NORTH CHICAGO, Ill.,
June 4, 2020 /PRNewswire/ -- AbbVie
(NYSE: ABBV), a research-based global biopharmaceutical company,
today announced new long-term results showing that once daily
upadacitinib continued to improve signs and symptoms in patients
with rheumatoid arthritis at 72 and 84 weeks in the SELECT-COMPARE
(upadacitinib, 15 mg in combination with methotrexate [MTX]) and
SELECT-MONOTHERAPY (upadacitinib, 15 mg and 30 mg) Phase 3 clinical
trials, respectively.1,2 The safety profile of
upadacitinib (15 mg and 30 mg) monotherapy or upadacitinib
(15 mg) in combination with MTX was consistent with that
observed in the previously reported integrated Phase 3 safety
analysis in rheumatoid arthritis, with no new safety risks
detected.1-5
Additionally, approximate two-year data (96 weeks) from the
SELECT-EARLY (upadacitinib, 15 mg and 30 mg) and SELECT-COMPARE
clinical trials showed that upadacitinib was effective in
inhibiting structural joint damage as monotherapy or in combination
with MTX.3 Full results were presented today at the 2020
Annual European E-Congress of Rheumatology (EULAR).
RINVOQ™, a selective and reversible JAK inhibitor
discovered and developed by AbbVie, is approved as an oral, once
daily, 15 mg therapy for adults with moderate to severe active
rheumatoid arthritis.1-5
"These new long-term data showcase the potential of
RINVOQ to provide relief from the signs and symptoms of
rheumatoid arthritis, both as a monotherapy and in combination with
methotrexate," said Isidro
Villanueva, vice president, medical affairs immunology,
AbbVie. "We are excited to share these results with the
rheumatology community reinforcing RINVOQ as an important treatment
option that may help more patients living with rheumatoid arthritis
reach their goals in disease management."
SELECT-COMPARE Results at 72 Weeks
Results of this
Long-Term Extension (LTE) of the SELECT-COMPARE study show that
RINVOQ plus MTX maintained higher levels of clinical response,
including remission compared to adalimumab plus MTX, through week
72.1
SELECT-COMPARE
Results* at 72 Weeks†,1
|
|
RINVOQ 15 mg
plus MTX (n=651)
|
Adalimumab
plus MTX (n=327)
|
ACR20a
|
64%
|
53%
|
ACR50a
|
51%
|
38%
|
ACR70a
|
38%
|
25%
|
Clinical
Remissionb
|
41%
|
26%
|
Low Disease
Activityc
|
49%
|
32%
|
* Efficacy
data reported based on randomized treatment. For patients who were
rescued, non-responder imputation (NRI) was used for binary
endpoints. All reported endpoints achieved p-values of ≤0.001 for
RINVOQ plus MTX versus adalimumab plus MTX through week 72, except
for ACR20 at week 72 (p≤0.01).
|
† Patients who received
adalimumab were switched to receive 15 mg of RINVOQ, and vice
versa, if they did not achieve at least a 20 percent improvement in
both tender and swollen joint count at weeks 14, 18 or 22, or if
Clinical Disease Activity Index (CDAI) was greater than 10 at week
26. NRI was used for rescue prior to week 26 and last observation
carried forward was used for rescue at week 26.
|
aACR20/50/70 is defined as at least a 20
percent/50 percent/70 percent reduction from baseline in the number
of both tender and swollen joint counts and equivalent improvement
in three or more of the five remaining American College of
Rheumatology core set measures: patient assessments of pain, global
disease activity and physical function, physician global assessment
of disease activity and acute phase reactant.
|
bClinical
remission is defined as Disease Activity Score with 28 joint counts
C-reactive protein (DAS28-CRP) less than 2.6.
|
cLow
disease activity (LDA) is defined as Disease Activity Score with 28
joint counts C-reactive protein (DAS28-CRP) less than or equal to
3.2.
|
The safety profile of RINVOQ (15 mg) in combination with MTX was
generally consistent with that observed in the previously
reported integrated Phase 3 safety analysis in rheumatoid
arthritis, with no new safety risks detected.1,4 Through
the data cut-off, serious adverse events (SAEs) occurred at 12.7
events/100PY (per 100 patient years) on RINVOQ (15 mg) in
combination with MTX, compared to 15.9 events/100PY on adalimumab
in combination with MTX.1 The rate of serious infections
was 3.7 events/100PY on RINVOQ (15 mg) plus MTX and 4.3
events/100PY on adalimumab plus MTX.1 There were eight
deaths on RINVOQ (0.6/100PY) and six deaths on adalimumab
(1.2/100PY), including non-treatment emergent deaths.1
There were eight major adverse cardiac events (MACE) through the
study duration, including five on RINVOQ (0.4/100PY) and three on
adalimumab (0.6/100PY).1 There were four patients with
venous thromboembolic events (VTE) reported on RINVOQ (0.3/100PY)
and five reported on adalimumab (1.0/100 PY).1
SELECT-MONOTHERAPY Results at 84 Weeks
In this LTE of
the SELECT-MONOTHERAPY study, patients who received continued MTX
in the first phase of the study were switched to receive blinded
upadacitinib (15 mg or 30 mg) at week 14 based on pre-specified
assignment at baseline.2 Results of this LTE show
that upadacitinib monotherapy resulted in continued improvements in
rheumatoid arthritis signs and symptoms through 84
weeks.2
SELECT-MONOTHERAPY
Results* at 84 weeks†,2
|
|
cMTX to
upadacitinib 15
mg
|
cMTX to
upadacitinib 30
mg
|
Continuous
upadacitinib 15
mg
|
Continuous
upadacitinib 30
mg
|
ACR20a
|
86%
|
90%
|
88%
|
96%
|
ACR50a
|
71%
|
68%
|
71%
|
78%
|
ACR70a
|
49%
|
50%
|
54%
|
66%
|
Clinical
Remissionb
|
56%
|
63%
|
60%
|
77%
|
Low Disease
Activityc
|
80%
|
79%
|
76%
|
85%
|
*Results
are based on as observed analyses.
|
†Upadacitinib 30 mg is not an
approved dose.
|
aACR20/50/70 is defined as at least a 20
percent/50 percent/70 percent reduction from baseline in the number
of both tender and swollen joint counts and equivalent improvement
in three or more of the five remaining American College of
Rheumatology core set measures: patient assessments of pain, global
disease activity and physical function, physician global assessment
of disease activity and acute phase reactant.
|
bClinical
remission is defined as Disease Activity Score with 28 joint counts
C-reactive protein (DAS28-CRP) less than 2.6.
|
cLow
disease activity (LDA) is defined as Disease Activity Score with 28
joint counts C-reactive protein (DAS28-CRP) less than or equal to
3.2.
|
The safety profile of upadacitinib (15 mg and 30 mg) monotherapy
at week 84 was generally consistent with that observed in the
previously reported integrated Phase 3 safety analysis in
rheumatoid arthritis, with no new safety risks
detected.2,4 Through week 84, SAEs occurred at 18.5
events/100PY (per 100 patient years) on upadacitinib 15 mg and 16.9
events/100PY on upadacitinib 30 mg.2 The most common SAE
was pneumonia.2 Events of herpes zoster, hepatic
disorder and creatine phosphokinase elevations were higher among
patients receiving upadacitinib 30 mg, while rates of serious
infection and malignancy were comparable between upadacitinib 30 mg
and 15 mg.2 Seven patients experienced MACE (15 mg,
0.5/100 PY; 30 mg, 1.2/100 PY) and there were five VTE (15 mg,
0.9/100 PY; 30 mg, 0.2/100 PY).2 All MACE and VTE
occurred in patients with underlying risk factors.2
There were three deaths each (0.7/100PY) on upadacitinib 15 mg and
30 mg, including non-treatment emergent deaths.2
Radiographic Inhibition at Approximately Two Years:
SELECT-EARLY and SELECT-COMPARE
Both SELECT-EARLY and
SELECT-COMPARE enrolled rheumatoid arthritis patients at high risk
for progressive structural damage with baseline erosive joint
damage and/or seropositivity.3 RINVOQ inhibited
structural joint damage in MTX-naïve patients receiving RINVOQ
monotherapy and in patients with an inadequate response to MTX in
combination with MTX.3
Radiographic
Inhibition at Approximately 2 Years (96
weeks)*,3
|
|
SELECT-EARLY
|
SELECT-COMPARE
|
|
Upadacitinib
30 mg
(n=231)
|
Upadacitinib
15 mg
(n=238)
|
MTX (n=186)
|
Continuous
RINVOQ
15 mg plus
MTX (n=327)
|
Placebo
plus MTX
to
RINVOQ
15 mg
plus MTX (n=529)
|
Continuous
adalimumab
plus MTX (n=125)
|
No Radiographic
Progressiond
|
91%
|
89%
|
76%
|
82%
|
77%
|
75%
|
*
Upadacitinib 30 mg is not an approved dose. RINVOQ is not approved
for the treatment of MTX-naïve patients.
|
d No
radiographic progression is defined as a change in modified Total
Sharp Score (mTSS)≤0.
|
About RINVOQ™ (upadacitinib, 15 mg)
Discovered and developed by AbbVie scientists, RINVOQ is a
selective and reversible JAK inhibitor that is being studied in
several immune-mediated inflammatory diseases.5-14
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 rheumatoid
arthritis, psoriatic arthritis, axial spondyloarthritis, Crohn's
disease, atopic dermatitis, ulcerative colitis and giant cell
arteritis are ongoing.1-3,7-14
About SELECT-COMPARE1
SELECT-COMPARE is a Phase 3, multicenter, randomized,
double-blind study designed to evaluate the safety and efficacy of
RINVOQ compared to placebo and adalimumab in adult patients with
moderate to severe active rheumatoid arthritis who had an
inadequate response to methotrexate and continued a stable
background of MTX. Patients received background MTX and were
randomized 2:2:1 to receive RINVOQ (15 mg, once daily), placebo or
adalimumab (given as a subcutaneous injection of 40 mg every other
week).
The primary endpoints of the first phase included the percentage
of subjects achieving ACR20 and clinical remission (based on
DAS28-CRP) after 12 weeks of treatment compared to placebo. Ranked
secondary endpoints included change in the mTSS compared to placebo
and a comparison versus adalimumab in percentage of subjects
achieving ACR50, low disease activity, changes in pain as measured
by the Patient's Assessment of Pain (based on VAS) and changes in
physical function, as measured by the Health Assessment
Questionnaire-Disability-Index (HAQ-DI). The trial is ongoing and
included a 48-week randomized, double-blind treatment period
followed by a long-term extension study of up to five years.
More information on this trial can be found
at www.clinicaltrials.gov (NCT02629159).
About SELECT-MONOTHERAPY2
SELECT-MONOTHERAPY is a Phase 3, multicenter, randomized,
double-blind, parallel-group study designed to evaluate the safety
and efficacy of upadacitinib monotherapy in adult patients with
moderate to severe active rheumatoid arthritis and an inadequate
response to a stable dose of methotrexate. Patients were randomized
to switch from MTX to upadacitinib monotherapy (15 mg or 30 mg,
once daily) or continue on their prior stable dose of MTX in a
blinded manner.
The primary endpoints of the first phase included the percentage
of patients achieving an ACR20 response and low disease activity
after 14 weeks of treatment. Secondary endpoints included
proportion of patients achieving ACR50, ACR70 and clinical
remission at week 14, HAQ-DI, duration of morning stiffness and
health-related quality of life (QoL) by SF-36. The trial is
ongoing, and the second phase is a blinded long-term extension
period to evaluate the long-term safety, tolerability and efficacy
of the two once daily doses of upadacitinib (15 mg and 30 mg)
monotherapy in patients who have completed the first phase.
More information on this trial can be found
at www.clinicaltrials.gov (NCT02706951).
About SELECT-EARLY3
SELECT-EARLY is a Phase 3, multicenter, randomized,
double-blind, parallel-group, active comparator controlled study
designed to evaluate the safety and efficacy of upadacitinib
monotherapy compared to MTX monotherapy in adult patients with
moderate to severe active rheumatoid arthritis who are MTX-naïve.
In the first phase of the study, patients were randomized 1:1:1 to
receive upadacitinib (15 mg or 30 mg, once daily) or MTX. It
includes a Japan sub-study in which subjects were
randomized 2:1:1:1 to receive upadacitinib (7.5 mg, 15 mg or 30 mg,
once daily) or MTX.
The primary endpoints included the percentage of subjects
achieving ACR50 response and clinical remission (based on
DAS28-CRP) compared to MTX after 12 weeks and 24 weeks of
treatment, respectively. Ranked secondary endpoints included the
percentage of patients achieving ACR20 response, ACR70 response and
low disease activity, as well as changes in the mTSS and HAQ-DI.
The trial is ongoing and includes a 48-week randomized,
double-blind treatment period followed by a long-term extension
period for up to an additional four years.
More information on this trial can be found
at www.clinicaltrials.gov (NCT02706873).
Important EU Safety Information about RINVOQ™
(upadacitinib)5
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 HUMIRA® in the European
Union15
HUMIRA, in combination with methotrexate, is indicated for the
treatment of moderate to severe, active rheumatoid arthritis in
adult patients when the response to disease-modifying
anti-rheumatic drugs, including methotrexate, has been
inadequate.
Important EU Safety Information about HUMIRA®
(adalimumab)15
HUMIRA is contraindicated in patients with active tuberculosis
or other severe infections such as sepsis, and opportunistic
infections and in patients with moderate to severe heart failure
(NYHA class III/IV). It is also contraindicated in patients
hypersensitive to the active substance or to any of the excipients;
serious allergic reactions including anaphylaxis have been
reported. The use of HUMIRA increases the risk of developing
serious infections, including hepatitis B reactivation, which may,
in rare cases, be life-threatening. Rare cases of lymphoma and
leukemia have been reported in patients treated with HUMIRA. On
rare occasions, a severe type of cancer called hepatosplenic T-cell
lymphoma has been observed and often results in death. A risk for
the development of malignancies in patients treated with
TNF-antagonists cannot be excluded. Rare cases of pancytopenia,
aplastic anaemia, demyelinating disease, lupus, lupus-related
conditions and Stevens-Johnson syndrome have been reported in
patients treated with HUMIRA. The most frequently reported adverse
events across all indications included respiratory infections,
injection site reactions, headache and musculoskeletal pain.
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, 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 2019 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.
References:
- Fleischmann R, et al. Long-Term Safety and Effectiveness of
Upadacitinib or Adalimumab in Patients with Rheumatoid Arthritis:
Results at 72 weeks from the SELECT-COMPARE Study. 2020 EULAR
E-Congress; THU0201.
- Smolen J, et al. Upadacitinib as Monotherapy in Patients with
Rheumatoid Arthritis and Prior Inadequate Response to Methotrexate:
Results at 84 Weeks From the SELECT-MONOTHERAPY Study. 2020 EULAR
E-Congress; THU0213.
- Peterfy CG, et al. Radiographic Outcomes in Patients with
Rheumatoid Arthritis Receiving Upadacitinib as Monotherapy or in
Combination with Methotrexate: Results at 2 years from the
SELECT-COMPARE and SELECT-EARLY Studies. 2020 EULAR E-Congress;
THU0211.
- Cohen S, et al. Safety Profile of Upadacitinib Up to 3 Years of
Exposure in Patients With Rheumatoid Arthritis. 2020 EULAR
E-Congress; THU0197.
- 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.
- Pipeline – Our Science | AbbVie. AbbVie. 2020. Available
at: https://www.abbvie.com/our-science/pipeline.html. Accessed
on May 18, 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 May 18, 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 May 18, 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 18, 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 18, 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 18, 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 18, 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 May 18, 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 May 18, 2020.
- HUMIRA [Summary of Product Characteristics]. AbbVie Deutschland
GmbH & Co KG. Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000481/WC500050870.pdf.
Accessed May 18, 2020.
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