PO:31:163 | Safety and tolerability of home-based prostacyclin analogue therapy in vascular manifestations of the scleroderma spectrum: results of a monocentric study

Alice Dionisi¹, Lucrezia Verardi², Annacarla Finucci², Paola Volpe², Anna Cinzia Raspa², Paola Cipriani¹, Raffaele Zicolella² | ¹Reumatologia,Dipartimento di Sscienze Cliniche Applicate e Biotecnologiche, Università degli Studi dell'Aquila; ²UOC Reumatologia, Ospedale Civile di Pescara, Italy

Background. To evaluate the safety and perceived efficacy of home-based prostacyclin analogue infusions compared with hospital administration in patients with vascular manifestations of the Scleroderma Spectrum.

Methods: In 2019, a pilot program for home-based Iloprost infusions was launched at the Local Health Authority (ASL) of Pescara. We performed a retrospective 6-year analysis including patients receiving home therapy for at least 6 months. Patients completed a structured questionnaire assessing: • frequency of vascular manifestations, • comparison between home (EL) and hospital (DH) administration in terms of side effects, • acceptability and overall impact of home treatment. Blood pressure values were collected before, during, and after each home infusion.

Results. Thirty-four patients were included. Most reported subjective improvement of Raynaud’s phenomenon. A moderate positive correlation (ρ ≈ 0.47) was observed between the duration of home treatment and perceived benefit. Among the 5 patients with active digital ulcers, 4 reported improvement. Only two patients had pulmonary arterial hypertension; therefore, no conclusions were drawn for this subgroup. Eight side effects were evaluated on a 0–3 scale. Nausea, flushing, and headache were significantly reduced during home treatment (p < 0.05), while hypotension and diarrhea showed no significant differences. Elastomer pump acceptability was high: 100% of patients judged it easy to handle, 97% felt safe using it, and 88% reported improved quality of life. Regarding hemodynamic effects, systolic blood pressure showed a significant reduction during infusion (−4.6 mmHg; p = 0.0015) followed by recovery afterwards (+3.1 mmHg; p = 0.011). Diastolic pressure changes were milder, with a slight decline during infusion (−1.5 mmHg; p = 0.083) and a significant increase at the end (+2.8 mmHg; p = 0.026). Mean arterial pressure varied transiently and was well tolerated. Only one patient showed marked variability, suggesting the need for individualized monitoring in unstable cases.

Conclusions. Home-based prostacyclin analogue infusions appear safe, well tolerated, and associated with high patient acceptance in the Scleroderma Spectrum. These findings support the implementation of home Iloprost therapy as an integral component of vascular management in this population.