Efficacy and safety of abrocitinib monotherapy in adolescents and adults: a post hoc analysis of the phase 3 JAK1 atopic dermatitis efficacy and safety (JADE) REGIMEN clinical trial

Figures & data

Table 1. Patient demographics and baseline characteristics.

	Adolescents	Adults
	(n = 246)	(n = 987)
Age, years, n (%)
12 to <15	93 (37.8)	NA
15 to <18	153 (62.2)	NA
≥18	NA	987 (100.0)
Mean (SD)	15.1 (1.8)	35.7 (13.8)
Median (Q1, Q3)	15.0 (14.0, 17.0)	32.0 (24.0, 44.0)
Sex, n (%)
Male	135 (54.9)	549 (55.6)
Female	111 (45.1)	438 (44.4)
Race/ethnicity, n (%)
White	179 (72.8)	752 (76.2)
Black or African American	23 (9.3)	52 (5.3)
Asian	38 (15.4)	158 (16.0)
Other^a	6 (2.4)	25 (2.5)
Not Hispanic or Latino	180 (73.2)	801 (81.2)
Hispanic or Latino	63 (25.6)	183 (18.5)
Not reported/unknown	3 (1.2)	3 (0.3)
Disease duration, median (Q1, Q3), y	12.8 (8.2, 15.0)	21.5 (10.3, 31.5)
EASI, median (Q1, Q3)	30.0 (21.6, 40.9)	27.5 (20.8, 37.0)
IGA, %
Moderate (3)	56.5	59.8
Severe (4)	43.5	40.2
%BSA affected by AD, median (Q1, Q3)	50.0 (33.0, 67.8)	44.8 (30.5, 62.0)
PP-NRS, median (Q1, Q3)	7.0 (6.0, 8.0)	8.0 (6.0, 9.0)
CDLQI,^b median (Q1, Q3)	12.0 (8.0, 16.0)	NA
DLQI,^c median (Q1, Q3)	NA	16.0 (12.0, 21.0)
Prior medication
No prior medication	1 (0.4)	3 (0.3)
Topical agents only^d	114 (46.3)	373 (37.8)
Systemic agents^e	131 (53.3)	611 (61.9)
Nonbiologic	124 (50.4)	532 (53.9)
Biologic	7 (2.8)	79 (8.0)
Dupilumab	2 (0.8)	63 (6.4)
Other biologic agents^f	5 (2.0)	22 (2.2)

%BSA: percentage of body surface area; AD: atopic dermatitis; CDLQI: Children’s Dermatology Life Quality Index; DLQI: Dermatology Life Quality Index; EASI: Eczema Area and Severity Index; IGA: Investigator’s Global Assessment; NA: not applicable; PP-NRS: Peak Pruritus Numerical Rating Scale; Q1: quartile 1; Q3: quartile 3; QOL: quality of life.

^aOther includes American Indian or Alaskan Native, Native Hawaiian or Other Pacific Islander, multiracial, and not reported.

^bCDLQI scores were collected for adolescent patients (12–17 years) only. Median scores at baseline correspond to a ‘moderate’ effect on QOL in adolescents.

^cDLQI scores were collected for adult patients (≥18 years) only. Median DLQI scores at baseline correspond to a ‘very large’ effect on QOL in adults.

^dTopical agents include corticosteroids, calcineurin inhibitors, and crisaborole.

^eSystemic agents include corticosteroids, cyclosporine, nonbiologic agents, and biologic agents.

^fOther biologic agents include lebrikizumab, tralokinumab, nemolizumab, and etokimab.

Figure 1. Probability of protocol-defined flare for adolescent and adult patients during the randomized maintenance period of the JADE REGIMEN study. Flare was defined in the protocol as ≥50% loss of initial EASI response at week 12 with a new IGA score ≥2. Patients at risk were defined as patients who did not experience flare and were continuing treatment. Missing event times were considered as right censored (censored at random) on the last date of randomized treatment. Patients included in the adolescent group were aged 12–17 years. Patients included in the adult group were aged ≥18 years. CI: confidence interval; EASI: Eczema Area and Severity Index; HR: hazard ratio; IGA: Investigator’s Global Assessment.

Figure 2. Proportion of patients who achieved ≥4-point improvement from study baseline in health-related quality-of-life index score at week 40 of the randomized maintenance period of the JADE REGIMEN study. Quality of life of adolescents (12–17 years old) was assessed using the CDLQI. Quality of life of adult patients (≥18 years old) was assessed using the DLQI. Study baseline was defined as the last measurement collected on or before day 1 of treatment. Patients who withdrew from the trial or experienced flare and received rescue treatment after randomization were counted as not having achieved the outcome after withdrawal. CDLQI: Children’s Dermatology Life Quality Index; CI: confidence interval; DLQI: Dermatology Life Quality Index.

Table 2. Summary of patient-year and incidence rates for TEAEs (any causality) for adolescents and adults treated in the randomized maintenance period of JADE REGIMEN.

	Adolescents			Adults
	Placebo (n = 49)	Abrocitinib 100 mg (n = 49)	Abrocitinib 200 mg (n = 47)	Placebo (n = 218)	Abrocitinib 100 mg (n = 216)	Abrocitinib 200 mg (n = 219)
Patients with TEAEs,^an (%)	22 (44.9)	29 (59.2)	32 (68.1)	99 (45.4)	114 (52.8)	136 (62.1)
SAEs,^a,^bn (%)	1 (2.0)	0	2 (4.3)	1 (0.5)	4 (1.9)	11 (5.0)
Severe AEs,^a,^cn (%)	3 (6.1)	0	2 (4.3)	12 (5.5)	9 (4.2)	13 (5.9)
Patients discontinued because of AEs,^a n (%)	1 (2.0)	0	2 (4.3)	3 (1.4)	5 (2.3)	14 (6.4)
Serious infection,^d n (%)	1 (2.0)	0	0	1 (0.5)	3 (1.4)	5 (2.3)
Total drug exposure (PY)	34.26	44.39	47.07	155.64	199.30	212.52
IR (95% CI)	2.92	0.00	0.00	0.64	1.51	2.35
	(0.07–16.26)	(0.00–8.31)	(0.00–7.84)	(0.02–3.58)	(0.31–4.40)	(0.76–5.49)
Herpes zoster infection,^d n (%)	0	2 (4.1)	2 (4.3)	5 (2.3)	7 (3.2)	10 (4.6)
Total drug exposure (PY)	34.36	43.89	46.35	153.80	197.63	208.31
IR (95% CI)	0.00	4.56	4.31	3.25	3.54	4.80
	(0.00–10.74)	(0.55–16.46)	(0.52–15.59)	(1.06–7.59)	(1.42–7.30)	(2.30–8.83)
Nausea,^d n (%)	9 (18.4)	8 (16.3)	14 (29.8)	35 (16.1)	27 (12.5)	35 (16.0)
Total drug exposure (PY)	29.46	38.02	35.45	132.91	176.93	181.07
IR (95% CI)	30.55	21.04	39.49	26.33	15.26	19.33
	(13.97–58.00)	(9.08–41.46)	(21.59–66.26)	(18.34–36.62)	(10.06–22.20)	(13.46–26.88)
Acne/folliculitis,^d n (%)	7 (14.3)	8 (16.3)	6 (12.8)	20 (9.2)	26 (12.0)	32 (14.6)
Total drug exposure (PY)	31.30	38.12	42.17	145.06	182.72	188.48
IR (95% CI)	22.36	20.99	14.23	13.79	14.23	16.98
	(8.99–46.08)	(9.06–41.35)	(5.22–30.97)	(8.42–21.29)	(9.29–20.85)	(11.61–23.97)
Conjunctivitis,^d n (%)	2 (4.1)	2 (4.1)	0	4 (1.8)	3 (1.4)	7 (3.2)
Total drug exposure (PY)	33.74	43.99	47.07	153.49	198.22	209.01
IR (95% CI)	5.93	4.55	0.00	2.61	1.51	3.35
	(0.72–21.41)	(0.55–16.42)	(0.00–7.84)	(0.71–6.67)	(0.31–4.42)	(1.35–6.90)
Platelet count decrease,^dn (%)	1 (2.0)	0	0	3 (1.4)	4 (1.9)	3 (1.4)
Total drug exposure (PY)	33.88	44.39	47.07	154.58	195.90	210.55
IR (95% CI)	2.95	0.00	0.00	1.94	2.04	1.42
	(0.07–16.45)	(0.00–8.31)	(0.00–7.84)	(0.40–5.67)	(0.56–5.23)	(0.29–4.16)

CI: confidence interval; IR: incidence rate; PY: patient-year; SAE: serious adverse event; TEAE: treatment-emergent adverse event.

Patients included in the adolescent group were aged 12–17 years. Patients included in the adult group were aged ≥18 years. Incidence rate expressed as number of events per 100 PY.

^aFrequencies reflect exposure during the randomized maintenance period only.

^bSAEs include any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization/prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect; or is considered an important medical event.

^cSevere AEs are judged by the investigator to interfere significantly with the patient’s usual function but do not meet the criteria for SAEs.

^dIncidence rates reflect exposure during the open-label induction period and randomized maintenance period.

Data availability statement

Upon request, and subject to review, Pfizer will provide the data that support the findings of this study. Subject to certain criteria, conditions, and exceptions, Pfizer may also provide access to the related individual de-identified participant data. See https://www.pfizer.com/science/clinical-trials/trial-data-and-results for more information.