Table 1 Demographic and clinical characteristics of the patient population at baseline

From: Dupilumab in patients with prurigo nodularis: two randomized, double-blind, placebo-controlled phase 3 trials

 

PRIME

PRIME2

Placebo n = 76

Dupilumab n = 75

Overall n = 151

Placebo n = 82

Dupilumab n = 78

Overall n = 160

Mean age (s.d.), years

51.1 (15.8)

49.2 (17.4)

50.1 (16.6)

46.7 (15.2)

51.0 (15.8)

48.8 (15.6)

Female sex, n (%)

48 (63.2)

52 (69.3)

100 (66.2)

51 (62.2)

52 (66.7)

103 (64.4)

Mean weight (s.d.), kg

71.4 (17.0)

75.2 (17.3)

73.3 (17.2)

75.0 (19.7)

73.9 (17.5)

74.5 (18.6)

Race, n (%)

 White

45 (59.2)

35 (46.7)

80 (53.0)

48 (58.5)

48 (61.5)

90 (60.0)

 Black or African Americana

3 (3.9)

8 (10.7)

11 (7.3)

5 (6.1)

3 (3.8)

8 (5.0)

 Asian

25 (32.9)

29 (38.7)

54 (35.8)

27 (32.9)

25 (32.1)

52 (32.5)

 Others or missing datab

3 (4.0)

3 (4.0)

6 (3.9)

2 (2.4)

2 (2.6)

4 (2.5)

Region, n (%)c

 Asia

23 (30.3)

27 (36.0)

50 (33.1)

23 (28.0)

20 (25.6)

43 (26.9)

 Eastern Europe

11 (14.5)

11 (14.7)

22 (14.6)

5 (6.1)

6 (7.7)

11 (6.9)

 Latin America

22 (28.9)

19 (25.3)

41 (27.2)

8 (9.8)

6 (7.7)

14 (8.8)

 Western countries

20 (26.3)

18 (24.0)

38 (25.2)

46 (56.1)

46 (59.0)

92 (57.5)

Mean duration of PN (s.d.), years

5.4 (6.2)

6.0 (7.6)

5.7 (6.9)

5.5 (7.0)

5.4 (6.9)

5.4 (6.9)

History of atopyd, n (%)

28 (38.6)

33 (44.0)

61 (40.4)

40 (48.8)

34 (43.6)

74 (46.3)

Ongoing mild AD

2 (2.6)

4 (5.3)

6 (4.0)

5 (6.1)

2 (2.6)

7 (4.4)

Stable use of TCS/TCIe, n (%)

45 (59.2)

47 (62.7)

92 (60.9)

46 (56.1)

44 (56.4)

90 (56.3)

Stable use of antidepressants, n (%)

9 (11.8)

9 (12.0)

18 (11.9)

8 (9.8)

7 (9.0)

15 (9.4)

Prior topical medication for PN

76 (100)

74 (98.7)

150 (99.3)

82 (100)

78 (100)

160 (100)

 TCS

75 (98.7)

74 (98.7)

149 (98.7)

80 (97.6)

77 (98.7)

157 (98.1)

 TCI

12 (15.8)

9 (12.0)

21 (13.9)

8 (9.8)

6 (7.7)

14 (8.8)

Prior systemic medication for PN

52 (68.4)

53 (70.7)

105 (69.5)

52 (63.4)

49 (62.8)

101 (63.1)

 Antihistamines

44 (57.9)

45 (60.0)

89 (58.9)

40 (48.8)

36 (46.2)

76 (47.5)

 Corticosteroids

13 (17.1)

17 (22.7)

30 (19.9)

15 (18.3)

9 (11.5)

24 (15.0)

 Non-steroidal immunosuppressants

10 (13.2)

16 (21.3)

26 (17.2)

18 (22.0)

20 (25.6)

38 (23.8)

 Gabapentinoids

2 (2.6)

5 (6.7)

7 (4.6)

1 (1.2)

0

1 (0.6)

 Opioid receptor antagonists

2 (2.6)

2 (2.7)

4 (2.6)

1 (1.2)

2 (2.6)

3 (1.9)

 Antidepressants

2 (2.6)

1 (1.3)

3 (2.0)

13 (15.9)

10 (12.8)

23 (14.4)

Mean WI-NRS (0–10) score (s.d.)

8.3 (1.1)

8.6 (0.9)

8.5 (1.0)

8.5 (1.0)

8.5 (1.0)

8.5 (1.0)

IGA PN-S (0–4), n (%)

 3

53 (70.7)

54 (72.0)

107 (71.3)

49 (60.5)

49 (62.8)

98 (61.6)

 4

22 (29.3)

21 (28.0)

43 (28.7)

32 (39.5)

29 (37.2)

61 (38.4)

Mean Skin Pain NRS (0–10) score (s.d.)

7.2 (2.3)

7.2 (2.5)

7.2 (2.4)

7.1 (2.5)

7.3 (2.4)

7.2 (2.4)

Mean Sleep NRS (0–10) score (s.d.)

4.3 (2.2)

4.4 (2.4)

4.3 (2.3)

4.2 (2.5)

4.4 (2.3)

4.3 (2.4)

Mean DLQI (0–30) score (s.d.)

15.7 (7.3)

17.8 (7.1)

16.7 (7.2)

18.2 (7.0)

18.2 (6.5)

18.2 (6.7)

Mean total HADS (0–42) score (s.d.)

14.3 (8.0)

14.5 (8.2)

14.4 (8.1)

15.9 (8.4)

16.2 (7.7)

16.0 (8.0)

 Anxiety (HADS-A)

8.3 (4.6)

8.5 (5.2)

8.4 (4.9)

9.5 (5.1)

9.3 (4.2)

9.4 (4.6)

 Depression (HADS-D)

6.0 (4.1)

6.0 (3.8)

6.0 (3.9)

6.3 (4.0)

6.9 (4.0)

6.6 (4.0)

Mean baseline exact number of lesions in representative area from PAS (s.d.)

25.1 (16.7)

27.0 (26.7)

26.1 (22.2)

26.4 (18.8)

25.6 (18.7)

26.0 (18.7)

  1. Note: Higher score indicates worse disease/larger impact, except for Patient Sleep Quality NRS, where higher score indicates better sleep quality.
  2. a31.4% of PRIME patients from the United States and 55.6% of PRIME2 patients from the United States were Black or African American.
  3. bIncluding American Indian, Alaska Native, Native Hawaiian or Pacific Islands, unknown.
  4. cPRIME: Argentina, China, France, Japan, Mexico, Russia, South Korea, United States; PRIME2: Canada, Chile, France, Hungary, Italy, Portugal, South Korea, Spain, Taiwan, United Kingdom, United States.
  5. dDefined as having a medical history of AD, allergic rhinitis/rhinoconjunctivitis, asthma or food allergy.
  6. eDefined as maintaining the same medicine (low-to-medium-potency TCS or TCI) and maintaining the same frequency of treatment (once or twice daily) used from 2 weeks before screening.
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