J&J's Icotrokinra Outperforms BMS's Sotyktu in Plaque Psoriasis Treatment, Setting New Industry Standard

Johnson & Johnson (J&J) has unveiled promising late-stage data for its investigational IL-23 receptor blocker, icotrokinra, positioning the oral therapy as a potential game-changer in the treatment of plaque psoriasis. The results not only demonstrate superiority over placebo but also outperform Bristol Myers Squibb's (BMS) Sotyktu, a recently approved oral TYK2 inhibitor.
Phase III Trial Results Showcase Icotrokinra's Efficacy
In the Phase III ICONIC-ADVANCE 1 & 2 trials, icotrokinra demonstrated superior outcomes compared to both placebo and BMS's Sotyktu in achieving skin clearance and improving symptom severity for patients with plaque psoriasis. These findings were further bolstered by data from the ICONIC-LEAD study, presented at the 2025 American Academy of Dermatology annual meeting.
The ICONIC-LEAD study revealed that 65% of patients with moderate-to-severe plaque psoriasis treated with icotrokinra achieved clear or almost-clear skin at 16 weeks, compared to only 8% in the placebo group. Additionally, 50% of icotrokinra-treated patients experienced a 90% improvement in symptom severity, versus 4% in the placebo arm.
Importantly, the skin clearance effects in the icotrokinra group not only persisted but showed continued improvement through 24 weeks of follow-up. The safety profile of icotrokinra was comparable to placebo, with adverse events occurring in 49% of participants in both groups.
Strategic Positioning and Market Potential
J&J's decision to test icotrokinra against established drugs in the psoriasis market demonstrates the company's confidence in the therapy's potential. Analysts at Guggenheim Partners expressed being "impressed" with icotrokinra's efficacy, noting that its safety profile "appears very reasonable."
The pharmaceutical giant has previously estimated annual peak sales of $5 billion or more for icotrokinra, a projection that seems increasingly plausible given the emerging clinical profile. To further solidify its position in the market, J&J plans to launch the Phase III ICONIC-ASCEND trial, which will directly compare icotrokinra to its own blockbuster antibody, Stelara.
Icotrokinra's oral administration and selective inhibition of the IL-23 receptor make it a promising candidate not only for plaque psoriasis but potentially for other inflammatory conditions such as ulcerative colitis, for which J&J is currently conducting a Phase IIb study (ANTHEM-UC).
As the pharmaceutical landscape continues to evolve, icotrokinra's performance against BMS's Sotyktu is particularly noteworthy. Sotyktu, approved by the FDA in September 2022, has been distinguished by its clean safety profile, with recently released long-term data showing consistent safety through five years and over 5,000 patient-years of follow-up. The emergence of icotrokinra as a potentially superior alternative signals a new chapter in the treatment of plaque psoriasis and related inflammatory conditions.
References
- J&J’s Oral IL-23R Blocker Sets New Standard in Plaque Psoriasis, Beating BMS’ Sotyktu
Late-stage data also showed that Johnson & Johnson’s icotrokinra was superior to Bristol Myers Squibb’ Sotyktu at clearing skin and easing symptom severity in patients with plaque psoriasis.
Explore Further
What are the key differences in the mechanism of action between icotrokinra and Sotyktu?
How does the safety profile of icotrokinra compare with Sotyktu's long-term safety data?
What implications could the success of icotrokinra have for the treatment of other inflammatory conditions?
What are the expected timelines for the completion and results of the ICONIC-ASCEND trial?
What impact could the projected $5 billion annual peak sales of icotrokinra have on J&J's overall market strategy?