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

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 Orencia as 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 Orencia were 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.

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. A pregnancy registry has been established to monitor pregnancy outcomes in women exposed to ORENCIA during pregnancy. Healthcare professionals are encouraged to register patients by calling 1-877-311-8972.

Lactation: There is no information regarding the presence of abatacept in human milk, the effects on the breastfed infant, or the effects on milk production. However, abatacept was present in the milk of lactating rats dosed with abatacept.

Most Serious Adverse Reactions: Serious infections (3% ORENCIA vs 1.9% placebo) and malignancies (1.3% ORENCIA vs 1.1% placebo).

Malignancies: The overall frequency of malignancies was similar between adult RA patients treated with ORENCIA or placebo. However, more cases of lung cancer were observed in patients treated with ORENCIA (0.2%) than those on placebo (0%). A higher rate of lymphoma was seen compared to the general population; however, patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of ORENCIA in the development of malignancies in humans is unknown.

Most Frequent Adverse Events (≥10%): Headache, upper respiratory tract infection, nasopharyngitis, and nausea were the most commonly reported adverse events in the adult RA clinical studies. Other events reported in ≥5% of pJIA patients were diarrhea, cough, pyrexia, and abdominal pain. In general, the adverse events in pediatric pJIA and adult PsA patients were similar in frequency and type to those seen in adult RA patients.

Note concerning ORENCIA administration options: ORENCIA may be administered as an intravenous infusion only for patients 6 years of age and older. PJIA patients may self-inject with ORENCIA or the patient’s caregiver may administer ORENCIA if both the healthcare practitioner and the parent/legal guardian determines it is appropriate. The ability of pediatric patients to self-inject with the autoinjector has not been tested.

Please click here for Full Prescribing Information.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results will be consistent with the results to date, that the treatments, including deucravacitinib, Orencia and iberdomide, may not receive regulatory approval for the indications described in this release and, if approved, whether such treatments for such indications described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2020, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

corporatefinancial-news

View source version on businesswire.com: https://www.businesswire.com/news/home/20210602005141/en/

$BMY presents data highlighting commitment to driving advancements across multiple immune-mediated rheumatic diseases at #EULAR2021