Author Interviews, Boehringer Ingelheim, Dermatology, Pharmacology / 08.03.2017
Psoriasis: Efficacy and Safety of Guselkumab vs Humira for Moderate to Severe Disease
MedicalResearch.com Interview with:
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Dr. Blauvelt[/caption]
Andrew Blauvelt, M.D., M.B.A.
President and Investigator
Oregon Medical Research Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Findings from the Phase 3 VOYAGE 1 study showed that patients with moderate to severe plaque psoriasis receiving guselkumab, an human anti-interleukin (IL)-23 monoclonal antibody, achieved significant improvement in skin clearance and in comparison with Humira® (adalimumab), a TNF blocker. The Phase 3 study and head-to-head analysis of guselkumab vs. adalimumab showed the significant and durable efficacy of guselkumab as maintained through one year when compared with adalimumab, and the robust efficacy of this novel IL-23 targeted therapy in meeting all primary and major secondary endpoints.
Dr. Blauvelt[/caption]
Andrew Blauvelt, M.D., M.B.A.
President and Investigator
Oregon Medical Research Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Findings from the Phase 3 VOYAGE 1 study showed that patients with moderate to severe plaque psoriasis receiving guselkumab, an human anti-interleukin (IL)-23 monoclonal antibody, achieved significant improvement in skin clearance and in comparison with Humira® (adalimumab), a TNF blocker. The Phase 3 study and head-to-head analysis of guselkumab vs. adalimumab showed the significant and durable efficacy of guselkumab as maintained through one year when compared with adalimumab, and the robust efficacy of this novel IL-23 targeted therapy in meeting all primary and major secondary endpoints.








Dr. Jonathan Silverberg[/caption]
Dr. Jonathan L. Silverberg MD PhD MPH
Assistant Professor in Dermatology
Medical Social Sciences and Preventive Medicine
Northwestern University, Chicago, Illinois
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Psoriasis is associated with a number of potential risk factors for developing serious infections, including impaired skin-barrier function, immune dysregulation, use of systemic immunosuppressant and biologic treatments. We hypothesized that adults with psoriasis have higher rates of serious infections.
We examined data from the 2002-2012 National Inpatient Sample, which contains a representative 20% sample of all hospitalizations in the United States. We found that psoriasis was associated with multiple serious infections, including methicillin-resistant Staphylococcus aureus, cellulitis, herpes simplex virus infection, infectious arthritis, osteomyelitis, meningitis, encephalitis and tuberculosis. Rates of serious infections increased over all time.
Significant predictors of serious infections in patients with psoriasis included non-white race, lower estimated income quartile, and Medicaid, Medicare, or self-pay insurance status. These findings suggest that poor access to adequate dermatologic care may be associated with higher rates of infections.
Dr. Lihi Eder[/caption]
Lihi Eder, MD, PhD
Assistant Professor of Medicine
University of Toronto
Scientist, Women’s College Research Institute,Room 6326
Women’s College Hospital
Toronto, ON, Canada
MedicalResearch.com: What is the background for this study?
Dr. Eder: Psoriasis is a chronic immune-mediated skin disease affecting 2-3% of the general population. Psoriatic arthritis (PsA) affects 15-30% of patients with psoriasis. Until recently, only few studies assessed the risk of developing cardiovascular events in patients with PsA and while most studies found a higher cardiovascular risk in these patients, others reported cardiovascular rates that were similar to the general population.
Prof. Rudi Beyaert[/caption]
Professor Rudi Beyaert
VIB - Inflammation Research Center Ghent University
Department for Biomedical Molecular Biology Unit of Molecular Signal Transduction in Inflammation
Technologiepark Ghent) Belgium
MedicalResearch.com: What is the background for this study? What are the main findings?
Prof. Beyaert: The interest of my laboratory is in understanding the molecular mechanisms that are responsible for the development of inflammatory diseases such as Crohn's disease, multiple sclerosis, rheumatoid arthritis and also psoriasis, which is the topic of the published study. We already know that genetic factors can determine the onset of these inflammatory diseases, but how these genetic factors drive an inflammatory response is still largely unclear. We were specifically interested in the CARD14 gene, because patients with mutations in CARD14 have a very high chance to develop psoriasis. Psoriasis-associated mutations in CARD14 trigger specific skin cells (keratinocytes) to produce and release large amounts of other proteins that recruit and activate specific white blood cells driving an inflammatory response. We now discovered that this effect is dependent on the physical interaction of CARD14 with the protease MALT1 in keratinocytes, leading to the activation of its enzymatic activity and the MALT1-mediated cleavage and inactivation of a number of cellular proteins that normally keep our immune system in check. Treatment of skin cells with small compound MALT1 inhibitors prevents the CARD14-induced production of several pro-inflammatory mediators.





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