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An open-label, phase II study of the safety and tolerability of pirfenidone in patients with scleroderma-associated interstitial lung disease: the LOTUSS trial.
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Nintedanib for systemic sclerosis-associated interstitial lung disease. [DOI] [PubMed] [Google Scholar]; • This was the largest RCT ever conducted in SSc and demonstrated that treatment with nintedanib slows the rate of decline of lung function in patients with SSc-ILD compared with placebo.
Frequently Asked Questions
Another hurdle in SSc therapeutics is identifying and defining objective treatment-responsive endpoints. While we have several valid endpoints to study ILD in SSc, endpoints for the other clinical manifestations of SSc are lacking. The GI tract is the perfect example of this. How can we determine whether biologics or anti-fibrotics modify the course of GI disease in SSc if no valid, objective SSc-GI endpoints exist? To this end, we are currently conducting studies to investigate whether the GI microbiome may be a marker of GI disease activity in SSc.
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However, additional dedicated research efforts primarily aimed at developing and validating endpoints in SSc are greatly needed. Finally, a significant unmet therapeutic need in SSc is prevention. The collective efforts to halt inflammation, fibrosis, and vascular changes in SSc are typically initiated after there is already evidence of end-organ damage (i.e. loss of lung function, renal insufficiency, etc.). Furthering our knowledge of the pathobiology of SSc may help uncover treatment targets that could curtail the progression of early SSc. Intravenous cyclophosphamide vs rituximab for the treatment of early diffuse scleroderma lung disease: open label, randomized, controlled trial. A multicenter, open-label, comparative study of B-cell depletion therapy with Rituximab for systemic sclerosis-associated interstitial lung disease.
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Rituximab in diffuse cutaneous systemic sclerosis: an open-label clinical and histopatho-logical study.
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The goal here would be to intervene early with an agent that could selectively target key mediators of profibrotic and proinflammatory pathways to reduce the likelihood of a patient developing specific clinical manifestations of SSc, such as ILD. In summary, despite the fact that the number of clinical trials in SSc has increased in recent years, there is still a great deal more work to do in SSc research to: (a) understand the optimal timing to initiate therapy in SSc; (b) discover how to combine therapies; (c) improve our ability to phenotype patients; (d) define new disease-specific endpoints; and (e) determine the best preventative treatment strategies. We anticipate that research conducted in the next decade will help address these unanswered questions and propel this field forward in new and exciting ways. A variety of novel therapeutic strategies for the management of SSc now exist and are grounded in solid scientific research. These therapeutic strategies primarily target individual organ manifestations of SSc.
7.2 An Old Success Story—Aspirin
Immunosuppressants with potential disease-modifying effects continue to be important components of the therapeutic armamentarium for SSc. Patients with refractory disease may require combination therapy with anti-fibrotics and/or other agents. Defining mechanistically based SSc subgroups based on biological and clinical profiles will reduce heterogeneity in clinical trial cohorts and may enhance our ability to detect treatment effects. Preventing both the onset and progression of individual organ manifestation remains an important unmet clinical need in SSc. Z McMahan is supported by the National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases via grant K23 AR071473, the Scleroderma Research Foundation and the Jerome L Greene Foundation. Effects and safety of rituximab in systemic sclerosis: an analysis from the European Scleroderma Trial and Research (EUSTAR) group.
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Combination therapy with rituximab and mycophenolate mofetil in systemic sclerosis. Clinical decision rule to predict the presence of interstitial lung disease in systemic sclerosis.
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Interstitial lung disease in systemic sclerosis: data from the spanish scleroderma study group.
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2.5. Gastrointestinal disease
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[DOI] [PMC free article] [PubMed] [Google Scholar]; • This was the second large, RCT to evaluate the safety and efficacy of HSCT in SSc and also demonstrated improved long-term mortality in dsSSc patients randomized to HSCT compared with CYC. Safety and efficacy of subcutaneous tocilizumab in systemic sclerosis: results from the open-label period of a phase II randomised controlled trial (faSScinate). [DOI] [PMC free article] [PubMed] [Google Scholar] 19.Khanna D, Spino C, Johnson S, et al. Abatacept in early diffuse cutaneous systemic sclerosis: results of a phase II investigator-initiated, multicenter, double-blind, sildenafil 50g randomized, placebo-controlled trial. [DOI] [PMC free article] [PubMed] [Google Scholar] 20.Gonzalez EG, Selvi E, Balistreri E, et al. Causes and risk factors for death in systemic sclerosis: a study from the EULAR Scleroderma Trials and Research (EUSTAR) database.
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October;69(10):1809–1815.
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ER Volkmann is supported by National Institutes of Health/The National Heart, Lung, and Blood Institute via grant K23 HL150237-01 and the Rheumatology Research Foundation. One referee has received speaker’s fees, travel grants, research funding, or compensation for consultancies or board memberships from Abbvie, Actelion, Baxalta/Shire, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Chugai, Genzyme, Gilead Biosciences, Hexal/Sandoz, Janssen-Cilag, Merck Sharp and Dohme, Novartis, Pfizer, Roche, Sanofi Pasteur and UCB Pharma. Peer reviewers on this manuscript have no other relevant financial buy sildenafil citrate online canada relationships or otherwise to disclose. ER Volkmann has received grant support from Corbus Pharmaceuticals and Forbius, and consulting fees from Forbius and Boehringer Ingelheim. ZH McMahan has received salary support from Corbus Pharmaceuticals for her work as a subinvestigator on the Lenabasum study.
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The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Papers of special note have been highlighted as either of interest (•) or of considerable interest (••) to readers. Treatment algorithms for systemic sclerosis according to experts. Emerging targets of disease-modifying therapy for systemic sclerosis. [DOI] [PMC free article] [PubMed] [Google Scholar] 4.Peoples C, Medsger TA Jr., Lucas M, et al. [DOI] [PubMed] [Google Scholar] 35.Volkmann ER, Tashkin DP, Kuwana M, et al.
| Brand Name | Dosage | Manufacturer | Form | Packaging |
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| Hexal | 100 mg | Hexal AG | Tablets | Blister packs (30) |
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Progression of Interstitial Lung Disease in Systemic Sclerosis: the Importance of Pneumoproteins Krebs von den Lungen 6 and CCL18.
| Property | Description | Value | Notes |
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| 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 |
December;71(12):2059–2067.
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[DOI] [PMC free article] [PubMed] [Google Scholar] 12.Tashkin DP, Roth MD, Clements PJ, et al. Mycophenolate mofetil versus oral cyclophosphamide in scleroderma-related interstitial lung disease (SLS II): a randomised controlled, double-blind, parallel group trial. [DOI] [PMC free article] [PubMed] [Google Scholar]; • This landmark RCT demonstrated that MMF was not only as effective as CYC at improving lung function and radiographic fibrosis in ILD, but was safer and better tolerated than CYC. Efficacy of mycophenolate mofetil and oral cyclophosphamide on skin thickness: post hoc analyses from two randomized placebo-controlled trials. [DOI] [PMC free article] [PubMed] [Google Scholar] 14.Volkmann ER, Tashkin DP, Li N, et al.
Erektile Dysfunktion (ED)
Mycophenolate mofetil versus placebo for systemic sclerosis-related interstitial lung disease: an analysis of scleroderma lung studies I and II. [DOI] [PMC free article] [PubMed] [Google Scholar] sildenafil 10mg 15.Kowal-Bielecka O, Fransen J, Avouac J, et al. Update of EULAR recommendations for the treatment of systemic sclerosis. [DOI] [PubMed] [Google Scholar]; • This was the first large, RCT to evaluate the safety and efficacy of HSCT in SSc and demonstrated improved long-term mortality in dsSSc patients randomized to HSCT compared with CYC. Myeloablative autologous stem-cell transplantation for severe scleroderma. [DOI] [PMC free article] [PubMed] [Google Scholar] 36.Fischer A, Strek ME, Cottin V, et al.
2. Novel strategies for treating complications of SSC
Synthetic cannabinoid ajulemic acid exerts potent antifibrotic effects in experimental models of systemic sclerosis. Safety and efficacy of lenabasum (JBT-101) in diffuse cutaneous systemic sclerosis subjects treated for one year in an open-label extension of trial JBT101-SSC-001. The American college of rheumatology provisional composite response index for clinical trials in early diffuse cutaneous systemic sclerosis. [DOI] [PMC free article] [PubMed] [Google Scholar] 23.R Dn S, Bloom B, White B, et al. Baseline subject demographics and disease characteristics in a phase 3 study of safety and efficacy of lenabasum in diffuse cutaneous systemic sclerosis.