Bristol Myers Squibb Data at ACR Convergence 2021 Illustrate Scientific Advances for Immune-Mediated Rheumatic Diseases

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)--$BMY--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. EST
  Oral 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. EST
  Oral 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. EST
  Oral 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. EST
  Oral 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. EST
  Oral 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 (<0.1%; n=2688) of anaphylaxis reactions in clinical trials with adult RA patients treated with intravenous ORENCIA. Other reactions potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea, each occurred in <0.9% of patients. There was one case of a hypersensitivity reaction with ORENCIA in pJIA clinical trials (0.5%; n=190). In postmarketing experience, fatal anaphylaxis following the first infusion of ORENCIA and life-threatening cases of angioedema have been reported. Angioedema has occurred as early as after the first dose of ORENCIA, but also has occurred with subsequent doses. Angioedema reactions have occurred within hours of administration and in some instances had a delayed onset (i.e., days). Appropriate medical support measures for treating hypersensitivity reactions should be available for immediate use. If an anaphylactic or other serious allergic reaction occurs, administration of intravenous or subcutaneous ORENCIA should be stopped immediately and permanently discontinued, with appropriate therapy instituted.

Infections: Serious infections, including sepsis and pneumonia, were reported in 3% and 1.9% of RA patients treated with intravenous ORENCIA and placebo, respectively. Some of these infections have been fatal. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy which, in addition to their underlying disease, could further predispose them to infection. Caution should be exercised in patients with a history of infection or underlying conditions which may predispose them to infections. Treatment with ORENCIA should be discontinued if a patient develops a serious infection. Patients should be screened for tuberculosis and viral hepatitis in accordance with published guidelines, and if positive, treated according to standard medical practice prior to therapy with ORENCIA.

Immunizations: Prior to initiating ORENCIA in pediatric and adult patients, update vaccinations in accordance with current vaccination guidelines. Live vaccines should not be given concurrently with ORENCIA or within 3 months after discontinuation. ORENCIA may blunt the effectiveness of some immunizations.

Use in Patients with Chronic Obstructive Pulmonary Disease (COPD): In Study V, adult COPD patients treated with ORENCIA for RA developed adverse events more frequently than those treated with placebo, including COPD exacerbations, cough, rhonchi, and dyspnea. In the study, 97% of COPD patients treated with ORENCIA developed adverse events versus 88% treated with placebo. Respiratory disorders occurred more frequently in patients treated with ORENCIA compared to those on placebo (43% vs 24%, respectively), including COPD exacerbation, cough, rhonchi, and dyspnea. A greater percentage of patients treated with ORENCIA developed a serious adverse event compared to those on placebo (27% vs 6%), including COPD exacerbation [3 of 37 patients (8%)] and pneumonia [1 of 37 patients (3%)]. Use of ORENCIA in patients with COPD should be undertaken with caution, and such patients monitored for worsening of their respiratory status.

Immunosuppression: In clinical trials in adult RA patients, a higher rate of infections was seen in ORENCIA-treated patients compared to placebo-treated patients. The impact of treatment with ORENCIA on the development and course of malignancies is not fully understood. There have been reports of malignancies, including skin cancer in patients receiving ORENCIA. Periodic skin examinations are recommended for all ORENCIA-treated patients, particularly those with risk factors for skin cancer.

Blood Glucose Testing: ORENCIA for intravenous administration contains maltose, which may result in falsely elevated blood glucose readings on the day of infusion when using blood glucose monitors with test strips utilizing glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ). Consider using monitors and advising patients to use monitors that do not react with maltose, such as those based on glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), glucose oxidase or glucose hexokinase test methods. ORENCIA for subcutaneous (SC) administration does not contain maltose; therefore, patients do not need to alter their glucose monitoring.

Pregnancy: There are no adequate and well-controlled studies of ORENCIA use in pregnant women and the data with ORENCIA use in pregnant women are insufficient to inform on drug-associated risk.

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