FDA Approval Sought for 2 Pediatric Indications for Guselkumab

These two trials were used for the FDA approval of guselkumab for the treatment of PsA in adult patients. The pharmacokinetic data from these trials were extrapolated for the biologics license applications submission for juvenile PsA. More treatments are needed for younger patients and time will tell whether this agent garners approval for these patients.

Plaque Psoriasis

The phase 3 PROTOSTAR study evaluated the efficacy, safety and pharmacokinetics of subcutaneous guselkumab for the treatment of chronic plaque psoriasis in pediatric patients 6 years and older. The study’s primary end points were an Investigator Global Assessment score of 0/1 and Psoriasis Area and Severity Index 75 response at week 16. This study has been completed, but results have not yet been reported.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

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3. Johnson & Johnson seeks U.S. FDA approval for first pediatric indications for Tremfya (guselkumab) [news release]. Johnson & Johnson. 2024 Dec 2.
4. Brunello F, Tirelli F, Pegoraro L, et al. New insights on juvenile psoriatic arthritis. Front Pediatr. 2022 May 26:10:884727.
5. A study evaluating the efficacy and safety of guselkumab administered subcutaneously in participants with active psoriatic arthritis including those previously treated with biologic anti-tumor necrosis factor (TNF) alpha agent(s) (DISCOVER-1) [NCT03162796]. ClinicalTrials.gov. 2021 Feb 3.
6. A study evaluating the efficacy and safety of guselkumab administered subcutaneously in participants with active psoriatic arthritis [NCT03158285]. ClinicalTrials.gov. 2022 Dec 22.
7. A study to evaluate the efficacy, safety, and pharmacokinetics of subcutaneously administered guselkumab for the treatment of chronic plaque psoriasis in pediatric participants (PROTOSTAR) [NCT03451851]. ClinicalTrials.gov. 2025 Jan 13.