Secukinumab retreatment-as-needed versus fixed-interval maintenance regimen for moderate to severe plaque psoriasis: A randomized, double-blind, noninferiority trial (SCULPTURE) - 17/06/15
, Craig L. Leonardi, MD b, Giampiero Girolomoni, MD c, Darryl Toth, MD, FRCPC d, Akimichi Morita, MD e, Shyamal A. Balki, FCPS f, Jacek C. Szepietowski, MD g, Pascaline Regnault, PhD h, Helen Thurston, MSc h, Charis Papavassilis, MD hfor the
SCULPTURE Study Group
Abstract |
Background |
Secukinumab has demonstrated high, sustained efficacy in psoriasis to 52 weeks on a fixed-interval regimen.
Objective |
We sought to compare a retreatment-as-needed versus a fixed-interval regimen.
Methods |
In this double-blind study, adults with moderate to severe plaque psoriasis were randomized 1:1 to subcutaneous secukinumab at 300 mg (n = 484) or 150 mg (n = 482) weekly from baseline until week 4, and at week 8. At week 12, patients achieving 75% or more improvement from baseline Psoriasis Area and Severity Index score (PASI 75) were rerandomized to 2 dose levels of secukinumab retreatment as needed (n = 217, 300 mg; n = 206, 150 mg) or fixed interval (n = 217; n = 203). Primary end point was noninferiority of retreatment as needed versus fixed interval for maintaining PASI 75 to week 52.
Results |
Secukinumab induced high responses by week 12 (84.4%-91.1% PASI 75 responders). From week 12 to week 52, more patients on fixed interval (78.2%, 300 mg; 62.1%, 150 mg) maintained PASI 75 versus retreatment as needed (67.7%; 52.4%); statistical noninferiority of retreatment as needed was not established. Overall safety, including very low incidences of treatment-emergent anti-drug antibodies (<0.5%), was similar between regimens.
Limitations |
The primary end point was developed without any known precedent.
Conclusion |
Secukinumab fixed interval showed clear benefit versus the study-specified retreatment-as-needed regimen for maintaining efficacy. Both regimens exhibited safety consistent with previous trials. The potential of retreatment as needed with secukinumab warrants further investigation.
Il testo completo di questo articolo è disponibile in PDF.Key words : clinical trial, dosing, immunogenicity, noninferiority, psoriasis, retreatment as needed, secukinumab
Abbreviations used : AE, DLQI, IGA, PASI, PASI 75, PASI 90, PASI 100, QOL, SCULPTURE, STATURE
Mappa
| Study funded by Novartis Pharmaceuticals. It was designed by the scientific steering committee and Novartis personnel. Investigators collected data, Novartis conducted data analyses, and all authors had access to data. The initial draft of the manuscript was written by a medical writer compensated by Novartis. All authors had final responsibility for the decision to submit for publication. |
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| Disclosure: The authors received writing and editorial support from Barry Weichman and Jinling Wu in the preparation of the manuscript from BioScience Communications, New York, NY, supported by Novartis. Dr Mrowietz has served as advisor and/or received speaker honoraria and/or received grants and/or participated in clinical trials for Abbott/AbbVie, Almirall, Amgen, BASF, Biogen Idec, Celgene, Centocor, Eli Lilly, Forward Pharma, Galderma, Janssen, Leo Pharma, Medac, MSD, Miltenyi Biotech, Novartis, Pfizer, Teva, VBL, and Xenoport. Dr Leonardi has served as consultant and/or investigator and/or participated in a speaker's bureau for AbbVie, Amgen, Celgene, Dermira, Eli Lilly, Galderma, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Sandoz, Stiefel, and UCB. Dr Girolomoni has received advisory/speaker honoraria and/or research funding from AbbVie, Almirall, Boehringer Ingelheim, Celgene, Dompé, Eli Lilly, Galderma, Janssen, Leo Pharma, Merck Serono, Maruho, MSD, Novartis, and Pfizer. Dr Toth has served as investigator for Novartis, Amgen, Eli Lilly, Johnson & Johnson, Abbott, Celgene, Merck, Galderma, and Leo Pharma. Dr Morita has served as consultant and/or paid speaker for and/or participated in psoriasis clinical trials sponsored by AbbVie, Mitsubishi Tanabe, Janssen, Novartis, Eli Lilly, Kyowa-Kirin, Leo Pharma, Maruho, and MSD. Dr Szepietowski has served as advisor and/or received speakers honoraria and/or participated in clinical trials for Abbott/AbbVie, Actavis, Amgen, BASF, Astellas, Berlin-Chemie/Menarini, Biogenetica International Laboratories, Centocor, Fresenius, Janssen, Leo Pharma, Mitsubishi Tanabe, Novartis, Pierre-Fabre, Takeda, Toray Corporation, and Vichy. Dr Regnault, Ms Thurston, and Dr Papavassilis are employees of and/or own stock in Novartis. Dr Balki has no conflicts of interest to declare. |
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| Reprints not available from the authors. |
Vol 73 - N° 1
P. 27 - luglio 2015 Ritorno al numero
Articolo precedente
- Change of Address
- Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, in patients with moderate to severe plaque psoriasis: Results of a phase III, randomized, controlled trial (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis [ESTEEM] 1)
- Kim Papp, Kristian Reich, Craig L. Leonardi, Leon Kircik, Sergio Chimenti, Richard G.B. Langley, ChiaChi Hu, Randall M. Stevens, Robert M. Day, Kenneth B. Gordon, Neil J. Korman, Christopher E.M. Griffiths
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