BACKGROUND: Psoriasis is a chronic skin condition that can negatively affect a patient's quality of life (QoL), often hindering social functioning. ISA247, a novel psoriatic agent, has shown clinical efficacy in moderate to severe psoriasis sufferers, but its effect on QoL is currently not reported. OBJECTIVE: The objective of this study was to assess the effect of ISA247 on the QoL in patients with stable, plaque-type psoriasis. METHODS: A phase II, randomized, double-blind, placebo-controlled, parallel-group, multicenter study assessed the effects of ISA247 doses of 0.5 mg/kg/d (n = 77) or 1.5 mg/kg/d (n = 83) compared with placebo (n = 41) for 12 weeks. QoL was assessed using the Dermatology Life Quality Index (DLQI) and Psoriasis Disability Index (PDI) scales. RESULTS:ISA247 treatment (pooled groups) significantly improved QoL scores as assessed by both the DLQI and the PDI compared with those receiving placebo (p < .05). Treatment with the higher dose of 1.5 mg/kg/d demonstrated a significantly greater response to many of the QoL scales compared with the 0.5 mg/kg/d group (p < .05). CONCLUSIONS:ISA247 appears to improve the QoL while also providing effective treatment for chronic, moderate to severe, plaque-type psoriasis.
RCT Entities:
BACKGROUND:Psoriasis is a chronic skin condition that can negatively affect a patient's quality of life (QoL), often hindering social functioning. ISA247, a novel psoriatic agent, has shown clinical efficacy in moderate to severe psoriasis sufferers, but its effect on QoL is currently not reported. OBJECTIVE: The objective of this study was to assess the effect of ISA247 on the QoL in patients with stable, plaque-type psoriasis. METHODS: A phase II, randomized, double-blind, placebo-controlled, parallel-group, multicenter study assessed the effects of ISA247 doses of 0.5 mg/kg/d (n = 77) or 1.5 mg/kg/d (n = 83) compared with placebo (n = 41) for 12 weeks. QoL was assessed using the Dermatology Life Quality Index (DLQI) and Psoriasis Disability Index (PDI) scales. RESULTS:ISA247 treatment (pooled groups) significantly improved QoL scores as assessed by both the DLQI and the PDI compared with those receiving placebo (p < .05). Treatment with the higher dose of 1.5 mg/kg/d demonstrated a significantly greater response to many of the QoL scales compared with the 0.5 mg/kg/d group (p < .05). CONCLUSIONS:ISA247 appears to improve the QoL while also providing effective treatment for chronic, moderate to severe, plaque-type psoriasis.
Authors: Nicole K Kelly; Aheli Chattopadhyay; S R Rathinam; John A Gonzales; Radhika Thundikandy; Anuradha Kanakath; S Bala Murugan; R Vedhanayaki; Dean Cugley; Lyndell L Lim; Eric B Suhler; Hassan A Al-Dhibi; Caleb D Ebert; Elyse J Berlinberg; Travis C Porco; Nisha R Acharya Journal: Ophthalmology Date: 2021-03-04 Impact factor: 14.277