A new drug for epidermatitis! Pfizer's next-generation oral JAK1 inhibitor abrocitinib 4 Phase III clinical studies have been successful!
Last Update: 2020-06-16
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June 11, 2020 /PRNewswire/ -- Pfizer has announced that the evaluation of an oral JAK1 inhibitor abrocitinib (PF-04965842) for treatment at an age of 12-18 years and also receiving background external therapy for moderate to severe epilytederitis (AD) adolescent patients has achieved positive results in STAGE III JADE (NCT3796666666) positive resultsThe data showed that both doses of abrocitinib reached the common primary endpoint, showing improvement in skin loss removal, disease degree and severity, itching, and overall toleranceabrocitinib is an oral small molecule that selectively inhibits Janus kinase 1 (JAK1)Inhibition of JAK1 is considered to be a variety of cytokines in the pathophysiological process of adjustable adhesionderitis (AD), including leukocyte interleukin (IL)-4, IL-13, IL-31, and interferonIn the United States, the FDA granted abrocitinib a breakthrough drug (BTD) for the treatment of moderate-to-severe AD in February 2018It is worth mentioning that the JADE TEEN study is the fourth successful study in the global development project JADE for the evaluation of abrocitinib treatment for moderate and severe aditonal dermatitis (AD)Three previousphase III studies (JADE MONO-1, JADE MONO-2, JADE COMPARE) previously completed in the project were also successful, showing that common primary and critical secondary endpoints associated with skin loss removal and itching relief were achievedJust recently, Pfizer released the full results of the second Phase III study OF JADE MONO-2The company will release detailed data on other studies of the JADE project later this yearData from the JADE COMPARE study, combined with the results of the JADE MONO-1 and JADE MONO-2 studies, will support the submission of listing applications to regulatorsPfizer plans to launch a new drug application (NDA) for abrocitinib for the treatment of moderate-to-severe aderypitis (AD) to the U.SFood and Drug Administration (FDA) later this yearDr Michael Corbo, Chief Development Officer for Inflammation and Immunology at Pfizer Global Product Development, said: "Up to 20% of children are affected by adhesion dermatitis (AD) and the need for new treatmentoptions that may improve care remains unmetFor children and adolescents, these findings from the JADE TEEN study build on the positive results of our previously published Phase III single drug therapy study, which included patients 12 years of age and older"Abrocitinib Molecular Structure (Photo: medchemexpress.cn) JADE TEEN is a randomized, double-blind, placebo-controlled, parallel group study of 285 patients aged 12 and above with moderate to severe AD in adolescents aged 12 and overIn the study, the patient was randomly assigned to receive one daily abrocitinib 200, abrocitinib 100 mg, placebo, treatment for 12 weeks, and also received background therapyEligible patients who complete 12 weeks of treatment may choose to enter a Long-Term Extension (LTE) study B7451015 Patients who have been suspended early or who do not qualify for LTE research will enter the follow-up period for 4 weeks The common primary endpoint of the study was the proportion of patients who achieved the total removal (0) of the skin loss (0) and the almost complete removal of the skin loss (1) and the reduction of the baseline level by 2 points compared to the baseline level, and the proportion of patients whose eczema area and severity index (EASI) score for the 12th week of treatment improved by at least 75% compared to the baseline Key secondary endpoints include the proportion of patients whose itching severity was reduced by 4 points compared to the baseline as measured by the Pp-NRS at the 2nd, 4th and 12th weeks of treatment, and the decrease in the rate of the special dermatitis itching and symptom assessment scale (PSAAD) score in the 12th week of treatment PSAAD is a patient report measurement scale developed by Pfizer The results showed that the study reached a common primary endpoint at week 12: the proportion of patients in the two doses abrocitinib treatment group was significantly higher than in each major therapeutic endpoint At the critical secondary endpoint, the proportion of patients with a clinically significantly reduced itching level at 200 mg abrocitinib at each point in each week of the treatment and 100 mg dose of abrocitinib was statistically significantly higher than in the placebo group at the time of the second week of treatment Although the 100 mg dose abrocitinib group reached a significant difference in week 2, no further testing of the critical secondary endpoint of the study was carried out due to the fact that there was no significant difference in week 4 Therefore, the improvement of the other key secondary endpoints, PSAAD, cannot be inferred In the study, the safety of abrocitinib was consistent with previous studies Safety results showed that patients treated with 100 mg or 200 mg abrocitinib had a higher proportion of adverse events than the placebo group (56.8%, 62.8%, 52.1%, respectively) In each group, the proportion of patients who had severe adverse events or those that led to the discontinuation of the study was similar, in the placebo group (2.1 per cent each), in the 100 mg dose abrocitinib group (0 per cent and 1.1 per cent, respectively), and in the 200 mg dose abrocitinib group (1.1 per cent and 2.1 per cent, respectively) The full results of the study will be presented at a future medical conference (BioValleyBioon.com) Original source: Pfizer Announces Positive Top-Line Results from JADE TEEN Trial of Abrocitinib in The San Ethan with Moderate-to-Severe Atopic Dermatitis
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