Icotrokinra Outperforms Deucravacitinib in Head-to-Head Psoriasis Study

Data from the phase 3 ICONIC-ADVANCE 1 (NCT06143878) and 2 (NCT06220604) clinical trials show that icotrokinra demonstrated superiority to deucravacitinib (Sotyktu; Bristol Myers Squibb) at multiple timepoints in adults with moderate-to-severe plaque psoriasis (PsO), with superior skin clearance at weeks 16 and 24 and numerically lower rates of adverse events (AEs) versus deucravacitinib, according to a news release from Johnson & Johnson.^1-3

Long-term data from the 52-week phase 3 ICONIC-LEAD (NCT06095115) study also indicated sustained skin clearance and favorable safety, key indicators of maintained efficacy and improved quality of life. The data were presented at the 2025 European Academy of Dermatology and Venereology (EADV).^1,4

What is Icotrokinra?

Icotrokinra, a first-in-class, investigational targeted oral peptide, has demonstrated significant efficacy and safety in individuals with PsO. Prior studies and analysis have affirmed such efficacy, with past data from ICONIC-LEAD indicating significant skin clearance in adults and adolescents aged 12 and older with moderate-to-severe PsO through 24 weeks. In ICONIC-TOTAL, individuals with difficult-to-treat scalp and genital psoriasis achieved improvements in skin clearance using icotrokinra.^5,6

Other standard-of-care options remain available, including deucravacitinib, a once-daily oral tyrosine kinase 2 inhibitor that has shown superior efficacy and safety to other agents. To fully elucidate the comparative effects between icotrokinra and deucravacitinib, ICONIC investigators initiated ICONIC-ADVANCE, comparing icotrokinra against both placebo and deucravacitinib.¹

What Did Researchers Find in the ICONIC-ADVANCE Study?

In ICONIC-ADVANCE 1 and 2, icotrokinra demonstrated superior skin clearance versus placebo at week 16 and deucravacitinib at weeks 16 and 24. Furthermore, icotrokinra demonstrated similar rates of adverse events (AEs) to placebo with no novel safety signals, while eliciting numerically lower rates of AEs compared with deucravacitinib through week 24. The data indicate the immense promise of icotrokinra to more meaningfully clear skin in patients with PsO compared with standard care, providing an effective new option for patients struggling with itch and quality of life burdens.¹

“These head-to-head data clearly demonstrate superior complete skin clearance rates for icotrokinra compared to deucravacitinib,” Linda Stein Gold, MD, ICONIC-ADVANCE study investigator, said in the news release. “With significantly higher response rates seen as early as week 16 and increasing at week 24, this novel targeted oral peptide treatment has the potential to be an appealing new option for patients with moderate-to-severe plaque psoriasis.”¹

What Did Researchers Find in the ICONIC-LEAD Study?

Novel, long-term data from ICONIC-LEAD was also presented at EADV. Through week 52, icotrokinra demonstrated sustained, meaningful skin clearance and a safety profile that was favorable and consistent with prior research, with no new safety signals identified. At week 52, adult responders to icotrokinra—according to the Psoriasis Area and Severity Index (PASI) 90 score—who were re-randomized to icotrokinra at week 24 had superior maintenance of PASI 90 response versus those re-randomized to placebo (84% versus 21%; P < .001).¹

Additionally, at week 52, 86% of adolescents who were administered icotrokinra for the full 52 weeks—and 77% of those who switched from placebo to icotrokinra at week 16—achieved quality PASI 90 responses. This demonstrates the feasibility of switching from another treatment to icotrokinra while not inducing any reductions in therapeutic effects. The data also indicates the long-term and sustained responses to icotrokinra as far as a year after treatment initiation, allowing patients to maintain their skin clearance and improve their quality of life without having setbacks.¹

“With a substantial proportion of adults and adolescents achieving clear or almost clear skin while maintaining a favorable safety profile through 52 weeks, icotrokinra could be a compelling new therapeutic option that aligns with both patient and provider goals for an oral treatment once approved,” Jennifer Soung, MD, ICONIC-LEAD study investigator, said in the news release.¹

What Should Pharmacists Know?

As icotrokinra continues through the ICONIC clinical development program, pharmacists should be sure to keep an eye on its regulatory status. The drug remains not yet approved, although Johnson & Johnson has submitted a new drug application to the FDA for icotrokinra’s consideration. They should familiarize themselves with facets of icotrokinra’s administration, including recommended dosage (as outlined in clinical trials), once-daily adherence, efficacy onset, and the duration of the therapy.

Pharmacists should be sure that patients undergo a baseline screening before using icotrokinra if the medication is approved to ensure a patient’s medical history—including past infections—is well known. Pharmacists also stand to play a critical role in monitoring for adverse events, while counseling patients on expected outcomes and a timeline for skin clearance.

REFERENCES

1. Icotrokinra shows superiority to deucravacitinib in first reported head-to-head trials reinforcing promise of novel targeted oral peptide for treatment of plaque psoriasis. Johnson & Johnson. News Release. Released September 17, 2025. Accessed October 6, 2025. https://www.jnj.com/media-center/press-releases/icotrokinra-shows-superiority-to-deucravacitinib-in-first-reported-head-to-head-trials-reinforcing-promise-of-novel-targeted-oral-peptide-for-treatment-of-plaque-psoriasis

2. A study of JNJ-77242113 for the treatment of participants with moderate to severe plaque psoriasis. ClinicalTrials.gov Identifier: NCT06143878. Last Updated September 18, 2025. Accessed October 6, 2025. https://clinicaltrials.gov/study/NCT06143878?term=jnj-77242113&rank=10

3. A study of JNJ-77242113 for the treatment of participants with moderate to severe plaque psoriasis (ICONIC-ADVANCE 2). ClinicalTrials.gov Identifier: NCT06220604. Last Updated September 12, 2025. Accessed October 6, 2025. https://clinicaltrials.gov/study/NCT06220604

4. A study of JNJ-7724113 in adolescent and adult participants with moderate to severe plaque psoriasis (ICONIC-LEAD). ClinicalTrials.gov Identifier: NCT06095115. Last Updated September 15, 2025. Accessed October 6, 2025. https://clinicaltrials.gov/study/NCT06095115

5. Halpern L. Icotrokinra demonstrates meaningful skin clearance in moderate-to-severe plaque psoriasis. Pharmacy Times. Published March 10, 2025. Accessed October 6, 2025. https://www.pharmacytimes.com/view/icotrokinra-demonstrates-meaningful-skin-clearance-in-moderate-to-severe-plaque-psoriasis

6. Halpern L. Icotrokinra demonstrates significant skin clearance in difficult-to-treat scalp, genital psoriasis. Pharmacy Times. Published May 14, 2025. Accessed October 6, 2025. https://www.pharmacytimes.com/view/icotrokinra-demonstrates-significant-skin-clearance-in-difficult-to-treat-scalp-genital-psoriasis