Subgroup Analysis Confirms Safety, Efficacy of Icotrokinra for Plaque Psoriasis
The subgroup analysis shows adolescents treated with the drug once daily had higher rates of clear or almost clear skin compared to patients receiving the placebo.
New data show icotrokinra (JNJ-2113) is efficacious and safe as a systemic therapy in both adolescents and adults, according to a phase 3 registrational study for moderate-to-severe plaque psoriasis. The subgroup analysis demonstrated that adolescents treated with the drug once daily had higher rates of clear or almost clear skin compared to patients receiving the placebo at week 16.1
The subgroup analysis demonstrates adolescents treated with the drug once daily had higher rates of clear or almost clear skin compared to patients receiving the placebo. | Image Credit: RFBSIP - stock.adobe.com
“Data from the Phase 3 ICONIC LEAD subgroup analysis demonstrate impressive efficacy rates, showing the promise of this novel therapeutic option in the treatment of adolescents with moderate-to-severe plaque psoriasis who’ve often not yet received an advanced therapy,” Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children‘s Hospital-San Diego, said in a news release.1 “Young patients with plaque psoriasis face unique challenges due to the visible and uncomfortable nature of the disease, making effective treatment options that align with their needs and preferences all the more important.”
Icotrokinra is a first-in-class oral peptide that blocks the IL-23 receptor and is being studied for adults and adolescents 12 years and older.1
Investigators reported that 84.1% of adolescent patients treated with the study drug once daily achieved 0 or 1 (clear or almost clear skin) on the investigator’s global assessment (IGA) compared with 27.3% on the placebo, and 70.5% achieved a psoriasis area and severity index 90 (PASI) response compared with 13.6% on the placebo at week 16. In the first analysis of the ICONIC-LEAD (NCT06095115) study, 64.7% of patients achieved an IGA score of 0 or 1 at 16 weeks, and 49.6% achieved PASI 90 compared with 8.3% and 4.4% on the placebo, respectively.1,2
Investigators found that the response rates were continued at week 24, with 74.1% of patients achieving an IGA score of 0 or 1 and 64.9% achieving PASI 90. In the new analysis, investigators found that 86.4% of adolescents achieved IGA 0 or 1 and 88.6% achieved PASI 90 at week 24. Furthermore, 75% of adolescents achieved IGA 0, and 63.6% achieved PASI 100.1,2
Furthermore, icotrokinra also had a favorable safety profile, with approximately 50% of adolescents treated with icotrokinra experiencing 1 or more adverse events compared with 73% in the placebo group at 16 weeks, according to the data.1
“Adolescents living with moderate to severe plaque psoriasis shouldn’t have to wait for effective treatment options that have the potential to deliver completely clear skin, which is the driving force for studying this younger population as part of the pivotal ICONIC program,” Liza O’Dowd, vice president of immunodermatology disease area lead at Johnson & Johnson Innovative Medicine, said in the news release.1 “These data underscore the promise of next-generation therapies and the potential for icotrokinra to offer adolescents with moderate-to-severe plaque psoriasis the unique combination of a favorable safety profile and complete skin clearance in a once-daily pill.”
The subgroup analysis was presented at the 2025 World Congress of Pediatric Dermatology Annual Meeting.1
READ MORE: Dermatology Resource Center
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