Baseline characteristics of patients with moderate-to-severe psoriasis according to previous systemic treatment exposure: the PROSE study population.

Abstract

Psoriatic disease is associated with considerable impairment of Quality of Life (QoL). The PROSE study (NCT02752776) examined the impact of secukinumab on patient-reported outcomes in patients with moderate-to-severe psoriasis (PsO) stratified by previous exposure to systemic treatment. In this prospective, non-randomized, multicentre study, patients were categorized at baseline according to previous exposure to systemic treatment: naïve [naïve to any systemic treatment (N=663)], conventional systemic [previously exposed to ≥1 conventional systemic therapy (N=673)] and biologics [previously exposed to ≥1 biologic (N=324)]. Baseline demographics including age, gender, race, body weight and body mass index, disease characteristics and patient-reported QoL outcomes [Dermatology Life Quality Index (DLQI), Family DLQI (F-DLQI)] of patients enrolled in the study are reported here. Baseline demographic characteristics were well balanced across the three subpopulations. Naïve patients had a shorter time since diagnosis (15.5±12.1years) compared with the conventional systemic (19.1±12.5years) and biologic patients (23.0±12.5years), and lower rates of psoriatic arthritis (6.6% vs. 17.4% and 27.8%, respectively). Metabolic syndrome (37.6-43.5%), obesity (16.9-19.1%), hyperlipidaemia (15.3-21.9%) and diabetes mellitus (6.8-14.2%) were reported at numerically higher rate in the biologic group. The mean PASI (19.7±7.9), affected Body Surface Area (28.2±15.3%) as well as the Investigator Global Assessment score (patients with score 4: 33.7%) indicated severe disease at baseline and were comparable for the three groups. QoL impairment was evident from mean DLQI (14.1±7.1: naïve=13.5±6.8; conventional systemic=14.3±7.0; biologic=14.8±7.7) and mean F-DLQI (11.5±7.0: naïve=11.3±7.1; conventional systemic=11.4±6.7; biologic=12.1±7.7) also indicated derangement of QoL of patients and their families. Patients naïve to systemic treatment had shorter disease journey compared with patients previously exposed to systemic treatments; despite this, the severe impact of disease on patient and family QoL outcomes can be as apparent in naïve patients as in systemically treated patients at baseline.