Secukinumab shows high efficacy irrespective of HLA ‐Cw6 status in patients with moderate to severe plaque‐type psoriasis: Results from extension phase of the SUPREME study

Background Understanding genetic variations is important in predicting treatment response and forms the basis for identifying new pharmacogenetic and pharmacogenomic targets for psoriasis treatment. There are limited data on the efficacy of secukinumab in relation to genetic markers. Objectives Methods 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. SUPREME was a 24-week, phase IIIb study with an extension period up to 72 weeks. Primary end point was Psoriasis Area Severity Index (PASI) 90 response rate after 16 weeks. Results Conclusions In total, 434 patients were recruited: 185 (42 center dot 6%) were Cw6-POS and 246 (56 center dot 7%) were Cw6-NEG (three not assessed). Mean +/- SD age was 45 center dot 2 +/- 13 center dot 2 years (Cw6-POS 42 center dot 7 +/- 13 center dot 1; Cw6-NEG 47 center dot 2 +/- 12 center dot 9). The baseline PASI score was comparable between the cohorts [Cw6-POS 20 center dot 7 +/- 8 center dot 99; Cw6-NEG 21 center dot 5 +/- 9 center dot 99 (P = 0 center dot 777)]. At week 16, PASI 90 was achieved in 80 center dot 4% of Cw6-POS and 79 center dot 7% of Cw6-NEG patients (difference 0 center dot 76; 95% confidence interval -7 center dot 04 to 8 center dot 23). No differences in absolute PASI at week 16 (Cw6-POS 1 center dot 36 +/- 3 center dot 58; Cw6-NEG 1 center dot 18 +/- 2 center dot 29) were observed. The overall safety profile of secukinumab was consistent with that previously reported. No statistically significant difference was detected in the rate of treatment-emergent adverse events [Cw6-POS 42 center dot 7%; Cw6-NEG 49 center dot 6% (P = 0 center dot 295)]. A high PASI 90 response was achieved with secukinumab with a fast reduction in absolute PASI. Determination of HLA-Cw6 status for secukinumab therapy is unnecessary, as it is highly effective regardless of HLA-Cw6 status.