LONG-TERM EVOLUTION OF BOSENTAN TREATMENT IN SYSTEMIC SCLEROSIS PATIENTS - THE EXPERIENCE OF A PRESCRIBING CENTRE FROM BUCHAREST, ROMANIA

Peripheral vasculopathy is a severe complication of systemic sclerosis (SSc) through digital ulcerations (DUs) that can lead to gangrene or amputations. Bosentan, an antagonist of endothelin receptor 1 with proven efficacy in preventing new onset of DUs in patients with SSc, was first introduced in Romania in 2014. Our objective was to evaluate the efficacy and long-term safety of bosentan in SSc patients in a prescribing centre in Bucharest. We included 49 patients with SSc (39 women, with a median (IQR) duration of follow-up of 25 (43) months), evaluated in our clinic between November 2014 and March 2021, who presented with DUs on admission or in the preceding three months. We compared clinical and laboratory data, including the number of DUs, Visual Analogue Scale (VAS) for Raynaud's phenomenon and DUs, Health Assessment Questionnaire disease index (HAQ) at baseline and follow-up. At the initiation of treatment, patients presented a median (IQR) of 4 (4) DUs, VAS Raynaud 8 (2), VAS DUs 9 (3), HAQ 1.75 (1), with a significant reduction at 12 months of the number of DUs to DUs 0 (0), VAS Raynaud 2 (2.9), VAS DUs 0.5 (1.75) and HAQ 0.88 (1.13), with a maintained efficacy for DUs, VAS Raynaud and VAS DUs for the entire follow-up period. There were 8 (16.3%) cases of hepatic cytolysis 3 - 6 times the upper normal limit which required discontinuation of treatment, but otherwise no severe reactions. The treatment with bosentan was efficient on the long-term and well-tolerated by most patients.