Efficacy of Secukinumab for Moderate-to-Severe Head and Neck Psoriasis Over 52 Weeks: Pooled Analysis of Four Phase 3 Studies

Abstract

Introduction: Psoriasis affecting the head and neck can be difficult to treat, and the presence of extensive and highly visible lesions may result in substantial psychosocial burdens. Secukinumab, a monoclonal antibody that selectively targets interleukin-17A, provides rapid and sustained clearance of moderate-to-severe psoriasis. The objective of this study was to evaluate the efficacy of secukinumab on moderate-to-severe psoriasis affecting the head and neck. The safety and overall efficacy of secukinumab in patients with moderate-to-severe psoriasis will be described.

Methods: Data were pooled from four phase 3 studies. To be included in the head and neck analysis, patients were required to have Baseline head and neck Psoriasis Severity Area Index (PASI) scores ≥12 and psoriasis covering ≥10% of the head and neck. Secukinumab (300 or 150 mg) was administered at Baseline, Weeks 1, 2 and 3, and then every 4 weeks from Week 4 to 48.

Results: Secukinumab demonstrated high efficacy on the head and neck and the whole body. At Week 52, head and neck PASI 90/100 subscore responses were achieved by 76.0%/68.7% of patients receiving secukinumab 300 mg, respectively, and by 61.4%/53.1% of patients receiving secukinumab 150 mg, respectively. At Week 52, whole body composite PASI 90/100 responses were achieved by 68.1%/40.8% of patients receiving secukinumab 300 mg, respectively, and by 47.6%/24.3% of patients receiving secukinumab 150 mg, respectively. Secukinumab also improved Dermatology Life Quality Index scores.

Conclusion: Secukinumab provided robust and sustained efficacy for head and neck, and whole body psoriasis, over 52 weeks, with a favorable safety profile.

Funding: Novartis Pharmaceuticals Corporation.

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

Keywords: Head and neck psoriasis; Moderate-to-severe psoriasis; Phase 3; Plaque psoriasis; Pooled analysis; Secukinumab.

Fig. 1

Efficacy of secukinumab on the head and neck over time. Missing values were imputed by multiple imputation. Clinical response rates for a HNPASI 75, b HNPASI 90, and c HNPASI 100 from Baseline to Week 52. n represents the number of evaluable subjects. HNPASI 75/90/100, 75%/90%/100% improvement from Baseline head and neck psoriasis area and severity index scores

Fig. 2

Percent change in mean HNPASI score over time. A repeated-measure, mixed-effects model was used to analyze the mean percent change from Baseline in PASI score. The median time to a 50% reduction in mean HNPASI score was estimated from parametric bootstrap samples with the use of linear interpolation between time points. CI confidence interval, HNPASI head and neck psoriasis area severity index

Fig. 3

Efficacy of secukinumab on the whole body over time. Missing values were imputed by multiple imputation. Clinical response rates for a PASI 75, b PASI 90, and c PASI 100 from Baseline to Week 52. PASI 75/90/100, 75%/90%/100% improvement from Baseline psoriasis area and severity index scores