INTRODUCTION: Patients with moderate-to-severe psoriasis often experience significant physical symptoms and notable psychosocial distress. Pruritus is the most bothersome symptom and a key contributor to sleep disturbances and reduced quality of life (QoL). Though biologics such as risankizumab have advanced clinical management, real-world evidence of patient-reported outcomes (PROMs) and objective pruritus assessment remains limited. This study assessed risankizumab's effectiveness in improving QoL, symptom burden, and sleep and evaluated the feasibility of nocturnal scratch monitoring using a wearable sensor. METHODS: PRIMMA was a multicenter, prospective, non-interventional study conducted in Israel among adults with moderate-to-severe psoriasis initiating label-approved risankizumab therapy. Outcomes were assessed at baseline and week 52, and included Dermatology Life Quality Index (DLQI), static Psoriasis Global Assessment (sPGA), Pruritus Numeric Rating Scale (PNRS), Psoriasis Symptoms Scale (PSS), Medical Outcomes Study Sleep Scale (MOS-SS), Work Productivity and Activity Impairment (WPAI), and adverse events. Objective nocturnal scratch activity was measured using ADAM digital patch sensors in a subgroup of patients. RESULTS: In 136 participants, the median age was 51 years, 57% were male, 43% were female, and 35% were bio-naïve. At week 52, 58% achieved DLQI 0/1 (versus 5.1% at baseline; p < 0.001) and 81% had PNRS 0-3 (versus 21% at baseline; p < 0.001). sPGA 0/1 was reached by 77% at week 52, and components of PSS and WPAI improved significantly. In patients who achieved any favorable outcome (DLQI 0/1, PNRS 0-3, sPGA 0/1) at week 24, ≥ 68% maintained it at week 52, demonstrating treatment durability. In the digital subcohort (n = 14), sensor data confirmed significant reduction in nocturnal scratch duration at week 4 and week 16 compared to baseline (both p ≤ 0.032). Adverse events were mostly mild to moderate. CONCLUSIONS: In real-world practice, risankizumab showed substantial improvements in QoL, pruritus, sleep, and work/activity impairment in moderate-to-severe psoriasis. Digital scratch monitoring showed reduction in nocturnal scratch duration. Integrating objective digital measures with PROMs may enable more data-driven, individualized management in psoriasis care. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT04780516.
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