Effect of secukinumab on clinical activity and disease burden of nail psoriasis: 32-week results from the randomized placebo-controlled TRANSFIGURE trial
Abstrakt
BACKGROUND: Nail psoriasis is associated with functional impairment, pain and reduced quality of life. OBJECTIVE: To demonstrate the superiority of secukinumab vs. placebo in clearing nail psoriasis as assessed by NAil Psoriasis Severity Index (NAPSI) at Week 16 and over time up to Week 132.
Presented here is the Week 32 interim analysis. Impact on quality of life was assessed by Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA) patient questionnaires.
METHODS: TRANSFIGURE is a double-blind, randomized, placebo-controlled study in subjects with moderate to severe plaque and nail psoriasis. RESULTS: The primary objective of this study was met: both doses of secukinumab were superior to placebo at Week 16 (NAPSI improvement of -45.3%, -37.9%, and -10.8%, for secukinumab 300 mg, 150 mg and placebo, respectively, P<0.0001).
Significant improvements were seen in patients' quality of life: NAPPA-QOL total score median decrease at Week 16 was 60.9%, 49.9% and 15.8% for secukinumab 300 mg, 150 mg and placebo, respectively (P<0.0001). Improvement in nail psoriasis continued to Week 32: NAPSI % change reached -63.2% and -52.6%, for secukinumab 300 mg and 150 mg, respectively.
Skin clearance was significant (PASI 90: 72.5%, 54.0% and 1.7% for secukinumab 300 mg, 150 mg and placebo at Week 16, respectively, P<0.0001) and was sustained to Week 32. The most common adverse events were nasopharyngitis, headache, and upper respiratory tract infections.
CONCLUSIONS: Secukinumab demonstrated significant and clinically meaningful efficacy and quality of life improvements for patients with nail psoriasis up to Week 32.