Two years follow-up of an open-label pilot study of treatment with rituximab in patients with early diffuse cutaneous systemic sclerosis

Melsens, Karin; Vandecasteele, Els; Deschepper, Ellen; Badot, Valérie; Blockmans, Daniel Engelbert; Brusselle, Guy; Langhe, Ellen De; Pauw, M. De; Debusschere, Claire; Decuman, Saskia; Deroo, Liselotte; Houssiau, Frédéric; Lenaerts, Jan; Piette, Yves; Thevissen, Kristof; Vanthuyne, Marie; Westhovens, René; Wijnant, Sara; Keyser, Filip De; Smith, Vanessa

doi:10.1080/17843286.2017.1372244

Cited by 39 publications

(44 citation statements)

References 23 publications

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“…Despite the fatal burden associated with this condition, treatment options for SSc remain limited 4. Preliminary case-reports and series have suggested that rituximab, a chimeric monoclonal antibody targeting B cells, could improve skin and lung fibrosis in SSc 5–19. However, these studies were mostly limited by small samples sizes, lack of control arms, single centre designs, discrepancies in study designs and short durations of follow-up.…”

Section: Introductionmentioning

confidence: 99%

Outcomes of patients with systemic sclerosis treated with rituximab in contemporary practice: a prospective cohort study

Elhaï

Boubaya

Distler³

et al. 2019

Ann Rheum Dis

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163

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ObjectiveTo assess the safety and efficacy of rituximab in systemic sclerosis (SSc) in clinical practice.MethodsWe performed a prospective study including patients with SSc from the European Scleroderma Trials and Research (EUSTAR) network treated with rituximab and matched with untreated patients with SSc. The main outcomes measures were adverse events, skin fibrosis improvement, lung fibrosis worsening and steroids use among propensity score-matched patients treated or not with rituximab.Results254 patients were treated with rituximab, in 58% for lung and in 32% for skin involvement. After a median follow-up of 2 years, about 70% of the patients had no side effect. Comparison of treated patients with 9575 propensity-score matched patients showed that patients treated with rituximab were more likely to have skin fibrosis improvement (22.7 vs 14.03 events per 100 person-years; OR: 2.79 [1.47–5.32]; p=0.002). Treated patients did not have significantly different rates of decrease in forced vital capacity (FVC)>10% (OR: 1.03 [0.55–1.94]; p=0.93) nor in carbon monoxide diffusing capacity (DLCO) decrease. Patients having received rituximab were more prone to stop or decrease steroids (OR: 2.34 [1.56–3.53], p<0.0001). Patients treated concomitantly with mycophenolate mofetil had a trend for better outcomes as compared with patients receiving rituximab alone (delta FVC: 5.22 [0.83–9.62]; p=0.019 as compared with controls vs 3 [0.66–5.35]; p=0.012).ConclusionRituximab use was associated with a good safety profile in this large SSc-cohort. Significant change was observed on skin fibrosis, but not on lung. However, the limitation is the observational design. The potential stabilisation of lung fibrosis by rituximab has to be addressed by a randomised trial.

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Section: Introductionmentioning

confidence: 99%

Outcomes of patients with systemic sclerosis treated with rituximab in contemporary practice: a prospective cohort study

Elhaï

Boubaya

Distler³

et al. 2019

Ann Rheum Dis

Self Cite

163

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“…There is no effective treatment for SSc as yet, even though several extensive clinical trials were investigated, for example. inhibition of β‐catenin signalling, inhibition of tyrosine kinase and B‐cell depletion . The several studies demonstrated that the contribution of B cell and T cell in SSc development and pathogenesis.…”

Section: Introductionmentioning

confidence: 99%

“…inhibition of β‐catenin signalling, inhibition of tyrosine kinase and B‐cell depletion . The several studies demonstrated that the contribution of B cell and T cell in SSc development and pathogenesis. In addition to the acquired immunological reaction on SSc, the role of the innate immune system in the pathogenesis of SSc is now being increasingly recognized .…”

Section: Introductionmentioning

confidence: 99%

Combination of 5‐aminolevulinic acid and iron prevents skin fibrosis in murine sclerodermatous graft‐versus‐host disease

Liu

Yang

Zhu

et al. 2018

Experimental Dermatology

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Scleroderma or systemic sclerosis (SSc) is a clinically heterogeneous rheumatological autoimmune disease affecting the skin, internal organs and blood vessels. There is at present no effective treatment for this condition. Our study investigated the effects of 5-aminolevulinic acid (5-ALA), which is a precursor of haem synthesis, on graft-vs-host disease (GvHD)-induced SSc murine model. Lymphocytes were intravenously injected from donor mice (B10.D2) into recipient BALB/c mice (recombination-activating gene 2 (Rag-2)-null mice) deficient in mature T and B cells to induce sclerodermatous GvHD (scl-GvHD). To investigate the effect of 5-ALA on scl-GvHD, combination of 5-ALA and sodium ferrous citrate (SFC) was orally administered to the recipient mice for 9 weeks. 5-ALA/SFC treatment significantly reduced progressive inflammation and fibrosis in the skin and ears. Furthermore, 5-ALA/SFC suppressed mRNA expression of transforming growth factor-β, type I collagen and inflammatory cytokines. These results indicate that the 5-ALA/SFC combination treatment has a protective effect against tissue fibrosis and inflammation in a murine scl-GvHD-induced skin and ear inflammation and fibrosis. Furthermore, the efficacy of 5-ALA/SFC suggests important implications of HO-1 protective activity in autoimmune diseases, and therefore, 5-ALA/SFC may have promising clinical applications. These findings suggested that the 5-ALA/SFC treatment may be the potential strategies for SSc.

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“…A small number of studies have evaluated the efficacy of rituximab (RTX) as overall disease therapy in SSc, with suggestions of efficacy in both the skin and the lung (75)(76)(77)(78)(79). An open-label randomized trial in 60 patients with dcSSc and ILD compared monthly pulses of CYC 500 mg/m 2 versus RTX 1,000 mg × 2 doses (80).…”

Section: Rituximabmentioning

confidence: 99%

Expert Perspectives On Clinical Challenges: Expert Perspectives: Challenges in Scleroderma

Simms

2020

Arthritis & Rheumatology

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You are consulted to evaluate a 56‐year‐old woman with known Raynaud's phenomenon, finger swelling of several; months’ duration, and new hypertension with a blood pressure of 160/100 mm/Hg. She also reports progressive shortness of breath. Physical examination reveals telangiectasias, sclerodactyly, and proximal skin sclerosis (thick shiny skin on the chest and upper arms), and bibasilar crackles are found on chest examination. Laboratory tests reveal evidence of microangiopathic hemolytic anemia, thrombocytopenia, and elevation of the serum creatinine level (previously normal), and chest computed tomography shows evidence of ground‐glass opacification in both lower lung fields.

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Two years follow-up of an open-label pilot study of treatment with rituximab in patients with early diffuse cutaneous systemic sclerosis

Cited by 39 publications

References 23 publications

Outcomes of patients with systemic sclerosis treated with rituximab in contemporary practice: a prospective cohort study

Outcomes of patients with systemic sclerosis treated with rituximab in contemporary practice: a prospective cohort study

Combination of 5‐aminolevulinic acid and iron prevents skin fibrosis in murine sclerodermatous graft‐versus‐host disease

Expert Perspectives On Clinical Challenges: Expert Perspectives: Challenges in Scleroderma

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