Guselkumab in paediatric plaque psoriasis: a profile of its use

Guselkumab (TREMFYA®), a first-in-class interleukin-23 (IL-23) antagonist, is a monoclonal antibody that expands the treatment options available for the systemic treatment of moderate-to-severe plaque psoriasis in paediatric patients ≥ 6 years of age who are candidates for systemic therapy in the EU and paediatric patients ≥ 6 years of age who weigh ≥ 40 kg and are candidates for systemic therapy or phototherapy in the USA. As shown in the randomized, placebo-controlled, multicentre, phase III PROTOSTAR trial, subcutaneous guselkumab significantly reduced disease severity compared with placebo at week 16 of treatment, meeting all co-primary and key secondary endpoints relating to Investigator Global Assessment score (clear or almost clear skin) and Psoriasis Area and Severity Index scores (≥ 75%, 90% or 100% improvement from baseline), as well as improvements in patient quality of life. Benefits were seen up to week 52 in a guselkumab crossover, withdrawal and re-treatment period as well as a 52-week open-label continuous guselkumab treatment period. Guselkumab is generally well tolerated; the most common adverse events in the trial were infections (most frequently nasopharyngitis and upper respiratory tract infection) and headache. Plaque psoriasis, a chronic, inflammatory skin condition with about a third of cases arising in childhood, is managed with topical therapies, light therapy and/or systemic treatments (non-biologic or biologic). Guselkumab (TREMFYA®) is an interleukin-23 (IL-23) blocker, meaning it binds selectively to the p19 subunit of IL-23 and blocks the IL-23-mediated inflammatory signalling involved in psoriasis. It is the first IL-23 blocker approved to treat moderate-to-severe plaque psoriasis in children and adolescents ≥ 6 years of age eligible to receive systemic and/or light therapy. As shown in a 52-week clinical trial in children and adolescents ≥ 6 years of age with moderate-to-severe plaque psoriasis, treatment with guselkumab resulted in completely or mostly cleared skin in significantly more patients than with placebo. Patient quality of life was also improved. Guselkumab is generally well tolerated and common side effects included infections and headaches. Guselkumab expands the systemic treatment options available for children and adolescents ≥ 6 years of age with moderate-to-severe plaque psoriasis.