Key clinical-trial evidence about dupilumab

Author: Anoma Ranaweera B.V.Sc; PhD (Clinical Biochemistry, University of Liverpool, UK). Chief Editor: Dr Amanda Oakley, Dermatologist, Hamilton, New Zealand, January 2017.

There have been three pivotal phase 3 clinical studies evaluating dupilumab in the treatment of atopic dermatitis.

Dupilumab (Dupixent™; Sanofi, Paris, France; Regeneron, New York, USA) has shown significant efficacy and a favourable safety profile in two pivotal Phase 3 studies in monotherapy for moderate-to-severe atopic dermatitis, and in concomitant administration with topical corticosteroids.

The US Food and Drug Administration (FDA) has granted dupilumab a breakthrough therapy designation; The Biologics License Application (BLA) for dupilumab was recently accepted for Priority Review by the FDA with a target action date of March 29, 2017.

Dupilumab inhibits signalling of interleukin (IL)-4 and IL-13, two key cytokines required for the type 2 (including Th2) immune response, which is believed to be a major driver in atopic dermatitis.

Evidence for dupilumab efficacy from SOLO 1 and SOLO 2 trials

Table 1. Improvements in atopic dermatitis at 16 Weeks

 

Placebo

Dupilumab every 2 weeks

Dupilumab     weekly

P value vs placebo

IGA (SOLO 1)

10%

38%

37%

< 0.0001

IGA (SOLO 2)

9%

36%

36%

< 0.0001

EASI-75 (SOLO 1)

15%

51%

53%

< 0.0001

EASI-75 (SOLO 2)

12%

44%

48%

< 0.0001

Adverse reactions: clinical trial experience

Event

SOLO1

SOLO2

No.patients  (%)

Placebo qw (n = 222)

Dupilumab 300mg q2w (n = 229)

Dupilumab 300mg qw  (n= 218)

Placebo qw (n = 234)

Dupilumab 300mg q2w (n = 236)

Dupilumab 300mg qw (n= 237)

Nasopharyngitis

17 (8)

22 (10)

25 (12)

22 (9)

20 (9)

20 (8)

Conjunctivitis

2 (1)

11 (5)

7 (3)

1 (< 1)

9 (4)

9 (4)

Upper respiratory tract infection

5 (2)

6 (3)

11 (5)

5 (2)

7 (3)

9 (4)

Injection site reaction

13 (6)

19 (8)

41 (19)

52 (16)

32 (14)

31 (13)

Atopic dermatitis exacerbation

67 (30)

30 (13)

21 (10)

81 (35)

32 (14)

38 (16)

Headache

13 (6)

21 (9)

11 (5)

11 (5)

19 (8)

22 (9)

Allergic conjunctivitis

2 (1)

12 (5)

7 (3)

2 (1)

2 (1)

3 (1)

Long-term follow-up – clinical trial evidence from CHRONOS

Co- primary endpoint results at week 16 were:

Co-primary end-point results at week 52 were:

Next steps with dupilumab

Related information

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