MedicalResearch.com Interview with:
Andrew Blauvelt, M.D., M.B.A.
President and Investigator
Oregon Medical Research Center
Portland, OR 97223
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Findings from the guselkumab Phase 3 VOYAGE 1 study showed that patients with moderate to severe plaque psoriasis receiving the anti-interleukin (IL)-23 monoclonal antibody (mAb) achieved significant improvements in skin clearance compared with patients receiving placebo and patients receiving Humira® (adalimumab), a TNF blocker. The Phase 3 study and head-to-head analysis of guselkumab vs. adalimumab in the treatment of moderate to severe plaque psoriasis also showed the significant efficacy of guselkumab maintained through week 48 compared with adalimumab, and the robust efficacy of guselkumab in meeting all primary and major secondary endpoints.
MedicalResearch.com: What should readers take away from your report?
Response: Guselkumab easily beat adalimumab by all measures and at all time points. These data follow a trend of recent results in psoriasis where newer biologics that block IL-17A and IL-23 have demonstrated superior efficacy to older biologics that block TNF.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Long-term safety still needs to be determined, although I am optimistic about this issue, given that long-term safety of ustekinumab, a related drug, has been so good.
MedicalResearch.com: Is there anything else you would like to add?
Response: Yes, 56.3% of guselkumab-treated patients demonstrated DLQI scores of 0 or 1 at week 16 compared to 38.6% of adalimuamb-treated patients. This score indicates that psoriasis had no impact on quality of life for these patients, which is a remarkable achievement given that psoriasis is such an impactful disease.
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
Kristian Reich, April W. Armstrong, Peter Foley, Michael Song, Yasmine Wasfi, Bruce Randazzo, Shu Li, Y.-K. Shen, Kenneth B. Gordon
Publication stage: In Press Corrected Proof
Published online: January 2, 2017
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