| | Study ID | Study time and sites | Design and phase | Protocol NCT number | Total number of patients | Inclusion criteria | Study arms and number of patients | Dose, route, and regimen of abrocitinib | Duration of treatment | Atopic dermatitis severity | Study conclusion |
| | Gooderham 2019 | From April 15, 2016, to April 4, 2017, at 58 centers in Australia, Canada, Germany, Hungary, and the United States | RCT, phase 2 | 02780167 | 267 | “Eligible patients were men or women aged 18 to 75 years with a clinical diagnosis of moderate to severe AD (percentage of affected body surface area (%BSA) ≥10; Investigator’s global assessment (IGA) score ≥3; and eczema area and severity index (EASI) score ≥12) for 1 year or more before day 1 of the study and inadequate response to topical medications (topical corticosteroids or topical calcineurin inhibitors) for 4 weeks or more (based on investigator’s judgment) or inability to receive topical treatment within 12 months before the first dose of study drug because it was medically inadvisable (e.g., application to a large %BSA, which is associated with increased risk for systemic absorption and suppression of the hypothalamic-pituitary-adrenal axis, and cutaneous adverse effects such as burning or stinging sensations with topical calcineurin inhibitors or skin atrophy, purpura, telangiectasia, and striae with chronic use of topical corticosteroids)” | Abrocitinib 10 mg, 49
Abrocitinib 30 mg, 51
Abrocitinib 100 mg, 56
Abrocitinib 200 mg, 55
Placebo, 56 | (10, 30, 100, 200) mg, oral, once daily | 12 weeks | Patients with moderate-to-severe atopic dermatitis | “Once-daily oral abrocitinib was effective and well tolerated for short-term use in adults with moderate to severe atopic dermatitis. Additional trials are necessary to evaluate long-term efficacy and safety” |
| | Silverberg 2020 | From June 29, 2018, to August 13, 2019, in Australia, Bulgaria, Canada, China, Czechia, Germany, Hungary, Japan, south, korea, Latvia, Poland, United Kingdom, and the United States. | RCT, phase 3 | 03575871 | 391 | “Eligible patients were 12 years or older, with body weight of at least 40 kg. Adolescent patients younger than 18 years (or country-specific age of majority) were eligible on a country-by-country basis as approved by the country or regulatory/health authority. Eligible patients had a confirmed diagnosis of chronic AD23 for at least 1 year before the first dose of study drug and moderate-to-severe AD (Investigator’s global assessment (IGA) score ≥3, eczema area and severity index (EASI) score 24 ≥ 16, affected body surface area ≥10%, and peak pruritus numerical rating scale (PP-NRS, used with permission of regeneron pharmaceuticals, inc, and sanofi SA) score 25 ≥ 4) at the baseline visit. Eligible patients also had a documented recent history (within 6 months before screening) of inadequate response to treatment with topical corticosteroids or topical calcineurin inhibitors given for at least 4 weeks, a history of topical AD treatments being considered medically inadvisable, or a history of receiving systemic therapies for AD” | Abrocitinib 100 mg, 158
Abrocitinib 200 mg, 155
Placebo, 78 | (100, 200) mg, oral, once daily | 12 weeks | Patients with moderate-to-severe atopic dermatitis | “Monotherapy with once daily oral abrocitinib was effective and well tolerated in adolescents and adults with moderate-to-severe AD” |
| | Simpson 2020 | From Dec 7, 2017, to March 26, 2019, in 69 hospitals and clinics in Australia, Canada, europe, and the United States. | RCT, phase 3 | 03349060 | 387 | “All eligible patients had a confirmed diagnosis of atopic dermatitis for at least 1 year before randomization (according to hanifin and rajka diagnostic criteria 21); had moderate -to- severe atopic dermatitis (investigator global assessment score ≥3, EASI score ≥16, percentage of body surface area affected ≥10%, and peak pruritus numerical rating scale [PP-NRS] score ≥4) at the baseline visit. The PP-NRS score was used with the permission of regeneron pharmaceuticals (tarrytown, NY, USA) and sanofi SA (paris, France).22 eligible patients also had a documented recent history (in the 6 months before screening) of inadequate response to treatment with topical corticosteroids or topical calcineurin inhibitors given for at least 4 weeks, or were patients for whom topical treatments were otherwise medically inadvisable, or required systemic therapies to control their disease” | Abrocitinib 100 mg, 156
Abrocitinib 200 mg, 154
Placebo, 77 | (100, 200) mg, oral, once daily | 12 weeks | Patients with moderate-to-severe atopic dermatitis | “Monotherapy with oral abrocitinib once daily was effective and well tolerated in adolescents and adults with moderate-to-severe atopic dermatitis” |
| | Pfizer (JADE compare trial) 2021 | | RCT, phase 3 | 03720470 | 837 | “Male or female subjects aged 18 years or older at the time of informed consent. Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, pruritus NRS severity 4). Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with medicated topical therapy for AD for at least 4 weeks, or who have required systemic therapies for control of their disease. Must be willing and able to comply with standardized background topical therapy, as per protocol guidelines throughout the study female subjects who are of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply: - Female subjects of childbearing potential must have a confirmed negative pregnancy test prior to randomization; - female subjects of childbearing potential must agree to use a highly effective method of contraception for the duration of the active treatment period and for at least 28 days after the last dose of investigational product. Female subjects of non-childbearing potential must meet at least 1 of the following criteria: have undergone a documented hysterectomy and/or bilateral oophorectomy; have medically confirmed ovarian failure; or achieved postmenopausal status, defined as follows: Cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state. All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential. If receiving concomitant medications for any reason other than AD, must be on a stable regimen prior to day 1 and through the duration of the study” | First 16 weeks final 4 weeks (16-20) | Abrocitinib 100 mg, 238
Abrocitinib 200 mg, 226
Placebo, 131
Dupilumab 300 mg, 242
-abrocitinib 100 mg, 238 (after 16 weeks abrocitinib 100 mg)
-Abrocitinib 200 mg, 226 (after 16 weeks abrocitinib 100 mg)
-Abrocitinib 100 mg, 60 (after 16 weeks placebo)
-Abrocitinib 200 mg, 57 (after 16 weeks placebo)
-Placebo, 242 (after 16 weeks dupilumab) | (100, 200) mg, oral, once daily | 20 weeks (initial 16 then 4) | Patients with moderate-to-severe atopic dermatitis |
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