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Randomized Controlled Trial
. 2019 Mar;46(3):186-192.
doi: 10.1111/1346-8138.14761. Epub 2019 Jan 23.

Long-term efficacy and safety of secukinumab in Japanese patients with moderate to severe plaque psoriasis: 3-year results of a double-blind extension study

Yukari Okubo  1 , Mamitaro Ohtsuki  2 , Akimichi Morita  3 , Masako Yamaguchi  4 , Tomohiro Shima  4 , Yumiko Tani  4 , Hidemi Nakagawa  5 ; Extension Study Japanese Subgroup
Affiliations
Randomized Controlled Trial

Long-term efficacy and safety of secukinumab in Japanese patients with moderate to severe plaque psoriasis: 3-year results of a double-blind extension study

Yukari Okubo et al. J Dermatol. 2019 Mar.

Abstract

Secukinumab, a fully human monoclonal antibody neutralizing interleukin-17A, has been shown to have significant efficacy in the treatment of moderate to severe psoriasis. Long-term (3-year) efficacy and safety of secukinumab in Japanese patients with moderate to severe psoriasis were evaluated in an extension study of a large phase 3 global study (SCULPTURE). In the core study, 52 Japanese patients with 75% improvement of Psoriasis Area and Severity Index (PASI-75) response at week 12 were re-randomized to a fixed interval (FI; every 4 weeks) schedule and retreatment as needed (RAN), in which patients received placebo until start of relapse, at which time secukinumab was reinitiated. Fifty Japanese patients completed the 52-week core study, and 47 patients entered the extension study with the same double-blind regimens up to week 152. All patients in the secukinumab 300 mg FI and seven patients in 150 mg FI groups completed 3 years of treatment. PASI-90 and -100 at the end of year 3 were achieved in 69.2% and 53.8%, respectively, in 300 mg FI and 42.9% and 42.9%, respectively, in 150 mg FI, indicating high sustained response in 300 mg FI. Mean absolute PASI was continually low in 300 mg FI and numerically higher in 150 mg FI. Dermatology Life Quality Index of 0/1 was maintained by approximately two-thirds of 300 mg FI patients, and all EuroQoL 5-Dimension Health Questionnaire domain measures were also improved. FI dosing was consistently more efficacious than RAN. The safety profile of secukinumab remained favorable, with no new safety concerns identified.

Keywords: Dermatology Life Quality Index; EuroQol 5-Dimension; psoriasis; randomized controlled trial; secukinumab.

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Figures

Figure 1
Figure 1
Percentage of patients with PASI response from week 12 through week 52 in the secukinumab 300 mg arm. The data was analyzed using observed values without imputation of any missing values. FI, fixed interval; PASI, Psoriasis Area and Severity Index; RAN, retreatment as needed.
Figure 2
Figure 2
Percentage of patients with PASI response from week 52 through week 152 in secukinumab 300 mg arm. The data was analyzed using observed values without imputation of any missing values. FI, fixed interval; PASI, Psoriasis Area and Severity Index; RAN, retreatment as needed.
Figure 3
Figure 3
Mean absolute PASI from week 0 through week 152 in secukinumab 300 mg arm. The data was analyzed using observed values without imputation of any missing values. FI, fixed interval; PASI, Psoriasis Area and Severity Index; RAN, retreatment as needed.
Figure 4
Figure 4
Proportion of DLQI total score 0/1 with the PASI response from week 0 through week 156 in the secukinumab 300 mg FI arm. *Week 0 (baseline): one patient had DLQI 0/1 at baseline. The data was analyzed using observed values without imputation of any missing values. DLQI, Dermatology Life Quality Index; FI, fixed interval; PASI, Psoriasis Area and Severity Index.
Figure 5
Figure 5
EQ‐5D domains from week 0 through week 76 in the secukinumab 300 mg FI arm. The data was analyzed using observed values without imputation of any missing values. EQ‐5D, EuroQoL 5‐Dimension Health Questionnaire; FI, fixed interval.
Figure 6
Figure 6
Health states of VAS over time change of secukinumab 300 mg FI arm and 300 mg RAN arm from week 0 through week 76. The data was analyzed using observed values without imputation of any missing values. EQ‐5D, EuroQoL 5‐Dimension Health Questionnaire; FI, fixed interval; RAN, retreatment as needed; VAS, visual analog scale.
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