On June 3, 2015 Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ:CELG), reported that data from 11 abstracts (two oral presentations, six poster presentations and three published in The Abstract Book) evaluating Celgene investigational and marketed products will be presented at the European League Against Rheumatism (EULAR) Annual Congress in Rome, Italy, June 10 – 13, 2015 (Press release, Celgene, JUN 3, 2015, View Source [SID:1234512521]). The data will include the latest research findings on Otezla (apremilast), the Company’s oral, selective inhibitor of phosphodiesterase 4 (PDE4), in psoriatic arthritis and plaque psoriasis, as well as CC-220, an investigational immunomodulatory compound for systemic lupus erythematosus (lupus).
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Among the data presented will be long-term (104-week) results from Celgene’s PALACE program, including pooled results of three phase III trials (PALACE 1, 2 and 3) assessing the effects of OTEZLA on two distinct manifestations of psoriatic arthritis – enthesitis (inflammation at sites where tendons or ligaments insert into bone) and dactylitis (inflammation of an entire digit). Additional analyses of PALACE trials will evaluate long-term safety and efficacy of OTEZLA in patients with active psoriatic arthritis, as well as the impact of OTEZLA on work productivity and physical function in these patients.
Data will also be presented on the effect of CC-220 on blood cell levels of Ikaros and Aiolos – transcription factors that, when mutated, are associated with an increased risk of systemic lupus erythematosus. The presentation will include phase I data on the impact of CC-220 on the immune response in healthy volunteers. Additional preclinical studies on CC-220 in lupus will be presented.
"We are excited about the presentation of these new long-term data of OTEZLA in psoriatic arthritis at EULAR. Additionally, data presented on our investigational compound CC-220 provide one example of the depth of Celgene’s clinical trial programs in other serious inflammatory diseases with high unmet medical need, including lupus," said Scott Smith, President, Celgene Inflammation & Immunology. "We remain committed to further developing our new and existing therapies to provide innovative treatment options for patients living with painful, debilitating chronic immune conditions."
Celgene will also host a variety of educational programs during the Congress on the unmet needs of patients with psoriatic arthritis, including a symposium for healthcare professionals as well as programs for patient/professional advocacy organizations and media.
The following abstracts will be presented at EULAR as an exchange of scientific and clinical information (all times, CEST):
OTEZLA (apremilast) Abstracts at a Glance
Oral Presentation 3594; Friday, June 12, 10:30 AM – 12:00 PM
Apremilast, an Oral Phosphodiesterase 4 Inhibitor, is Associated with Long-Term (104-Week) Improvements in Enthesitis and Dactylitis in Patients with Psoriatic Arthritis: Pooled Results from Three Phase III Randomized, Controlled Trials; Dafna Gladman, MD
Location: Hall 3, 10:45 AM – 10:55 AM
Poster Number 1113; Poster Tour Presentation Thursday, June 11, 12:05 PM – 1:45 PM
Apremilast, an Oral Phosphodiesterase 4 Inhibitor: Improvements in Nail and Scalp Psoriasis and Psoriasis Area and Severity Index in Patients with Moderate to Severe Plaque Psoriasis (ESTEEM 1 and 2); Kim Papp, MD
Poster Tour Presentation location and time: Hall 5, 12:05 PM
Poster Number 2907; Poster Display Thursday, June 11, 8:00 AM – 5:30 PM
Long-Term (104-Week) Efficacy and Safety Profile of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients with Psoriatic Arthritis: Results from a Phase III, Randomised, Controlled Trial and Open-Label Extension (PALACE 1); Arthur Kavanaugh, MD
Poster Tour Presentation location and time: Hall 5, 12:00 PM – 1:45 PM
Poster Number 2889; Poster Tour Presentation Thursday, June 11, 12:05 PM – 1:45 PM
Disease Activity and Safety During Long-Term (104-Week) Treatment with Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients with Psoriatic Arthritis: Results from a Phase III, Randomized, Controlled Trial and Open-Label Extension (PALACE 3); Christopher Edwards, MD
Poster Tour Presentation location and time: Hall 5, 12:05 PM
Poster Number 2986; Poster Tour Presentation Saturday, June 13, 10:20 AM – 12:00 PM
Long-Term (104-Week) Efficacy and Safety of Apremilast Monotherapy in DMARD-Naïve Patients with Psoriatic Arthritis: A Phase III, Randomized, Controlled Trial and Open-Label Extension (PALACE 4); Alvin Wells, MD
Poster Tour Presentation location and time: Hall 5, 11:20 AM
Poster Number 3582; Poster Display Thursday, June 11, 8:00 AM – 5:30 PM
Long-Term (104-Week) Safety Profile of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients with Psoriatic Arthritis: Pooled Safety Analysis of Three Phase III, Randomized, Controlled Trials; Philip Mease, MD
Poster Tour Presentation location and time: Hall 5, 12:00 PM – 1:45 PM
Poster Number 3590; Poster Display Saturday, June 13, 8:15 AM – 2:00 PM
Long-Term Work Productivity Improvement Associated with Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients with Psoriatic Arthritis: Pooled Analysis of Three Phase III Studies; Frank Zhang, MD
Poster Tour Presentation location and time: Hall 5, 10:15 AM – 12:00 PM
Publication Number 4114
Long-Term Impact of Apremilast on Physical Function in Patients with Psoriatic Arthritis Using the HAQ-DI Assessment; Frank Zhang, MD
CC-220 Abstracts at a Glance
Oral Presentation 3498; Thursday, June 11, 10:30 AM – 12:00 PM
The CRL4CRBN E3 Ubiquitin Ligase Modulator CC-220 Induces Degradation of the Transcription Factors Aiolos and Ikaros: Immunomodulation in Healthy Volunteers and Relevance to Systemic Lupus Erythematosus; Peter Schafer, Ph.D.
Oral Presentation location and time: Hall 8 – Room 8A, 11:35 AM (preliminary)
Publication Number 3187
B-Cell Proliferation and Plasmablast Generation from Naïve and Memory B Cells are Differentially Regulated by Baff, Il-21, and Cd40l and Inhibited by the Systemic Lupus Erythematosus Drug Candidate CC-220; Yumi Nakayama, MD
Publication Number 3487
Effects of CC-220, a CRL4CRBN E3 Ubiquitin Ligase Modulator, on Immune Responses; Ying Ye, Ph.D.