Guselkumab: an anti-IL-23 antibody for the treatment of moderate-to-severe plaque psoriasis
Andrea Chiricozzi, Antonio Costanzo, Maria Concetta Fargnoli, Piergiorgio Malagoli, Stefano Piaserico, Paolo Amerio, Giuseppe Argenziano, Nicola Balato, Federico Bardazzi, Luca Bianchi, Carlo Giovanni Carrera, Andrea Conti, Paolo Dapavo, Clara De Simone, Francesco Loconsole, Ada Lo Schiavo, Giovanna Malara, Maria Letizia Musumeci, Aurora Parodi, Ketty Peris, Francesca Prignano, Franco Rongioletti, Marina Talamonti, Concetta Potenza
Abstract
Guselkumab, a subcutaneously administered fully human IgG1λ monoclonal antibody that selectively inhibits the p19 subunit of interleukin 23, is approved in both the USA and the EU for the treatment of adult patients with moderate-to-severe plaque psoriasis. The efficacy and safety of guselkumab were demonstrated in four randomized, double-blind, Phase III trials (VOYAGE 1 and 2, NAVIGATE, and ECLIPSE), which demonstrated high levels of clinical response over three years of continuous treatment, regardless of sex, age, body weight, and race, maintaining a favourable safety profile and long-term tolerability. Guselkumab was shown to be efficacious in patients with prior failure of other biologics, including adalimumab and ustekinumab, and was superior to both adalimumab and secukinumab in head-to-head trials. Guselkumab efficacy was also observed in the treatment of psoriasis localized in difficult-to-treat body regions including the scalp, palms and/or soles, and fingernails. Treatment with guselkumab improved health-related quality of life and patient-reported signs and symptoms. Guselkumab has a consistently favourable safety profile and is well tolerated over the long-term. Clinical development of guselkumab as a treatment is ongoing for other immune-mediated inflammatory diseases, including psoriatic arthritis, Crohn's disease, and ulcerative colitis. In the overall management of patients with plaque psoriasis, guselkumab is a robust treatment option with durable maintenance of response over time.