Civinco, an oral JAK inhibitor, has been covered for adult and adolescent patients with chronic severe atopic dermatitis. The photo is a product image of Cibinco. © Pfizer Korea Pharmaceutical
Pfizer Pharmaceuticals Korea (CEO Dong-wook Oh) announced that its oral JAK inhibitor Cibinco Tab. 200mg, 100mg, 50mg (Abrocitinib) is a treatment for chronic severe atopic dermatitis in adults and adolescents aged 12 years or older from the 1st, and is covered by health insurance benefits. It was announced on the 3rd.
According to this notice, Civinco is a topical treatment (moderate or higher corticosteroid) as the first treatment among adults (18 years of age or older) and adolescents (12 to 17 years of age) patients with chronic severe atopic dermatitis whose symptoms last for more than 3 years. or calcineurin inhibitor) was administered for 4 weeks or more, but the response (EASI (Eczema Area and Severity Index) decreased by 50% or more even though systemic immunosuppressants (cyclosporine or methotrexate) were administered for 3 months or more ), or if it cannot be used due to side effects, etc., and △EASI is 23 or higher before the start of administration, benefits are applied.
Atopic dermatitis is a chronic inflammatory skin disease affecting about 10% of adults. A key factor that makes atopic dermatitis chronic is ‘itching’, which is constantly amplified by the vicious cycle of ‘itching-scratching’. Itching can cause sleep disorders, emotional and physical stress beyond physical symptoms, so it is important to actively treat itching to prevent its chronic course and recurrence.
Civinco has established the basis for this benefit application by confirming the rapid itching and skin symptom improvement effects through numerous clinical studies. Through the JADE MONO-2 study, 200mg monotherapy showed significantly higher itching improvement compared to placebo within 24 hours after the first administration, and in the MONO-1 and 2 studies, significant improvement in skin symptoms compared to placebo at 12 weeks showed
In addition, most of the patients who achieved responses after 12 weeks of administration in JADE MONO-1,2, COMPARE, and REGIMEN and enrolled in EXTEND, a long-term extension study, maintained responses at 48 weeks of cumulative administration. In the JADE TEEN study, significantly higher itching and skin symptom improvement effects were confirmed compared to the placebo group in adolescent patients with moderate to severe atopic dermatitis aged 12-17 years.
In addition, through the JADE COMPARE subgroup analysis, a local treatment combination therapy clinical trial, Civinco demonstrated a rapid and superior anti-itching effect compared to dupilumab, a biologic agent. Specifically, the Civinco 200mg administration group showed a higher PP-NRS4 achievement rate than the dupilumab and placebo groups on the 4th day of treatment, confirming the rapid improvement in itching.
The Civinco 100mg group also showed a significantly higher PP-NRS4 achievement rate compared to the placebo group on the 9th day of treatment, demonstrating a rapid improvement in itching. In addition, in the case of patients who rapidly improved itching within 2 weeks through Civinco administration, it was confirmed that skin symptoms and quality of life were also improved at 12 weeks compared to patients who did not improve. Civinco 200mg has proven superior to dupilumab in terms of skin condition improvement and itching relief in the JADE DARE topical treatment combination clinical study, which directly compared the effect with dupilumab.
Kang Min-hee, executive director of Pfizer Korea’s inflammatory and immune disease division, said, “Civinco is a powerful treatment option with rapid and excellent effects, durability, and convenience in dosing and dose control. It will be able to solve the unmet demand of patients for phosphorus pruritus 3,” he said. “Through this benefit listing, we expect to improve treatment access for more patients with atopic dermatitis, and will continue to improve the quality of life for patients with inflammatory and immune diseases. I will do my best to contribute.”
2023-07-03 11:23:00
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