Video: Every Case Tells a Story| Webinar: ACR/CHEST ILD Guidelines in Practice

An official publication of the ACR and the ARP serving rheumatologists and rheumatology professionals

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

ADVERTISEMENT
SCROLL TO CONTINUE

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.

ADVERTISEMENT
SCROLL TO CONTINUE

References

  1. Tremfya (guselkumab) injection biologics license application approval letter. U.S. Food & Drug administration. 2017 Jul 13.
  2. Highlights of prescribing information: Tremfya (guselkumab) injection. U.S. Food & Drug administration. 2024 Sep 11.
  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.

Related Articles

    FDA Approves Tremfya (Guselkumab) for Adult Patients with Psoriatic Arthritis

    HORSHAM, PA—The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for adult patients with active psoriatic arthritis (PsA), a chronic progressive disease characterized by painful joints and skin inflammation.1,2 Tremfya is the first treatment approved for active PsA that selectively inhibits interleukin (IL)…

    The Heterogeneity of Psoriatic Arthritis

    SAN DIEGO—Differences between psoriatic arthritis and rheumatoid arthritis highlight the need for the development of imaging modalities, laboratory tests and other biomarkers that are explored and validated specifically for PsA to advance the goal of personalized or precision medicine. In this article, expert David S. Pisetsky, MD, PhD, explores the top research in psoriatic arthritis presented at ACR Convergence 2023.

    MicroOne / shutterstock.com

    Rheumatology Drugs at a Glance, Part 2: Psoriasis

    Over the past few years, bio­similars and other new drugs have been introduced to treat rheumatic illnesses. Some of the conditions we treat have numerous drug option; others have few or only off-label options. This series, “Rheumatology Drugs at a Glance,” provides streamlined information on the administration of biologic, biosimilar and other medications used to…