Linda Stein Gold, MD, is a dermatologist at Henry Ford Health. 

Linda Stein Gold, MD

Panelists discuss how including adolescent patients (12 years and older) from the outset of phase 3 studies provides immediate treatment options for younger patients and increases clinician confidence in prescribing to this population.

Adolescent Oral Agent Data Implications

Patients in adolescent age groups benefited from inclusion in pivotal icotrokinra trials from the outset, providing immediate access to safety and efficacy data for individuals 12 years and older. This approach differs from traditional drug development, which typically studies adults first, then conducts separate pediatric trials years later, leaving younger patients without treatment options during critical developmental periods. Early inclusion ensures adolescent patients and their families have comprehensive data supporting treatment decisions without lengthy delays.

Health care providers gain confidence in prescribing oral treatments to younger patients when robust adolescent data exist from initial phase 3 studies rather than extrapolated adult data. Patients 12 years and older demonstrated excellent responses to oral treatment, with safety profiles supporting use in younger individuals who may have decades of psoriasis management ahead of them. The comprehensive study approach provides reassurance for families considering long-term treatment options for adolescent patients.

Adolescent patients typically prefer oral medication options over injectable treatments, making convenient once-daily oral therapy particularly appealing for this age group. Young patients often struggle with injection anxiety or may feel self-conscious about biologic administration, whereas oral medication eliminates these barriers to treatment adherence. The ease of oral administration supports consistent treatment during adolescence, when establishing lifelong health management patterns is crucial for optimal outcomes.

Videos

Panelists discuss how icotrokinra demonstrated significant efficacy in high-impact areas, achieving clear or almost clear scalp in 66% of patients and clear or almost clear genital psoriasis in 77% of patients at week 16.

CONIC-TOTAL Trial Results and Impact on Sensitive Areas in Psoriasis

Patients with scalp psoriasis experienced significant improvement in the ICONIC-TOTAL studies, with approximately two-thirds achieving clear or almost clear scalp at 16 weeks of icotrokinra treatment. Individuals entering the trial with moderate to severe scalp involvement found substantial relief from persistent itching, flaking, and visible scaling that had previously affected their daily interactions and self-confidence. The oral treatment eliminated the need for topical scalp applications that many patients find messy, inconvenient, or ineffective.

Patients with genital psoriasis, representing about one-third of individuals with psoriasis, achieved clear or almost clear genital area involvement in 77% of cases at 16 weeks. This high-impact area significantly affects patients’ intimate relationships and overall quality of life, often causing embarrassment that prevents individuals from discussing the condition with health care providers. The remarkable response rates provide substantial relief for patients dealing with this sensitive area of involvement, which profoundly impacts personal relationships and emotional well-being.

Patients benefit from oral treatment that eliminates the challenges of applying topical medications to sensitive, hard-to-reach, or highly visible areas, such as the scalp and genital region. Many individuals prefer oral therapy to avoid the inconvenience, messiness, or inadequate coverage associated with topical treatments in these areas. The oral approach provides comprehensive treatment without requiring patients to navigate complex topical application routines or worry about product visibility in hair or intimate areas.

ICONIC-TOTAL Trial Results and Impact on Sensitive Areas in Psoriasis

Panelists discuss how the durability data through week 52 show nearly 90% of adult patients and over 90% of adolescent patients maintaining PASI 75 response, addressing patient concerns about long-term treatment effectiveness.

Results of Week 52 ICONIC-LEAD Data From EADV

Patients receiving icotrokinra maintain excellent treatment responses over extended periods, with week 52 data demonstrating sustained efficacy across adult and adolescent populations. Nearly 90% of adult patients maintained PASI 75 responses through 1 full year of treatment; over 90% of adolescent patients sustained similar response levels. This durability addresses patient concerns about treatment effectiveness declining over time, a common worry expressed by individuals considering long-term psoriasis management.

Long-term response maintenance proves critical for patients managing psoriasis as a chronic, lifelong condition that may persist for decades. Many patients express anxiety about treatments losing effectiveness over time, often based on previous experiences with therapies that provided initial improvement followed by diminished results. The sustained efficacy data provide reassurance for patients considering oral treatment, demonstrating that initial improvements can be maintained with continued therapy.

Adolescent patients particularly benefit from oral treatment options that offer sustained efficacy with convenient once-daily administration, comparable to taking daily vitamins. The ease of use for younger patients eliminates injection-related challenges while providing reliable, long-term disease control throughout critical developmental years. Patients in this age group achieve excellent outcomes with simple oral administration, which supports adherence and consistent treatment throughout adolescence, when peer relationships and self-image concerns are particularly important.

Panelists discuss how the ICONIC-LEAD placebo-controlled studies showed icotrokinra achieving clear or almost clear skin in about 75% of patients at week 24, representing unprecedented efficacy for an oral psoriasis therapy.

The ICONIC-LEAD Trial Design of Icotrokinra vs Placebo

Patients with moderate to severe psoriasis achieved unprecedented oral treatment outcomes in the ICONIC-LEAD pivotal studies comparing icotrokinra with placebo. Approximately three-quarters of patients progressed from moderate to severe disease at baseline to clear or almost clear skin at 24 weeks, representing efficacy levels not previously observed with oral psoriasis treatments. The studies included both adults and adolescents 12 years and older, providing comprehensive efficacy data across age groups most affected by psoriasis.

The pivotal trial program demonstrated consistent, reproducible efficacy data across multiple studies, providing patients with confidence in treatment reliability and effectiveness. Patients achieved remarkable response rates with safety profiles similar to placebo, addressing key concerns about oral medication tolerability and long-term use. The inclusion of adolescent patients from initial phase 3 studies represents an advancement for younger individuals seeking effective oral treatment options without waiting years for pediatric-specific trials.

Clinical trial results establish icotrokinra as fulfilling critical unmet needs for patients seeking convenient oral therapy with superior efficacy, excellent safety, and favorable tolerability. Patients now have potential access to oral treatment that delivers a depth of response previously unavailable outside biologic therapy, combined with ease of use that supports long-term adherence. The robust clinical trial program provides patients and health care providers with comprehensive data supporting treatment decisions for moderate to severe psoriasis across diverse patient populations.

Linda Stein Gold, MD

Articles