J. Sullivan, K. Reich, P. Arenberger, U. Mrowietz, S. Jazayeri, M. Augustin, A. Parneix, P. Regnault, R. You, M. Milutinovic
Introduction: TRANSFIGURE is a phase 3b study designed to evaluate the efﬁcacy and safety of secukinumab (an anti-IL-17A monoclonal antibody) in patients with moderate to severe psoriasis with signiﬁcant nail involvement. Here we report the 32-week data.
Materials and Methods: A total of 198 patients were randomized 1:1:1 to receive either secukinumab 300 mg/ 150 mg/placebo up to Week 128. At Week 16, all subjects receiving placebo were re-randomized 1:1 to receive 300 mg/150 mg secukinumab. Efﬁcacy was assessed by measuring the Nail Psoriasis Severity Index (NAPSI) of ﬁngernails (sum of NAPSI scores from all 10 ﬁngernails; total score 0–80) at Week 16 and Week 32. Impact on quality of life was assessed by Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA) Patient Beneﬁt Index (-PBI) and Quality of Life (-QOL) at Week 16.
Results: The primary objective of this study was met. Both doses of secukinumab were superior to placebo at Week
16 (mean NAPSI improvement from Baseline: -45.3%/37.9%/-10.8%, for secukinumab 300 mg/150 mg/placebo, respectively (p < 0.0001)). Responses improved further by Week 32 with a total ﬁngernail NAPSI change of -63.2%/52.6%, for secukinumab 300 mg/150 mg, respectively. At Week 16, patients showed signiﬁcant improvements in NAPPA-QOL with a median decrease in total score of 60.9%/49.9%/15.8% for secukinumab 300 mg/150 mg/placebo, respectively. The percentage of subjects achieving a weighted NAPPA-PBI global score of 2 and above (i.e. moderate beneﬁts) was 75.4%/61.3%/8.6% for secukinumab 300 mg/150 mg/placebo, respectively. The safety proﬁle was similar to other secukinumab phase 3 studies. Conclusion: Secukinumab demonstrated signiﬁcant efﬁcacy, quality of life improvement and patient-reported beneﬁt in nail psoriasis.