NORTH CHICAGO, Ill.,
Nov. 4, 2019 /PRNewswire/ -- AbbVie
(NYSE: ABBV), a research-based global biopharmaceutical company,
today announced it will present data from multiple studies of
RINVOQ™ (upadacitinib), HUMIRA® (adalimumab) and SKYRIZI™
(risankizumab) at the 2019 American College of
Rheumatology/Association of Rheumatology Professionals (ACR/ARP)
Annual Meeting, November 8-13, in
Atlanta. A total of 38 abstracts
will be presented across multiple rheumatic conditions, including
rheumatoid arthritis (RA), ankylosing spondylitis (AS) and
psoriatic arthritis (PsA).
"AbbVie looks forward to sharing the latest research across our
recently expanded rheumatology portfolio at this year's meeting,
including data that further support our recent FDA approval of
RINVOQ," said Marek Honczarenko,
M.D., Ph.D., vice president, global immunology development, AbbVie.
"New data being presented on upadacitinib, risankizumab and
adalimumab across multiple rheumatic diseases will highlight the
potential for all three treatment options to help more patients
achieve their treatment goals."
For the first time, safety and efficacy data
evaluating upadacitinib versus placebo for the treatment of
signs and symptoms in patients with active AS who had an inadequate
response to nonsteroidal anti-inflammatory drugs will be presented
during a plenary session at the meeting. A number of upadacitinib
RA abstracts will also be featured, including:
- Investigators will present clinical remission data in patients
treated with upadacitinib compared to placebo and methotrexate
- Long-term data from the SELECT program will be presented
evaluating the efficacy and safety of upadacitinib across clinical
measures and patient reported outcomes
- Investigators will share data evaluating upadacitinib compared
to adalimumab across clinical and functional responses
- Data will also be presented among patients who experience an
initial insufficient response to either upadacitinib or adalimumab
and switched to the other therapy
Investigators will also present new patient-reported outcomes in
patients with moderate to severe PsA who were treated with
adalimumab, as well as data evaluating the safety and efficacy
of risankizumab in patients with active PsA.
KEY ABSTRACTS OF INTEREST:
UPADACITINIB ABSTRACTS
Ankylosing Spondylitis
- Exposure-Response Analyses for Upadacitinib Efficacy and Safety
in Ankylosing Spondylitis – Analyses of the SELECT-AXIS I Study;
Poster Session; Monday, November 11,
2019, 9:00 a.m.-11:00 a.m. EST
- Efficacy and Safety of Upadacitinib in a Randomized,
Double-Blind, Placebo-Controlled, Multicenter Phase 2/3 Clinical
Study of Patients with Active Ankylosing Spondylitis; Plenary
Session III; Tuesday, November 12,
2019, 11:00 a.m.-12:30 p.m.
EST
Rheumatoid Arthritis
- Upadacitinib as Monotherapy in Patients with Rheumatoid
Arthritis: Results at 48 weeks; Poster Session; Sunday, November 10, 2019, 9:00 a.m.-11:00 a.m. EST
- Upadacitinib in Patients with Rheumatoid Arthritis and
Inadequate Response or Intolerance to Biological DMARDs: Results at
60 Weeks; Poster Session; Sunday, November
10, 2019, 9:00 a.m.-11:00 a.m.
EST
- Safety and Effectiveness of Upadacitinib or Adalimumab in
Patients with Rheumatoid Arthritis: Results at 48 Weeks; Poster
Session; Sunday, November 10,
2019, 9:00 a.m.-11:00 a.m.
EST
- Characterization of Remission in Patients with Rheumatoid
Arthritis Treated with Upadacitinib or Comparators; Poster Session;
Sunday, November 10, 2019, 9:00
a.m.-11:00 a.m. EST
- Inhibition of Structural Joint Damage with Upadacitinib as
Monotherapy or in Combination with Methotrexate in Patients with
Rheumatoid Arthritis; Poster Session; Sunday, November 10, 2019, 9:00 a.m.-11:00 a.m. EST
- Upadacitinib Treatment and the Routine Assessment of Patient
Index Data 3 (RAPID3) Among Patients with Rheumatoid Arthritis;
Poster Session; Sunday, November 10,
2019, 9:00 a.m.-11:00 a.m. EST
- Monotherapy with Upadacitinib in MTX-naïve Patients with
Rheumatoid Arthritis: Results at 48 Weeks; Oral Presentation;
Sunday, November 10, 2019,
4:30 p.m.-6:00 p.m. EST
- Effects of Upadacitinib on Patient-Reported Outcomes After 24
Weeks in Patients with Active Rheumatoid Arthritis and an
Inadequate Response to Conventional Synthetic or Biologic
Disease-Modifying Anti-Rheumatic Drugs: Results from SELECT-NEXT
and SELECT-BEYOND Phase 3 Studies; Poster Session; Monday, November 11, 2019, 9:00 a.m.-11:00 a.m. EST
- Patient-Reported Outcomes of Upadacitinib versus Adalimumab Use
in Patients with Moderately to Severely Active Rheumatoid Arthritis
and an Inadequate Response to Methotrexate: 26-Week Analysis of a
Phase 3 Study; Poster Session; Monday,
November 11, 2019, 9:00 a.m.-11:00
a.m. EST
- Impact of 24- or 26-Week Upadacitinib Monotherapy on
Patient-Reported Outcomes in Patients with Moderately to Severely
Active Rheumatoid Arthritis and No Prior Use of or an Inadequate
Response to Methotrexate: Results from Two Phase 3 Trials; Poster
Session; Monday, November 11, 2019,
9:00 a.m.-11:00 a.m. EST
- Clinical and Functional Outcomes Among Rheumatoid Arthritis
Patients Switching Between JAK1-Selective Inhibitor Upadacitinib
and Adalimumab Following Insufficient Response; Oral Presentation;
Wednesday, November 13, 2019,
11:00 a.m.-12:30 p.m. EST
ADALIMUMAB ABSTRACTS
Psoriatic Arthritis
- The Impact of Adalimumab vs Placebo on Patient-Reported
Outcomes and Utility Measures Among Patients with Moderately to
Severely Active Psoriatic Arthritis; Poster Session; Sunday, November 10, 2019, 9:00 a.m.-11:00 a.m. EST
- The Impact of Psoriasis Severity on Outcomes Among Psoriatic
Arthritis Patients Receiving Adalimumab; Poster Session;
Tuesday, November 12, 2019,
9:00 a.m.-11:00 a.m. EST
RISANKIZUMAB ABSTRACT
Psoriatic Arthritis
- Safety and Efficacy Results from the Open Label Extension of a
Phase 2 Trial of Risankizumab, a Selective IL-23p19 Inhibitor in
Patients with Active Psoriatic Arthritis; Oral Presentation;
Wednesday, November 13, 2019,
9:00 a.m.-10:30 a.m. EST
The 2019 ACR/ARP Annual Meeting abstracts are available at
www.acrabstracts.org.
Rheumatic diseases affect patients' joints, tendons, ligaments,
bones and muscles.1 Early diagnosis and intervention
with an effective treatment is critical to controlling rheumatic
diseases and preventing permanent damage.2
About RINVOQ3
Discovered and developed by AbbVie, RINVOQ is an oral JAK inhibitor
approved by the U.S. Food and Drug Administration (FDA) and under
review with health authorities globally for the treatment of
moderately to severely active rheumatoid arthritis and being
studied in other immune-mediated inflammatory
diseases.4-13 Earlier this year, RINVOQ received U.S.
Food and Drug Administration approval for patients with moderately
to severely active rheumatoid arthritis. RINVOQ also received a
positive opinion from the Committee for Medicinal Products for
Human Use and is currently in European Union regulatory review for
patients with moderately to severely active rheumatoid arthritis.
Phase 3 trials of RINVOQ in psoriatic arthritis, Crohn's disease,
atopic dermatitis, ulcerative colitis and giant cell arteritis are
ongoing and it is also being investigated to treat ankylosing
spondylitis. 4,8-12
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.
Important Safety Information about RINVOQ™
(upadacitinib)
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
|
̶ Muscle
aches
|
̶
Cough
|
̶
Shortness of breath
|
̶ Feeling
tired
|
̶ Weight
loss
|
̶ Warm,
red, or painful skin
or sores on your body
|
̶ Blood
in phlegm
̶
Diarrhea or stomach pain
|
̶ 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 SKYRIZI14
SKYRIZI is an
interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by
binding to its p19 subunit. IL-23, a cytokine involved in
inflammatory processes, is thought to be linked to a number of
chronic immune-mediated diseases, including
psoriasis.15
SKYRIZI is approved in the U.S., European Union
and Canada for the treatment of moderate to severe plaque
psoriasis in adults who are candidates for systemic therapy or
phototherapy, and in Japan for the treatment of plaque
psoriasis, generalized pustular psoriasis, erythrodermic psoriasis
and psoriatic arthritis in adult patients who have an inadequate
response to conventional therapies.
Phase 3 trials of SKYRIZI in Crohn's disease and psoriatic
arthritis are ongoing, and it is also being investigated to treat
ulcerative colitis.13,16-19
SKYRIZI (risankizumab-rzaa) U.S. Use and Important Safety
Information
SKYRIZI™ is a prescription medicine used to
treat adults with moderate to severe plaque psoriasis who may
benefit from taking injections or pills (systemic therapy) or
treatment using ultraviolet or UV light (phototherapy).
What is the most important information I should know about
SKYRIZI?
SKYRIZI may cause serious side effects,
including infections. SKYRIZI is a prescription medicine that may
lower the ability of your immune system to fight infections and may
increase your risk of infections. Your healthcare provider should
check you for infections and tuberculosis (TB) before starting
treatment with SKYRIZI and may treat you for TB before you begin
treatment with SKYRIZI if you have a history of TB or have active
TB. Your healthcare provider should watch you closely for signs and
symptoms of TB during and after treatment with SKYRIZI.
- Tell your healthcare provider right away if you have an
infection or have symptoms of an infection, including:
-
- fever, sweats, or chills
- muscle aches
- weight loss
- cough
- warm, red, or painful skin or sores on your body different from
your psoriasis
- diarrhea or stomach pain
- shortness of breath
- blood in your mucus (phlegm)
- burning when you urinate or urinating more often than
normal
Before using SKYRIZI, tell your healthcare provider about
all of your medical conditions, including if you:
- have any of the conditions or symptoms listed in the section
"What is the most important information I should know about
SKYRIZI?"
- have an infection that does not go away or that keeps coming
back.
- have TB or have been in close contact with someone with
TB.
- have recently received or are scheduled to receive an
immunization (vaccine). You should avoid receiving live vaccines
during treatment with SKYRIZI.
- are pregnant or plan to become pregnant. It is not known if
SKYRIZI can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if
SKYRIZI passes into your breast milk.
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements.
What are the possible side effects of
SKYRIZI?
SKYRIZI may cause serious side effects. See
"What is the most important information I should know about
SKYRIZI?"
The most common side effects of SKYRIZI include upper
respiratory infections, fungal skin infections, headache, feeling
tired and injection site reactions.
These are not all the possible side effects of SKYRIZI. Call
your doctor for medical advice about side effects.
Use SKYRIZI exactly as your healthcare provider tells you to use
it.
Please click here for the Full Prescribing Information and
Medication Guide.
About HUMIRA in the U.S.
Uses20
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
AbbVie is a global, research and
development-based biopharmaceutical company committed to developing
innovative advanced therapies for some of the world's most complex
and critical conditions. The company's mission is to use its
expertise, dedicated people and unique approach to innovation to
markedly improve treatments across four primary therapeutic areas:
immunology, oncology, virology and neuroscience. In more than 75
countries, AbbVie employees are working every day to advance health
solutions for people around the world. 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, competition from
other products, challenges to intellectual property, 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 2018 Annual Report on Form
10-K, which has been filed with the Securities and Exchange
Commission. 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.
|
1 National
Institutes of Health. National Institute of Arthritis and
Musculoskeletal and Skin Diseases. Arthritis and Rheumatic
Diseases. Available at:
https://www.niams.nih.gov/health-topics/arthritis-and-rheumatic-diseases.
Last accessed September 13, 2018.
|
2
Kwiatkowska B, Raciborski F, Klak A, et al. Early diagnosis of
rheumatic diseases: an evaluation of the present situation and
proposed changes. Reumatologia. 2015; 53(1): 3–8.
|
3 RINVOQ™
(upadacitinib) [Package Insert]. North Chicago, Ill.: AbbVie
Inc.
|
4 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. 2019. Available at:
https://clinicaltrials.gov/ct2/show/NCT03104374. Accessed on
October 31, 2019.
|
5 Cohen
S., et al. Safety profile of upadacitinib in Rheumatoid Arthritis:
Integrated analysis from the SELECT Phase 3 Clinical Program. EULAR
2019; THU0167.
|
6 Bergman
M., et al. Upadacitinib Treatment and the Routine Assessment of
Patient Index Data 3 (RAPID3) Among Patients with Rheumatoid
Arthritis. 2019 ACR/ARHP Annual Meeting; 551.
|
7
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.
|
8 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. 2019.
Available at: https://clinicaltrials.gov/ct2/show/NCT02365649.
Accessed on October 23, 2019.
|
9
Evaluation of Upadacitinib in Adolescent and Adult Patients With
Moderate to Severe Atopic Dermatitis (Eczema)- Measure Up 1.
ClinicalTrials.gov. 2019. Available at:
https://clinicaltrials.gov/ct2/show/NCT03569293. Accessed on
October 23, 2019.
|
10 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. 2019. Available at:
https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed on
October 23, 2019.
|
11 A Study
Evaluating the Safety and Efficacy of Upadacitinib in Subjects With
Active Ankylosing Spondylitis (SELECT Axis 1). ClinicalTrials.gov.
2019. Available at:
https://clinicaltrials.gov/ct2/show/study/NCT03178487. Accessed on
October 23, 2019.
|
12 A Study
to Evaluate the Safety and Efficacy of Upadacitinib in Participants
With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. 2019.
Available at: https://clinicaltrials.gov/ct2/show/NCT03725202.
Accessed on October 23, 2019.
|
13
Pipeline – Our Science | AbbVie. Available at:
https://www.abbvie.com/our-science/pipeline.html. Accessed on March
8, 2019.
|
14 SKYRIZI
(risankizumab) [Package Insert]. North Chicago, Ill.: AbbVie
Inc.
|
15
Duvallet, E., Sererano, L., Assier, E., et al. Interleukin-23: a
key cytokine in inflammatory diseases. Ann Med. 2011
Nov;43(7):503-11.
|
16 A Study
of the Efficacy and Safety of Risankizumab in Subjects With
Moderately to Severely Active Crohn's Disease. ClinicalTrials.gov.
Available at: https://clinicaltrials.gov/ct2/show/NCT03105128.
Accessed on March 8, 2019.
|
17 BI
655066/ABBV-066/Risankizumab Compared to Placebo in Patients With
Active Psoriatic Arthritis. ClinicalTrials.gov. Available at:
https://clinicaltrials.gov/ct2/show/NCT02719171. Accessed on March
8, 2019.
|
18 A Study
to Assess the Efficacy and Safety of Risankizumab in Subjects With
Ulcerative Colitis Who Responded to Induction Treatment in M16-067
or M16-065. ClinicalTrials.gov. 2018. Available at:
https://www.clinicaltrials.gov/ct2/show/NCT03398135. Accessed on
March 8, 2019.
|
19 A Study
to Evaluate the Efficacy and Safety of Risankizumab in Subjects
With Moderately to Severely Active Ulcerative Colitis Who Have
Failed Prior Biologic Therapy. ClinicalTrials.gov. 2018. Available
at: https://www.clinicaltrials.gov/ct2/show/NCT03398148. Accessed
on March 8, 2019.
|
20 HUMIRA
Injection [package insert]. North Chicago, IL: AbbVie
Inc.
|
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SOURCE AbbVie