Safety and efficacy of brodalumab for psoriasis after 120 weeks of treatment - 15/11/14
, 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 dAbstract |
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. |
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| 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. |
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| Supplemental tables are available at www.jaad.org. |
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| Reprints not available from the authors. |
Vol 71 - N° 6
P. 1183 - décembre 2014 Retour au numéro
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
- 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
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