Background: Iloprost is widely used to manage vascular manifestations in Systemic Sclerosis (SSc) patients, including Raynaud’s phenomenon (RP) and digital ulcers (DU). However, repeated Iloprost hospital infusion (IHI) may negatively impact on the quality of life and healthcare resources. Iloprost home-based administration (IHBa) via elastomeric pumps may represent a valid alternative, but real-life data on safety, tolerability and acceptability are still limited.

Objectives: To evaluate efficacy, safety, tolerability and patient acceptability of IHBa compared with IHI in patients with SSc.

Methods: In 2019, a pilot project was initiated at ASL Pescara, involving the use of IHBa in patients with SSc who had previously been treated with IHI for at least six months. A retrospective analysis was performed on the data collected over 6 years. Patients included in the project answered a structured questionnaire comparing the two route of administration exploring: (i)Differences in frequency of vascular manifestations; (ii) Differences in intensity and frequency of 6 adverse events (AE): hypotension, diarrhea, cutaneous flushing, nausea, muscle contractures, headache. Any change in the frequency of AE was scored using a 3-point ordinal scale (0=worse; 1=the same; 2=better). In addition, data on blood pressure (BP) recorded pre-, during, and post-infusions were analyzed to evaluate any hemodynamic effects. (iii) Treatment acceptance and its impact on daily life.

Results: Data of 34 patients included in the project were analysed, 32 of them (94.1%) were female, the mean age was 58.7 years. At the moment of the analysis the mean duration of IHBa was 34.1 months. RP and DU history were present respectively in 33 (97%) and 21 (61.7%) patients. Active DU were present in 5 (14.7%) patients at the time of initiating IHBa.

With IHBa most patients reported an improvement of RP frequency and intensity (p<0.05), and a resolution of active digital ulcers in 4 patients 11.7%. Intensity and frequency of nausea, cutaneous flushing and headache and muscle contractures were reported significantly lower in IHBa compared to IHI (p<0.05). No differences were found for the other AE. A correlation analysis revealed a moderate positive association between duration of IHBa and perceived improvement (Spearman’s ρ≈0.47). Systolic BP showed a decrease during infusion (mean −4.6 mmHg; p=0.0015), followed by a complete recover at infusion completion (mean +3.1 mmHg; p=0.011). Mean arterial pressure decreased from 89.5 mmHg to 87.0 mmHg during infusion and returned to 89.9 mmHg afterwards (p<0.05, mean SD 3.7–4.6 mmHg).

Patient acceptance of IHBa was high: 100% of patients reported the device was easy to handle, 97% felt confident using it, and 88% perceived an improvement in quality of life. No major practical issues were reported.

Conclusions: Iloprost has been shown to be effective in improving acral SSc patients vascular manifestations. However, its administration is often limited by poor tolerability, leading to dose reduction or treatment discontinuation. In addition, hospitalization negatively impacts both patients’ quality of life and healthcare resource utilization. Administration at a very low flow rate using an elastomeric pump improves drug tolerability. In our single-centre experience, IHBa appeared more efficacious, tolerated and better acceptable by SSc patients compared to IHI. These results support IHBa as a potentially more sustainable, patient-centred model for long-term management of vascular complications in scleroderma.

REFERENCES: NIL.

Acknowledgments: NIL.

Disclosure of Interests: None declared.