Breaking News
November 12, 2018 - Biogen and Eisai Announce Presentation of Detailed Analyses from the Phase 1b Long-Term Extension Study of Aducanumab at Clinical Trials on Alzheimer’s Disease (CTAD)
November 12, 2018 - Scientists reveal new cystic fibrosis treatments work best in inflamed airways
November 12, 2018 - Testing coronary calcium levels can better predict patient’s risk for coronary heart disease
November 12, 2018 - FDA conducts mass seizure of food and medical products held under insanitary conditions
November 12, 2018 - FDA Approves Invokana (canagliflozin) to Reduce the Risk of Heart Attack, Stroke or Cardiovascular Death in Adults with Type 2 Diabetes and Established Cardiovascular Disease
November 12, 2018 - Hormone helps reverse brain damage caused by obesity
November 12, 2018 - Grants aim to provide better cancer clinical trial access for military veterans
November 12, 2018 - Mitochondrial DNA may have strong influence on cellular metabolism and disease susceptibility
November 12, 2018 - High stakes, entrenched interests and the Trump rollback of environmental regs
November 12, 2018 - Stem cells transplanted for treatment of Parkinson’s disease
November 12, 2018 - Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)
November 12, 2018 - Protein found in patients with severe asthma can help identify who would benefit from targeted drugs
November 12, 2018 - Experts develop a list of competencies in antimicrobial prescribing and stewardship
November 12, 2018 - Allied BioScience receives approved label from EPA for new bacteriostatic surface coating
November 12, 2018 - FDA announces emergency use authorization of Ebola fingerstick test with portable reader
November 12, 2018 - Grieving spouses with sleep problems have increased risk of chronic immune activation
November 12, 2018 - Exercise routines affect mental health in Japanese expatriates
November 12, 2018 - Fish oil and vitamin D pills no guard against cancer or serious heart trouble
November 12, 2018 - Excess Gestational Weight Gain Not Better for Child Bone Health
November 12, 2018 - Immune receptor provides protective immunity against Group A Streptococcus
November 12, 2018 - Scientists develop new method to produce irradiated nanomaterials for medical applications
November 12, 2018 - Blue light exposure decreases blood pressure
November 12, 2018 - Researchers discover two proteins essential for development of skeletal muscle
November 12, 2018 - Yelp reviews help understand strengths, weaknesses of emergency departments and urgent care centers
November 12, 2018 - Adolescent obesity linked with increased risk of pancreatic cancer later in life
November 12, 2018 - AHA: Poor Teeth-Brushing Habits Tied to Higher Heart Risk
November 12, 2018 - Researchers find how natural killer cells regulate protective HIV antibodies
November 12, 2018 - Rutgers receives $4.2 million federal grant to improve mental health services
November 12, 2018 - Sussex scientists develop a piece of hardware to show how brains function
November 12, 2018 - Study shows pivotal role of parents in efforts to change sexual orientation of LGBT teens
November 12, 2018 - Neck scan detects dementia way before symptoms appear
November 12, 2018 - Risk-profiling can benefit HIV prevention
November 12, 2018 - New thrombolytic based on magnetite nanoparticles successfully tested on animals
November 12, 2018 - Smoking rates go down in the US, lowest since 1965
November 12, 2018 - Phase III Trial of Darolutamide in Patients with Non-metastatic Castration-resistant Prostate Cancer Meets Primary Endpoint
November 12, 2018 - Moderate exercise before conception resulted in lower body weight, increased insulin sensitivity of offspring
November 11, 2018 - Community choirs for older adults reduce loneliness and increase interest in life
November 11, 2018 - Trevena Receives Complete Response Letter for Oliceridine from FDA
November 11, 2018 - More adults and children are using yoga and meditation
November 11, 2018 - Female smokers at greater risk of heart attacks, finds study
November 11, 2018 - Happy Childhood Memories Associated With Better Health
November 11, 2018 - X-linked infantile spinal muscular atrophy – Genetics Home Reference
November 11, 2018 - RNA thought to spread cancer shows ability to suppress breast cancer metastasis
November 11, 2018 - Study finds that thymus plays key role during normal pregnancy
November 11, 2018 - Exploring why some athletes ice their muscles after exercise
November 11, 2018 - Female Genital Mutilation Decreasing in African Nations
November 11, 2018 - Are humans immune to the CRISPR-Cas9 gene editing scissors?
November 11, 2018 - Breastmilk and saliva mixtures regulate oral microbiome of newborn babies
November 11, 2018 - Learning familiar faces through social interactions reduces variability in face recognition
November 11, 2018 - New open source decision support tool could help clinicians chose chemotherapy drugs
November 11, 2018 - New weapons drawn in global TB fight
November 11, 2018 - UCB and Biogen Announce Topline Results from a Phase 2b Study of Dapirolizumab Pegol in Systemic Lupus Erythematosus
November 11, 2018 - Surgery restores boy’s ability to walk post-acute flaccid myelitis
November 11, 2018 - Comorbidity negatively impacts quality of life in people with dementia
November 11, 2018 - Neuroscientists receive $16.75 million from BRAIN Initiative to decipher the brain’s visual system
November 11, 2018 - Purdue researchers invent new smart drainage device to help glaucoma patients
November 11, 2018 - New initiative may benefit entrepreneurs working to transform patient care
November 11, 2018 - Sage Therapeutics Announces FDA Advisory Committee Votes 17-1 in Support of Benefit-Risk Profile of Zulresso (brexanolone) Injection for Treatment of Postpartum Depression
November 11, 2018 - Exercise could delay progression of type 1 diabetes when first diagnosed
November 11, 2018 - Study of gaze fixation in monkeys reveals role of dopamine neurons in response inhibition
November 11, 2018 - Bilingual therapy is vital to improve language disorders in dual-language children, finds study
November 11, 2018 - More Frequent Surveillance No Benefit After NSCLC Resection
November 11, 2018 - Phenylketonuria (PKU) Screening: MedlinePlus Lab Test Information
November 11, 2018 - Researchers discovered a new mechanism of action in a first-line drug for diabetes
November 11, 2018 - Study explains how dermal fibroblasts age
November 11, 2018 - New multi-allergen test works just as well with dried blood
November 11, 2018 - CWRH/UH researcher receives grant to study role of KLF2 factor in vascular-related disorders
November 11, 2018 - New infrared detector may transform smartphones into pocket-sized portable labs
November 11, 2018 - AHA: Young Golfer Returns to Sport He Loves After Stroke
November 11, 2018 - Yuan-Harel-Lupski syndrome – Genetics Home Reference
November 11, 2018 - Effective diagnosis of persistent facial pain will benefit patients and save money
November 11, 2018 - Loyola tests new catheter ablation system that can reach deeper into heart muscle
November 11, 2018 - Pilates exercise program offers many benefits for people with musculoskeletal conditions
November 11, 2018 - Mutant p53 protein ‘tackles’ DNA guardian to drive tumor development
November 11, 2018 - House Dems in new seats of power will steer health policy, attack drug prices
November 11, 2018 - Maximal longevity in species can be better explained by number of neurons in the brain
November 10, 2018 - Research on designing, delivering, physical activity programs for different audiences
November 10, 2018 - Why heart contractions are weaker in those with hypertrophic cardiomyopathy
November 10, 2018 - AbbVie’s Upadacitinib Shows Significant Improvements in Physical Function, Pain and Quality of Life as a Monotherapy in Patients with Rheumatoid Arthritis in Phase 3 Patient-Reported Outcomes Data
November 10, 2018 - Acute Flaccid Myelitis: MedlinePlus
AbbVie’s Upadacitinib Shows Positive Results as Monotherapy in Phase 3 Rheumatoid Arthritis Study, Meeting All Primary and Key Secondary Endpoints

AbbVie’s Upadacitinib Shows Positive Results as Monotherapy in Phase 3 Rheumatoid Arthritis Study, Meeting All Primary and Key Secondary Endpoints

image_pdfDownload PDFimage_print

NORTH CHICAGO, Ill., Dec. 20, 2017 /PRNewswire/ — AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-MONOTHERAPY clinical trial. This ongoing study evaluated upadacitinib (ABT-494), an investigational oral JAK1-selective inhibitor, as a monotherapy treatment in patients with moderate to severe rheumatoid arthritis (RA) who did not adequately respond to treatment with methotrexate. Results showed that after 14 weeks of treatment, both once-daily doses of upadacitinib (15 mg and 30 mg) met the study’s primary endpoints of ACR20** and low disease activity (LDA)*** versus continuing prior stable methotrexate therapy.1 Both doses also achieved all ranked and all key secondary endpoints.1 Upadacitinib is not approved by regulatory authorities and its safety and efficacy have not been established.

“The positive results from the SELECT-MONOTHERAPY study are encouraging, as they are the first evidence to support the potential of upadacitinib as a therapy without the need for background methotrexate,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “These findings add to the growing body of data showing the potential for upadacitinib as a meaningful treatment option for patients suffering from rheumatoid arthritis. We look forward to sharing additional data from the upadacitinib Phase 3 rheumatoid arthritis program with the scientific community in 2018.”

Rheumatoid arthritis, which affects an estimated 23.7 million people worldwide, is a chronic and debilitating disease.14 Methotrexate is commonly used as a first-line therapy in rheumatoid arthritis, but many patients do not respond to or cannot tolerate methotrexate, which puts them at risk for disease progression.15-17

“This trial addresses the clinical impact of switching from methotrexate to upadacitinib as monotherapy in patients with an inadequate response to methotrexate. Results suggested that both doses of upadacitinib can provide clinically meaningful responses,” said Josef S. Smolen, M.D., Department of Medicine, Division of Rheumatology, Medical University of Vienna, Austria, and an investigator in the study. “These findings support the potential for upadacitinib monotherapy as a treatment option for patients with rheumatoid arthritis.”

The study showed that at week 14, 68/42/23 percent of patients switched to 15 mg once-daily upadacitinib and 71/52/33 percent of patients switched to 30 mg once-daily upadacitinib achieved an ACR20/50/70** response, compared to 41/15/3 percent of patients continuing on methotrexate.1 These results were statistically significant (p1

Additionally, a significantly higher proportion of upadacitinib patients in both dose groups achieved LDA and clinical remission targets at week 14 compared to patients continuing on methotrexate (p1 Low disease activity was achieved by 45 percent and 53 percent of patients in the 15 mg and 30 mg groups, respectively, compared to 19 percent of patients continuing on methotrexate.1 Clinical remission was achieved by 28 percent and 41 percent of patients in the 15 mg and 30 mg groups, respectively, compared to 8 percent of patients continuing on methotrexate.1

In this study, the safety profile of upadacitinib was consistent with previously reported Phase 3 SELECT clinical trials and Phase 2 studies.1-5 No new safety signals were detected.1 Serious adverse events occurred in 5/3 percent of patients in the 15 mg/30 mg upadacitinib groups, respectively, compared to 3 percent in the methotrexate group.1 One patient, with pre-existing cardiovascular risk factors, had a fatal event of hemorrhagic stroke caused by a ruptured aneurysm, while receiving upadacitinib 15 mg.1 There was one event of pulmonary embolism (PE) in the study, which occurred in the 15 mg dose group in a patient with pre-existing risk factors for PE.1 Across the SELECT rheumatoid arthritis program, including both the placebo-controlled and extension periods, the rate of deep vein thrombosis and PE remains consistent with the background rate for the RA patient population.1-3,18,19

Further results of SELECT-MONOTHERAPY, the third of six studies in the SELECT rheumatoid arthritis clinical trial program, will be presented at a future medical meeting and published in a peer-reviewed publication.

AbbVie is evaluating the potential of upadacitinib across several immune-mediated conditions. Phase 3 trials in psoriatic arthritis are ongoing, and it is also being investigated to treat Crohn’s disease, ulcerative colitis, ankylosing spondylitis and atopic dermatitis.8-13

About SELECT-MONOTHERAPY

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 rheumatoid arthritis and an inadequate response to a stable dose of methotrexate. Patients were randomized to switch from methotrexate to upadacitinib monotherapy (15 mg or 30 mg once-daily) or continue on their prior stable dose of methotrexate in a blinded manner.

The primary endpoints of the first phase included the percentage of subjects achieving an ACR20 response and low disease activity (LDA) after 14 weeks of treatment. Secondary endpoints included proportion of patients achieving ACR50, ACR70 and clinical remission at week 14. 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 (15 mg and 30 mg) of upadacitinib monotherapy in patients who have completed the first phase. More information on this trial can be found at www.clinicaltrials.gov (NCT02706951).

About the SELECT Study Program

The robust SELECT Phase 3 rheumatoid arthritis program evaluates more than 4,000 patients with moderate to severe rheumatoid arthritis in six studies. The studies include assessments of efficacy, safety and tolerability across multiple rheumatoid arthritis patient populations. 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 agent engineered to selectively inhibit JAK1, which plays an important role in the pathophysiology of rheumatoid arthritis and other immune-mediated inflammatory disorders.6-7 Phase 3 trials of upadacitinib in psoriatic arthritis are ongoing and it is also being investigated to treat Crohn’s disease, ulcerative colitis, ankylosing spondylitis and atopic dermatitis.8-13

Upadacitinib is an investigational oral agent and is not approved by regulatory authorities. Safety and efficacy have not been established.

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 or LinkedIn.

Forward-Looking Statements

Some statements in this news release may be 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, 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,” in AbbVie’s 2016 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 AbbVie. Data on File, ABVRRTI65458.
2 AbbVie. Data on File, ABVRRTI64730.
3 AbbVie. Data on File, ABVRRTI64466.
4 Kremer JM, Emery P, Camp HS, et al. A Phase 2b study of ABT-494, a selective JAK1 inhibitor, in patients with rheumatoid arthritis and an inadequate response to anti-TNF therapy. Arthritis Rheumatol 2016; (doi:10.1002/art.39801):July 7 [Epub ahead of print].
5 Genovese MC, Smolen JS, Weinblatt ME, et al. A randomized Phase 2b study of ABT-494, a selective JAK1 inhibitor in patients with rheumatoid arthritis and an inadequate response to methotrexate. Arthritis Rheumatol 2016;(doi: 10.1002/art.39808):July 7 [Epub ahead of print].
6 Voss, J, et al; Pharmacodynamics Of a Novel Jak1 Selective Inhibitor In Rat Arthritis and Anemia Models and In Healthy Human Subjects. [abstract]. Arthritis Rheum 2013;65 Suppl 10 :2374. DOI: 10.1002/art.2013.65.issue-s10
7 Pipeline – Our Science | AbbVie. AbbVie. 2017. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed December 19, 2017.
8 A Study Comparing ABT-494 to Placebo in Subjects With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone (SELECT-NEXT) – Full Text View – ClinicalTrials.gov. Clinicaltrialsgov. 2017. Available at: https://clinicaltrials.gov/ct2/show/NCT02675426?term=select+next&rank=1. Accessed December 19, 2017.
9 A Study Comparing 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). Clinicaltrialsgov. 2017. Available at: https://clinicaltrials.gov/ct2/show/NCT03104400?term=ABT-494&phase=2&rank=10. Accessed December 19, 2017.
10 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 – Full Text View – ClinicalTrials.gov. Clinicaltrialsgov. 2017. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed December 19, 2017.
11 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. Clinicaltrialsgov. 2017. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed December 19, 2017.
12 A Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis (SELECT Axis 1). 2017. Available at: https://clinicaltrials.gov/ct2/show/study/NCT03178487?term=ABT-494&cond=ankylosing+spondylitis&rank=1. Accessed December 19, 2017.
13 A Study to Evaluate ABT-494 in Adult Subjects With Moderate to Severe Atopic Dermatitis. Clinicaltrialsgov. 2017. Available at: https://clinicaltrials.gov/ct2/show/NCT02925117. Accessed December 19, 2017.
14 World Health Organization. The Global Burden of Disease, 2004 Update. Available at: http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf. Accessed December 19, 2017.
15 Shinde, CG, Venkatesh, MP, Pramod Kumar, TM, Shivakumar, HG. J Pain Palliat Care Pharmacother. 2014 Dec;28(4):351-8. doi: 10.3109/15360288.2014.959238. Epub 2014 Oct 16.
16 Swierkot J and Szechinski J. Methotrexate in rheumatoid arthritis. Pharmacol Rep. 20116 Jul-Aug;58(4)473-92.
17 Fautrel B, Nab HW, et al. Identifying patients with rheumatoid arthritis with moderate disease activity at risk of significant radiographic progression despite methotrexate treatment. RMD Open. 2015; 1(1). DOI: 10.1136/rmdopen-2014-000018.
18 AbbVie. Data on File, ABVRRTI64959.
19 Kim SC. Risk of Venous Thromboembolism in Patients with Rheumatoid Arthritis. Arthritis Care & Research. Vol. 65, No. 10, October 2013, pp 1600–1607.

SOURCE AbbVie

Posted: December 2017

Tagged with:

About author

Related Articles