Understanding genetic variations is important in predicting the treatment response and forms the basis for identifying new pharmacogenetic and pharmacogenomic targets for the treatment of psoriasis. Limited data are available for the efficacy of secukinumab in relation to genetic markers. OBJECTIVE: To evaluate the efficacy and safety of secukinumab 300 mg in HLA-Cw6-positive (Cw6-POS) and HLA-Cw6-negative (Cw6-NEG) patients with moderate-to-severe chronic plaque-type psoriasis. METHODS: SUPREME was a 24-week, Phase 3b study with an extension period up to 72 weeks. The primary endpoint was Psoriasis Area Severity Index (PASI) 90 response rate after 16 weeks. RESULTS: Patients (434) were recruited: 185 (42.6%) were Cw6-POS, and 246 (56.7%) were Cw6-NEG (3 not assessed). The mean age was 45.2±13.2 years (Cw6-POS, 42.7±13.1; Cw6-NEG, 47.2±12.9). The baseline PASI score was comparable between the two cohorts (Cw6-POS, 20.7±8.99; Cw6-NEG, 21.5±9.99; p=0.7766). At Week 16, PASI 90 was achieved in 80.4% of Cw6-POS and 79.7% of Cw6-NEG patients (difference: 0.76; 95% confidence interval: -7.04, 8.23). No differences in the mean (standard deviation) absolute PASI at Week 16 (Cw6-POS, 1.36±3.58; Cw6-NEG, 1.18±2.29) were observed. The overall safety profile of secukinumab was consistent with that reported in earlier studies. No statistically significant difference was detected in the rate of treatment-emergent adverse events (Cw6-POS, 42.7%; Cw6-NEG, 49.6%; p=0.2955). A high PASI 90 response was achieved with secukinumab irrespective of the HLA-Cw6 status, with a fast reduction in absolute PASI. CONCLUSION: Determination of the HLA-Cw6 status for secukinumab therapy is unnecessary, as it is highly effective regardless of the HLA-Cw6 status. This article is protected by copyright. All rights reserved.

Costanzo, A., Bianchi, L., Flori, M., Malara, G., Stingeni, L., Bartezaghi, M., et al. (2018). Secukinumab shows high efficacy irrespective of HLA-Cw6 status in patients with moderate-to-severe plaque-type psoriasis: SUPREME study. BRITISH JOURNAL OF DERMATOLOGY, 179(5), 1072-1080 [10.1111/bjd.16705].

Secukinumab shows high efficacy irrespective of HLA-Cw6 status in patients with moderate-to-severe plaque-type psoriasis: SUPREME study.

Bianchi, L;Carraro, L;Galluzzo, M;
2018-01-01

Abstract

Understanding genetic variations is important in predicting the treatment response and forms the basis for identifying new pharmacogenetic and pharmacogenomic targets for the treatment of psoriasis. Limited data are available for the efficacy of secukinumab in relation to genetic markers. OBJECTIVE: To evaluate the efficacy and safety of secukinumab 300 mg in HLA-Cw6-positive (Cw6-POS) and HLA-Cw6-negative (Cw6-NEG) patients with moderate-to-severe chronic plaque-type psoriasis. METHODS: SUPREME was a 24-week, Phase 3b study with an extension period up to 72 weeks. The primary endpoint was Psoriasis Area Severity Index (PASI) 90 response rate after 16 weeks. RESULTS: Patients (434) were recruited: 185 (42.6%) were Cw6-POS, and 246 (56.7%) were Cw6-NEG (3 not assessed). The mean age was 45.2±13.2 years (Cw6-POS, 42.7±13.1; Cw6-NEG, 47.2±12.9). The baseline PASI score was comparable between the two cohorts (Cw6-POS, 20.7±8.99; Cw6-NEG, 21.5±9.99; p=0.7766). At Week 16, PASI 90 was achieved in 80.4% of Cw6-POS and 79.7% of Cw6-NEG patients (difference: 0.76; 95% confidence interval: -7.04, 8.23). No differences in the mean (standard deviation) absolute PASI at Week 16 (Cw6-POS, 1.36±3.58; Cw6-NEG, 1.18±2.29) were observed. The overall safety profile of secukinumab was consistent with that reported in earlier studies. No statistically significant difference was detected in the rate of treatment-emergent adverse events (Cw6-POS, 42.7%; Cw6-NEG, 49.6%; p=0.2955). A high PASI 90 response was achieved with secukinumab irrespective of the HLA-Cw6 status, with a fast reduction in absolute PASI. CONCLUSION: Determination of the HLA-Cw6 status for secukinumab therapy is unnecessary, as it is highly effective regardless of the HLA-Cw6 status. This article is protected by copyright. All rights reserved.
2018
Pubblicato
Rilevanza internazionale
Articolo
Esperti anonimi
Settore MED/35 - MALATTIE CUTANEE E VENEREE
English
Costanzo, A., Bianchi, L., Flori, M., Malara, G., Stingeni, L., Bartezaghi, M., et al. (2018). Secukinumab shows high efficacy irrespective of HLA-Cw6 status in patients with moderate-to-severe plaque-type psoriasis: SUPREME study. BRITISH JOURNAL OF DERMATOLOGY, 179(5), 1072-1080 [10.1111/bjd.16705].
Costanzo, A; Bianchi, L; Flori, M; Malara, G; Stingeni, L; Bartezaghi, M; Carraro, L; Castellino, G; Galluzzo, M; Supreme Study, G
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2108/201529
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