Secukinumab long-term safety experience: A pooled analysis of 10 phase II and III clinical studies in patients with moderate to severe plaque psoriasis - 21/06/16
, Christopher E.M. Griffiths, MD b, Kristian Reich, MD, PhD c, Craig L. Leonardi, MD d, Andrew Blauvelt, MD, MBA e, Tsen-Fang Tsai, MD f, Yankun Gong, PhD g, Jiaqing Huang, MD, PhD h, Charis Papavassilis, MD, PhD i, Todd Fox, RPh, PharmB, ACPR iAbstract |
Background |
Secukinumab, a fully human anti–interleukin-17A monoclonal antibody, has demonstrated efficacy and safety in patients with moderate to severe plaque psoriasis.
Objective |
We reviewed safety data from the secukinumab psoriasis phase II/III program.
Methods |
Data were pooled from 10 phase II/III secukinumab psoriasis studies.
Results |
Analysis included 3993 subjects; 3430 received secukinumab, representing 2725 subject-years (SYs) of exposure. Over 52 weeks, for secukinumab 300 mg, 150 mg, and etanercept, respectively, exposure-adjusted incidence rates (IRs) per 100 SYs were comparable across treatments for total adverse events (AEs; 236.1, 239.9, and 243.4, respectively); infections (91.1, 85.3, and 93.7, respectively); serious AEs (7.4, 6.8, and 7.0, respectively); serious infections (1.4, 1.1, and 1.4, respectively); malignant or unspecified tumors (0.77, 0.97, and 0.68, respectively); and adjudicated major adverse cardiovascular events (0.42, 0.35, and 0.34, respectively). AEs were not dose-related except for nonserious, mild/moderate, skin/mucosal candidiasis (IRs 3.55, 1.85, and 1.37 for secukinumab 300 mg, 150 mg, and etanercept, respectively).
Limitations |
There was a limited number of patients in comparator groups and the exposure to placebo was short.
Conclusion |
Secukinumab had a favorable safety profile, had no meaningful difference between the 300- and 150-mg doses and, in terms of safety, was comparable to etanercept over 52 weeks in patients with moderate to severe plaque psoriasis.
Le texte complet de cet article est disponible en PDF.Key words : long-term safety, phase II studies, phase III studies, pooled analysis, psoriasis, secukinumab
Abbreviations used : AE, ANC, BCC, CI, IBD, IL, IR, MACE, MI, NMSC, SAE, SCC, SOC, SY, TNF
Plan
| Supported by Novartis Pharma AG. The authors received writing and editorial support in the preparation of the manuscript from BioScience Communications, New York, NY, supported by Novartis Pharma AG. |
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| Dr van de Kerkhof has carried out clinical trials or provided consultancies and/or acted as a speaker for AbbVie, Almirall, Amgen, Celgene, Centocor, Eli Lilly, Galderma, Janssen-Cilag, Leo Pharma, Mitsubishi, Novartis, Pfizer, Philips, and Sandoz. Dr Griffiths has received honoraria or research grants from AbbVie, Amgen, Bristol-Meyers Squibb, Celgene, Eli Lilly, GSK, Janssen-Cilag, Leo, MSD, Novartis, Pfizer, Sandoz, Trident, and UCB. Dr Reich has served as a consultant or paid speaker for or participated in clinical trials sponsored by AbbVie, Amgen, Biogen-Idec, Celgene, Centocor, Covagen, Eli Lilly, Forward Pharma, GSK, Janssen-Cilag, Leo, Medac, MSD, Novartis, Pfizer, Takeda, and Vertex. Dr Leonardi has served as consultant or investigator or participated in a speakers' bureau for AbbVie, Amgen, Celgene, Dermira, Eli Lilly, Galderma, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Sandoz, Stiefel, and UCB. Dr Blauvelt has served as a scientific consultant and clinical study investigator for AbbVie, Amgen, Boehringer Ingelheim, Celgene, Demira, Eli Lilly, Genentech, Janssen, Merck, Novartis, Pfizer, Regeneron, and Sandoz. Dr Tsai has carried out clinical trials or provided consultancies or acted as a speaker for AbbVie, Allergan, Celgene, Eli Lilly, Galderma, Janssen-Cilag, Leo Pharma, Novartis, and Pfizer. Drs Gong, Huang, and Papavassilis and Mr Fox are full-time employees of or own stock in Novartis. |
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| Supplementary materials are available at www.jaad.org. |
Vol 75 - N° 1
P. 83 - juillet 2016 Retour au numéro
Article précédent
- Clinical meaningfulness of complete skin clearance in psoriasis
- Bruce Strober, Kim A. Papp, Mark Lebwohl, Kristian Reich, Carle Paul, Andrew Blauvelt, Kenneth B. Gordon, Cassandra E. Milmont, Hema N. Viswanathan, Joanne Li, Lionel Pinto, David J. Harrison, Greg Kricorian, Ajay Nirula, Paul Klekotka
- Apremilast, an oral phosphodiesterase-4 inhibitor, in the treatment of palmoplantar psoriasis: Results of a pooled analysis from phase II PSOR-005 and phase III Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) clinical trials in patients with moderate to severe psoriasis
- Robert Bissonnette, David M. Pariser, Norman R. Wasel, Joana Goncalves, Robert M. Day, Rongdean Chen, Michael Sebastian
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