Background: Nail psoriasis is associated with functional impairment, pain and reduced quality of life. Objectives: To demonstrate the superiority of secukinumab over placebo in clearing nail psoriasis as assessed by the 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 patients 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 improvements of -45,3%, -37,9% and -10,8% for secukinumab 300 mg and 150 mg and placebo, respectively, P<0,001). Significant improvements were seen in patients’ quality of life: the NAPPA-Quality of Life total score median decreases at week 16 were 60,9%, 49,9% and 15,8% for secukinumab 300 mg and 150 mg and placebo, respectively (P < 0_001). Improvement in nail psoriasis continued to week 32: NAPSI percentage change reached -63,2% and -52,6% for secukinumab 300 mg and 150 mg, respectively. Skin clearance measured by ≥90% improvement in Psoriasis. Area and Severity Index was significant (rates of 72,5%, 54,0% and 1,7% for secukinumab 300mg and 150mg and placebo at week 16, respectively, P<0,001) and was sustained to week 32. The most common adverse events were nasopharyngitis, headache and upper respiratory tract infections. Conclusion: Secukinumab demonstrated significant and clinically meaningful efficacy and quality-of-life improvements for patients with nail psoriasis up to week 32.
The use of rheumatoid arthritis health-related quality of life patient questionnaires in clinical practice: Lessons learned
