Icotrokinra for Moderate-to-Severe Plaque Psoriasis: A Dermatologist's Guide for Primary Care

The FDA has approved icotrokinra (Icotyde; Johnson & Johnson), marking a significant shift in how moderate-to-severe plaque psoriasis can be managed. Icotrokinra is the first and only targeted oral peptide that precisely blocks the IL-23 receptor. It is approved for adults and pediatric patients 12 years of age and older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy.¹

For primary care physicians, the approval matters because treatment inertia remains a persistent challenge. According to dermatologist Linda Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health and an investigator on the ICONIC clinical program, patients on topical therapies who aren't achieving meaningful improvement are often not progressed to systemic treatment as quickly as they should be. New guidance from the International Psoriasis Council recommends transitioning to systemic therapy if 2 cycles of topical medications applied for 4 weeks fail to bring meaningful improvement.^1,2

Icotrokinra offers a practical option for patients who may have previously declined injectable biologics. Taken once daily on an empty stomach upon waking, the therapy demonstrated rapid onset of efficacy, with improvements appearing within the first several weeks of treatment. In head-to-head superiority studies, approximately 70% of patients achieved clear or almost clear skin at Week 16, and 55% achieved a PASI 90 response — outcomes that were superior to both placebo and deucravacitinib, the previous highest-efficacy oral agent.

Safety data from over 2500 patients across 4 phase 3 studies showed that rates of adverse reactions for icotrokinra-treated patients were within 1.1% of placebo through Week 16, with no new safety signals identified through Week 52. The most common side effects include headache, nausea, cough, fungal infection, and fatigue.

Stein Gold emphasized that psoriasis is a systemic disease, and patients with moderate-to-severe disease deserve systemic treatment. With icotrokinra now available, primary care providers have a concrete reason to reopen the conversation with patients who have stalled on topicals, particularly those who have been reluctant to consider injections.

References:

1. Johnson and Johnson. FDA approves ICOTYDE (icotrokinra), the first and only targeted oral peptide IL-23 receptor antagonist, for the treatment of moderate-to-severe plaque psoriasis. Press release. Published March 18, 2026. Accessed March 19, 2026. https://www.jnj.com/media-center/press-releases/fda-approval-of-icotyde-icotrokinra-ushers-in-new-era-for-first-line-systemic-treatment-of-plaque-psoriasis-with-a-targeted-oral-peptide
2. Strober BE et al. Establishing consensus on defining failure of topical therapy in psoriasis: Recommendations from the International Psoriasis Council. Journal of the American Academy of Dermatology, Volume 94, Issue 1, 372 – 375.