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Home Topics A–Z 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.
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 |
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:
If you are not based in New Zealand, we suggest you refer to your national drug approval agency for further information about medicines (eg, the Australian Therapeutic Goods Administration and the US Food and Drug Administration) or a national or state-approved formulary (eg, the New Zealand Formulary and New Zealand Formulary for Children and the British National Formulary and British National Formulary for Children).
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