NORTH CHICAGO, Ill.,
June 12, 2019 /PRNewswire/ -- AbbVie
(NYSE: ABBV), a research-based global biopharmaceutical company,
today announced new results from the Phase 3 clinical trials
SELECT-EARLY and SELECT-COMPARE showing that patients receiving
upadacitinib once-daily (15 mg or 30 mg, SELECT-EARLY; 15 mg plus
methotrexate (MTX), SELECT-COMPARE) through 48 weeks continue to
demonstrate improved signs and symptoms of rheumatoid arthritis, as
measured by ACR20/50, and clinical remission based on Disease
Activity Score 28 C-Reactive Protein
(DAS28-CRP)<2.6.1,2 The studies evaluate
upadacitinib, an investigational, once-daily JAK1-selective
inhibitor, in patients with moderately to severely active
rheumatoid arthritis.1,2 Additionally, data from an
integrated safety analysis across five Phase 3 SELECT clinical
trials show that treatment with upadacitinib in patients with
moderately to severely active rheumatoid arthritis demonstrates a
consistent safety profile.3
These results are being presented at the European League Against
Rheumatism (EULAR) Annual European Congress of Rheumatology,
June 12-15, in Madrid.
"These data continue to support the potential of upadacitinib to
help maintain consistent disease control for patients living with
moderately to severely active rheumatoid arthritis," said Professor
Ronald van Vollenhoven, M.D., Ph.D.,
Amsterdam Rheumatology and Immunology Center,
Amsterdam, The Netherlands. "While
remission is the primary treatment goal, in accordance with the
American College of Rheumatology and the European League Against
Rheumatism recommendations, a majority of patients do not achieve
clinical remission today, despite currently available treatment
options."
Rheumatoid arthritis is a chronic and debilitating disease that
affects an estimated 23.7 million people worldwide.18
Many patients with rheumatoid arthritis still do not achieve
clinical remission or low disease activity
targets.19-21
"Over the past decade, important advances have been made in the
understanding of rheumatoid arthritis and its management, looking
beyond treating symptoms to achieving remission," said Marek
Honczarenko, M.D., Ph.D., vice president, immunology development,
AbbVie. "As data continue to emerge from the SELECT program, we
look forward to deepening our understanding of the benefits and
risks of JAK inhibition on treatment outcomes in different patient
populations with moderately to severely active rheumatoid
arthritis."
Upadacitinib is an investigational oral agent and has not been
approved by any regulatory authorities.
About the SELECT Study Program4-9
The robust SELECT Phase 3 rheumatoid arthritis program evaluates
more than 4,900 patients with moderately to severely
active rheumatoid arthritis in six studies. The studies
include assessments of safety, efficacy, and tolerability in
rheumatoid arthritis patients across a broad spectrum of subjects
including those who were naïve to MTX and those who had an
inadequate response or intolerance to one or more csDMARDs or
bDMARDs. Key measures of efficacy evaluated include ACR responses,
Disease Activity Score (DAS28-CRP) and inhibition of radiographic
progression. More information on these trials can be found at
www.clinicaltrials.gov (NCT02706847, NCT03086343, NCT02629159,
NCT02706873, NCT02706951, NCT02675426).
About Upadacitinib
Discovered and developed by AbbVie, upadacitinib is an
investigational, oral, small molecule JAK1-selective inhibitor
being studied for moderately to severely active rheumatoid
arthritis and other immune-mediated inflammatory
diseases.4-17 Phase 3 trials of upadacitinib in
psoriatic arthritis, Crohn's disease, atopic dermatitis and
ulcerative colitis are ongoing and it is also being investigated to
treat ankylosing spondylitis and giant cell
arteritis.12-17 Upadacitinib is not approved and
its safety and efficacy have not been evaluated by regulatory
authorities.
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.
References:
- van Vollenhoven R, et al. Monotherapy with Upadacitinib in
MTX-naïve Patients with Rheumatoid Arthritis: Results at 48 Weeks
from the SELECT-EARLY Study. 2019 EULAR; THU0197.
- Fleischmann R, et al. Safety and Effectiveness of Upadacitinib
or Adalimumab in Patients with Rheumatoid Arthritis: Results at 48
weeks from the SELECT-COMPARE Study. 2019 EULAR; FRI0147.
- Cohen S, et al. Safety profile of upadacitinib in Rheumatoid
Arthritis: Integrated analysis from the SELECT Phase 3 Clinical
Program. 2019 EULAR; THU0167.
- Burmester GR, et al. Safety and efficacy of upadacitinib in
patients with rheumatoid arthritis and inadequate response to
conventional synthetic disease-modifying anti-rheumatic drugs
(SELECT-NEXT): a randomised, double-blind, placebo-controlled phase
3 trial. Lancet. 2018 Jun 23;391(10139):2503-2512. doi:
10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 18.
- Genovese MC, et al. Safety and efficacy of upadacitinib in
patients with active rheumatoid arthritis refractory to biologic
disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a
double-blind, randomised controlled phase 3. Lancet. 2018 Jun
23;391(10139):2503-2512. doi: 10.1016/S0140-6736(18)31115-2. Epub
2018 Jun 18.
- Smolen, J. et al. Upadacitinib as monotherapy in patients with
active rheumatoid arthritis and inadequate response to methotrexate
(SELECT-MONOTHERAPY): a randomised, placebo-controlled,
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- A Phase 3 Study to Compare ABT-494 to Abatacept in Subjects
With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic
Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an
Inadequate Response or Intolerance to Biologic DMARDs
(SELECT-CHOICE). Clinicaltrials.gov. 2018. Available at:
https://clinicaltrials.gov/ct2/show/NCT03086343. Accessed on
April 5, 2019.
- Voss, J, et al; Pharmacodynamics Of a Novel Jak1 Selective
Inhibitor In Rat Arthritis and Anemia Models and In Healthy Human
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10.1002/art.2013.65.issue-s10.
- Pipeline – Our Science | AbbVie. AbbVie. 2018. Available at:
https://www.abbvie.com/our-science/pipeline.html. Accessed on
April 5, 2019.
- 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. 2019.
Available at: https://clinicaltrials.gov/ct2/show/NCT03104400.
Accessed on April 5, 2019.
- 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 April 5, 2019.
- 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
April 5, 2019.
- 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 April 5, 2019.
- 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
April 5, 2019.
- 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
April 24, 2019.
- World Health Organization. The Global Burden of Disease, 2004
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http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf.
Accessed on April 5, 2019.
- Nagy G, van Vollenhoven RF. Sustained biologic-free and
drug-free remission in rheumatoid arthritis, where are we now?
Arthritis Res Ther 2015; 17:181.
- Smolen JS, Landewé R, Bijlsma J, et al. EULAR recommendations
for the management of rheumatoid arthritis with synthetic and
biological disease-modifying antirheumatic drugs: 2016 update. Ann
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print].
- Singh JA, et al. 2015 American College of Rheumatology
Guideline for the Treatment of Rheumatoid Arthritis. Arthritis
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Nov 6.
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