Johnson & Johnson’s Tremfya seeks to expand FDA approval for pediatric indications to treat juvenile psoriatic arthritis

1. Adult clinical trials found that Tremfya could treat plaque psoriasis by 16 weeks.
2. Follow-up analysis found that roughly 23% of patients remained plaque free for more than 156 weeks.

The Latest

Tremfya is a first-in-class, fully human monoclonal antibody targeting the interleukin-23 (IL-23) cytokine to treat moderate-to-severe plaque psoriasis. Johnson & Johnson’s application to the FDA seeks to broaden the drug’s indications following the success of the phase 3 PROTOSTAR clinical trial involving pediatric patients 6 years and older. Prior phase 3 studies showed positive results against placebo achieving clear or almost clear skin by week 16 in adults. The PROTOSTAR trial aimed to evaluate significant improvements in skin clearance for children, as measured by PASI (Psoriasis Area and Severity Index) 75 scores at week 16, and a safety profile consistent with previous studies in adult populations based on pharmacokinetic data. The new submission for supplemental biologics license applications suggests positive outcomes were achieved in the PROTOSTAR trial such as skin clearance and absence of significant adverse side effects.

Physician’s Perspective

Plaque psoriasis is an immune-mediated condition resulting in the overproduction of skin cells. It is characterized by raised, red, scaly patches on the skin, which can significantly impact a patient’s quality of life. While the condition is prevalent among adults, pediatric cases, though less common, often lead to psychological distress, social stigmatization, and functional impairment in affected children. Almost one-third of pediatric psoriasis cases begin in childhood with roughly 20,000 children under 10 diagnosed with psoriasis each year. Current therapeutic options for pediatric plaque psoriasis are limited, making the expansion of Tremfya’s indication a potential game-changer. Based on clinical trial data in adults, Tremfya administered 100mg subcutaneously every 4 weeks for 16 weeks was able to produce a noticeable result. Tremfya may increase the risk of infection and should not be initiated in patients with an active infection.

Molecular Target of Therapy

In patients with plaque psoriasis, a cytokine known as Interleukin-23 (IL-23) is involved in the inflammatory pathways that create the symptoms of psoriasis. Tremfya’s mechanism of action involves selectively inhibiting IL-23 to stop the inflammation pathways that create the chronic inflammation and excessive keratinocyte proliferation. Additionally, Tremfya also inhibits a protein known as CD64. CD64 is inhibited to prevent further production of IL-23. By stopping the downstream inflammatory pathways as well as the production inflammatory chemical messengers, it is hoped that this will stop and eventually clear the plaques on the skin.

Company History

Johnson & Johnson is an American pharmaceutical company and global leader in healthcare innovation. With large Oncology and Immunology portfolios, Johnson & Johnson has multiple phase 3 trials underway including trials for Tecvayli and Talvey which are currently being evaluated to treat patients with relapsed or refractory multiple myeloma. New frontline data for Tacvayli show promising efficacy and a tolerable safety profile.

Additional Reading: https://pmc.ncbi.nlm.nih.gov/articles/PMC10866772/