New and Emerging Therapeutic Options

Dupilumab: Trial Findings in Safety

Long-term (52 Weeks) Safety Analysis in CHRONOS

Adverse Events (AEs)

N
Placebo qw + TCS (n=315)	Dupilumab 300 mg q2w + TCS (n=110)	Dupilumab 300 mg qw + TCS (n=315)

N per 100 Patient-years
Placebo qw + TCS (n=315)	Dupilumab 300 mg q2w + TCS (n=110)	Dupilumab 300 mg qw + TCS (n=315)

Total number of AEs

1493

478

1482

532.38

476.23

507.73

Total number of serious adverse events (SAEs)

7.85

4.98

3.43

Patients with AEs

≥1 AEs

84% (266)

88% (97)

83% (261)

321.38

383.68

322.89

Death^a

<1% (1)

.34

≥1 SAE

5% (16)

4% (4)

3%(9)

5.86

4.05

3.12

AEs leading to treatment discontinuation

8% (24)

2% (2)

3% (9)

8.52

2.70

2.81

Adverse events

Infections and infestations

58% (182)

57% (63)

53%(166)

108.08

101.50

94.33

Nasopharyngitis

19% (61)

23% (25)

19% (60)

24.80

29.23

23.67

Upper respiratory tract Infection

10% (32)

10% (11)

14% (43)

12.27

11.89

16.17

Sinusitis

3% (9)

2% (2)

6% (18)

3.26

2.00

6.43

Influenza

5% (17)

4% (4)

3% (9)

6.24

4.06

3.13

Eye disorders

15% (46)

31% (34)

32% (102)

17.99

43.63

44.85

Conjunctivitis

8% (25)

14% (15)

19% (61)

9.42

16.36

23.81

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Efficacy of Dupilumab

^aThe 1 death was caused by a motor vehicle accident that was not considered to be related to study drug.