Use of Digital Methods to Collect Real-World Data in Participants With Psoriatic Arthritis Treated With the IL-23 Inhibitor Guselkumab or IL-17 Inhibitors: Baseline Characteristics From the eDaily Psabiond Sub-Study

OBJECTIVES: Psoriatic arthritis (PsA) is a chronic inflammatory disease with fluctuating and unpredictable course, yet patients are seen every ~3-6 months in routine practice, thus missing between-visit clinical insight. Electronic devices can provide a more detailed and continuous picture of PsA impact on patient health.

METHODS: In the PsABIOnd observational study (NCT05049798)¹ of PsA participants initiating IL-23 inhibitor (i) guselkumab or IL-17i, eDaily is an ongoing sub-study enrolling in 5 countries. eDaily participants used their internet-enabled mobile phone to access the Daman eDaily app and collect daily self-reported ratings (eDiary), weekly/monthly electronic patient-reported outcomes (ePROs), and a wearable actigraphy device² to continuously monitor physical activity and sleep. Baseline characteristics and eDiary ratings of mood, pain, fatigue, skin disease, and morning stiffness, and weekly ePROs (including Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F] and Medical Outcomes Study [MOS] Sleep scale) were analysed descriptively, pooling treatment groups.

RESULTS: Between 07-February-2023 and 08-January-2024, eDaily enrolled 17 evaluable participants (target of 30, recruitment ongoing). Baseline mean participant age was 51.9yrs, 53% were male, clinical Disease Activity Index for PsA (cDAPSA) score was 30.2, participant‑assessed pain was 67.2, and 37% had >3% psoriatic body surface area. During the eDaily pre‑treatment period (≥9‑14 days), eDiary mean daily levels of mood, pain, fatigue, skin disease, and morning stiffness were 51.2, 29.8, 37.9, 56.3, and 43.5, respectively (0-100 scale, higher scores=better health); FACIT-F (25.9) and MOS-Sleep Index II (47.4) scores indicated substantial levels of fatigue and sleep disturbance. eDiary and ePRO completion rates ranged from 76-88%.

CONCLUSIONS: Despite challenges with eDaily enrolment, high eDiary and ePRO completion rates were observed among participants. Baseline participant-assessed and eDiary pain scores (inverted scales) were consistent. Participants had multi-domain PsA and negatively impacted quality-of-life. eDaily will capture between-visit patient health status, thereby enhancing health economic assessment of PsA impact and treatment decision-making.