PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY) today announced that data from 26 company-sponsored and collaborative studies, which demonstrate the depth and breadth of the company’s immunology pipeline and portfolio and commitment to the rheumatology community, will be presented at the American College of Rheumatology (ACR) Convergence 2020, taking place virtually November 5-9, 2020.

Research will be shared on three Bristol Myers Squibb assets spanning four disease areas, including:

• Deucravacitinib (BMS-986165): Late-breaking data from a Phase 2 trial evaluating deucravacitinib in patients with active psoriatic arthritis, which met the primary endpoint and key secondary objectives. In this trial, deucravacitinib was well-tolerated and the safety profile was similar to that observed in the previously reported Phase 2 psoriasis trial. The data will be presented as part of the Late-Breaking Posters Session on November 9 from 9:00 – 11:00 a.m. EST.
• Orencia: A total of 13 company-led presentations demonstrating Bristol Myers Squibb’s leadership in precision medicine in rheumatology with Orencia, including:
  • Data from patients with moderate-to-severe early rheumatoid arthritis (RA) who tested positive (seropositive) for autoantibodies called anti-citrullinated protein antibodies (ACPA) and/or carry the “Shared Epitope” genotype, both of which increase the risk of the development of RA and rapid progression of the disease. This includes a real-world analysis on the comparative effectiveness of Orencia versus TNF-inhibitors in this patient population.
  • New biomarker data showing that higher baseline levels of fine-specificity ACPAs predict greater treatment response in seropositive RA patients receiving Orencia on background methotrexate therapy versus methotrexate alone.
• Iberdomide: Findings from a Phase 2b trial in patients with active systemic lupus erythematosus (SLE) assessing iberdomide, a novel, oral, high-affinity, cereblon ligand that induces degradation of transcription factors Aiolos and Ikaros, which play critical roles in regulating the balance of the immune system. The study met its primary endpoint of SLE Responder Index (SRI-4) response at Week 24, with a greater treatment response in patients with high Type 1 interferon or Aiolos gene expressions. An oral presentation of the efficacy and safety results will take place November 7 at 3:20 p.m. EST. Additionally, a poster detailing the pharmacokinetics, pharmacodynamics and impact on key SLE biomarkers of iberdomide will be shared on November 7 from 9:00 – 11:00 a.m. EST.

“Bristol Myers Squibb’s data at this year’s ACR Convergence embody our science-driven pathway approach and demonstrate our commitment to collaborating with the rheumatology community in pursuit of discoveries that can lead to novel therapies across a number of immune-mediated diseases,” said Mary Beth Harler, M.D., head of Immunology and Fibrosis Development, Bristol Myers Squibb. “Emerging biology in key diseases like psoriatic arthritis and lupus, in concert with our continued work in rheumatoid arthritis and juvenile idiopathic arthritis, drives important progress in our mission to deliver transformative therapies for patients living with immune-mediated diseases.”

Bristol Myers Squibb-sponsored abstracts that will be presented at the ACR Convergence 2020 can be found below. Complete abstracts may be accessed online here.

Deucravacitinib Presentation

• Efficacy and Safety of Deucravacitinib (BMS-986165), an Oral, Selective Tyrosine Kinase 2 Inhibitor, in Patients with Active Psoriatic Arthritis: Results From a Phase 2, Double-Blind, Randomized, Placebo-Controlled Trial Author: Mease Abstract Number: L03 Session Title: Late-Breaking Posters Monday, November 9, 9:00 – 11:00 a.m. EST

Orencia Presentations

• The Comparative Effectiveness of Abatacept Versus TNF Inhibitors in Patients who are ACPA Positive and Have the Shared Epitope: Results from a US National Observational Study Author: Harrold Abstract Number: 0801 Session Title: RA – Treatments Poster II: Comparative Effectiveness, Biosimilars, Adherence & the Real World Poster Session B Saturday, November 7, 9:00 – 11:00 a.m. EST

• Higher Baseline Fine-Specificity ACPAs Predict Greater Treatment Response with Abatacept + MTX Versus MTX Monotherapy in Seropositive RA: A Post Hoc Analysis Author: Robinson Abstract Number: 0743 Session Title: RA – Diagnosis, Manifestations, & Outcomes Poster II: Biomarkers Poster Session B Saturday, November 7, 9:00 – 11:00 a.m. EST

• Clinical Responses and Patient Flow Over 2 Years of Treatment with Abatacept, Including Dose De-Escalation, in Patients with Early, MTX-Naïve, ACPA+ RA: Results From a Phase IIIb Study Author: Emery Abstract Number: 0826 Session Title: RA – Treatments Poster II: Comparative Effectiveness, Biosimilars, Adherence & the Real World Poster Session B Saturday, November 7, 9:00 – 11:00 a.m. EST

• The Comparative Effectiveness of Abatacept Versus Tofacitinib After 6 Months of Treatment in Patients with RA Who Were Anti-citrullinated Protein Antibody Positive at Baseline: Results from a U.S. National Observational Study Author: Harrold Abstract Number: 0824 Session Title: RA – Treatments Poster II: Comparative Effectiveness, Biosimilars, Adherence & the Real World Poster Session B Saturday, November 7, 9:00 – 11:00 a.m. EST

• Infection and Malignancy Outcomes in Patients with RA Treated With Abatacept: Results From a Multinational Surveillance Study Author: Hetland Abstract Number: 1010 Session Title: Clinical Practice II (1457–1461) Poster Session C Sunday, November 8, 9:00 – 11:00 a.m. EST

• A Novel Method for Predicting 1-Year Retention of Abatacept Using Machine Learning Technique Author: Alten Abstract Number: 1745 Session Title: RA – Diagnosis, Manifestations, & Outcomes Poster IV: Lifespan of a Disease Poster Session D Monday, November 9, 9:00 – 11:00 a.m. EST

• Fifty-Two Week Outcomes of Biologic-Naïve RA Patients Treated with Subcutaneous Abatacept in Japanese Multicenter Investigational Study (ORIGAMI Study) Author: Tamura Abstract Number: 0206 Session Title: RA – Treatments Poster I: RA Treatments & Their Safety Poster Session A Friday, November 6, 9:00 – 11:00 a.m. EST

• JIA-ACR50 Response as a Predictor of Minimal Disease Activity in Patients Aged 2–17 Years with Polyarticular-Course JIA Treated With SC Abatacept Author: Ruperto Abstract Number: 0715 Session Title: Pediatric Rheumatology – Clinical Poster II: JIA Poster Session B Saturday, November 7, 9:00 – 11:00 a.m. EST

• Longitudinal Effectiveness of Abatacept in JIA: Results from an Ongoing JIA Registry Author: Lovell Abstract Number: 0713 Session Title: Pediatric Rheumatology – Clinical Poster II: JIA Poster Session B Saturday, November 7, 9:00 – 11:00 a.m. EST

• Response to Abatacept in JIA Categories: Results From the PRCSG/PRINTO JIA Abatacept Phase IV Registry Author: Lovell Abstract Number: 0714 Session Title: Pediatric Rheumatology – Clinical Poster II: JIA Poster Session B Saturday, November 7, 9:00 – 11:00 a.m. EST

• Serum Proteomics from a Phase III, Randomized, Placebo-Controlled Study of Patients with Active Lupus Nephritis: Correlation With Baseline Disease Characteristics and Response to Therapy Author: Furie Abstract Number: 1822 Session Title: SLE – Treatment Poster II Poster Session D Monday, November 9, 9:00 – 11:00 a.m. EST

Iberdomide Presentations

• Efficacy and Safety of Iberdomide in Patients with Active Systemic Lupus Erythematosus: 24-Week Results of a Phase 2, Randomized, Placebo-Controlled Study Author: Merrill Abstract Number: 0987 Session Title: SLE – Treatment (0985–0989) Saturday, November 7, 3:20 – 3:30 p.m. EST Oral presentation

• Iberdomide Decreases B Cells and Plasmacytoid Dendritic Cells, Increases Regulatory T cells and IL-2, and Has Enhanced Clinical Efficacy in Active Systemic Lupus Erythematosus Patients with High Aiolos or the IFN Gene Expression Signature Author: Lipsky Abstract Number: 0851 Session Title: SLE – Treatment Poster I Poster Session B Saturday, November 7, 9:00 – 11:00 a.m. EST

Health Economics and Outcomes Research (HEOR) Presentations

• Prevalence of Morbidity Prior to Diagnosis of Incident Systemic Lupus Erythematosus in the Danish Population Author: Hansen Abstract Number: 1287 Session Title: SLE – Diagnosis, Manifestations, & Outcomes Poster II: Comorbidities Poster Session C Sunday, November 8, 9:00 – 11:00 a.m. EST

• Risk Factors Associated with Interstitial Lung Disease in Patients With RA: Findings From a Retrospective Healthcare Database Analysis Author: Craig Abstract Number: 1046 Session Title: Reproductive Issues in Rheumatic Disorders (1497–1501) Poster Session C Sunday, November 8, 9:00 – 11:00 a.m. EST

• Increased Risk of Hospitalization in Patients with RA who are ACPA+ and Shared Epitope Positive Author: Shadick Abstract Number: 0756 Session Title: RA – Diagnosis, Manifestations, & Outcomes Poster II: Biomarkers Poster Session B Saturday, November 7, 9:00 – 11:00 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 becomes inflamed), dactylitis (inflammation of the fingers and toes), and psoriatic skin and nail lesions. Up to 30 percent of patients with psoriasis will 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. Patients with psoriatic arthritis are also 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 limited range of motion and decreased joint function with long-term disability. The condition is more common in women than in men, who account for 75 percent of patients diagnosed with 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, brain, lungs, kidneys and blood vessels, 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). Up to 60 percent of patients will develop significant kidney disease, lupus nephritis, that can lead to end-stage renal failure and death.

About Deucravacitinib

Deucravacitinib (BMS-986165) is the first and only novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor in clinical studies across multiple immune-mediated diseases. Deucravacitinib’s selectivity is driven by a unique mechanism of action that is distinct from other kinase inhibitors. TYK2 is an intracellular signaling kinase that mediates signaling of IL-23, IL-12 and Type I IFN, which are naturally occurring cytokines involved in inflammatory and immune responses.

Deucravacitinib is being studied in a wide spectrum of immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus and inflammatory bowel disease. Deucravacitinib is not approved for any 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 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).

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 (