Long-term effectiveness and safety of upadacitinib for Japanese patients with moderate-to-severe atopic dermatitis: a real-world clinical study

Figures & data

Table 1. Baseline demographic and disease characteristics of patients with atopic dermatitis treated with upadacitinib.

	15 mg (n = 216)	30 mg (n = 71)
Male sex, n (%)	154 (71.3)	55 (77.5)
Age (years)^a	36 [16–51.5]	40 [33–48]
Body mass index (kg/m2)^a	22.1 [20.1–25.0]	23.6 [21.5–27.2]
Disease duration (years)^a	28 [13.3–44]	33 [22.0–43.0]
Presence of allergic conjunctivitis	31 (14.4)	13 (18.3)
Presence of allergic rhinitis	66 (30.6)	30 (42.3)
Presence of bronchial asthma	61 (28.2)	30 (42.3)
Pretreatment, n (%)
Previous dupilumab	12 (5.6)	12 (16.9)
Previous upadacitinib 15 mg	NA	27 (38.0)
Previous baricitinib 4 mg	4 (1.9)	27 (38.0)
Clinical indexes
EASI^a	23.9 [17.2–32.0]	13.0 [8.6–19.6]
IGA, n (%)
Mild (score of 2)	19 (8.8)	25 (35.2)
Moderate (score of 3)	116 (53.7)	33 (46.5)
Severe (score of 4)	81 (37.5)	13 (18.3)
ADCT^a	14 [10–19]	8.0 [5.0–13.0]
PP-NRS^a	8 [7–10]	6 [3–8]

^a Data provided as the median [interquartile range].

EASI: eczema area and severity index; IGA: investigator’s global assessment; ADCT: atopic dermatitis control tool; PP-NRS: peak pruritus numerical rating scale; NA: not applicable.

Table 2. The clinical indexes at weeks 0, 4, 12, 24, 36, and 48 of upadacitinib 15 mg treatment for patients with atopic dermatitis, and the comparisons between the stages.

	Week 0 (n = 216)	Week 4 (n = 191)	Week 12 (n = 171)	Week 24 (n = 127)	Week 36 (n = 89)	Week 48 (n = 68)
Median [interquartile range]
EASI^a	23.5 [17.2–32]	4.6 [2.75–8.1]	2.0 [1.0–6.7]	3.4 [0.9–5.7]	3.4 [1.2–8]	3.65 [1.2–6.65]
ADCT^a	14 [10–19]	2.0 [1.0–4.0]	3.0 [1–5.0]	3.0 [1.0–5.0]	2.0 [1.0–5]	3.0 [1.0–6.0]
PP-NRS^a	8 [7–10]	2.0 [1.0–3.0]	2.0 [1–4.0]	2.0 [1.0–3.0]	2.0 [1.0–3]	2.0 [1.0–4.0]
IGA, n (%)
Clear (score 0)^b	0	12 (6.3)	24 (14.0)	18 (14.2)	9 (10.1)	6 (8.8)
Almost clear (score 1)^b	0	14 (7.3)	23 (13.5)	21 (16.5)	15 (16.9)	12 (17.6)
Mild (score 2)^b	19 (8.8)	153 (80.1)	112 (65.5)	81 (63.8)	54 (60.7)	42 (61.8)
Moderate (score 3)^b	116 (53.7)	12 (6.3)	12 (7.0)	7 (5.5)	11 (12.6)	8 (11.8)
Severe (score 4)^b	81 (37.5)	0	0	0	0	0

^a Data provided as the median [interquartile range].

^b Data provided as n (%).

EASI: eczema area and severity index; IGA: investigator’s global assessment; PP-NRS: peak pruritus numerical rating scale; ADCT: atopic dermatitis control tool.

Table 3. The clinical indexes at weeks 0, 4, 12, 24, 36 and 48 of upadacitinib 30 mg treatment for patients with atopic dermatitis, and the comparisons between the stages.

	Week 0 (n = 71)	Week 4 (n = 67)	Week 12 (n = 62)	Week 24 (n = 51)	Week 36 (n = 38)	Week 48 (n = 34)
Median [interquartile range]
EASI^a	13.2 [8.8–19.8]	4.8 [1.7–7.45]	2.9 [0.98–4.85]	2.5 [0.9–4.5]	1.4 [0.8–4.3]	1.85 [0.83–2.9]
ADCT^a	8.0 [5.0–13.0]	2.0 [1.0–5.0]	2.0 [1.0–4.0]	4.0 [1.0–5.0]	2.0 [0–4.0]	1.5 [0–4.0]
PP-NRS^a	6.0 [3.0–8.0]	2.0 [1.0–3.0]	2.0 [1.0–3.0]	2.0 [1.0–3.0]	2.0 [1.0–2.5]	2.0 [1.0–3.0]
IGA, n (%)
Clear (score 0)^b	0	4 (6.0)	3 (4.8)	3 (5.9)	5 (13.2)	1 (2.9)
Almost clear (score 1)^b	0	7 (11.3)	15 (24.2)	18 (35.3)	12 (31.8)	14 (41.2)
Mild (score 2)^b	25 (35.2)	52 (77.6)	42 (67.7)	27 (52.9)	19 (50.0)	18 (52.9)
Moderate (score 3)^b	33 (46.5)	4 (6.0)	2 (3.2)	3 (5.9)	2 (5.3)	1 (2.9)
Severe (score 4)^b	13 (18.3)	0	0	0	0	0

^a Data provided as the median [interquartile range]; ^bData provided as n (%).

EASI: eczema area and severity index; IGA: investigator’s global assessment; PP-NRS: peak pruritus numerical rating scale; ADCT: atopic dermatitis control tool.

Figure 1. Achievement rates of eczema area and severity index (EASI) 75, EASI 90, EASI 100 (a), EASI ≤2, EASI ≤1 (b), investigator’s global assessment (IGA) 0/1, atopic dermatitis control tool 7 (ADCT 7), peak pruritus numerical rating scale 4 (PP-NRS 4) (c), during upadacitinib 15 mg or 30 mg treatment in patients with atopic dermatitis (n = 216, or 71, respectively).

Table 4. Treatment-emergent adverse events (TEAEs) during 48-week treatment with upadacitinib 15 mg or 30 mg in patients with atopic dermatitis.

	Upadacitinib 15 mg (n = 216)^a	Upadacitinib 30 mg (n = 71)^a
TEAE	n (%)
All TEAEs	93 (43.1)	31 (52.1)
Severe AE	2 (1.0)	2 (2.8)
Serious AE	0	0
AE leading to discontinuation of treatment	6 (2.8)	1 (1.4)
AE leading to death	0	0
AEs of special interest
Serious infections	0	0
Active tuberculosis	0	0
Acne	43 (19.9)	17 (23.9)
Tonsillitis	0	2 (2.8)
Peritonsillar abscess	1 (0.5)	1 (1.4)
Cellulitis	0	1 (1.4)
Contagious impetigo	0	1 (1.4)
Bronchitis	1 (0.5)	0
Pneumonia	0	1 (1.4)
Herpes labialis	9 (4.2)	6 (8.5)
Herpes zoster	6 (2.8)	6 (8.5)
Kaposi’s varicelliform eruption	1 (0.5)	3 (4.2)
Tinea corporis	2 (1.0)	0
NMSC	0	0
Cancer other than NMSC	0	0
Lymphoma	0	0
Hepatic disorder (increase of transaminases)	6 (2.8)	1 (1.4)
Adjudicated gastrointestinal perforation	0	0
Anemia	8 (3.7)	2 (2.8)
Neutropenia	1 (0.5)	1 (1.4)
Lymphopenia	0	1 (1.4)
Elevation of creatinine phosphokinase	46 (21.3)	17 (23.9)
Pyrexia	2 (1.0)	0
Headache	4 (1.9)	1 (1.4)
Nausea	1 (0.5)	1 (1.4)
Fatigue	2 (1.0)	0
Renal disorder (increase of creatinine)	0	0
Adjudicated MACE	0	0
Adjudicated VTE	0	0

AE: adverse event; MACE: major adverse cardiovascular event; NMSC: nonmelanoma skin cancer; VTE: venous thromboembolic event.

^a Includes all patients in the main study who received at least 1 dose of upadacitinib.

Data availability statement

The datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request.