Pfizer abrocitinib achieves positive results in phase III clinical treatment of atopic dermatitis in adolescents
Last Update: 2020-06-16
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JADE TEEN was a randomized, double-blind, placebo-controlled, parallel group study in which 285 patients aged 12 to 18 were randomly assigned to receive 200 mg of rocaabitinib, 100 mg of gamitinib, or placebo, as well as external topical therapyEligible subjects who completed the 12-week treatment period may choose to enter the Long Extended (LTE) study B7451015, while subjects who terminate early from treatment or other subjects who do not qualify for LTE studies will be enrolled in a four-week follow-up studyThe common primary endpoint of the study was the proportion of patients with an overall assessment (IGA) rash disappearing (0) or almost disappearing (1) at the 12th week and having a reduction of two or more points compared to the baseline, and at the 12th week, the proportion of patients with an eczema area and severity index (EASI) score of at least 75% or higher than the baselineThe main secondary endpoints were patients with a reduction in the severity of itching by four or more points compared to the baseline using the Itching Numerical Score Scale (PP-NRS) at weeks 2, 4 and 12, and the magnitude of the decrease in PSAAD scores in week 12The results showed that both doses of abrocitinib reached the common primary therapeutic endpoint at the 12th weekAt the same time, several secondary studies were reached, with a greater reduction in itching in patients in two dose groups at week 2 and 200 mg in the 4th and 12th weeks, compared to placebosSince the 100 mg dose group did not reach a statistically significant difference in the 4th week, no further tests were carried out on the critical secondary endpointThe safety shown by abrocitinib in the experiment was consistent with previous studiesJADE TEEN is the fourth trial in the global development plan for the efficacy and safety of abrocitinib termatitisA week ago, Pfizer announced the full results of jade MONO-2, the second individual drug trial of the program, showing statistically significant superiority in improved skin loss removal, eczema area and severity, and itching of both doses compared to placebos(See: Pfizer JAK1 inhibitor sauor PHASE III STUDY REACHED DOUBLE ENDPOINT!) THE FULL RESULTS OF JADE TEEN WILL ALSO BE PUBLISHED AT FUTURE SCIENTIFIC CONFERENCES AND IN THE JOURNAL OF MEDICINESource: Pfizer announces positive top-line results from jade jade teen trial of abrocitinib in the nos nos-moderate-to-severe atopic dermatitis
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