arthritis and Inadequate Response to Biologic
Disease-Modifying Anti-Rheumatic Drugs: A Double-Blind, Randomized
Controlled Phase 3 Trial. MC Genovese, et al. Abstract Number:
0504; Oral Presentation: Friday, November
6, 3 – 3:50 p.m. EST
- Impact of Upadacitinib on Reducing Pain in Patients with
Active Psoriatic Arthritis: Results from Two Phase 3 Trials in
Patients with Inadequate Response to Non-biologic or Biologic
DMARDs. IB McInnes, et al. Abstract Number: 0896; Poster
Session: Saturday, November 7, 9 –
11 a.m. EST
- Improvement in Patient-Reported Outcomes in Patients with
Psoriatic Arthritis with Inadequate Response to Non-Biologic DMARDs
Treated with Upadacitinib versus Placebo or Adalimumab: Results
from a Phase 3 Study. V Strand, et al. Abstract Number: 1341;
Poster Session: Sunday, November 8, 9
– 11 a.m. EST
- Improvement in Patient-Reported Outcomes for Upadacitinib
Versus Placebo Among Patients With Psoriatic Arthritis and an
Inadequate Response to Biologic Disease-Modifying Anti-Rheumatic
Drugs. V Strand, et al. Abstract Number: 1371; Poster Session:
Sunday, November 8, 9 – 11 a.m. EST
- Safety Profile of Upadacitinib in Psoriatic Arthritis:
Integrated Analysis From Two Phase 3 Trials. GR Burmester, et
al. Abstract Number: 1350; Poster Session: Sunday, November 8, 9 – 11
a.m. EST
- Characterization of Remission in Patients with Psoriatic
Arthritis Treated with Upadacitinib: Post-hoc Analysis from Two
Phase 3 Trials. P Mease, et al. Abstract Number: 1355; Poster
Session: Sunday, November 8, 9 –
11 a.m. EST
- 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: A Double-Blind, Randomized Controlled Phase 3
Trial. IB McInnes, et al. Abstract Number: 2026; Oral
Presentation: Monday, November 9, 11
– 11:50 a.m. EST
Ankylosing Spondylitis
- Effect of Upadacitinib on Reducing Pain in Patients with
Active Ankylosing Spondylitis and Inadequate Response to
Nonsteroidal Anti-inflammatory Drugs. A Deodhar, et al.
Abstract Number: 0369; Poster Session: Friday, November 6, 9 – 11
a.m. EST
- Efficacy and Safety of Upadacitinib in Patients with Active
Ankylosing Spondylitis: 1-Year Results from a Randomized,
Double-Blind, Placebo-Controlled Study with Open-Label
Extension. A Deodhar, et al. Abstract Number: 2023; Oral
Presentation: Monday, November 9, 11
– 11:50 a.m. EST
A full list of all 38 AbbVie abstracts accepted for presentation
at ACR Convergence 2020 can be found here.
About RINVOQ™ (upadacitinib)
Discovered and
developed by AbbVie, RINVOQ is a selective and reversible JAK
inhibitor that is being studied in several immune-mediated
inflammatory diseases.1-3 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 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, giant cell arteritis and Takayasu arteritis are
ongoing.4-12 Use of RINVOQ in ankylosing spondylitis and
psoriatic arthritis is not approved and its safety and efficacy
have not been established by regulatory authorities.
Important Safety Information about RINVOQ™
(upadacitinib)13
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.
About HUMIRA in the U.S.
Uses
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 bones and joints
and may help the 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 bones and joints and may help the 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 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.
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, 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 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.
References:
- AbbVie Data on File. ABVRRTI70713.
- AbbVie Data on File. ABVRRTI70838.
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- 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.
- A Study to Evaluate the Efficacy and Safety of Upadacitinib in
Subjects With Takayasu Arteritis (SELECT-TAK). ClinicalTrials.gov.
2020. Available at
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October 13, 2020.
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