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Msg  7210 of 7605  at  6/2/2021 7:14:39 AM  by

Biotech2050


Bristol Myers Squibb Data at EULAR 2021 Highlight Commitment to Driving Advancements Across Multiple Immune-Mediated Rheumatic Diseases

06/02/2021
CATEGORY: Corporate/Financial News
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY) today announced that data from 28 company-sponsored and investigator-sponsored studies will be presented at the EULAR 2021 Virtual Congress taking place June 2-5, 2021. The research highlights the depth and strength of the company's growing immunology pipeline and portfolio, commitment to the rheumatology research community and focus on delivering meaningful solutions that address unmet patient needs across immune-mediated diseases.

Research will be shared on multiple Bristol Myers Squibb assets spanning several disease areas, including:

Deucravacitinib: An analysis of musculoskeletal disease improvements from the Phase 2 trial evaluating deucravacitinib, a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor, in active psoriatic arthritis reveals that patients treated with deucravacitinib showed consistent improvement across all American College of Rheumatology (ACR) components versus placebo-treated patients, ACR 20 responses were consistent regardless of prior TNF experience, and soft tissue manifestations such as enthesitis were completely resolved in half of patients.
These data (abstract OP0227) will be featured as an oral presentation on Friday, June 4 from 10:15 a.m. – 11:45 a.m. CEST. Additionally, a poster (POS0198) on the Phase 2 results previously announced at ACR Convergence in November 2020 will be presented on Friday, June 4 from 11:50 a.m. – 1:30 p.m. CEST.
Author: Mease
Orencia (abatacept): A real-world analysis showing that patients with rheumatoid factor (RF) positive and anti-citrullinated protein antibodies (ACPA) positive rheumatoid arthritis, known as “double positive,” treated with Orenciaas a first-line treatment had higher retention than patients receiving Orencia as a second-line or later therapy. Patients with RF and ACPA are considered to have more highly active, progressive RA and a poor disease prognosis. Remission rates on Orenciawere higher in patients with double positive RA versus double negative RA.
These data (abstract OP0180) will be featured as an oral presentation on Thursday, June 3 from 10:15 a.m. – 11:45 a.m. CEST.
Author: Alten
Iberdomide: Findings from the Phase 2b trial in patients with active systemic lupus erythematosus (SLE) assessing effects of iberdomide on cutaneous (skin) manifestations in SLE. Iberdomide is a novel, oral, high-affinity, cereblon ligand that induces degradation of transcription factors Aiolos and Ikaros, which play critical roles in immune cell development and regulating the balance of the immune system and are linked to the genetic risk for SLE. The study showed beneficial effects on skin manifestations in patients with SLE treated with iberdomide. Efficacy appeared to be more pronounced in patients with subacute cutaneous lupus erythematosus (SCLE) and chronic cutaneous lupus erythematosus (CCLE) subtypes.
These data (abstract OP0132) will be featured as an oral presentation on Thursday, June 3 from 10:15 a.m. – 11:45 a.m. CEST.
Author: Werth
“Rheumatic diseases can be debilitating for the tens of millions of people worldwide who live with these conditions. With the understanding that these diseases can behave very differently from person to person, Bristol Myers Squibb is pursuing pathbreaking science to tailor therapies to individual needs, improve outcomes and expand treatment options,” said Mary Beth Harler, M.D., head of Immunology and Fibrosis Development, Bristol Myers Squibb. “Our presentations at EULAR, which span early discovery, late-stage studies and real-world data, represent our robust and growing Immunology pipeline and portfolio, and our focus on driving forward the next wave of immune-modulators and precision medicines.”

Bristol Myers Squibb-sponsored abstracts that will be presented at EULAR 2021 can be found below. Complete abstracts may be accessed online here.

Deucravacitinib Presentations

Efficacy of Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 Inhibitor, in Musculoskeletal Manifestations of Active Psoriatic Arthritis in a Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial
Author: Mease
Abstract Number: OP0227
Session Title: Psoriatic Arthritis – Treatment
Friday, June 4, 10:15 a.m. – 11:45 a.m. CEST
Oral Presentation
Efficacy and Safety of Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 Inhibitor, in Patients with Active Psoriatic Arthritis: Results from a Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial
Author: Mease
Abstract Number: POS0198
Session Title: PsA Treatment: What is New?
Poster Tour: Friday, June 4, 11:50 a.m. – 1:30 p.m. CEST
Efficacy and Safety of Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 (TYK2) Inhibitor, Compared with Placebo and Apremilast in Moderate to Severe Plaque Psoriasis: Results from the Phase 3 POETYK PSO-1 Study
Author: Armstrong
Abstract Number: POS1042
Poster View: Wednesday, June 2, 8:00 a.m. – Monday, July 5, 11:59 p.m. CEST
Orencia Presentations

Impact of RF and ACPA Serostatus on 2-Year Retention of Abatacept in Patients with RA
Author: Alten
Abstract Number: OP0180
Session Title: Rheumatoid Arthritis – Prognosis, Predictors and Outcomes
Thursday, June 3, 10:15 a.m. – 11:45 a.m. CEST
Oral Presentation
Implementation of the OMERACT PsAMRIS in a Phase IIb, Randomised Placebo-Controlled Study of Abatacept in Psoriatic Arthritis
Author: Østergaard
Abstract Number: POS1040
Poster View: Wednesday, June 2, 8:00 a.m. – Monday, July 5, 11:59 p.m. CEST
Disease Activity in Patients with RA by Serostatus and Treatment Line, Following Treatment with Abatacept: Results From an International Observational Study
Author: Alten
Abstract Number: POS0599
Poster View: Wednesday, June 2, 8:00 a.m. – Monday, July 5, 11:59 p.m. CEST
Physical Function in Patients with RA, Stratified by Serostatus And Treatment Line, Following SC Abatacept: Post Hoc Analysis of an Observational, 2-Year Study Conducted in Routine Clinical Practice (ASCORE)
Author: Alten
Abstract Number: POS0447
Poster View: Wednesday, June 2, 8:00 a.m. – Monday, July 5, 11:59 p.m. CEST
S100A8/A9 and S100A12 as Potential Predictive Biomarkers of Abatacept Response in Polyarticular Juvenile Idiopathic Arthritis
Author: Ruperto
Abstract Number: POS0076
Session Title: Pediatric Rheumatology – Clinical
Poster Tour: Thursday, June 3, 11:50 a.m. – 1:30 p.m. CEST
Analysis of Factors Associated with the Effectiveness of Abatacept in the ORIGAMI Study
Author: Misaki
Abstract Number: POS0603
Poster View: Wednesday, June 2, 8:00 a.m. – Monday, July 5, 11:59 p.m. CEST
Iberdomide Presentation

Effect of Iberdomide on Cutaneous Manifestations in Systemic Lupus Erythematosus: Results of a 24-Week, Placebo-Controlled, Phase 2 Study
Author: Werth
Abstract Number: OP0132
Session Title: SLE, Sjögren’s and APS – Treatment and SLE, Sjögren’s and APS – Clinical Aspects (Other Than Treatment)
Thursday, June 3, 10:15 a.m. – 11:45 a.m. CEST
Oral Presentation
Early Asset Presentation

Investigating the Anti-Inflammatory Potential of a Novel MK2 Inhibitor in a Vitro Model of Enthesitis
Author: Bridgewood
Abstract Number: POS0408
Poster View: Wednesday, June 2, 8:00 a.m. – Monday, July 5, 11:59 p.m. CEST
Health Economics and Outcomes Research (HEOR) Presentations

Epidemiology and Mortality of RA-Associated Interstitial Lung Disease: Data from a French Administrative Healthcare Database
Author: Juge
Abstract Number: OP0099
Session Title: Rheumatoid Arthritis – Comorbidity and Clinical Aspects – I
Thursday, June 3, 10:15 a.m. – 11:45 a.m. CEST
Oral Presentation
Estimated Prevalence, Incidence and Healthcare Costs of Sjögren’s Syndrome in France: A National Claims-Based Study
Author: Seror
Abstract Number: POS0024
Session Title: Epidemiology: Big Questions – Big Studies
Poster Tour: Thursday, June 3, 11:50 a.m. – 1:30 p.m. CEST
Extrapolation of Long-Term Outcomes in Systemic Lupus Erythematosus: Replicating a Hopkins Lupus Cohort Analysis with the Systemic Lupus International Collaborating Clinics (SLICC) Inception Cohort
Author: Clarke
Abstract Number: POS0734
Poster View: Wednesday, June 2, 8:00 a.m. – Monday, July 5, 11:59 p.m. CEST
Substantial Impact of Autoantibody Enrichment on Outcomes in Early Rheumatoid Arthritis Treated with Abatacept: Data from a Large Pooled Analysis of 4 RCTs
Author: Michaud
Abstract Number: POS0474
Poster View: Wednesday, June 2, 8:00 a.m. – Monday, July 5, 11:59 p.m. CEST
Risk of ACPA Positivity by Motif-Based Classification of HLA-DRB1 Shared Epitope Alleles in RA
Author: Wipfler
Abstract Number: POS0344
Poster View: Wednesday, June 2, 8:00 a.m. – Monday, July 5, 11:59 p.m. CEST
Abstract Book Publications

Effect of Deucravacitinib on the Psoriatic Arthritis Impact of Disease (PsAID) Questionnaires 12 and 9: Analysis of a Phase 2 Study of Active Psoriatic Arthritis
Author: Gossec
Abstract Number: AB0560
A Novel Method for Predicting 1-Year Retention of Abatacept Using Machine Learning Techniques: Directionality and Importance of Predictors
Author: Alten
Abstract Number: AB0205
Analysis of Abatacept Treatment Retention and Efficacy According to Disease Duration and Treatment Line in a Real-World Setting
Author: Alten
Abstract Number: AB0207
Changes in Extracellular Matrix Biomarker C3M Correlate with Abatacept Response in Seropositive Early RA
Author: Bridges
Abstract Number: AB0107
Improvement in Clinical Disease Activity and Patient-Reported Outcomes After 6 Months of Treatment with Abatacept, Stratified by Line of Therapy, in Patients with RA: Results from a Large, US, National Observational Study
Author: Harrold
Abstract Number: AB0202
Construction of the Veterans Affairs National Rheumatoid Arthritis Database (VANRAD)
Author: Joseph
Abstract Number: AB0128
About Psoriatic Arthritis

Psoriatic arthritis is a chronic, immune-mediated, heterogenous disease with multiple musculoskeletal and skin manifestations, including inflammatory arthritis, enthesitis (which occurs when the connective tissue between tendons or ligaments and bone called enthesis becomes inflamed), dactylitis (inflammation and swelling of the fingers and toes), spinal inflammation and psoriatic skin and nail lesions. Up to 42 percent of patients with psoriasis may develop psoriatic arthritis. In addition to the loss of physical function, pain and fatigue caused by psoriatic arthritis, the disease can significantly impact the mental and emotional well-being of patients. Additionally, patients with psoriatic arthritis are at increased risk of developing serious comorbidities, including cardiovascular disease, metabolic syndrome and depression, as well as extraarticular manifestations of disease, such as inflammatory bowel disease.

About Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a destructive immune-mediated disease of the joints characterized by inflammation in the joint lining (or synovium), leading to joint damage with chronic pain, stiffness and swelling. RA causes limitations in range of motion and decreased joint function with long-term disability. Women are three times more likely than men to develop RA.

About Lupus

Lupus is a chronic, complex immune-mediated disease that results in the immune system attacking multiple organs in the body. Lupus most often affects the joints, skin, kidneys, blood vessels, blood cells, brain, and lungs, causing widespread inflammation and tissue damage in the affected organ(s). There are more than five million people around the world with a form of lupus, and it is most often diagnosed in young women between the ages of 15 and 44. The most common type of lupus is systemic lupus erythematosus (SLE), which accounts for approximately 70 percent of all lupus cases. Within five years of disease onset, 40-60 percent of patients with SLE develop lupus nephritis (renal involvement), the most important predictor of SLE morbidity and mortality.

About Deucravacitinib

Deucravacitinib (pronounced doo-krav-a-sih-ti-nib) is a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action. Deucravacitinib is the first and only TYK2 inhibitor in clinical studies across multiple immune-mediated diseases. Bristol Myers Squibb scientists designed deucravacitinib to selectively target TYK2, thereby inhibiting signaling of interleukin (IL)-12, IL-23 and Type 1 interferon (IFN), key cytokines involved in the pathogenesis of multiple immune-mediated diseases. Deucravacitinib achieves a high degree of selectivity by binding to the regulatory domain of TYK2, resulting in allosteric inhibition of TYK2 and its downstream functions. Deucravacitinib selectively inhibits TYK2, unlike approved Janus kinase (JAK) 1, 2 and 3 inhibitors, at physiologically relevant concentrations. At therapeutic doses, deucravacitinib does not inhibit JAK1, JAK2 or JAK3. Due to the innovative design of deucravacitinib, Bristol Myers Squibb earned recognition with the 2019 Thomas Alva Edison Patent Award for the science underpinning the clinical development of deucravacitinib.

Deucravacitinib is being studied in multiple immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus and inflammatory bowel disease. Deucravacitinib is not approved for use in any country.

About Iberdomide

Iberdomide is a novel, oral, high-affinity, cereblon ligand that induces degradation of transcription factors Aiolos and Ikaros, which play critical roles in immune cell development and regulating the balance of the immune system and are genetically linked to the risk of developing lupus and other diseases. Iberdomide is currently under investigation for the treatment of multiple myeloma, lymphoma and lupus and is not approved for use in any country.

About Orencia

Orencia is an immunomodulator that disrupts the continuous cycle of T-cell activation that characterizes RA, psoriatic arthritis and juvenile idiopathic arthritis (JIA). In RA, Orencia targets unique and fundamental drivers of the disease, resulting in improved efficacy and durability in seropositive RA patients (patients with key biomarkers of the disease). Approved for RA by the FDA in 2005 and by the European Commission in 2007, Orencia is an established treatment with a proven safety profile across the disease continuum.

U.S. Indications/Usage and Important Safety Information for ORENCIA® (abatacept)

Indications and Usage

Adult Rheumatoid Arthritis: ORENCIA® (abatacept) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

Polyarticular Juvenile Idiopathic Arthritis: ORENCIA is indicated for the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA).

Adult Psoriatic Arthritis: ORENCIA is indicated for the treatment of adult patients with active psoriatic arthritis (PsA).

Limitations of Use: The concomitant use of ORENCIA with other potent immunosuppressants [e.g., biologic disease-modifying antirheumatic drugs (bDMARDS), Janus kinase (JAK) inhibitors] is not recommended.


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