08 Mar Psoriasis: Efficacy and Safety of Guselkumab vs Humira for Moderate to Severe Disease
MedicalResearch.com Interview with:
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.
MedicalResearch.com: What should readers take away from your report?
Response: The VOYAGE 1 study elucidates the important role of IL-23 in the pathogenesis of psoriasis. By selectively targeting the IL-23 pathway, guselkumab works ‘upstream’ of TNF-alpha and IL-17A cytokines and as a result, establishes a more psoriasis-specific cytokine inhibition. As seen in this study and the complimentary VOYAGE 2 study, this results in significant and sustained efficacy and high levels of skin clearance as measured by PASI 90 and PASI 100 scores.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Clinical studies that include active comparator assessments – in this case guselkumab compared with adalimumab – are important for physicians in understanding differences in treatment options. In addition, VOYAGE 1 evaluated the effect of guselkumab in difficult-to-treat areas of psoriasis (nail, scalp and hand/foot) and in health-related quality of life and patient reported outcome measures, all important data points for continued research in the future.
MedicalResearch.com: Is there anything else you would like to add?
Response: While long-term safety is an important consideration for any investigational therapy, I am optimistic about the profile of guselkumab from the data accumulated to date through the Phase 3 program and given that long-term safety of Stelara® (ustekinumab), a related drug, that has been so good.
Interestingly, guselkumab is the first IL-23 targeted therapy to also demonstrate efficacy in the treatment of psoriatic arthritis as reported in a Phase 2 study. I look forward future Phase 3 results given the number of patients with moderate to severe plaque psoriasis who also develop psoriatic arthritis.
Disclosures: I have served as a scientific adviser and clinical study investigator for AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, Genentech, GlaxoSmithKline, Janssen, Eli Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Regeneron, Sandoz, Sanofi Genzyme, Sun Pharma, UCB, and Valeant, and as a paid speaker for Lilly.
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Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator–controlled VOYAGE 1 trial
Blauvelt, Andrew et al.
Journal of the American Academy of Dermatology , Volume 76 , Issue 3 , 405 – 417
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