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As bosentan demonstrated success

in its positive effects on

Anwendungsbeschränkungen und Nebenwirkungen

The phase III trial of tocilizumab for SSc did not meet the primary endpoint of mRSS [43]. As with cutaneous sclerosis treatment, rituximab is frequently used to treat SSc patients with progressive ILD resistant to CYC and MMF. Evidence for using rituximab in SSc-ILD is largely based on observational studies [27–30] and one small RCT of short duration, which demonstrated an improvement in lung function over 6 months in patients randomized to rituximab versus CYC [26]. In addition, a nested case-control analysis of the EUSTAR cohort found that the SSc-ILD patients (N = 9) treated with rituximab experienced stability in the FVC; whereas the matched-control patients experienced a significant decline in FVC over a median of 6 months [29]. To date, only one small RCT has been published on rituximab for SSc-ILD, and this study found that treatment with rituximab was associated with a significant improvement in lung function compared with placebo [44].

Idiopathische pulmonal-arterielle Hypertonie

In this study, the majority of the rituximab-treated patients also experienced a reduction in ground glass opacities (but not reticulations) on HRCT at 18 months (based on visual assessment) [44]. A larger double-blind, RCT comparing IV CYC (600 mg/m2 body surface area monthly for 6 months) versus rituximab (1 g at baseline and at 2 weeks) for connective tissue disease-related ILD, including SSc-ILD, is currently underway in the UK (NCT01862926). The primary outcome for this study is the change in FVC at 48 weeks [45] (Table 3). Approximately 90–95% of patients with SSc have Raynaud phenomenon (RP), and it is often the presenting feature of SSc. It is characterized by peripheral vasospasm that leads to a transient discoloration (erythema, cyanosis, and/or pallor) and/or numbness in the digits immediately following specific triggers, such as exposure to cold temperatures, relative changes in the temperature of the surrounding environment, and/or exposure to stress.

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The complications of RP are particularly severe in SSc, as the vasospasm compounds the already reduced blood flow in vessels affected by SSc vasculopathy [46]. Up to about 50% of patients with SSc are affected by RP may experience ischemic complications such as digital ulcers, pits, or gangrene [47]. This subset of patients requires more aggressive therapy with medication to prevent the loss of digital tissue. Recent studies have focused on determining whether specific drugs are more effective in preventing or healing digital ulcers, as some medications are known to be more effective for one than the other. The current standard of care for the management of patients experiencing RP-related digital ischemia involves minimizing environmental triggers and initiating medications that maximize peripheral blood flow (e.g. digital ulcer preventions, an international

group of investigators evaluated the

efficacy of a newer dual

Externe Links zu erwähnten Verbindungen

Forty-one patients were enrolled and randomized to receive either intravenous iloprost or placebo infusion, and the primary endpoint is the change in weekly frequency of symptomatic RP attacks at 21 days. Results of this study are pending (NCT03867097), and the phase 3 trial is enrolling (NCT04040322). Endothelin-1 is a well-recognized promoter of vasculopathy in SSc. Prior studies have demonstrated that bosentan, a dual endothelin receptor antagonist, successfully prevents RP-related digital ulcers in SSc. In an earlier clinical trial, RAPIDS-1, which enrolled SSc patients with or without digital ulcers at baseline, bosentan significantly reduced the number of new digital ulcers compared to placebo. endothelin receptor antagonist, macitentan, in

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reducing the number of new

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digital ulcers in SSc patients.

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Collectively, these data suggest that phosphodiesterase-inhibitors play an important role in the healing and prevention of digital ulcers in SSc-related RP. Prostacyclins and prostaglandins continue to serve as key therapies used to treat challenging cases of RP in the context of SSc. Iloprost, for example, serves as a standard treatment of existing digital ulcers [54–56]. It is currently indicated for patients with severe disabling Raynaud’s unresponsive to other therapies for the prevention of ischemic pain, peripheral ulcers, and necrosis of the digits to prevent amputation. It may be administered by one of three schedules: (a) 3-day schedule as an inpatient for RP/SSc; (b) 5-day schedule as an outpatient for RP/SSc; or (c) continuous infusion for the treatment of patient with active or extensive digital ulcers, severe digital ischemia, or for patients who cannot tolerate higher rates of the infusion.

7.2 An Old Success Story—Aspirin

Details of the complex infusion protocols can be found here [57]. Treprostanil, a synthetic analog of prostacyclin (PGI2), has also been studied as a therapy for patients with SSc-associated Raynaud’s and/or digital ulcers, in both oral and topical formulations. Oral treprostanil initially showed promise in patients with SSc and digital ischemia in a phase 1 study, where effective absorption and temporal associations with improved cutaneous perfusion and temperature were noted [58]. The recurrence of digital ulcers in patients with SSc after discontinuation of oral treprostanil was also noted in a multicentered retrospective study, also suggesting some benefit [59]. However, the association between vascular biomarkers and digital ulcerations in SSc was recently evaluated using the DISTOL-1 randomized controlled trial cohort, and a lack of strong response to any vascular, angiogenic, or inflammatory markers suggested that these patways are not primary drivers in the development of digital ulcer clinical outcomes in an SSc population [60].

Active Substance

The effects of topical treprostanil have also been a focus of recent work. Treprostanil iontophoresis in patients with SSc was also studied to determine its ability to improve digital blood flow during local (hand) cooling [61]. It showed promised as digital treprostanil iontophoresis shifted skin blood flow upward during local cooling on the hand and during the initial rewarming phase in patients with SSc. The safety profile of treprostinil hydrogel iontophoresis was also recently examined in a 2-stage randomized, placebo-controlled single ascending-dose study among healthy volunteers and patients with SSc-related digital ulcers and was found to be fairly well-tolerated, with 2 minimal local adverse effects reported among 5 SSc patients with digital ulcers [62]. A phase 2 multi-center, double-blind, RCT is currently examining the effects of intravenous iloprost on RP in patients with SSc.