Post Hoc Analysis Highlights Zasocitinib’s Efficacy Across Patient Groups

Image Credit: © Diego Cervo - stock.adobe.com

Warren Winkelman, MD, PhD, a board-certified dermatologist and global medical unit head for dermatology at Takeda, recently discussed the findings of a post hoc analysis on zasocitinib, an investigational treatment for psoriasis, presented at the American Academy of Dermatology Annual Meeting in Orlando, Florida. The analysis aimed to assess the efficacy of zasocitinib across different patient subgroups based on baseline characteristics such as body mass index (BMI), gender, age, race, ethnicity, disease duration, prior biologic use, and baseline Psoriasis Area and Severity Index (PASI).¹

Key Findings and Efficacy Trends

According to Winkelman, "there were no negative influences of any of these baseline characteristics in the population on the measurement of efficacy," he stated. This suggests that zasocitinib’s performance was consistent across various demographic and clinical subgroups when compared to placebo.

While he said the study did not reveal any significant differences in efficacy based on prior biologic use or systemic therapy exposure, Winkelman emphasized the importance of continued research. "None that we could see," he noted when asked about differences in response among patients with previous biologic treatment.

AI-Driven Drug Development

One aspect of zasocitinib's development that has generated interest is its formulation using artificial intelligence (AI). “What I can say is that the design of the molecule was designed to optimize the potential biochemical characteristics and pharmacologic characteristics in a population, but again, it's based on its artificial intelligence, right? So, it's based on millions of data points.," Winkelman explained. AI-driven drug discovery leverages vast datasets to refine molecular structures, potentially leading to enhanced treatment precision and efficiency.

Promising Results and Future Implications

One of the most compelling findings from the study was zasocitinib’s ability to achieve complete skin clearance (PASI 100) in a notable percentage of patients within 3 months. "At week 12, that's just 3 months, to see 32.7% of patients showing clear skin, 100% clearance versus no patients in the placebo arm. With a pill, that is something that I can see my patients thinking, ‘Oh my gosh, isn't there a pill doctor that can help clear my skin?’ And I would say, ‘No, there isn't.’ But now, who knows, maybe there might be. I might have to backtrack on my statements to my patients in the past, and say, ‘No, there is a pill,’" Winkelman shared. These findings suggest that zasocitinib could provide an effective oral alternative to biologic injections, which patients can find cumbersome.

Expanding Indications and Patient-Centered Approach

Zasocitinib is currently undergoing phase 3 trials for psoriasis and is set to enter phase 3 trials for psoriatic arthritis. Additionally, phase 2 studies are in progress for inflammatory bowel disease, including Crohn’s disease and ulcerative colitis. Winkelman emphasized the significance of offering treatment choices to patients: "I think it's important for us to remember that every patient is different. Patients are individuals, we study them in populations, but patients are first and foremost people, and they have needs and preferences that reflect their life experiences, their family lives, their experiences with the health care system. It isn't fair to sweep all of patients into 1 group and force them to take a particular type of medicine, if that's not what they like. So choices are really important for patients.They don't feel disempowered and unseen. That's sort of how I see it.”

Conclusion

While zasocitinib remains an investigational drug, the preliminary data from post hoc analyses and clinical trials are encouraging. Winkelman reiterated the mission of Takeda, a company with over 240 years of experience in patient-centered medicine: "Yes, it's exciting that we're developing an oral medication, but more importantly, its offering patients choices, and patients deserve to have those choices. They deserve not to be forced into something that they don't want if they prefer something else." With further research, zasocitinib has the potential to transform psoriasis treatment by providing an effective and convenient oral alternative to existing therapies.

References

1. Winkelman et al. Zasocitinib (TAK-279), an oral, allosteric, selective TYK2 inhibitor, in moderate-to-severe plaque psoriasis: efficacy analysis by baseline characteristics from a randomized phase 2b trial. Poster presented at the 2025 American Academy of Dermatology Annual Meeting. March 7-11. Orlando, FL.