Promising Use of Filgotinib in Patients Affected by Systemic Sclerosis: Preliminary Data From a Monocentric, Prospective, Open-label Study

Abstract Objective To assess the efficacy and safety of Filgotinib for the management of cutaneous, visceral and articular involvement in patients affected by Systemic sclerosis. Methods 5 patients affected by SSc referring to the Scleroderma Units of Modena and Reggio Emilia between October 2021 and February 2023, were enrolled. Patients received 200 mg of Filgotinib once daily for a period of 52 weeks. Skin, articular and visceral organ involvement were evaluated at the baseline and every 12 weeks after the start of the treatment. Results A significant improvement of articular involvement was seen at 12 th week. All patients confirmed a significant amelioration in articular involvement at 52 th week, with a significant reduction in TJ, SDAI/CDAI, DAS28-CRP. PDUS performed after 24 and 52 weeks of treatment supported the remission. A significant decrease of mRSS, improvement of other skin manifestations and a stabilization of ILD, assessed through HRCT and PFTs, were noticed in patients with dcSSc. The 2 patients with dsSSC showed a clinical improvement assessed using the CRISS score. No drug-related side effects were recorded and neither patients discontinued the treatment. No deaths were reported. Conclusion Filgotinib was safe, effective and well tolerated in the treatment of articular and visceral involvement in patients affected by SSc.