Bosentan in Clinical Practice for Treating Digital and Other Ischemic Ulcers in Spanish Patients with Systemic Sclerosis: IBER-DU Cohort Study

Abstract

Previously reported results of bosentan efficacy in DU management are reproducible in clinical practice. This efficacy is maintained in the longterm followup. Bosentan treatment was well tolerated and adverse events were comparable with those observed in previous reports.

Effectiveness of bosentan in the treatment of systemic sclerosis-related digital ulcers: Systematic review and meta-analysis

“…The weighted mean difference (WMD) of SSc-HAQ score following bosentan treatment was reported in four studies. [ 11 12 18 20 ] Our results indicated a nonsignificant pooled WMD decrease of − 0.09 (95%CI: −0.020,0.02, P = 0.1; I 2 = 0%, P = 0.96) in SSc-HAQ score [ Figure 4a ]. In addition, a nonsignificant publication bias was suggested according to Egger's test ( P > 0.05) and funnel plot [ Figure 4b ].…”

“…Ultimately, 16 full texts were retrieved for further examination. A total of eight articles met our inclusion criteria, comprising three RCTs,[ 11 12 16 ] four prospective,[ 17 18 19 20 ] and one retrospective[ 21 ] study conducted between 2004 and 2021. Details of the included studies in the systematic review and meta-analysis are summarized in Table 1 .…”

“…Details of the included studies in the systematic review and meta-analysis are summarized in Table 1 . Four studies were from Europe and North America,[ 11 12 20 21 ] two from Asia,[ 15 18 ] one from Eurasia,[ 16 ] and one from South America. [ 17 ] Eligible studies included a total of 469 SSc patients with a mean age ranging from 48.1 to 63.7 years.…”

<p>Management of digital ulcers in systemic sclerosis</p>

“…43 As previously written, neither trial indicated that bosentan was superior to placebo in the healing of active DUs.In the literature, there are several works that instead report a beneficial effect of bosentan onexisting DUs. [44][45][46] Further data are needed to settle the question of whether bosentan is useful not only in the prevention but also in the healing of DUs. Multiple studies have finally proven that the efficacy and safety of bosentan is maintained in the long term.…”

“…Multiple studies have finally proven that the efficacy and safety of bosentan is maintained in the long term. [44][45][46][47] On the basis of all these results, EULAR guidelines state that bosentan should be considered for reduction in the number of new DUs in SSc, especially in patients with multiple DUs despite the use of calciumchannel blockers (CCBs), PDE5 inhibitors, or iloprost therapy (strength of recommendation: A). 26 The aforementioned data refer only to bosentan, but recently data about other endothelin-receptor antagonists (ERAs) were published.…”