Aug 21 · Results of PIII JADE TEEN (NCT03796676) RCT reported in JAMA [20].
Mar 21 · Further results from JADE TEEN are available; at week 12, 46.2% of those on abrocitinib 200mg and 41.6% of those on abrocitinib 100mg achieved IGA responses vs. 24.5% of those on placebo. Additionally, 72% of those on 200mg and 68.5% of those on 100mg had a 75% or greater improvement in EASI-75 vs. 41.5% of those on placebo [18].
Mar 21 · Results of PIII JADE COMPARE trial (NCT03720470) reported in NEJM [16].
Nov 20 · Pfizer announce data from fifth PIII trial of abrocitinib at a dose of 200mg once a day for 12 weeks. Patients who responded were then randomised to placebo, or 200mg or 100mg of abrocitinib for 40 weeks. The probability of not experiencing a flare was 81.8% in the 200mg cohort, 57.4% in the 100mg arm and 19.1% in the placebo arm [11].
Jul 20 · The PIII JADE-MONO1 study (n=387) is published; more patients randomised to abrocitinib achieved an Investigator Global Assessment response (24% for 100mg [p=0.0037] and 44% for 200mg [p<0.0001] vs 8% placebo) and an EASI-75 response (40% for 100mg [p<0.0001] and 63% for 200mg [p<0.0001] vs 12% placebo) [12].
Jun 20 · Positive top-line data from the Jade TEEN study announced. The company said that both doses of abrocitinib met the co-primary endpoints and were generally well tolerated with safety consistent with previous studies. Full data were not made available. [11]
May 20 · PIII JADE MONO-2 (n=391) is published; it reported that abrocitinib was well tolerated and significantly improved signs and symptoms of atopic dermatitis based on IGA response and EASI-75 compared with placebo in adolescent and adult patients at week 12. Among patients with available data at week 12, greater proportions of patients in the 200- and 100-mg abrocitinib groups vs placebo achieved IGA (59 of 155 [38.1%] and 44 of 155 [28.4%] vs 7 of 77 [9.1%]; P < .001) and EASI-75 (94 of 154 [61.0%] and 69 of 155 [44.5%] vs 8 of 77 [10.4%]; P < .001), greater estimated proportions achieved PP-NRS (55.3% [95% CI, 47.2%-63.5%] and 45.2% [95% CI, 37.1%-53.3%] vs 11.5% [95% CI, 4.1%-19.0%]; P < .001), and/or greater proportions achieved EASI-90 (58 of 154 [37.7%] and 37 of 155 [23.9%] vs 3 of 77 [3.9%]) responses [10].
Apr 20 · PIII JADE TEEN trial has completed; the randomized, double blind, placebo controlled, parallel group study evaluated the efficacy and safety of abrocitinib in adolescent participants 12 to <18 years of age with moderate to severe AD. Results are awaited [9].
Mar 20
· Positive top-line results from PIII JADE COMPARE trial which met its co-primary efficacy endpoints. The PIII study evaluated the safety and efficacy of abrocitinib 200mg + background topical therapy vs. s.c. dupilumab and placebo. The percentage of pts achieving each co-primary efficacy endpoint at Wk 12 was superior vs. placebo. Dupilumab demonstrated superiority vs. placebo at Week 12 and Week 16. A larger percentage of pts receiving abrocitinib 200mg experienced adverse events (61.9%) than in other treatment arms. [8]
Oct 19: Data from completed PIII JADE MONO-1 trial in pts aged >12 with moderate to severe AD presented who received abrocitinib 200mg (n=154), 100mg (n=156) or placebo (n=77). Co-primary endpoints were met; the proportion of pts acheiving an Investigator Global Assessment (IGA) score of clear (0) or almost clear (1) skin was 43.8%, 23.7% and 7.9% fpr 200mg or 100mg abcrocitibib and placebo respectively. The proportion with >2-point improvement vs. baseline and >75% change from baseline in Eczema Area and Severity Index (EASI) scores were 62.7%, 39.7% and 11.8% respectively. A key secondary endpoint was the proportion of pts achieving >4-point reduction in itch severity on the pruritus numerical rating scale (NRS) - this was acheived by 57.2%, 37.7% and 15.2% respectively. Abrocitinib was well tolerated and safety data were consistent with JADE MONO-2 trial. The most frequently reported adverse events in abrocitinib-treated pts were short-lasting nausea (20.1%, 9.0%), headache (9.7%, 7.7%), and nasopharyngitis (11.7%, 14.7%), while for placebo, it was dermatitis (16.9%). [7]/p>
Jun 18: PIII JADE Mono-2 trial (NCT03575871) to evaluate the safety and efficacy of abrocitinib in patients aged 12 years and older with moderate-to-severe atopic dermatitis. The study aims to enrol around 375 patients in the US [3].
Mar 18: PIII JADE EXTEND trial (NCT03422822) to evaluate the safety and efficacy abrocitinib, with or without topical medications in patients aged 12 years and older with moderate-to-severe atopic dermatitis, has started. The study is enrolling around 1,435 patients in the US [3].
Dec 17: PIII trial is a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of PF-04965842 in 375 patients 12 years and older with moderate-to-severe AD [1].