Table 1 Baseline characteristics

From: Benralizumab versus placebo for hypereosinophilic syndrome: a randomized, placebo-controlled phase 3 trial

Characteristic

Benralizumab (n = 67)

Placebo (n = 66)

Total (N = 133)

Age (years)

 Median (range)

49.0 (14.0–87.0)

53.5 (16.0–83.0)

51.0 (14.0–87.0)

 ≤21

9 (13.4%)

7 (10.6%)

16 (12.0%)

 22–65

45 (67.2%)

45 (68.2%)

90 (67.7%)

 ≥66

13 (19.4%)

14 (21.2%)

27 (20.3%)

Sex

 Female

43 (64.2%)

39 (59.1%)

82 (61.7%)

 Male

24 (35.8%)

27 (40.9%)

51 (38.3%)

Region

 North America

12 (17.9%)

9 (13.6%)

21 (15.8%)

 Europe

45 (67.2%)

45 (68.2%)

90 (67.7%)

 Asia

10 (14.9%)

11 (16.7%)

21 (15.8%)

 Rest of the world

0

1 (1.5%)

1 (0.8%)

Race

 White

42 (72.4%)

45 (78.9%)

87 (75.7%)

 Black or African American

3 (5.2%)

1 (1.8%)

4 (3.5%)

 Asian

10 (17.2%)

11 (19.3%)

21 (18.3%)

 Othera

3 (5.2%)

0

3 (2.6%)

Time since first appearance of HES symptoms (years), median (range)b

6.1 (0.5–39.5)

3.8 (0.5–36.7)

4.9 (0.5–39.5)

Time since HES diagnosis (years), median (range)c

1.9 (0.1–32.3)

2.0 (0.1–25.4)

1.9 (0.1–32.3)

Eosinophil count before OCS-responsiveness assessment and randomization: local result (cells µl−1), median (range)d

1,600 (1,000–10,250)

1,550 (1,000–25,150)

1,600 (1,000–25,150)

HES subtypes

 I-HES

49 (73.1%)

51 (77.3%)

100 (75.2%)

 L-HES

5 (7.5%)

11 (16.7%)

16 (12.0%)

 SO-HESe

10 (14.9%)

3 (4.5%)

13 (9.8%)

 EGPA/HES overlapf

3 (4.5%)

0

3 (2.3%)

 Unknown

0

1 (1.5%)

1 (0.8%)

HES organ involvementg

 Pulmonary

34 (50.7%)

42 (63.6%)

76 (57.1%)

 Dermatologic

33 (49.3%)

37 (56.1%)

70 (52.6%)

 Gastrointestinal

33 (49.3%)

30 (45.5%)

63 (47.4%)

 Musculoskeletal

25 (37.3%)

24 (36.4%)

49 (36.8%)

 Sinus

25 (37.3%)

20 (30.3%)

45 (33.8%)

 Cardiac

7 (10.4%)

6 (9.1%)

13 (9.8%)

 Neurological

6 (9.0%)

9 (13.6%)

15 (11.3%)

 Other

11 (16.4%)

10 (15.2%)

21 (15.8%)

Number of organs involvedh

 Median (range)

2 (1–5)

3 (1–5)

3 (1–5)

 1

19 (28.4%)

17 (25.8%)

36 (27.1%)

 2

15 (22.4%)

15 (22.7%)

30 (22.6%)

 3

11 (16.4%)

11 (16.7%)

22 (16.5%)

 4

15 (22.4%)

16 (24.2%)

31 (23.3%)

 5

7 (10.4%)

7 (10.6%)

14 (10.5%)

Most bothersome HES symptom at baseline

 Fatigue

22 (32.8%)

30 (45.5%)

52 (39.1%)

 Shortness of breath

20 (29.9%)

25 (37.9%)

45 (33.8%)

 Cough

17 (25.4%)

19 (28.8%)

36 (27.1%)

 General weakness

17 (25.4%)

12 (18.2%)

29 (21.8%)

 Skin itching

13 (19.4%)

15 (22.7%)

28 (21.1%)

PROMIS Fatigue, median (range)i

55.1 (29.4–74.8)

56.4 (29.4–71.1)

51.1 (29.4–74.8)

Number of HES flares in the previous 12 months

 Median (range)

2 (0–12)

2 (1–12)

2 (0–12)

 0

1 (1.5%)

0

1 (0.8%)

 1

13 (19.4%)

13 (19.7%)

26 (19.5%)

 2

28 (41.8%)

30 (45.5%)

58 (43.6%)

 ≥3

25 (37.3%)

23 (34.8%)

48 (36.1%)

Actively flaring at screening

   

 No

5 (7.5%)

7 (10.6%)

12 (9.0%)

 Yes

62 (92.5%)

59 (89.4%)

121 (91.0%)

HES background therapy at baseline

 Systemic OCSj

47 (70.1%)

55 (83.3%)

102 (76.7%)

 Median (range), mg day−1

5.0 (2.5–45.0)

6.8 (1.0–30.0)

5.0 (1.0–45.0)

 ≤10 mg day−1

43 (64.2%)

45 (68.2%)

88 (66.2%)

 >10 to ≤20 mg day−1

4 (6.0%)

9 (13.6%)

13 (9.8%)

 >20 mg day−1

0

1 (1.5%)

1 (0.8%)

 Oral budesonide

3 (4.5%)

1 (1.5%)

4 (3.0%)

 Cytotoxic//immunosuppressive therapiesk

6 (9.0%)

5 (7.6%)

11 (8.3%)

 Not on background systemic OCSl or cytotoxic//immunosuppressive therapiesk

12 (17.9%)

6 (9.1%)

18 (13.5%)

 Other HES therapiesm

45 (67.2%)

46 (69.7%)

91 (68.4%)

 

Benralizumab (n = 67)

Placebo (n = 65)

Total (N = 132)

SF-36v2 physical component score, median (range)

46.1 (17.2–58.5)

43.6 (22.6–65.2)

–

SF-36v2 mental component score, median (range)

45.6 (17.8–64.5)

46.7 (15.8–61.5)

–

PGI-S categoryn

 No symptoms

4 (6.0%)

4 (6.2%)

8 (6.0%)

 Very mild

10 (14.9%)

8 (12.3%)

18 (13.6%)

 Mild

10 (14.9%)

11 (16.9%)

21 (15.9%)

 Moderate

30 (44.8%)

19 (29.2%)

49 (37.1%)

 Severe

10 (14.9%)

21 (32.3%)

31 (23.5%)

 Very severe

3 (4.5%)

2 (3.1%)

5 (3.8%)

  1. Data are n (%) unless otherwise indicated.
  2. aIncludes race categories ‘Native Hawaiian or other Pacific islander’, ‘American Indian or Alaska native’ and ‘Other’.
  3. bThe time to first appearance of HES symptoms (years) = (date of randomization − start date of HES worsening + 1)/365.25.
  4. cTime since HES diagnosis (years) = (date of randomization − date of HES diagnosis + 1)/365.25.
  5. dEligibility was confirmed on the basis of local laboratory results.
  6. eHES with involvement of a single organ system.
  7. fHES with clinical features suggestive of EGPA (that is, asthma, chronic rhinosinusitis with nasal polyposis), but ANCA-negative and no history of documented or suspected vasculitis.
  8. gPercentages do not equal 100%, patients may have had multiple organ involvement.
  9. hOne primary and up to four other organs could be selected by patients.
  10. iStandardized T-score range for Short Form 7a is from 29.4 to 83.2; higher scores indicate greater fatigue severity.
  11. jPrednisone equivalent.
  12. kCytotoxic//immunosuppressive therapies include, but are not limited to, hydroxyurea, cyclosporine, imatinib, methotrexate, tacrolimus and azathioprine.
  13. lSystemic OCS includes oral budesonide. Four patients were taking oral budesonide; three in the benralizumab group and one in the placebo group.
  14. mOther HES therapies include, but are not limited to, beclomethasone dipropionate, formoterol fumarate, omeprazole, salbutamol, tiotropium bromide, triamcinolone, acetonide and cetirizine.
  15. nPGI-S is a single item to capture the patient’s perception of overall symptom severity.
  16. ANCA, antineutrophil cytoplasmic antibodies; I-HES, idiopathic HES; L-HES, lymphocytic HES; SO-HES, single-organ HES.
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