New Oral Therapy Approved for Moderate to Severe Plaque Psoriasis
A new treatment option is now available for adults and adolescents (12 years and older, weighing at least 40 kg) with moderate to severe plaque psoriasis. The U.S. Food and Drug Administration (FDA) has approved icotrokinra, an oral medication that offers an alternative to injectable therapies commonly used to manage this chronic skin condition .
Understanding Plaque Psoriasis
Plaque psoriasis is the most prevalent form of psoriasis, affecting approximately 80–90% of individuals with the disease. It’s a chronic inflammatory autoimmune condition characterized by an accelerated skin cell turnover rate. Normally, skin cells regenerate over 28-30 days, but in psoriasis, this process occurs in just 3-4 days . This rapid turnover leads to the formation of thickened, raised, pink patches of skin covered with silvery-white scales, often accompanied by itching, stinging, and discomfort.
The disease affects both men and women equally, typically appearing between the ages of 15 and 30, although it can develop at any age . Although the exact cause of psoriasis remains unknown, it’s understood to be linked to the immune system and a genetic predisposition. Stress can too exacerbate symptoms.
Psoriasis Prevalence and Related Conditions
Romania has a high prevalence of psoriasis in Europe, with approximately 400,000 people affected. Importantly, 20-30% of these patients also develop psoriatic arthritis, a condition that can lead to severe and debilitating joint damage over time .
How Icotrokinra Works
Icotrokinra is an oral targeted peptide that functions by blocking the interleukin-23 (IL-23) receptor. IL-23 is a key pathway involved in the inflammatory processes associated with psoriasis . By targeting this receptor, icotrokinra helps to reduce inflammation and alleviate psoriasis symptoms.
This approval marks the first oral treatment in a new class of therapeutics specifically targeting the IL-23 receptor, expanding the systemic treatment options available for moderate to severe plaque psoriasis . The treatment is developed by Johnson & Johnson.
Clinical Trial Results
The FDA’s approval is based on data from the ICONIC Phase 3 clinical program, which involved multiple studies of adults and adolescents (12 years and older) with moderate to severe plaque psoriasis. These studies demonstrated that icotrokinra met its primary efficacy endpoints and exhibited a safety profile comparable to placebo . Clinical data showed significant improvements in skin lesions, including in challenging areas like the scalp and genital region.
Administration and Availability
Icotrokinra is administered once daily in tablet form, providing a convenient alternative to injectable biologic therapies .