Journal
JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Volume 73, Issue 1, Pages 27-U109Publisher
MOSBY-ELSEVIER
DOI: 10.1016/j.jaad.2015.04.011
Keywords
clinical trial; dosing; immunogenicity; noninferiority; psoriasis; retreatment as needed; secukinumab
Categories
Funding
- Novartis Pharmaceuticals
Ask authors/readers for more resources
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.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available