Pfizer Korea Pharmaceutical has announced the approval of Cibinco, an oral JAK inhibitor, for the treatment of chronic severe atopic dermatitis in adults and adolescents aged 12 years and older. The medication has been added to health insurance benefits, allowing for greater accessibility for patients. Atopic dermatitis is a chronic inflammatory skin disease that affects approximately 10% of adults. A key characteristic of this condition is the constant itchiness that patients experience, leading to sleep disorders and increased emotional and physical stress. Treating the itchiness is essential in preventing the chronic progression and recurrence of the disease.
Cibinco has been proven effective in improving skin symptoms and providing rapid relief from itching through various clinical studies. In the JADE MONO-2 study, patients treated with 200mg of Cibinco showed significant improvement in itching within 24 hours of the first administration. Furthermore, the MONO-1 and 2 studies demonstrated significant improvement in skin symptoms after 12 weeks compared to a placebo.
Long-term studies, such as JADE TEEN and EXTEND, have shown that patients who responded well to Cibinco after 12 weeks of administration maintained their positive response even after 48 weeks. Additional analysis of the JADE COMPARE study revealed that Cibinco, when used in combination with local treatments, had a superior and rapid anti-itching effect compared to dupilumab, a biological agent.
Notably, Cibinco 200mg showed a higher achievement rate in improving itching compared to both dupilumab and the placebo groups within just four days of treatment. The 100mg group also demonstrated significant improvement in itching after nine days of treatment. Patients who experienced rapid relief from itching within two weeks of Cibinco administration also reported improved skin symptoms and quality of life after 12 weeks.
Kang Min-hee, executive director of Pfizer Korea’s inflammatory and immune disease division, emphasized that Cibinco offers powerful and rapid effects with durability and convenient dosing options. This medication aims to address the unmet needs of patients suffering from this condition. The approval of Cibinco will increase access to effective treatment for more patients, ultimately improving the quality of life for individuals with inflammatory and immune diseases.
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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