Abstract
Background: Secukinumab has demonstrated significant efficacy with a good safety profile through 1 year in plaque psoriasis. Given the chronic nature of this disease, long-term follow-up is needed to evaluate psoriasis therapies fully. Objectives: To determine the long-term (3-year) efficacy and safety of secukinumab in moderate-to-severe psoriasis. Methods: Patients completing 52 weeks of secukinumab treatment in the SCULPTURE core study entered an extension in which they continued the same double-blind regimens. Dosing regimens included a fixed-interval schedule (FI; every 4 weeks) and retreatment as needed (RAN), in which patients were withdrawn from secukinumab and received placebo until the start of relapse, at which time secukinumab every 4 weeks was reinitiated. The study was registered with number NCT01640951. Results: In total 168 patients receiving secukinumab 300 mg FI and 172 receiving secukinumab 300 mg RAN entered the extension. Secukinumab 300 mg FI sustained high efficacy: at the end of year 3, the proportion of responders achieving ≥ 90% improvement in Psoriasis Area and Severity Index (PASI 90) was 63·8%, and of PASI 100 responders it was 42·6%. The mean absolute PASI remained low (2–4) from week 52 to week 152 with 300 mg FI, with approximately two-thirds of patients reporting no impact of skin disease on their lives (Dermatology Life Quality Index of 0 or 1). Improvements in overall and subscale scores on all quality-of-life instruments were well sustained. As in the core study, FI dosing was consistently more efficacious than RAN. No new safety signals were identified to year 3. Conclusions: Secukinumab 300 mg FI sustained high responses and improved quality of life with no new safety concerns through 3 years.
| Original language | English |
|---|---|
| Journal | British Journal of Dermatology |
| Volume | 177 |
| Issue number | 4 |
| Pages (from-to) | 1033-1042 |
| Number of pages | 10 |
| ISSN | 0007-0963 |
| DOIs | |
| Publication status | Published - 10.2017 |
Funding
1Innovaderm Research Inc, Montreal, QC, Canada 2Department of Dermatology, University of M€unster, M€unster, Germany 3Comprehensive Center for Inflammation Medicine, University Hospital Schleswig-Holstein, L€ubeck, Germany 4XLR8 Medical Research, Windsor, ON, Canada 5Novartis Pharmaceuticals, East Hanover, NJ, U.S.A. 6Novartis Beijing Novartis Pharma Co. Ltd, Shanghai, China 7Novartis Pharma AG, Basel, Switzerland 8Psoriasis-Center, Department of Dermatology, University Medical Center Schleswig-Holstein, Kiel, Germany The authors received writing and editorial support from Andrew Horgan, PhD (BioScience Communications, New York, NY), which was supported by Novartis. Conflicts of interest: R.B. is an advisory board member for and has received honoraria from AbbVie, Amgen, BMS, Janssen and Merck. He is a consultant for and receives honoraria from Abb-Vie, Amgen, Celgene, Eli Lilly and Company, Galderma, Incyte, Janssen, LEO Pharma, Merck and Novartis. He is a speaker for and receives honoraria from AbbVie, Amgen, Galderma, Jans-sen, LEO Pharma and Merck. He is an investigator for and his institution receives grant support from AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly and Company, Galderma, GSK-Stiefel, Merck, Novartis, Pfizer, Kineta, Incyte, Janssen and LEO Pharma. T.L. has been an investigator and consultant for AbbVie, Almirall, Bayer, Biogen, Boehringer Ingelheim, Cel-gene, CERIES, Delenex, Galderma, Janssen, La Roche Posay, LEO Pharma, Eli Lilly, Maruho, Meda, MSD, Novartis, Pfizer, Sanofi-Aventis, Symrise and Wolff. D. Tha©ci has been working as an advisor and/or presenter for and/or has been a recipient of research support from and/or has participated in clinical studies for the following companies: Abbott/AbbVie, Almirall-Hermal, Amgen, Celgene, Dignity Pharma, Dr. Reddy, Eli Lilly, Forward Pharma, Galderma, Galapagos, Janssen, LEO Pharma, Maruho, Meda, Medac, MSD, Novartis, Pfizer, Regeneron, Sandoz-Hexal, Sanofi and VBI. D. Toth has been a principal investigator for Abbott, Amgen, Celgene, Eli Lilly, Merck, Janssen, Novartis, Pfizer, Regeneron, Genentech, LEO Pharma and Gal-derma, and has served on advisory boards for Abbott, Celgene, Amgen, Eli Lilly, Janssen, Novartis, Regeneron, Genentech, LEO Pharma and Galderma. I.M., R.Y., A.G., T.F., C.P. and I.G. are employees of Novartis. U.M. has been working as an advisor and/or presenter for and/or is a recipient of research support from and/or is a participant at clinical studies for the following companies: AbbVie, Almirall, Amgen, BASF, Biogen, Celgene, Centocor, Eli Lilly, Forward Pharma, Galderma, Janssen-Cilag, LEO Pharma, Medac, MSD, Miltenyi Biotech, Novartis, Pfizer, VBL and Xenoport.
Research Areas and Centers
- Academic Focus: Center for Infection and Inflammation Research (ZIEL)
