In an interview with Pharmacy Times, Linda Stein Gold, MD, director of dermatology clinical research at Henry Ford Health, discusses the FDA approval of icotrokinra (Icotyde; Johnson & Johnson) and its significance as a novel oral therapeutic option for patients with moderate to severe plaque psoriasis.
"We haven't always been able to have an oral option that combined efficacy, safety, and tolerability. So now when we're having that conversation—and we know that psoriasis is a systemic disease—we can now give them more choices and give them the possibility of using an oral agent that has the efficacy that's similar to a biologic drug." — Linda Stein Gold, MD, director of dermatology clinical research, Henry Ford Health
Stein Gold explains that icotrokinra is a peptide with a unique circular molecular structure that enables superior gastrointestinal absorption. Mechanistically, the agent functions by blocking a subunit of the IL-23 receptor, thereby interrupting a key proinflammatory signaling pathway central to the pathogenesis of psoriasis—an approach that mirrors the efficacy profile of biologic therapies while remaining orally administered.
Key Takeaways
- Icotrokinra is a first-in-class oral IL-23 receptor blocker that delivers biologic-level efficacy, safety, and tolerability in a single agent, which is a combination previously unavailable in oral psoriasis therapy.
- In head-to-head phase 3 trials against deucravacitinib, icotrokinra produced faster, deeper skin clearance in twice as many patients, with a safety profile comparable to placebo and fewer infections than the active comparator.
- Icotrokinra is FDA approved for patients as young as 12, with adolescents demonstrating even stronger efficacy than adults, making it a meaningful new counseling option for pharmacists treating younger psoriasis patients.
A significant challenge Stein Gold highlights is treatment inertia in dermatology, wherein clinicians often delay escalating patients from topical to systemic therapies. Icotrokinra addresses this gap by uniquely combining robust efficacy, a favorable safety profile, and strong tolerability in a single oral agent—3 characteristics that, until now, were not simultaneously available in the oral therapeutic class.
Data from the phase 3 clinical trials are particularly compelling for pharmacists to understand. Icotrokinra was evaluated head-to-head not only against placebo but also against deucravacitinib (Sotyktu; Bristol Myers Squibb), previously the leading oral agent for this indication. Icotrokinra demonstrated more rapid and complete responses, with statistically significant separation from both the placebo and active comparator as early as week 4. Notably, twice as many patients achieved complete skin clearance with icotrokinra compared with deucravacitinib. The safety profile was comparable to placebo, with a lower rate of infections relative to the active comparator.
Of particular relevance to pharmacists, icotrokinra is approved by the FDA for patients as young as 12 years of age. Adolescent patients demonstrated even stronger efficacy outcomes than adults, with a similarly reassuring safety profile. As psoriasis is increasingly recognized as a systemic disease, icotrokinra expands the treatment conversation pharmacists can have with patients, offering a biologic-level oral option for those who prefer or require noninjectable therapy.
