EU approves Tremfya (guselkumab) for the treatment of children with plaque psoriasis, marking the first paediatric indication for an IL-23 inhibitor – Johnson & Johnson

Johnson & Johnson announced that the European Commission (EC) has extended the marketing authorisation for Tremfya (guselkumab) as a subcutaneous treatment to treat moderate to severe plaque psoriasis (Pso) in children and adolescents from the age of 6 years who are candidates for systemic therapy. This milestone makes guselkumab the first IL-23 inhibitor approved for any paediatric indication, building on EC approval in adults living with moderate to severe plaque Pso in 2017.

Almost one-third of Pso cases begin in childhood, and the inflamed, scaly plaques caused by chronic disease may be itchy or painful and can be highly stressful for children, leading to a potential long-term impact on those affected. Paediatric Pso has been associated with certain comorbidities, such as obesity, hypertension, hyperlipidemia, diabetes mellitus, and psoriatic arthritis, further impacting quality of life.

“Despite progress in the treatment of paediatric Pso, there continues to be a significant gap in available therapies for children living with this debilitating immune-mediated disease, which can impact a child’s physical and mental wellbeing during critical years,” said Marieke Seyger, Associate Professor, Radboud University Medical Centre Nijmegen, Netherlands, and PROTOSTAR study investigator. “The approval of guselkumab offers physicians, parents, and care givers a treatment option that can significantly improve the signs and symptoms of Pso in children living with this disease.”

The EC approval was based on results from the Phase III PROTOSTAR study in 120 paediatric patients with moderate to severe plaque Pso and bridging pharmacokinetic (PK) data from the Phase III VOYAGE 1 and 2 studies in adult patients with moderate to severe plaque Pso. In the PROTOSTAR study, the co-primary endpoints of Psoriasis Area Severity Index (PASI) 75 and Investigator’s Global Assessment (IGA) score of 0/1 were achieved at Week 16. Approximately 76% of 41 patients receiving guselkumab achieved PASI 75, compared to 20% of 25 patients receiving placebo (p<0.001). At Week 16, 66% of patients receiving guselkumab compared to 16% of patients receiving placebo (p<0.001) achieved high levels of skin clearance (IGA score of 0/1). Nearly 40% of patients receiving guselkumab achieved complete clearance (IGA 0) at Week 16, compared to 4% on placebo (p<0.01). The safety profile for guselkumab subcutaneous injection in paediatric patients 6 to 17 years was consistent with the safety profile reported in the adult plaque psoriasis studies.

“Guselkumab is the first fully-human dual-acting IL-23 inhibitor approved for the treatment of moderate to severe paediatric plaque psoriasis, marking an important step forward not only for children, but also for the parents and care givers who support them every day,” commented Mark Graham, Senior Director, Therapeutic Area Head, Immunology, Johnson & Johnson Innovative Medicine EMEA. “We’re steadfast in our commitment to advancing research that supports the long-term efficacy and safety profile of guselkumab, and to meet the unmet needs of adult and paediatric patients.”

This EC approval is an important milestone for patients and is emblematic of Johnson & Johnson’s continuous commitment to innovating to improve the lives of people living with chronic immune-mediated diseases. Guselkumab first received approval in the EU in November 2017 for the treatment of moderate-to-severe Pso in adults who are candidates for systemic therapy. In November 2020, guselkumab received EU approval for active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy. In 2025, guselkumab received EC approval for ulcerative colitis (UC) and Crohn’s Disease (CD) in adults, which includes both an intravenous (IV) and a subcutaneous (SC) induction dosing option followed by SC maintenance dosing.

ABOUT THE PHASE 3 PROTOSTAR PROGRAMME (EudraCT 2017-003053-42)
PROTOSTAR is a Phase III, multi-centre, randomised, placebo- and active comparator-controlled study evaluating the efficacy, safety, and pharmacokinetics of subcutaneously administered guselkumab for the treatment of chronic plaque Pso in paediatric patients six years of age up to 18 years. Co-primary endpoints of the study were IGA 0/1 (clear/almost clear skin) and PASI 75 at Week 16.

ABOUT THE PHASE 3 VOYAGE STUDIES (EudraCT 2014-00719-15 and EudraCT 2014-000720-18)
VOYAGE 1 and 2 were Phase III randomised, double-blind, placebo- and active comparator-controlled studies designed to evaluate the efficacy and safety of guselkumab compared with placebo and adalimumab in adults with moderate to severe plaque Pso. The co-primary endpoints of the studies were the proportions of patients receiving guselkumab versus patients receiving placebo achieving IGA 0/1 (clear/almost clear skin) and PASI 90 at Week 16.