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Cibinco: A New Oral JAK Inhibitor Approved for Chronic Severe Atopic Dermatitis

Pfizer Korea Pharmaceutical has recently received approval for its oral JAK inhibitor, Cibinco, as a treatment for adults and adolescents with chronic severe atopic dermatitis. This innovative product is now covered by health insurance benefits, providing hope for patients suffering from this debilitating condition.

Chronic severe atopic dermatitis is a condition that affects approximately 10% of adults and is characterized by persistent itching and inflammation of the skin. The constant cycle of itching and scratching can lead to sleep disorders, emotional distress, and physical discomfort. Therefore, finding an effective treatment that addresses these symptoms is crucial in preventing the chronic progression of the disease.

Civinco has demonstrated its efficacy in improving skin symptoms and relieving itching through extensive clinical studies. In various trials, patients who received the 200mg dosage of Civinco showed significant improvements in itching within 24 hours of the first administration. Moreover, over a 12-week period, this medication showcased a remarkable enhancement in skin symptoms compared to placebo.

Furthermore, long-term extension studies have indicated that patients who initially responded positively to Civinco maintained their responses even after 48 weeks of continuous treatment. This suggests that Civinco can provide sustainable relief for those suffering from chronic severe atopic dermatitis.

Notably, when compared to other treatments, Civinco exhibited a faster and more effective anti-itching effect. In a clinical trial that directly compared Civinco to the biological agent dupilumab, Civinco demonstrated superior results in terms of relieving itching and improving skin condition.

The availability of Civinco on the market addresses the unmet needs of patients experiencing chronic severe atopic dermatitis and provides them with a powerful treatment option. With its rapid onset of action, durability, convenient dosing, and dose management, Civinco aims to improve the quality of life for patients suffering from inflammatory and immune diseases.

Kang Min-hee, the executive director of Pfizer Korea’s inflammatory and immune disease division, expressed optimism about the impact of Civinco on patients. By expanding access to this innovative treatment, Pfizer Korea aims to make a significant contribution to the lives of individuals coping with atopic dermatitis and other inflammatory conditions.

In conclusion, the approval and availability of the oral JAK inhibitor, Civinco, underscore Pfizer Korea Pharmaceutical’s commitment to addressing the needs of patients with chronic severe atopic dermatitis. Through its proven efficacy in alleviating itching, improving skin symptoms, and enhancing quality of life, Civinco offers a ray of hope to those struggling with this debilitating condition.

Cibinco, an oral JAK inhibitor, is approved for adult and adolescent patients with chronic severe atopic dermatitis. The photo is an image of a Cibinco product. © 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, published on the 3rd.

According to this notice, Civinco is a topical treatment (moderate or higher corticosteroid) as the first treatment in adult (18 years or older) and adolescent (12 to 17 years) patients with chronic severe atopic dermatitis whose symptoms last for more than 3 years or a calcineurin inhibitor) for 4 weeks or more, but there has been a 50% or more reduction in response (EASI (Eczema Area and Severity Index)) despite systemic immunosuppressants (cyclosporine or methotrexate) given for 3 months or more. more ) or cannot be used due to side effects, etc., and △EASI 23 or higher before starting administration, benefits are applied.

Atopic dermatitis is a chronic inflammatory skin disease that affects around 10% of adults. A key factor that makes atopic dermatitis chronic is ‘itching’, which is constantly exacerbated by the vicious cycle of ‘itch-scratch’. Itching can cause sleep disorders, emotional and physical stress beyond physical symptoms, so it is important to actively treat itchiness to prevent its chronic course and recurrence.

Civinco has established the basis for this claim of benefits by confirming the effects of improving skin symptoms and rapid itching through several clinical studies. In the JADE MONO-2 study, 200mg monotherapy showed a significantly greater improvement in itching than placebo within 24 hours after the first administration, and in the MONO-1 and 2 studies, a significant improvement of skin symptoms was shown at 12 weeks compared to placebo.

In addition, most patients who had 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 compared to the placebo group were confirmed in adolescent patients with moderate to severe atopic dermatitis aged 12 to 17 years.

In addition, through the subgroup analysis of JADE COMPARE, a local treatment combination therapy clinical trial, Civinco showed a rapid and superior anti-itching effect compared to dupilumab, a biological agent. In particular, 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, indicating a rapid improvement in itching. In addition, in the case of patients who rapidly improved itching within two weeks by administering Civinco, it was confirmed that skin symptoms and quality of life also improved after 12 weeks compared to patients who did not improve. Civinco 200mg has been superior to dupilumab in terms of improvement of skin condition and relief of itching 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 management. It will be able to solve the unmet demand of patients for phosphorus pruritus 3,” he said. “Through this list of benefits, we expect to improve access to treatment for more patients with atopic dermatitis, and we will continue to improve the quality of life for patients with inflammatory and immune diseases. my best to contribute.”

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