Research to be presented on Orencia, deucravacitinib and pipeline assets highlights breadth of data and focus on transforming treatment paradigms for people living with rheumatic diseases
PRINCETON, N.J.--(BUSINESS WIRE)--
Bristol Myers Squibb (NYSE:BMY) today announced data from 29 company-sponsored presentations across Orencia, deucravacitinib and pipeline assets will be presented at the American College of Rheumatology (ACR) Convergence 2021, taking place virtually November 3-10, 2021.
Research at the meeting includes 17 company-led presentations supporting Orencia’s established clinical profile. These data include:
- Post hoc analysis of the ASCORE study in rheumatoid arthritis (RA) demonstrated that several baseline characteristics were associated with remission in patients with RA treated with subcutaneous Orencia. In the study, patients with seropositive RA, no previous biologic disease-modifying antirheumatic drug use, low HAQ-disability index and low BMI at baseline were more likely to achieve Disease Activity Score 28 (DAS28), Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) remission when treated with Orencia; seropositivity was associated with remission regardless of Orencia treatment line (abstract number 1228).
- Health economics outcomes research of seropositive RA Medicare beneficiaries showed that among Medicare beneficiaries with seropositive RA, those on Orencia were more often persistent to their index treatment and had longer time to treatment discontinuation at one year compared to patients on tumor necrosis factor inhibitors or Janus kinase inhibitors.
“At ACR Convergence 2021, our studies deepen our understanding of Orencia as an important treatment for people living with moderate-to-severe rheumatoid arthritis and highlight the potential of deucravacitinib in treating immune-mediated rheumatic diseases," said Jonathan Sadeh, M.D., M.Sc., senior vice president of Immunology and Fibrosis Development, Bristol Myers Squibb. “We look forward to presenting our data, demonstrating our ongoing commitment to the rheumatology research community. With our robust rheumatology portfolio, Bristol Myers Squibb continues to expand upon the foundation in rheumatology established over 20 years ago and are following the science to deliver the next wave of immune-modulators and precision medicines.”
Bristol Myers Squibb will also present six abstracts from the Phase 2 study of deucravacitinib, a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor, in patients with active psoriatic arthritis. These data continue to shed light on the expected clinical profile of deucravacitinib and the pharmacodynamics of key biomarkers involved in the pathogenesis of the disease. These data include:
- Biomarker analyses from a Phase 2 study that showed deucravacitinib suppressed blood biomarkers of the IL-23/IL-17 and IFN-1 pathways and key markers of joint damage, concomitant with clinical symptom improvements in patients with psoriatic arthritis in comparison with placebo (abstract number 0490). There were no clinically meaningful changes in mean levels of serum cholesterol, creatinine, neutrophils and platelets over time with deucravacitinib treatment.
Additional data will also be presented from Bristol Myers Squibb’s immunology pipeline, including iberdomide and BMS-986256 (TLR7/8 inhibitor) data in lupus and CC-99677 (MK2 inhibitor) data in ankylosing spondylitis, psoriasis and psoriatic arthritis. These data reinforce Bristol Myers Squibb’s commitment to developing new treatments for rheumatic diseases.
Bristol Myers Squibb-sponsored abstracts that will be presented at the ACR Convergence 2021 can be found below. Complete abstracts may be accessed online here. Visit this page on BMS.com for more information on Bristol Myers Squibb’s scientific approach and resources on rheumatic diseases.
Orencia Presentations
- Analysis of Abatacept Treatment Retention and Efficacy According to Disease Duration and Treatment Line in a Real-World Setting
Author: Rieke Alten
Abstract Number: 0816
Session Title: RA - Treatments Poster I: Comparative Effectiveness, Biosimilars, Withdrawal, & the Real World (0813-0845)
Sunday, November 7, 8:30 – 10:30 a.m. EST
- Prediction of 1-Year Intravenous Abatacept Retention in Patients with RA Using Novel Machine Learning Techniques: Directionality and Importance of Predictors
Author: Rieke Alten
Abstract Number: 1212
Session: RA - Diagnosis, Manifestations, & Outcomes Poster III: Prediction, Biomarkers, & Treatment Response (1196-1222)
Monday, November 8, 8:30 – 10:30 a.m. EST
- Baseline Extracellular Matrix Biomarkers Predict Abatacept Treatment Response in MTX-Naive, ACPA+ Patients with Early RA
Author: Paul Emery
Abstract Number: 1225
Session: RA - Treatments Poster II: PROs, Biomarkers, & Systemic Inflammation (1223-1256)
Monday, November 8, 8:30 – 10:30 a.m. EST
- Predicting RA Remission with Subcutaneous Abatacept Treatment in the Real-World Setting
Author: Rieke Alten
Abstract Number: 1228
Session: RA - Treatments Poster II: PROs, Biomarkers, & Systemic Inflammation (1223-1256)
Monday, November 8, 8:30 – 10:30 a.m. EST
- Baseline Characteristics Predictive of Remission in Patients with RA Following Treatment with IV Abatacept: Post Hoc Analysis of a Real-World Observational Study
Author: Rieke Alten
Abstract Number: 0821
Session: RA - Treatments Poster I: Comparative Effectiveness, Biosimilars, Withdrawal, & the Real World (0813-0845)
Sunday, November 7, 8:30 – 10:30 a.m. EST
- Histopathological Changes in Parotid and Labial Salivary Gland Tissue in Primary Sjögren’s Syndrome Patients After Abatacept Treatment
Author: Uzma Nakshbandi
Abstract Number: 0322
Session: Sjögren's Syndrome – Basic & Clinical Science Poster
Saturday, November 6, 8:30 – 10:30 a.m. EST
- Long-term Safety and Effectiveness of Abatacept Treatment in Patients with JIA: 5-year Results from the PRCSG/PRINTO JIA Real-World Registry
Author: Hermine Brunner
Abstract Number: 0245
Session: Pediatric Rheumatology - Clinical Poster I: JIA (0241-0265)
Saturday, November 6, 8:30 – 10:30 a.m. EST
- Effectiveness of Abatacept in Patients with JIA, Classified by Category: Results from the PRCSG/PRINTO JIA Real-World Registry
Author: Daniel Lovell
Abstract Number: 0243
Session: Pediatric Rheumatology - Clinical Poster I: JIA (0241-0265)
Saturday, November 6, 8:30 – 10:30 a.m. EST
- Three-year Effectiveness in Patients with JIA Initiating Abatacept: Results from the PRCSG/PRINTO JIA Real-World Registry
Author: Nicolino Ruperto
Abstract Number: 0247
Session: Pediatric Rheumatology - Clinical Poster I: JIA (0241-0265)
Saturday, November 6, 8:30 – 10:30 a.m. EST
- 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: Leslie Harrold
Abstract Number: 0813
Session: RA - Treatments Poster I: Comparative Effectiveness, Biosimilars, Withdrawal, & the Real World (0813-0845)
Sunday, November 7, 8:30 – 10:30 a.m. EST
- Does BMI Influence the Efficacy of Subcutaneous or Intravenous Abatacept in Patients with RA in Routine Clinical Practice? A Post Hoc Analysis of Two Real-World Observational Studies
Author: Rieke Alten
Abstract Number: 1229
Session: RA - Treatments Poster II: PROs, Biomarkers, & Systemic Inflammation (1223-1256)
Monday, November 8, 8:30 – 10:30 a.m. EST
Orencia Health Economics and Outcomes Research (HEOR) Presentations
- Treatment Persistence Among Medicare Beneficiaries with Seropositive Rheumatoid Arthritis Initiating Biologic or Targeted Synthetic DMARDs
Author: Sang Hee Park
Abstract Number: 0463
Session: Abstracts: Health Services Research (0462-0465)
Saturday, November 6, 10:30 – 11:30 a.m. ESTOral Presentation
- Examining the Relationship Between Shared Epitope, ACPA Seropositivity, and Real-World Drug Effectiveness in Patients with Rheumatoid Arthritis
Author: Kristin Wipfler
Abstract Number: 1214
Session: RA - Diagnosis, Manifestations, & Outcomes Poster III: Prediction, Biomarkers, & Treatment Response (1196-1222)
Monday, November 8, 8:30 – 10:30 a.m. EST
- Disparities in Burden of Disease in Patients with RA Across Racial and Ethnic Groups
Author: Jacqueline O’Brien
Abstract Number: 0604
Session: Healthcare Disparities in Rheumatology Poster (0594-0622)
Sunday, November 7, 8:30 – 10:30 a.m. EST
- Adjusted Analyses of the Benefits of Autoantibody Enrichment on Efficacy Outcomes in Early RA, from a Pooled Analysis of 4 Abatacept RCTs
Author: Janet Pope
Abstract Number: 1248
Session: RA - Treatments Poster II: PROs, Biomarkers, & Systemic Inflammation (1223-1256)
Monday, November 8, 8:30 – 10:30 a.m. EST
- Consistent Impact of Autoantibody Enrichment Across all ACR Core Measures in Early Rheumatoid Arthritis Treated with Abatacept: Data from a Large Pooled Analysis of 4 Randomized Controlled Trials
Author: Philip Conaghan
Abstract Number: 1231
Session: RA - Treatments Poster II: PROs, Biomarkers, & Systemic Inflammation (1223-1256)
Monday, November 8, 8:30 – 10:30 a.m. EST
- Construction of the Veterans Affairs National Rheumatoid Arthritis Database (VANRAD)
Author: Amy Joseph
Abstract Number: 0568
Session: Epidemiology & Public Health Poster II: Inflammatory Arthritis - RA, SpA, & Gout (0560-0593)
Sunday, November 7, 8:30 – 10:30 a.m. EST
Deucravacitinib Presentations
- Biomarker Changes with Selective Tyrosine Kinase 2 Inhibitor, Deucravacitinib, in PsA: Effects on Disease Markers and Tyrosine Kinase 2‒ Versus Janus Kinase 1/2/3‒Mediated Pathways
Author: Oliver Fitzgerald
Abstract Number: 0490
Session Title: Abstracts: Spondyloarthritis Including PsA – Treatment I: Emerging Therapies (0488–0491)
Saturday, November 6, 2:00 – 3:00 p.m. ESTOral Presentation
- The Impact of Deucravacitinib on Health-Related Quality of Life Measured by the Short Form Health Survey 36-Item Questionnaire: Analysis of a Phase 2 Trial in Patients with Active PsA
Author: Vibeke Strand
Abstract Number: 0232
Session Title: Patient Outcomes, Preferences, & Attitudes Poster I: Impact (0225–0240)
Saturday, November 6, 8:30 – 10:30 a.m. EST
- Deucravacitinib Efficacy in Psoriatic Arthritis (PsA) by Baseline DMARD Use: Exploratory Analysis from a Phase 2 Study
Author: Atul Deodhar
Abstract Number: 1352
Session Title: Spondyloarthritis Including PsA - Treatment Poster II: Psoriatic Arthritis I (1329–1363)
Monday, November 8, 8:30 – 10:30 a.m. EST
- Selective Inhibition of Tyrosine Kinase 2 With Deucravacitinib Compared with Janus Kinase 1/2/3 Inhibitors
Author: Anjaneya Chimalakonda
Abstract Number: 0509
Session Title: Cytokines & Cell Trafficking Poster (0508-0516)
Sunday, November 7, 8:30 – 10:30 a.m. EST
- Effect of Deucravacitinib on the Psoriatic Arthritis Impact of Disease Questionnaires 12 and 9: Analysis of a Phase 2 Study of Active Psoriatic Arthritis
Author: Laure Gossec
Abstract Number: 0750
Session Title: Patient Outcomes, Preferences, & Attitudes Poster II: Measurements (0739-0763)
Sunday, November 7, 8:30 – 10:30 a.m. EST
- Efficacy of Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 Inhibitor, in Musculoskeletal Manifestations of Active PsA in a Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial
Author: Philip Mease
Abstract Number: 1820
Session Title: Spondyloarthritis Including PsA - Treatment Poster III: Psoriatic Arthritis II (1801-1835)
Tuesday, November 9, 8:30 – 10:30 a.m. EST
Iberdomide Presentation
- Sustained Efficacy and Safety of Iberdomide to Week 52 in Patients with Active Systemic Lupus Erythematosus (SLE) in a Phase 2, Randomized, Placebo-Controlled Study
Author: Joan Merrill
Abstract Number: 1458
Session Title: SLE - Treatment: New Agents, Old Agents (1458-1463)
Monday, November 8, 3:30 – 5:00 p.m. ESTOral Presentation
MK2i Presentations
- CC-99677: a Novel, Oral, Selective MK2 Inhibitor with Sustainable Multi-Cytokine Inhibition for the Treatment of Ankylosing Spondylitis and Other Inflammatory Diseases
Author: Kofi Mensah
Abstract Number: 0489
Session Title: Abstracts: Spondyloarthritis Including PsA - Treatment I: Emerging Therapies (0488-0491)
Saturday, November 6, 2:00 – 3:00 p.m. ESTOral Presentation
- CC-99677, a Novel, Selective, Oral MK2 Inhibitor, Sustainably Reduces Pro-Inflammatory Cytokine Production and Ameliorates Inflammation in the Mannan-Induced Murine Model of Psoriasis and Psoriatic Arthritis
Author: Rajula Guar
Abstract Number: 0049
Session Title: Spondyloarthritis Including PsA - Basic Science Poster (0046-0068)
Saturday, November 6, 8:30 – 10:30 a.m. EST
TLR7/8 Presentations
- Inhibition of Toll-Like Receptor 7 (TLR7) with the Potent and Selective Inhibitor of Human TLR7 and TLR8 BMS-986256 Provides Robust Efficacy in Murine Lupus Models, Reversing Established Disease
Author: Shailesh Dudhgaonkar
Abstract Number: 0470
Session Title: Abstracts: SLE - Animal Models (0470-0473)
Saturday, November 6, 11:00 – 12:00 p.m. ESTOral Presentation
- First-in-Human Safety, Pharmacokinetic and Pharmacodynamic Study of Escalating Single- and Multiple-Doses of BMS-986256, a Novel, Potent, Oral Inhibitor of TLR7 and TLR8
Author: Melanie Harrison
Abstract Number: 1771
Session Title: SLE – Treatment Poster (1732-1772)
Tuesday, November 9, 8:30 – 10:30 a.m. EST
- BMS-986256, an Oral Novel Toll-like Receptor 7 and 8 (TLR7/8) Inhibitor, does not Affect the Pharmacokinetics of Mycophenolate Mofetil in Healthy Subjects
Author: Manoj Chiney
Abstract Number: 1769
Session Title: SLE – Treatment Poster (1732-1772)
Tuesday, November 9, 8:30 – 10:30 a.m. EST
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 and is the first and only selective 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)-23, IL-12 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.
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 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.
Important Safety Information for ORENCIA® (abatacept)
Concomitant Use with TNF Antagonists, Other Biologic RA/PsA Therapy, or JAK Inhibitors: Concurrent therapy with ORENCIA and a TNF antagonist is not recommended. In controlled clinical trials, adult RA patients receiving concomitant intravenous ORENCIA and TNF antagonist therapy experienced more infections (63% vs 43%) and serious infections (4.4% vs 0.8%) compared to patients treated with only TNF antagonists, without an important enhancement of efficacy. Additionally, concomitant use of ORENCIA with other biologic RA/PsA therapy or JAK inhibitors is not recommended.
Hypersensitivity: There were 2 cases (