Médecine

Paramédical

Autres domaines


S'abonner

Safety and efficacy of brodalumab for psoriasis after 120 weeks of treatment - 15/11/14

Doi : 10.1016/j.jaad.2014.08.039 
Kim Papp, MD, PhD a, , Craig Leonardi, MD b, Alan Menter, MD c, Elizabeth H.Z. Thompson, PhD d, Cassandra E. Milmont, PhD d, Greg Kricorian, MD d, Ajay Nirula, MD, PhD d, Paul Klekotka, MD, PhD d
a Probity Medical Research, Waterloo, Ontario, Canada 
b Saint Louis University, Saint Louis, Missouri 
c Baylor University Medical Center, Dallas, Texas 
d Amgen Inc, Thousand Oaks, California 

Correspondence to: Kim Papp, MD, PhD, Probity Medical Research, 135 Union St E, Waterloo, Ontario N2J 1C4 Canada.

Abstract

Background

Brodalumab (anti–interleukin-17-receptor antibody) was effective in treating moderate to severe psoriasis in a 12-week, dose-ranging, placebo-controlled trial.

Objective

We sought to evaluate efficacy and safety of long-term brodalumab treatment.

Methods

In this interim analysis at week 120 of an open-label extension study, patients received brodalumab 210 mg every 2 weeks. Protocol amendments reduced the dose (140 mg) in patients weighing 100 kg or less and subsequently increased the dose (210 mg) in patients with inadequate responses. Efficacy was measured by static physician global assessment and 75% or greater, 90% or greater, or 100% improvement in Psoriasis Area and Severity Index score (PASI-75, PASI-90, and PASI-100, respectively).

Results

Of 181 patients, 144 completed week 120. Static physician global assessment scores of clear/almost clear and clear were achieved by 90% and 63% of patients, respectively, at week 12 and by 72% and 51% at week 120. The PASI-75, PASI-90, and PASI-100 response rates at week 12 (95%/85%/63%) were sustained through week 120 (86%/70%/51%). Most commonly reported adverse events were nasopharyngitis (26.5%), upper respiratory tract infection (19.9%), arthralgia (16.0%), and back pain (11.0%). Four patients had grade-2 absolute neutrophil count.

Limitations

There was no control group in this open-label extension.

Conclusion

Brodalumab demonstrated sustained clinical response and an acceptable safety profile through 120 weeks in patients with moderate to severe psoriasis.

Le texte complet de cet article est disponible en PDF.

Key words : anti–interleukin-17 therapy, brodalumab, clinical trial, efficacy, long-term treatment, open-label extension, psoriasis, safety

Abbreviations used : AE, DLQI, IL, OLE, PASI, PASI-75, PASI-90, PASI-100, Q2W, SF-36v2, sPGA


Plan


 Supported by Amgen Inc. Brodalumab is being co-developed by Amgen Inc and AstraZeneca/MedImmune.
 Disclosure: Dr Papp is a consultant, an investigator, and on the speakers bureau for AbbVie, Amgen, Astellas, Bayer, Boehringer Ingelheim, Celgene, Eli Lilly, Forward, Galderma, Janssen, LEO, Merck, Novartis, Pfizer, Roche, and UCB. Dr Leonardi has served as a consultant, an investigator, and/or speaker for Abbott, Amgen, Celgene, Centocor, Eli Lilly, Galderma, Genentech, Genzyme, GlaxoSmithKline, Incyte, Janssen Biotech, Maruho, Novartis, Novo Nordisk, Pfizer, Schering-Plough, Sirtris, Stiefel, Vascular Biogenics, and/or Wyeth. Dr Menter is on an advisory board for AbbVie, Allergan, Amgen, Boehringer Ingelheim, Genentech, Janssen Biotech, LEO, and Pfizer; is a consultant for AbbVie, Allergan, Amgen, Convoy Therapeutics, Eli Lilly, Janssen Biotech, LEO, Novartis, Pfizer, Syntrix Biosystems, Wyeth, and XenoPort; is an investigator for AbbVie, Allergan, Amgen, ApoPharma, Boehringer Ingelheim, Celgene, Convoy Therapeutics, Eli Lilly, Genentech, Janssen Biotech, LEO, Merck, Novartis, Pfizer, Symbio/Maruho, Syntrix Biosystems, and Wyeth; and is on the speakers bureau for AbbVie, Amgen, Janssen Biotech, LEO, and Wyeth. Drs Milmont, Kricorian, Nirula, and Klekotka are employees and shareholders of Amgen. Dr Thompson is a former employee of Amgen and is a shareholder of Amgen.
 Supplemental tables are available at www.jaad.org.
 Reprints not available from the authors.


© 2014  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
Ajouter à ma bibliothèque Retirer de ma bibliothèque Imprimer
Export

    Export citations

  • Fichier

  • Contenu

Vol 71 - N° 6

P. 1183 - décembre 2014 Retour au numéro
Article précédent Article précédent
  • A 52-week, open-label study of the efficacy and safety of ixekizumab, an anti-interleukin-17A monoclonal antibody, in patients with chronic plaque psoriasis
  • Kenneth B. Gordon, Craig L. Leonardi, Mark Lebwohl, Andrew Blauvelt, Gregory S. Cameron, Daniel Braun, Janelle Erickson, Michael Heffernan
| Article suivant Article suivant
  • A population-based study of the association between bullous pemphigoid and neurologic disorders
  • Katherine E. Brick, Chad H. Weaver, Rodolfo Savica, Christine M. Lohse, Mark R. Pittelkow, Bradley F. Boeve, Lawrence E. Gibson, Michael J. Camilleri, Carilyn N. Wieland

Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.

Déjà abonné à cette revue ?

;

Mon compte


Plateformes Elsevier Masson

Déclaration CNIL

EM-CONSULTE.COM est déclaré à la CNIL, déclaration n° 1286925.

En application de la loi nº78-17 du 6 janvier 1978 relative à l'informatique, aux fichiers et aux libertés, vous disposez des droits d'opposition (art.26 de la loi), d'accès (art.34 à 38 de la loi), et de rectification (art.36 de la loi) des données vous concernant. Ainsi, vous pouvez exiger que soient rectifiées, complétées, clarifiées, mises à jour ou effacées les informations vous concernant qui sont inexactes, incomplètes, équivoques, périmées ou dont la collecte ou l'utilisation ou la conservation est interdite.
Les informations personnelles concernant les visiteurs de notre site, y compris leur identité, sont confidentielles.
Le responsable du site s'engage sur l'honneur à respecter les conditions légales de confidentialité applicables en France et à ne pas divulguer ces informations à des tiers.