Efficacy of Secukinumab on Moderate-to-severe Plaque Psoriasis Affecting Different Body Regions: a Pooled Analysis of Four Phase 3 Studies

Abstract

Introduction: The impact of psoriasis varies with the body region affected. In addition, patients have different perceptions of disease improvement and treatment satisfaction based on the location of skin clearance with treatment. The monoclonal antibody secukinumab selectively targets interleukin-17A-a central cytokine of psoriasis-and provides rapid and sustained clearance for moderate-to-severe psoriasis affecting all body regions. The objective of this study was to evaluate the efficacy of secukinumab on moderate-to-severe psoriasis affecting the trunk, upper limbs, and lower limbs.

Methods: Data were pooled from four phase 3 studies. To be included in the analysis for each body region, patients were required to have a Psoriasis Area and Severity Index (PASI) score ≥12 for that body region and psoriasis covering ≥10% of the surface area of that region. Secukinumab was administered at Baseline, Weeks 1, 2 and 3, and then every 4 weeks from Week 4 to 48.

Results: Across the trunk, upper limbs, and lower limbs, initial PASI subscore responses were sustained to Week 52. At Week 52, trunk (T) PASI 90/100 responses were achieved by 78.4%/71.1% of patients receiving secukinumab 300 mg, respectively, and by 66.3%/56.9% of patients receiving secukinumab 150 mg, respectively. At Week 52, upper limb (UL) PASI 90/100 responses were achieved by 67.3%/59.1% of patients receiving secukinumab 300 mg, respectively, and by 50.3%/43.3% of patients receiving secukinumab 150 mg, respectively. At Week 52, lower limb (LL) PASI 90/100 responses were achieved by 63.9%/55.3% of patients receiving secukinumab 300 mg, respectively, and by 45.1%/36.4% of patients receiving secukinumab 150 mg, respectively. A 50% reduction in mean PASI subscore occurred after 2.8, 2.9, and 3.4 weeks with secukinumab 300 mg on the trunk, upper limbs, and lower limbs, respectively.

Conclusion: Secukinumab provided robust and sustained efficacy for moderate-to-severe psoriasis affecting the trunk, upper limbs, and lower limbs.

Funding: Novartis Pharmaceuticals Corporation.

Trial registration: ClinicalTrials.gov identifiers: NCT01365455, NCT01358578, NCT01555125, and NCT01636687.

Keywords: Lower limbs; Moderate-to-severe psoriasis; Phase 3; Plaque psoriasis; Pooled analysis; Secukinumab; Trunk; Upper limbs.

Figures

Fig. 1

PASI 90 subscore response rates by body region. Missing values were imputed by multiple imputation. Clinical response rates for a trunk, b upper limbs, and c lower limbs from Baseline to Week 52. n Represents the number of evaluable subjects. PASI 90 90% improvement from Baseline Psoriasis Area and Severity Index

Fig. 2

PASI 100 subscore response rates by body region. Missing values were imputed by multiple imputation. Clinical response rates for a trunk, b upper limbs, and c lower limbs from Baseline to Week 52. n Represents the number of evaluable subjects. PASI 100 100% improvement from Baseline Psoriasis Area and Severity Index

Fig. 3

Percent change in mean PASI subscore over time by body region. A repeated-measures, mixed-effects model was used to analyze the mean percent change from Baseline for a TPASI, b ULPASI, and c LLPASI subscores. The median time to a 50% reduction in mean PASI subscore was estimated from parametric bootstrap samples with the use of linear interpolation between time points. CI confidence interval, LLPASI lower limb Psoriasis Area and Severity Index, TPASI trunk Psoriasis Area and Severity Index, ULPASI upper limb Psoriasis Area and Severity Index