Abbvie's Robust ACR Presentations Save

AbbVie announced that data from 38 abstracts of HUMIRA® (adalimumab) and the company's portfolio of investigational immunology medicines will be presented at the 2017 American College of Rheumatology (ACR)/Association for Rheumatology Health Professionals (ARHP) Annual Meeting, November 3-8, in San Diego.

"Building on more than two decades of clinical trial experience with HUMIRA, AbbVie's body of research reinforces our commitment to developing treatment options for people living with immune-mediated inflammatory diseases," said Shao-Lee Lin, M.D., Ph.D., vice president, therapeutic areas and international development, AbbVie. "We look forward to sharing new developments that illustrate our patient-centered approach to treating rheumatic conditions, and the depth and breadth of AbbVie's portfolio."

AbbVie will present results from two Phase 3 trials of upadacitinib, an investigational oral JAK1-selective inhibitor, evaluating safety and efficacy in patients with moderate to severe rheumatoid arthritis. This includes late-breaking data from the Phase 3 SELECT-BEYOND study of upadacitinib in patients who did not adequately respond or were intolerant to treatment with biologic DMARDs (bDMARDs).

Additionally, data from SELECT-NEXT, a Phase 3 study of upadacitinib in patients with moderate to severe rheumatoid arthritis who did not adequately respond to treatment with conventional synthetic DMARDs (csDMARDs), will be featured as an oral presentation. Upadacitinib is not approved by regulatory authorities and safety and efficacy have not been established.

HUMIRA data to be presented at the meeting will include an analysis of long-term safety in nearly 30,000 patients across multiple immune-mediated conditions, highlighting the breadth of continued research in this population. HUMIRA is one of the most comprehensively-studied biologics available for immune-mediated inflammatory diseases, and is supported by more than 20 years of clinical trial experience in immunology.1

Abstracts of Interest

Upadacitinib Abstracts

• Long-Term Safety and Efficacy of Upadacitinib (ABT-494), an Oral JAK-1 Inhibitor in Patients with Rheumatoid Arthritis in an Open Label Extension Study; Abstract #509; Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy Poster I: Comorbidities and Adverse Events; Efficacy and Safety of Small Molecules; Sunday, November 5; 9:00-11:00 a.m. PT
• A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study of Upadacitinib (ABT-494), a Selective JAK-1 Inhibitor, in Patients with Active Rheumatoid Arthritis with Inadequate Response to Conventional Synthetic DMARDs; Abstract #1904; Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy II: Trials Therapy; Monday, November 6; 4:30-6:00 p.m. PT
• Upadacitinib (ABT-494) in Patients with Active Rheumatoid Arthritis and Inadequate Response or Intolerance to Biological DMARDs: A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study of a Selective JAK-1 Inhibitor; Abstract #10L; ACR Late-Breaking Abstract Poster; Tuesday, November 7; 9:00-11:00 a.m. PT

Risankizumab Abstracts

• Efficacy and Safety Results from a Phase 2 Trial of Risankizumab, a Selective IL-23p19 Inhibitor, in Patients with Active Psoriatic Arthritis; Abstract #2L; ACR Late-Breaking Abstract Session; Tuesday, November 7; 4:45-5:00 p.m. PT

HUMIRA Abstracts

Safety

• Long-Term Safety of Adalimumab (HUMIRA) in Adult Patients from Global Clinical Trials across Multiple Indications: An Updated Analysis in 29,987 Patients Representing 56,951 Patient Years; Abstract #2481; Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy Poster III: Efficacy and Safety of Originator Biologics and Biosimilars; Tuesday, November 7; 9:00-11:00 a.m. PT

Rheumatoid Arthritis

• The Value of Adalimumab Trough Levels and Clinical Assessments in Predicting Clinical Response in Patients with Established Rheumatoid Arthritis and an Inadequate Response to Methotrexate; Abstract #1418; Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy Poster II: Prognostic Factors, Imaging and Miscellaneous Reports; Monday, November 6; 9:00-11:00 a.m. PT
• Impact of Patient Support Program Utilization on Patient Activation Measure Scores Among Patients with Rheumatoid Arthritis; Abstract #1038; Health Services Research Poster II: Osteoarthritis and Rheumatoid Arthritis; Monday, November 6; 9:00-11:00 a.m. PT
• The Ability of Patients with Early Rheumatoid Arthritis to Taper Low-Dose Glucocorticoids on Methotrexate Monotherapy and in Combination with Adalimumab; Abstract #1420; Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy Poster II: Prognostic Factors, Imaging and Miscellaneous Reports; Monday, November 6; 9:00-11:00 a.m. PT

 Juvenile Idiopathic Arthritis

• Safety of Adalimumab±Methotrexate for the Treatment of Polyarticular Juvenile Idiopathic Arthritis (pJIA); Abstract #2271; Pediatric Rheumatology – Clinical and Therapeutic Aspects Poster III: Juvenile Arthritis; Tuesday, November 7, 2017; 9:00-11:00 a.m. PT

Spondyloarthritis (SpA)

• Impact of Time Since Diagnosis, Age and Number of Prior Non-Steroidal Anti-Inflammatory Drugs on 52-Week Clinical Response to Adalimumab in Patients with Ankylosing Spondylitis; Abstract #1521; Spondyloarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment Poster II; Monday, November 6; 9:00-11:00 a.m. PT
• Inhibition of Radiographic Progression in Psoriatic Arthritis By Adalimumab Independent of the Control of Clinical Disease Activity; Abstract #2970; Spondyloarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment V; Wednesday, November 8; 11:00-12:30 p.m. PT

Uveitis

• Impact of Adalimumab on Immunosuppressant Use in Patients with Active and Inactive Non-Infectious Intermediate, Posterior, or Pan-Uveitis in the Ongoing Open Label Study: Visual-III; Abstract #1155; Miscellaneous Rheumatic and Inflammatory Diseases Poster I; Monday, November 6; 9:00-11:00 a.m. PT