Correlation Between Change in Psoriasis Area and Severity Index and Dermatology Life Quality Index in Patients with Psoriasis: Pooled Analysis from Four Phase 3 Clinical Trials of Secukinumab

Abstract

Introduction: Patients with psoriasis (PsO) experience impaired health-related quality of life due to physical and psychosocial burdens. The objective of this study was to assess the correlation between change in Psoriasis Area and Severity Index (PASI) score and selected Dermatology Life Quality Index (DLQI) domain scores in patients with moderate-to-severe PsO and those with PsO and comorbid psoriatic arthritis (PsA).

Methods: This post hoc analysis of four phase 3 clinical trials included patients with moderate-to-severe PsO randomized to secukinumab 150/300 mg, etanercept, or placebo. Pairwise latent growth models were applied to assess the longitudinal correlation between change in PASI scores and changes in three DLQI domain scores (daily activities, leisure activities, and symptoms/feelings). The initial (baseline to week 12) and sustained (week > 12 to week 52) treatment exposures were analysed by population type (total, PsO only, and PsO with comorbid PsA) and treatment arm (secukinumab, etanercept, or placebo).

Results: Among the total population (N = 2401), PASI change was positively correlated with change in each assessed DLQI domain; correlations were weak to moderate over the initial treatment exposure period (β range, 0.20-0.29; all P < 0.001) and moderate to strong over the sustained exposure period (β range, 0.63-0.69; all P < 0.001). Similar trends were observed regardless of the presence of comorbid PsA. These relationships were confirmed among patients treated with secukinumab, etanercept, or placebo.

Conclusions: Improvements in PASI scores were directly moderately related to improvements in DLQI domain scores from initiation of treatment and extended over time, regardless of presence of comorbid PsA or treatment received.

Clinical trial registration: ERASURE (NCT01365455), FIXTURE (NCT01358578), FEATURE (NCT01555125), and JUNCTURE (NCT01636687).

Keywords: Clinical outcomes; Psoriasis; Quality of life.

Fig. 1

Study design. PsA psoriatic arthritis, PsO psoriasis. ^aNumber of patients who had Psoriasis Area and Severity Index and Dermatology Life Quality Index data available

Fig. 2

Correlation of change in PASI and DLQI domains in a all patients, b patients with PsO only, and c patients with PsO and comorbid PsA. DLQI, Dermatology Life Quality Index; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; PsO, psoriasis. ^aβ (standardized residual covariance: i.e. the correlation between the slopes not explained by the included covariates) indicates that a change of 1 standardized value on the PASI will result in a change in a standardized value on the DLQI at the reported value (e.g. 0.20 for the initial treatment exposure on daily activities for the total population)

Fig. 3

Correlation of change in PASI score with DLQI domains in patients with PsO receiving a secukinumab, b etanercept, or c placebo. DLQI, Dermatology Life Quality Index; PASI, Psoriasis Area and Severity Index; PsO, psoriasis. ^aβ (standardized residual covariance: i.e. the correlation between the slopes not explained by the included covariates) indicates that a change of 1 standardized value on the PASI will result in a change in a standardized value on the DLQI at the reported value (e.g. 0.25 for the initial treatment exposure of secukinumab on daily activities). ^bPatients who did not achieve PASI75 at week 12 were re-randomized 1:1 to receive secukinumab 300–150 mg