Format

Send to

Choose Destination
J Am Acad Dermatol. 2019 Jul 30. pii: S0190-9622(19)32465-X. doi: 10.1016/j.jaad.2019.07.074. [Epub ahead of print]

Dupilumab shows long-term safety and efficacy in moderate-to-severe atopic dermatitis patients enrolled in a phase 3 open-label extension study.

Author information

1
Aarhus University Hospital, Aarhus, Denmark. Electronic address: mettdele@rm.dk.
2
Universityof Lübeck, Lübeck, Germany.
3
University of Rochester Medical Center, Rochester, NY, USA.
4
University Medical Centre Utrecht, Utrecht, Netherlands.
5
Oregon Medical Research, Portland, OR, USA.
6
Forman Dermatology and Skin Cancer Institute, Tampa, FL, USA.
7
Innovaderm Research, Montreal, Canada.
8
Center for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Skinflammation® Center, Hamburg, Germany, and Dermatologikum Berlin, Berlin, Germany.
9
Alabama Allergy & Asthma Center, Birmingham, AL, USA.
10
Vital Prospects Clinical Research Institute, PC, Tulsa, OK, USA.
11
University of Melbourne, Skin & Cancer Foundation Inc., Carlton, Australia.
12
Hiroshima University, Hiroshima, Japan.
13
Saint-Louis Hospital, Paris, France.
14
University of Pennsylvania, Philadelphia, PA, USA.
15
Peninsula Research Associates, Rolling Hills Estates, CA, USA.
16
University of Groningen, University Medical Centre Groningen, Groningen, Netherlands.
17
Regeneron Pharmaceuticals, Inc., Basking Ridge, NJ, USA.
18
Regeneron Pharmaceuticals, Tarrytown, NY, USA.
19
Sanofi, Chilly-Mazarin, France.
20
Sanofi, Bridgewater, NJ, USA.

Abstract

BACKGROUND:

Significant unmet need exists for long-term treatment of moderate-to-severe atopic dermatitis (AD).

OBJECTIVE:

To assess long-term safety and efficacy of dupilumab in AD patients.

METHODS:

This ongoing, multicenter, open-label extension (OLE) study (NCT01949311) evaluated long-term dupilumab treatment in adults who had previously participated in phase 1-3 dupilumab clinical trials in AD. This analysis examined patients given 300mg dupilumab weekly for up to 76 weeks at data cutoff (April 2016). Safety was the primary outcome; efficacy was also evaluated.

RESULTS:

Of 1,491 enrolled patients (1,042.9 patient-years), 92.9% remained on treatment at cutoff. The safety profile was consistent with previously reported trials (420.4 adverse events [AEs]/100 patient-years [100PY] and 8.5 serious AEs/100PY), with no new safety signals; common AEs included nasopharyngitis, conjunctivitis, and injection-site reactions. Sustained improvement was seen up to 76 weeks in all efficacy outcomes, including measures of skin inflammation, pruritus, and quality of life.

LIMITATIONS:

Lack of control arm, limited number of patients with ≥76 weeks of treatment (median follow-up: 24 weeks), and patients not receiving the approved 300mg every 2 weeks dose regimen.

CONCLUSION:

The safety and efficacy profile from this study supports the role of dupilumab as continuous long-term treatment for patients with moderate-to-severe AD.

KEYWORDS:

IL-13; IL-4; atopic dermatitis; biologic therapy; dupilumab; efficacy; long-term; monoclonal antibody; open label; quality of life; safety

PMID:
31374300
DOI:
10.1016/j.jaad.2019.07.074
Free full text

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center