Adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Human monoclonal IgG1-lambda antibody that selectively binds to the p19 subunit of IL-23, thereby inhibiting the proinflammatory actions of IL-23.
100 mg SC at week 0, week 4, and q8wk thereafter.
Approval was based on three phase 3 studies (n>2000). The VOYAGE I and 2 trials compared guselkumab with adalimumab. At 16 weeks, at least 7 of 10 patients treated with guselkumab achieved at least 90% clearer skin (Psoriasis Area and Severity Index [PASI 90]), and more than 80% demonstrated cleared or almost cleared skin. Results were maintained at week 48. The drug also demonstrated effectiveness in patients who had an inadequate response to ustekinumab.
Blauvelt A, et al. 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. J Am Acad Dermatol. 2017 Mar;76(3):405-17.
Reich K, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: Results from the phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial. J Am Acad Dermatol. 2017 Mar;76(3):418-31.
Langley RG, et al. Efficacy and safety of guselkumab in patients with psoriasis who have an inadequate response to ustekinumab: Results of the randomized, double-blind, Phase 3 NAVIGATE trial. Br J Dermatol. 2017 Jun 21.
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Cite this: Mary L Windle. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review - Medscape - Jan 11, 2018.