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FRI0460 Secukinumab Shows Significant Efficacy in Nail Psoriasis: Week 32 Results from The Transfigure Study
  1. K. Reich1,
  2. J. Sullivan2,
  3. P. Arenberger3,
  4. U. Mrowietz4,
  5. S. Jazayeri5,
  6. M. Augustin6,
  7. A. Parneix7,
  8. P. Regnault8,
  9. R. You9,
  10. M. Milutinovic8
  1. 1Dermatologikum, Hamburg, Germany
  2. 2Holdsworth House Dermatology, Sydney, Australia
  3. 3Department of Dermatology, Charles University, Prague, Czech Republic
  4. 4Psoriasis Center at the Department of Dermatology, University Medical Center Schleswig-Holstein, Kiel, Germany
  5. 5Alliance Dermatology and MOHS Center, Phoenix, United States
  6. 6Universität Hamburg, Hamburg, Germany
  7. 7Novartis Pharmaceuticals Corporation, East Hanover, United States
  8. 8Novartis Pharma AG, Basel, Switzerland
  9. 9Beijing Novartis Pharma Co. Ltd, Shanghai, China

Abstract

Background Nail psoriasis is associated with decreased finger mobility, functional impairment, pain and reduced quality of life [1] and is often resistant to available therapies.[2] It correlates with more severe psoriatic disease and is an important predictor of psoriatic arthritis (PsA).[3] The incidence of nail psoriasis in PsA patients is up to 80%.[4]

Objectives We assessed superiority of secukinumab 300 mg and/or 150 mg vs. placebo (PBO) in treating subjects with moderate to severe psoriasis and significant nail involvement, as assessed by NAil Psoriasis Severity Index (NAPSI) at Week (Wk) 16 and Wk 32 and Psoriasis Area and Severity Index (PASI) at Wk 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 Wk 16.

Methods TRANSFIGURE is a double-blind, randomized, PBO-controlled, parallel-group multicentre phase 3b study. Subjects (N=198) were randomized 1:1:1 to receive either secukinumab 300 mg, secukinumab 150 mg or PBO subcutaneously up to Wk 128. At Wk 16, all subjects receiving PBO were re-randomized 1:1 to receive 300 mg or 150 mg secukinumab.

Results The primary objective of this study was met. Both doses of secukinumab were superior to PBO at Wk 16 with a mean percentage NAPSI improvement from Baseline of -45.3%, -37.9%, and -10.8%, for secukinumab 300 mg, 150 mg and PBO, respectively (P <0.0001). Responses improved further by Wk 32 with a NAPSI change of -63.2% and -52.6%, for secukinumab 300 mg and 150 mg, respectively. At Wk 32, PASI 90 responses were achieved in 72.1% and 61.4% of subjects, and PASI 100 responses in 36.9% and 28.1% for secukinumab 300 mg and 150 mg, respectively. At Wk 16, subjects on secukinumab showed significant improvements in NAPPA-QOL with a median decrease in total score of 60.9%, 49.9% and 15.8% for secukinumab 300 mg, 150 mg and PBO, respectively. The percentage of subjects achieving a weighted NAPPA-PBI global score of 2 and above (i.e. at least moderate benefits) was 75.4%, 61.3% and 8.6% for secukinumab 300 mg, 150 mg and PBO, respectively. The most common adverse events were nasopharyngitis, headache and upper respiratory tract infections, similar to previous studies.

Conclusions In the prospective, placebo-controlled TRANSFIGURE trial, secukinumab demonstrated significant and clinically meaningful efficacy, quality of life improvement and patient-reported benefit in nail psoriasis.

  1. Baran R. Dermatology. 2010;221 Suppl 1:1–5

  2. Thaci D, Unnebrink K, Sundaram M, et al. JEADV. 2015 Feb; 29(2):353–360

  3. Langenbruch A, Radtke MA, Krensel M, et al. Br J Dermatol. 2014 Nov; 171(5):1123–8

  4. Reich K. JEADV. 2009 Sep; 23 Suppl 1:15–21

Acknowledgement This investigation was sponsored by Novartis Pharma AG, Basel, Switzerland. Medical writing assistance was provided by Gillian Brodie, Novartis Ireland Ltd.

Disclosure of Interest K. Reich Grant/research support from: K Reich has participated in clinical trials sponsored by AbbVie, Amgen, Biogen-Idec, Celgene, Centocor, Covagen, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, Leo, Lilly, Medac, MSD, Novartis, Pfizer, Takeda, and Vertex, Consultant for: K Reich has served as a consultant for AbbVie, Amgen, Biogen-Idec, Celgene, Centocor, Covagen, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, Leo, Lilly, Medac, MSD, Novartis, Pfizer, Takeda, and Vertex, J. Sullivan Grant/research support from: J Sullivan has received educational grants from Novartis, Abbvie and Pfizer., Consultant for: J Sullivan has received consultancy fees from Novartis, Abbvie, Pfizer and Eli Lilly. P. Arenberger Grant/research support from: P Arenberger has received grants from Novartis. U. Mrowietz Grant/research support from: U Mrowietz has received grants and/or participated in clinical trials for Abbott/AbbVie, Almirall, Amgen, BASF, Biogen Idec, Celgene, Centocor, Eli Lilly, Forward Pharma, Galderma, Janssen, Leo Pharma, Medac, MSD, Miltenyi Biotech, Novartis, Pfizer, Teva, VBL, and Xenoport. Consultant for: U Mrowietz has served as advisor and/or received speaker honoraria and/or received grants for Abbott/AbbVie, Almirall, Amgen, BASF, Biogen Idec, Celgene, Centocor, Eli Lilly, Forward Pharma, Galderma, Janssen, Leo Pharma, Medac, MSD, Miltenyi Biotech, Novartis, Pfizer, Teva, VBL, and Xenoport. S. Jazayeri Grant/research support from: S Jazayeri has received a grant from Novartis and personal fees outside of the submitted work., M. Augustin Grant/research support from: M Augustin has received grants and/or participated in clinical trials for Abbvie, Almirall, Amgen, Biogen Idec, Boehringer Ingelheim, Celgene, Centocor, Eli Lilly, Janssen-Cilag, Leo, Medac, MSD (formerly Essex, Schering-Plough), Mundipharma, Novartis, Pfizer (formerly Wyeth), Pohl Boskamp, Sandoz, Xenoport. Consultant for: M Augustin has served as advisor and/or received speaker honoraria from Abbvie, Almirall, Amgen, Biogen Idec, Boehringer Ingelheim, Celgene, Centocor, Eli Lilly, Janssen-Cilag, Leo, Medac, MSD (formerly Essex, Schering-Plough), Mundipharma, Novartis, Pfizer (formerly Wyeth), Pohl Boskamp, Sandoz, Xenoport. A. Parneix Employee of: A Parneix is a full time employee of Novartis, P. Regnault Employee of: P Regnault is a full time employee of Novartis, R. You Employee of: R You is a full time employee of Novartis, M. Milutinovic Employee of: M Milutinovic is a full time employee of Novartis

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