Janssen's Portfolio of New Biologics Roll Out for ACR 2016 Save

Janssen has announced the listings for it's presentations at the upcoming annual ACR/ARHP 2016 meeting in Washington. Beyond the new data for Remicade, Simponi, Simponi Aria and Stelara, there will be numerous abstracts presented on products in development, including guselkumab (anti-IL-23) and sirukumab (anti-IL-6).

Guselkumab, a novel anti-interleukin (IL)-23 monoclonal antibody (mAb)  is being studied for the treatment of adults with active PsA. Phase 3 data on sirukumab, an IL-6 mAb, in the treatment of moderately to severely active RA. Several posters highlighting research in systemic lupus erythematosus (SLE) and health outcomes will also be presented.

Janssen ACR abstract to be presented (grouped by drug) includes:

SIMPONI ARIA (golimumab)

• Safety and Efficacy of Intravenous Golimumab in Adult Patients with Active Ankylosing Spondylitis: Results through Week 28 (Presentation 56212), Oral Presentation: Sunday, November 13, 4:30 pm – 6:00 pm
• Real World United States-based Clinical Experience with Prior Biologic Use Among First Time Golimumab Intravenous and Infliximab Treated Rheumatoid Arthritis Patients (Presentation 55984). Poster Presentation: Sunday, November 13, 9:00 am – 11:00 am
• Efficacy and Safety of Intravenous Golimumab Plus Methotrexate in Patients 65 Years and Younger and Those Greater than 65 Years of Age-A Post Hoc Analysis (Presentation 56208). Poster Presentation: Sunday, November 13, 9:00 am – 11:00 am
• Patient Characteristics and Medication Utilization Patterns of Infliximab-treated Rheumatoid Arthritis Patients Subsequently Transitioned to Intravenous Golimumab (Presentation 56707). Poster Presentation: Sunday, November 13, 9:00 am – 11:00 am

STELARA (ustekinumab)

• An Integrated Safety Data Analysis Across All Phase II and Phase III Clinical Programs for Ustekinumab in Psoriatic Arthritis, Crohn’s Disease, and Psoriasis (Presentation 1726). Poster presentation: Monday, November 14, 9:00 am – 11:00 am

REMICADE (infliximab)

• Disease Activity Trends After Dose Escalation of Infliximab (Remicade) – Results From the US Corrona Registry (Presentation 55991). Poster Presentation: Sunday, November 13, 9:00 am – 11:00 am
• A Descriptive Analysis of Real-World Treatment Patterns of Innovator Infliximab (Remicade) and Biosimilar Infliximab in a Treatment Naïve Turkish Rheumatologic Disease Population (Presentation 58565). Poster Presentation: Monday, November 14, 9:00 am – 11:00 am
• A Descriptive Analysis of Real-world Treatment Patterns in a Turkish Rheumatology Population That Continued Innovator Infliximab (Remicade) Therapy or Switched to Biosimilar Infliximab (Presentation 58557). Poster Presentation: Tuesday, November 15, 9:00 am – 11:00 am

COMPOUNDS IN DEVELOPMENT

Guselkumab (Anti-IL23 mAb)

• Efficacy and Safety Results of Guselkumab, an Anti-IL-23 Monoclonal Antibody, in Patients With Active Psoriatic Arthritis Over 24 weeks: a Phase 2a, Randomized, Double-blind, Placebo-controlled Study (Presentation 4L)
  ACR Late-breaking Abstract Oral Presentation: Tuesday, November 15, 2016; 4:30 pm – 6:00 pm

Sirukumab (Anti-IL6 mAb)

• In Vitro Cellular Profiling of Sirukumab, an Anti-IL-6 Cytokine Monoclonal Antibody, Reveals a Distinct Phenotypic Signature Compared to Tocilizumab, an Anti-IL-6 Receptor Monoclonal Antibody (Presentation 57359). Poster Presentation: Monday, November 14, 9:00 am – 11:00 am
• Analysis of a Phase 3 Study Evaluating the Efficacy of Sirukumab, an Anti-IL-6 Cytokine Monoclonal Antibody, Across Subgroups in Patients With Active Rheumatoid Arthritis Despite Treatment With Disease-Modifying Anti-Rheumatic Drugs (Presentation 59004). Poster Presentation: Monday, November 14, 9:00 am – 11:00 am
• Prediction of Inhibition of Radiographic Progression by Sirukumab, an Anti-IL-6 Cytokine Monoclonal Antibody, in Patients With Active Rheumatoid Arthritis Despite Disease-Modifying Anti-Rheumatic Drug Treatment: Results of a Global, Phase 3 Trial (Presentation 59324). Poster Presentation : Tuesday, November 15, 9:00 am – 11:00 am
• Consistent Pharmacodynamic Effects of Sirukumab, an Anti-IL-6 Cytokine Monoclonal Antibody, on Serum Analytes Across Four Phase 3 Clinical Trials in Rheumatoid Arthritis (Presentation 59542). Poster Presentation: Monday, November 14, 9:00 am – 11:00 am
• Treatment With Sirukumab, an Anti-IL-6 Cytokine Monoclonal Antibody, Improves Fatigue and Health-Related Physical and Emotional Well Being in Patients With Active Rheumatoid Arthritis Refractory to Conventional or Biologic Therapy: Results of Two Global, Placebo-Controlled, Phase 3 Trials (Presentation 57844). Poster Presentation: Monday, November 14, 9:00 am – 11:00 am
• Efficacy and Safety of Sirukumab, an Anti-IL-6 Cytokine Monoclonal Antibody, in Patients With Active Rheumatoid Arthritis Despite Anti-TNF Therapy: Results From a Randomized, Double-Blind, Placebo-Controlled, Global, Phase 3 Study (Presentation 59233). Oral Presentation: Wednesday, November 16, 11:00 am – 12:30 pm
• Efficacy of Sirukumab, an Anti-IL-6 Cytokine Monoclonal Antibody, Based Upon Prior Use of Non-Anti-TNF Biologics in Patients With Active Rheumatoid Arthritis Despite Anti-TNF Therapy: Results From a Global Phase 3 Study (Presentation 59315). Oral Presentation: Wednesday, November 16, 11:00 am – 12:30 pm
• Sirukumab, an Anti–IL-6 Cytokine Monoclonal Antibody, Significantly Improves Physical Function and Reduces Morning Stiffness in Patients With Active Rheumatoid Arthritis Despite Anti-TNF Therapy: Results From a Global, Randomized, Placebo-Controlled, Phase 3 Trial (Presentation 57645). Poster Presentation: Monday, November 14, 9:00 am – 11:00 am
• Efficacy and Safety of Monotherapy With Sirukumab, an Anti-IL-6 Cytokine Monoclonal Antibody, Compared With Adalimumab Monotherapy in Biologic-Naive Patients With Active Rheumatoid Arthritis: Results of a Global, Randomized, Double-Blind, Parallel-Group, Phase 3 Study (Presentation 57374). Oral Presentation: Wednesday, November 16, 11:00 am – 12:30 pm
• Network Meta-Analysis to Assess the Relative Efficacy of Sirukumab, an Anti-IL-6 Cytokine Monoclonal Antibody, in Combination Therapy for Patients With Active Rheumatoid Arthritis Despite Conventional Disease-Modifying Anti-Rheumatic Drugs (DMARDs) (Presentation 59357). Poster Presentation: Monday, November 14, 9:00 am – 11:00 am

SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

• Blood And Kidney Molecular Profiles Distinguish Individuals With Lupus Nephritis From Other Kidney Disorders (Presentation 2064). Oral Presentation: Monday, November 14, 4:30 pm – 6:00 pm
• Results From a Phase 0 Longitudinal Clinical Trial in Cutaneous Lupus Erythematosus: Analysis of the Type 1 Interferon (IFN) Signature in the Skin and Blood and Its Relationship With Disease Activity Scores and Autoantibody Profiles (Presentation 2857). Poster Presentation: Tuesday, November 15, 9:00 am – 11:00 am
• Introducing a Novel SLE-Specific Interferon-1 (IFN-1) Inhibitor CNTO 6358: Laying the Groundwork for Precision Medicine in Lupus (Presentation 770). Poster Presentation: Sunday, November 13, 9:00 am – 11:00 am
• Broad Autoantibody Profiling in Ethnically Diverse SLE Cohorts Reveals a Set of Conserved Autoantibodies That are Correlated to a Type 1 Interferon Signature (Presentation 2816). Poster Presentation: Tuesday, November 15, 9:00 am – 11:00 am
• Comparative Analysis of Anti-Nuclear Antibody Testing Using Blinded Replicate Samples Reveals Variability Between Commercial Testing Laboratories (Presentation 2809). Poster Presentation: Tuesday, November 15, 9:00 am – 11:00 am

HEALTH ECONOMICS AND OUTCOMES RESEARCH DATA

• Updated Results for Serious Infections in Psoriasis Patients With Psoriatic Arthritis in the Psoriasis Longitudinal Assessment and Registry Study (Presentation 56212). Poster Presentation: Monday, November 14, 9:00 am – 11:00 am
• Updated Results for All-cause Mortality and Malignancies in Psoriasis Patients With Psoriatic Arthritis in the Psoriasis Longitudinal Assessment and Registry Study (Presentation 56211). Poster Presentation: Monday, November 14, 9:00 am – 11:00 am
• Physician/Site Staff Assessments Contribute to High Placebo Response in Rheumatoid Arthritis Clinical Trials (Presentation 55935). Poster Presentation: Tuesday, November 15, 9:00 am – 11:00 am
• Utilization Patterns of Subcutaneously Administered Biologic Medications Within a Sample of Rheumatoid Arthritis Patients (Presentation 59885). Poster Presentation: Tuesday, November 15, 9:00 am – 11:00 am