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options for the treatment of SSc-related
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Moreover, during a 12-year follow-up period, there was no difference in long-term morbidity and mortality outcomes between patients randomized to CYC versus placebo in SLS I [40], suggesting that 1 year of treatment does not lead to a sustained improvement in health outcomes in SSc-ILD, and maintenance therapy is important. In SLS II [12], treatment with MMF for 24 months led to a significant improvement in FVC%-predicted [12], quantitative radiographic fibrosis [37], and patient-reported outcomes [41]. There was no significant difference in efficacy outcomes between patients randomized to MMF versus CYC in SLS II, although MMF was better tolerated and had a more favorable safety profile compared with CYC in this study [12]. For instance, there were 15 versus 4 premature study drug with-drawals in the CYC and MMF arms, respectively, and over twice as many deaths in the CYC arm (11 CYC; 5 MMF), with most deaths attributable to progressive of ILD. When the MMF arm of SLS II was compared with the placebo arm of SLS I (with adjustment for baseline disease severity), patients treated with MMF demonstrated a significant improvement in FVC % predicted, DLCO% predicted, and dyspnea compared with the placebo group [14].
2.3. Raynaud phenomenon
The collective findings from SLS I and II suggest that: (1) the duration of treatment for SSc-ILD should be longer than 1 year to yield a sustained benefit; (2) treatment with MMF and CYC both lead to short-term improvements in lung function, radiographic fibrosis, and quality of life; and (3) MMF appears to be safer and better tolerated than CYC. Similar to cutaneous sclerosis, a substantial portion of patients with SSc-ILD experience progression of ILD despite treatment with CYC or MMF. HSCT may ameliorate ILD in carefully selected patients with dcSSc [16,17]. In the ASTIS study, in which 86% and 87% of the patients randomized to HSCT and CYC, respectively, had ILD, more patients in the HSCT arm experienced an improvement in the FVC compared with the CYC arm [16]. Similarly, in the SCOT study, in which 100% and 95% of the patients randomized to HSCT and CYC, respectively, had ILD, fewer patients randomized to HSCT experienced respiratory failure in the HSCT arm (N = 5) compared with the CYC arm (N = 13) at 1 year [17]. RP attacks, tadalafil was studied in
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a prospective double-blind placebo-controlled crossover study.
| Property | Description | Value | Notes |
|---|---|---|---|
| Active ingredient | Sildenafil citrate | - | Main component |
| Mechanism of action | PDE5 inhibitor | - | Enhances blood flow |
| Half-life | Approximately 4 hours | 3-5 hours | Duration of effect |
| Absorption | Rapid, peaks in 30-120 minutes | - | After oral intake |
Patients were randomized to receive a fixed dose of tadalafil
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The tyrosine kinase inhibitor, nintedanib, was recently found to slow the rate of progression of ILD in the largest RCT (SENSCIS) ever conducted in SSc (N = 576) [25]. In this study, patients were randomized to 12 months of nintedanib versus 12 months of placebo, and the entry criteria permitted patients to continue treatment with MMF if they were taking a stable dose of MMF for at least 6 months prior to screening. Approximately half of all patients in each study arm were taking MMF at baseline. The rate of decline of FVC (mL/year) was greatest in the placebo arm not on background MMF at baseline (−119.3), and lowest in the nintedanib arm taking MMF at baseline (−40.2), and similar in the nintedanib alone arm (−63.9) and placebo arm on background MMF at baseline (−66.5). In contrast with MMF and CYC [12,41], treatment with nintedanib did not lead to an improvement in self-reported dyspnea as measured by the St.
Off-Label und potentielle Anwendungsgebiete
George’s Respiratory sildenafil 12 5 mg Questionnaire (SGRQ), nor mRSS [25]. It is unclear why patients randomized to nintedanib did not experience an improvement in the SGRQ relative to placebo; however, it may be because responses to this questionnaire are influenced by extra-pulmonary manifestations of SSc not targeted by nintedanib (e.g. In terms of safety, patients on combination therapy (MMF + nintedanib) appeared to have a similar adverse event profile compared with patients on nintedanib alone; however, the majority of patients on nintedanib (76%) reported diarrhea (compared with 32% in the placebo arm), and this should be taken into consideration, particularly when treating patients who have co-morbid SSc-related lower gastrointestinal tract involvement. Although it is difficult to draw meaningful conclusions about the benefits of upfront combination therapy (MMF + nintedanib) for SSc-ILD since patients were not randomized to MMF in the SENSCIS trial, the results support the hypothesis that using nintedanib as add-on therapy to MMF may be advantageous from a lung function standpoint. To this end, SLS III (NCT03221257) was conceived and designed to test the hypothesis that combining an anti-fibrotic therapy (e.g. at 20 mg daily or placebo for a 4 week
Anwendungsbeschränkungen und Nebenwirkungen
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]. 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 buy pills sildenafil ILD, including SSc-ILD, is currently underway in the UK (NCT01862926).
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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. 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]. period, and the RP condition score, frequency of RP episodes,
| Side Effect | Frequency | Severity | Common Symptoms | Advice |
|---|---|---|---|---|
| Headache | Very common | Mild | Throbbing pain in head | Hydrate, take pain relievers if needed |
| Flushing | Common | Mild | Warmth and redness in face | Reduce dose, avoid alcohol |
| Nasal congestion | Common | Mild | Stuffiness in nasal passages | Decongestants may help |
| Visual disturbances | Less common | Moderate | Blurred vision, color changes | Seek medical attention if persists |
and duration of RP episodes between treatment groups was compared. While tadalafil was well-tolerated, there
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was no significant difference in
Frequently Asked Questions
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. On-demand therapy with phosphodiesterase inhibitors (i.e. sildenafil) for the treatment of primary or secondary RP was recently shown not to have clinically relevant efficacy, given the significant heterogeneity in patient responses [48].
Expert opinion:
Few studies have focused on the prevention of RP-associated ulcers. In the past decade, these areas of study have become areas of increasing interest (Table 4). The specific roles of phosphodiesterase inhibitors in healing RP-associated digital ulcers in SSc continues to be an active area of investigation, as this class of medications improves digital blood flow, and has been shown to have significant efficacy in secondary Raynaud’s [49,50]. The SEDUCE study group recently evaluated the effects of sildenafil on ischemic digital ulcer healing in SSc in a randomized placebo-controlled trial [51]. Eighty-three patients with a total of 192 digital ulcers were included in the intention-to-treat analysis (89 in the sildenafil group, 103 in the placebo group), however the primary endpoint was not reached. treatment response between the tadalafil
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arm and the placebo arm [52].
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pirfenidone) with a cytotoxic, immunosuppressive agent (e.g. mycophenolate) upfront may lead to an improved and faster treatment response compared with using an immunosuppressive agent alone. In SLS III, patients with SSc-ILD who are treatment naïve or early in their course of treatment with MMF (treatment with MMF for ≤6 months prior to enrollment) are randomized to either treatment with MMF alone or treatment with MMF plus pirfenidone for 18 months. In the prior open-label study phase II study on pirfenidone for SSc, MMF was combined with pirfenidone in 63.5% of patients with good tolerability [24]. The monoclonal antibody against the interleukin (IL)-6 receptor, tocilizumab, may play a role in the treatment of ILD in SSc, particularly in patients with early dcSSc with inflammatory features.
Nicht-medizinische Verwendung
Two RCTs have investigated the safety and efficacy of tocilizumab in patients with early dSSc with elevated acute phase reactant proteins, and while the primary outcome for these studies was mRSS, the FVC was a key secondary endpoint [18,42]. In the phase II faSScinate trial, fewer patients in the tocilizumab arm experienced a decline in FVC at 48 weeks than in the placebo group (p = 0.0373) [42]. Furthermore, the FVC treatment effect appeared to be sustained in the open-label extension period [18]. 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.