R Bissonnette1, T Luger2, D Thaçi3, D Toth4, I Messina5, R You6, A Guana5, T Fox7, C Papavassilis7, I Gilloteau7, U Mrowietz8. 1. Innovaderm Research Inc, Montréal, QC, Canada. 2. Department of Dermatology, University of Münster, Münster, Germany. 3. Comprehensive Center for Inflammation Medicine, University Hospital Schleswig-Holstein, Lübeck, Germany. 4. XLR8 Medical Research, Windsor, ON, Canada. 5. Novartis Pharmaceuticals, East Hanover, NJ, U.S.A. 6. Novartis Beijing Novartis Pharma Co. Ltd, Shanghai, China. 7. Novartis Pharma AG, Basel, Switzerland. 8. Psoriasis-Center, Department of Dermatology, University Medical Center Schleswig-Holstein, Kiel, Germany.
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regimens included a fixed-interval schedule (FI; every 4 weeks) and retreatment as needed (RAN), in which patients were withdrawn from secukinumab and received placebo until the start of relapse, at which time secukinumab every 4 weeks was reinitiated.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 receivingsecukinumab 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.
RCT Entities:
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.
Authors: Marloes E Van Muijen; Sarah E Thomas; Hans M M Groenewoud; Marisol E Otero; Paul M Ossenkoppele; Marcellus D Njoo; Sharon R P Dodemont; Else N Kop; Maartje A M Berends; Marjolein I A Koetsier; Johannes M Mommers; John E M Körver; Ron A Tupker; Marjolein S De Bruin-Weller; Lizelotte J M T Weppner-Parren; Bas Peters; Marloes M Kleinpenning; Astrid L A Kuijpers; W Peter Arnold; Paula P M Van Lümig; Juul M P A Van den Reek; Elke M G J De Jong Journal: Acta Derm Venereol Date: 2022-05-16 Impact factor: 3.875
Authors: R Bissonnette; T Luger; D Thaçi; D Toth; A Lacombe; S Xia; R Mazur; M Patekar; P Charef; M Milutinovic; C Leonardi; U Mrowietz Journal: J Eur Acad Dermatol Venereol Date: 2018-03-22 Impact factor: 6.166