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.
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Acknowledgments and disclosures. Acknowledgments: editorial support and assistance were provided by Melanie Gatt, an independent medical writer, on behalf of Springer Healthcare. This assistance was funded by Janssen. Financial support: The project was sponsored through an unconditional contribution of Janssen, without any intervention or influence in the development of the contents reported. Conflicts of interest: Andrea Chiricozzi has served as an advisory board member and consultant, and has received fees and speaker’s honoraria or has participated in clinical trials for Abbvie, Almirall, Biogen, Fresenius Kabi, Leo Pharma, Lilly, Janssen, Novartis, Pfizer, Sanofi Genzyme, and UCB-Pharma. Antonio Costanzo is supported by grants from the Ministry of Health (grant no. CO-2013-02356463), has served as an advisory board member and consultant, and has received fees and speaker’s honoraria or has participated in clinical trials for Abbvie, Almirall, Biogen, Leo Pharma, Lilly, Janssen, Novartis, Pfizer, Sanofi Genzyme, and UCB-Pharma. Maria Concetta Fargnoli has served as an advisory board member, and has received honoraria for lectures and research grants from Almirall, Celgene, Eli Lilly, Galderma, Janssen, Leo Pharma, Medac Pharma, Mylan, Novartis, Pfizer, Roche, Sanofi, UCB, Sunpharma, and Pierre Fabre. Piergiorgio Malagoli has received fees for board participation or events from Lilly, Novartis, AbbVie, Janssen, Celgene, Leopharma, and Almirall. Stefano Piaserico has served as a consultant or speaker for Abbvie, Celgene, Pfizer, Sanofi-Genzyme, Almirall, Eli Lilly, Jannsen, Galderma, and Novartis. Paolo Amerio has served as a consultant or speaker for Abbvie, Celgene, Pfizer, Sanofi-Genzyme, Eli Lilly, and Jannsen, Galderma. Federico Bardazzi has received honoraria as a consultant or speaker for Novartis, Abbvie, Janssen-cilag, Leopharma, Sandoz, Bristol Mayers, and Almirall. Luca Bianchi has received honoraria as a speaker or consultant for Abbvie, Janssen, Almirall, Eli Lilly, Leopharma, Novartis, Sanofi, Pfizer, and UCB Pharma. Carlo Giovanni Carrera has served as a board participant or speaker for Abbvie, Lilly, Jannsen, Novartis, Celgene, Almirall, and Leopharma. Andrea Conti has served as an advisory board member and consultant, and has received fees and speaker’s honoraria or has participated in clinical trials for Abbvie, Almirall, Biogen, Cellgene, Leo Pharma, Eli Lilly, Janssen Cilag, MSD, Novartis, Pfizer, and UCB. Clara De Simone has received honoraria as a speaker and consultant for Abbvie, Almirall, Biogen, Eli Lilly, Leopharma, Novartis, Janssen, Sanofi, Pfizer, and UCB Pharma. Ada Lo Schiavo has received honoraria as a speaker and consultant for Novartis, Celgene, Janssen, Eli Lilly, Genzyme, and Abbvie. Giovanna Malara has received honoraria as a speaker and consultant for Janssen, Sanofi, Abbvie, Eli Lilly, Novartis, Janssen, Sanofi, and Celgene. Maria Letizia Musumeci served as advisory board member and consultant, participated to clinical trials and received fees and speaker’s honoraria from Celgene, Novartis, Eli Lilly, Janssen-Cilag, Biogen and AbbVie. Aurora Parodi has participated in clinical trials and has served as an advisory board member for Abbvie, Pfizer, Celgene, Novartis, Galderma, Lilly, LEO pharma, Almirall. Ketty Peris has received grants and personal fees from Almirall and Abb-Vie, during the conduct of the study, and personal fees from Biogen, Lilly, Celgene, Galderma, Leo Pharma, Novartis, Pierre Fabre, Sanofi, Sandoz, Sun Pharma, and Janssen. Francesca Prignano has been a consultant, adviser and clinical study investigator for Eli-Lilly, Abbvie, Novartis, Leo-Pharma, Abiogen-Pharma, Celgene, and Janssen-Cilag. Franco Rongioletti has received honoraria as a consultant or speaker for Abbvie, Lilly, Janssen, Novartis, and Sanofi Genzyme. Francesco Loconsole, Giuseppe Argenziano, Nicola Balato, Paolo Dapavo, Marina Talamonti, and Concetta Potenza have no conflicts of interest to declare.
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Chiricozzi, A., Costanzo, A., Fargnoli, M.C. et al. Guselkumab: an anti-IL-23 antibody for the treatment of moderate-to-severe plaque psoriasis. Eur J Dermatol 31, 3–16 (2021). https://doi.org/10.1684/ejd.2021.3965
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DOI: https://doi.org/10.1684/ejd.2021.3965