Efficacy and Safety of Secukinumab in Elderly Subjects with Moderate to Severe Plaque Psoriasis: A Pooled Analysis of Phase III Studies

Abstract

Background: Psoriasis is a chronic inflammatory skin disease, affecting patients of a wide age range, including elderly patients. Elderly patients can respond differently to drug treatments and can be more vulnerable to adverse reactions. There are limited data on biologic therapies for psoriasis in elderly subjects. Secukinumab, a fully human monoclonal antibody that selectively neutralizes IL-17A, has proven significant efficacy in the treatment of moderate to severe psoriasis.

Aims: A post-hoc analysis of three phase III trials (ERASURE, FIXTURE and CLEAR) was performed to evaluate the efficacy and safety of secukinumab in elderly subjects.

Methods: Studies were multicentre, randomized, parallel-group, double-blind, 52-week phase III trials in subjects with moderate to severe plaque psoriasis. For efficacy analyses, 67 elderly subjects (≥ 65 years) treated with secukinumab 300 mg were compared with 841 younger subjects (18-64 years). Psoriasis Area and Severity Index (PASI), Dermatological Life Quality Index (DLQI) and safety were analysed.

Results: Elderly subjects had higher baseline frequencies of cardiovascular and metabolic disorders. Secukinumab efficacy in elderly subjects was comparable to that in younger subjects throughout 52 weeks of treatment. PASI 75 response was reached by 81.8% of elderly subjects and 79.4% of younger subjects at Week 52. Similar rates of DLQI 0/1 response were observed. The total rate of adverse events was similar between elderly and younger subjects.

Conclusions: Secukinumab at the recommended dose (300 mg) is effective and acceptably safe in subjects aged ≥ 65 years with moderate to severe psoriasis, with quality-of-life benefits, despite an increased prevalence of cardiovascular and metabolic comorbidities in this population.

Fig. 1

Secukinumab efficacy in elderly and younger subjects in pooled studies. PASI and IGA mod 2011 0/1 response rates in the analysis population comprising patients treated with secukinumab 300 mg for up to 52 weeks in ERASURE, FIXTURE and CLEAR (non-responder imputation). PASI Psoriasis Area and Severity Index, DLQI Dermatological Life Quality Index, IGA mod 2011 0/1 modified Investigator’s Global Assessment

Fig. 2

Absolute PASI scores at Week 52 in the analysis population comprising patients treated with secukinumab 300 mg for up to 52 weeks in ERASURE, FIXTURE and CLEAR. PASI Psoriasis Area and Severity Index, Q4 W every 4 weeks

Fig. 3

DLQI response at Week 52 in the analysis population comprising patients treated with secukinumab 300 mg for up to 52 weeks in ERASURE, FIXTURE and CLEAR (last observation carried forward). DLQI Dermatological Life Quality Index