Secukinumab shows significant efficacy in palmoplantar psoriasis: Results from GESTURE, a randomized controlled trial
Background: Plaque psoriasis affecting palms and soles is disabling and often resistant to treatment. Objective: Evaluate the efficacy and safety of secukinumab, an anti-interleukin 17A antibody, in subjects with palmoplantar psoriasis. Methods: In this double-blinded, randomized controlled trial, 205 subjects were randomized 1:1:1 to secukinumab 300 mg, 150 mg, or placebo. The primary endpoint was Palmoplantar Investigator's Global Assessment (ppIGA) 0 (clear) or 1 (almost clear/minimal) response at week 16. Results: At week 16, the percentage of subjects who achieved clear or almost clear palms and soles (or ppIGA 0/1) with secukinumab 300 mg (33.3%) and 150 mg (22.1%) was superior to the percentage achieved with placebo (1.5%, . P < .001). Palmoplantar Psoriasis Area and Severity Index (ppPASI) was significantly reduced with secukinumab 300 mg (-54.5%) and 150 mg (-35.3%) compared with placebo (-4.0%, . P < .001). Dermatology Life Quality Index (DLQI) 0/1 responses from subjects in the secukinumab groups were also significantly higher compared with placebo at week 16 (P < .01) and pain and function of palms and soles was markedly improved with secukinumab as measured by the palmoplantar Quality-of-Life Instrument. Secukinumab 300 mg consistently showed the best outcomes. The safety profile was favorable and similar to previous studies. Limitations: Lack of active comparator. Conclusion: In GESTURE, the largest randomized controlled trial in palmoplantar psoriasis, secukinumab demonstrated the greatest efficacy to date for treating difficult-to-treat psoriasis.
|Keywords||Clear or almost clear skin, Clinical trial, Palmoplantar psoriasis, Quality of life, Secukinumab, Superiority|
|Persistent URL||dx.doi.org/10.1016/j.jaad.2016.07.058, hdl.handle.net/1765/94629|
|Journal||American Academy of Dermatology. Journal|
Gottlieb, A. (Alice), Sullivan, J. (John), van Doorn, M. (Martijn), Kubanov, A. (Alexey), You, R. (Ruquan), Parneix, A. (Anne), … Milutinovic, M. (Marina). (2017). Secukinumab shows significant efficacy in palmoplantar psoriasis: Results from GESTURE, a randomized controlled trial. American Academy of Dermatology. Journal, 76(1), 70–80. doi:10.1016/j.jaad.2016.07.058