Artikel
Secukinumab shows significant efficacy in nail psoriasis: week 32 results from the TRANSFIGURE study
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Autoren
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Kristian Reich
- Dermatologikum Hamburg, Hamburg
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John Sullivan
- Holdsworth House Dermatology, Sydney, Australia
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Peter Arenberger
- Dermatologische Klinik, Karls Universität Prag, Prag, Tschechische Republik
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Ulrich Mrowietz
- Universitätsklinikum Schleswig-Holstein, Klinik für Dermatologie, Venerologie und Allergologie, Kiel
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Sasha Jazayeri
- Alliance Dermatology and MOHS Center, Phoenix, USA
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Matthias Augustin
- Universitätsklinikum Hamburg-Eppendorf, IVDP - Institut für Versorgungsforschung in der Dermatologie und bei Pflegeberufen, Hamburg
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Anne Parneix
- Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
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Pascaline Regnault
- Novartis Pharma AG, Basel, Schweiz
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Ruquan You
- Novartis Beijing Novartis Pharma Co. Ltd, Shanghai, China
-
Marina Milutinovic
- Novartis Pharma AG, Basel, Switzerland
| Veröffentlicht: | 29. August 2016 |
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Gliederung
Text
Background: Nail psoriasis is associated with decreased finger mobility, functional impairment, pain, 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 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. PBO in treating subjects with moderate to severe psoriasis and significant nail involvement, as assessed by NAPSI at Wk 16 and Wk 32 and PASI at Wk 32. Impact on quality of life was assessed by NAPPA-PBI and -QOL at Wk 16.
Methods: TRANSFIGURE is a double-blind, randomized, PBO-controlled, parallel-group multicentre phase 3b study. 198 Patients were randomized 1:1:1 to receive either secukinumab 300 mg, 150 mg or PBO s.c. 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: 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.
Conclusion: 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.
References
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- 2.
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- Reich K. Approach to managing patients with nail psoriasis. J Eur Acad Dermatol Venereol. 2009 Sep;23 Suppl 1:15-21. DOI: 10.1111/j.1468-3083.2009.03364.x
