Secukinumab Shows High and Sustained Efficacy in Nail Psoriasis

2.5-year Results From the Randomized Placebo-controlled TRANSFIGURE Study

K. Reich; J. Sullivan; P. Arenberger; S. Jazayeri; U. Mrowietz; M. Augustin; B. Elewski; R. You; P. Regnault; J.A. Frueh

Disclosures

The British Journal of Dermatology. 2021;184(3):425-436. 

In This Article

Patients and Methods

Study Design

TRANSFIGURE is a randomized, double-blind, placebo-controlled, parallel-group phase IIIb trial conducted across 39 study locations in 10 countries. The study was conducted in accordance with the principles of the Declaration of Helsinki (Appendix S1; see Supporting Information).

The study consisted of a screening period of up to 6 weeks, followed by a 16-week placebo-controlled treatment period (Treatment Period 1). Patients were randomized 1 : 1 : 1 to receive secukinumab 300 mg, secukinumab 150 mg or placebo. At week 16, all patients receiving placebo were rerandomized 1 : 1 to receive secukinumab 300 mg or 150 mg. This was followed by a further 2·5 years of treatment (Treatment Period 2), and an 8-week treatment-free follow-up period (Figure 1). Patients received subcutaneous treatment once weekly for 5 weeks (at BL, weeks 1–4), followed by dosing every 4 weeks, starting at week 4.

Figure 1.

Study design. BL, baseline; EOTP, end of treatment period; EOF, end of follow-up period; s.c., subcutaneous.

Study Population

Patients eligible for the study included men or women aged ≥ 18 years with moderate-to-severe PsO [BL Psoriasis Area and Severity Index (PASI) ≥ 12 and body surface area (BSA) ≥ 10%] that included significant nail involvement (defined by fingernail NAPSI ≥ 16 and at least four involved fingernails). Eligible patients must have had psoriasis that was previously inadequately controlled by topical treatment and/or phototherapy and/or systemic therapy. Key exclusion criteria are defined in Appendix S2 (see Supporting Information).

Study Objectives

As previously reported by Reich et al.,[25] the primary objective of the study was to demonstrate the superiority of secukinumab 300 mg and/or 150 mg over placebo in patients with nail psoriasis as assessed by NAPSI at week 16.[21] Secondary objectives included the evaluation of the efficacy of secukinumab treatment in patients with nail psoriasis up to 2·5 years (week 132), as assessed by change in NAPSI score over time, PASI 75/90/100 response, Novartis Investigator's Global Assessment (IGA) modified in 2011 (IGA mod 2011) response (IGA 0 or 1), and safety and tolerability at week 16 compared with placebo, and over time up to 2·5 years. Exploratory objectives included assessing the number of fingernails involved and patient-reported outcomes, which included two assessments specific for nail psoriasis, i.e. NAPPA-QoL and NAPPA-PBI,[26] and generic assessment tools such as the EuroQol 5-Dimension (EQ-5D) health status questionnaire,[27] Dermatology Life Quality Index (DLQI)[28] and Subject's Global Assessment (SGA) of nail psoriasis using visual analogue scale (VAS) (Appendix S3; see Supporting Information).

Safety Assessments

Safety was evaluated by monitoring adverse events (AEs), laboratory and vital sign assessments, electrocardiograms, physical condition and body height/weight.

Statistical Analyses

The detailed analyses have been described previously (by Reich et al.)[25] and in Appendix S4 (see Supporting Information). All safety evaluations were performed on the safety set. For safety analyses, treatment groups analysed for the entire treatment period were defined as any secukinumab 150 mg, any secukinumab 300 mg, placebo and any secukinumab dose.

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