Effect of mycophenolate mofetil (MMF) on systemic sclerosis-related interstitial lung disease with mildly impaired lung function: a double-blind, placebo-controlled, randomized trial

Naidu, Gsrsnk; Sharma, Shefali; Adarsh, M B; Dhir, Varun; Sinha, Anindita; Dhooria, Sahajal; Jain, Sanjay

doi:10.1007/s00296-019-04481-8

Cited by 37 publications

(35 citation statements)

References 35 publications

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“…Baseline values of efficacy outcomes were similar across trials with Naidu, G.S.R.S.K.N., 2011 [ 25 ], Domiciano, D.S., 2011 [ 23 ], and Sircar, G., 2018 [ 26 ] enrolling patients with milder disease. All studies enrolled subjects with disease duration <5 years, with the exception of Domiciano, D.S., 2011 [ 23 ] (mean disease duration 5.8/6.0 years).…”

Section: Resultsmentioning

confidence: 85%

“…Nine RCTs (SLS-I, 2006 [ 8 ]; SLS-II, 2016 [ 7 ]; Domiciano, D.S., 2011 [ 23 ]; Hoyles, R.K., 2006 [ 24 ]; Naidu, G.S.R.S.N.K., 2020 [ 25 ]; SENSCIS, 2019 [ 10 ]; Sircar, G., 2018 [ 26 ]; Acharya, N., 2019 [ 27 ]; Hsu, V.M., 2018 [ 28 ]) were considered eligible and were included in the final quantitative analysis (see Supplementary material 1.1, page 5 ). These studies were conducted in a total of 926 participants, comparing 8 interventions (cyclophosphamide, mycophenolate, cyclophosphamide plus high dose prednisone (CYCPRED), cyclophosphamide followed by azathioprine (CYCAZA), rituximab, pirfenidone, nintedanib, and pomalidomide), and placebo for an average follow-up of 1 year.…”

Section: Resultsmentioning

confidence: 99%

“…SSc-ILD was diagnosed using HRCT criteria in 5 RCTs (SLS-II, 2016 [ 7 ]; Naidu G.S.R.S.N.K., 2020 [ 25 ]; SENSCIS, 2019 [ 10 ]; Acharya, N., 2019 [ 27 ]; Hsu, V.M., 2018 [ 28 ]), HRCT plus biopsy, PFTs or biopsy in 3 RCTs (SLS-I, 2006 [ 8 ]; Hoyles, R.K., 2006 [ 24 ]; Sircar, G., 2018 [ 26 ]), and biopsy only in the remaining RCT (Domiciano, D.S., 2011 [ 23 ]). Domiciano, D.S., 2011 [ 23 ] enrolled only SSc-ILD patients with biopsy-proven nonspecific interstitial pneumonia (NSIP), while Naidu, G.S.R.S.N.K., 2020 [ 25 ], Sircar, G., 2018 [ 26 ], and Acharya, N., 2019 [ 27 ] enrolled patients with both NSIP and usual interstitial pneumonia (UIP). SSc-ILD pattern was not specified in the remaining RCTs (see Supplementary material 1.2, page 6 ).…”

Section: Resultsmentioning

confidence: 99%

“…Four trials were scored with a low RoB (Tashkin, D.P., 2006 [ 8 ]; Tashkin, D.P., 2016 [ 7 ]; SENSCIS, 2019 [ 10 ]; Acharya, N., 2019 [ 27 ]), whereas the remaining five trials were scored with a high RoB (Domiciano, D.S., 2011 [ 23 ]; Hoyles, R.K., 2006 [ 24 ]; Naidu, G.S.RS.N.K., 2020 [ 25 ]; Sircar, G., 2018 [ 26 ]; Hsu, V.M., 2018 [ 28 ]). No trial was scored with an intermediate RoB (see Supplementary Material 3.1–3.3, pages 30–31 ).…”

Section: Resultsmentioning

confidence: 99%

“…According to the selection criteria, the period of observation was one year in six trials and six months in the remaining three trials (Naidu, G.S.R.S.N.K., 2020 [ 25 ]; Sircar, G., 2018 [ 26 ]; Acharya, N., 2019 [ 27 ]).…”

Section: Resultsmentioning

confidence: 99%

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Efficacy, Safety, and Tolerability of Treatments for Systemic Sclerosis-Related Interstitial Lung Disease: A Systematic Review and Network Meta-Analysis

Erre

Sebastiani

Fenu

et al. 2020

JCM

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Background: There is a paucity of head-to-head comparisons of the efficacy and harms of pharmacological treatments for systemic sclerosis-related interstitial lung disease (SSc-ILD). Methods: We conducted a network meta-analysis (NMA) in order to compare the effects of different treatments with the placebo on change in forced vital capacity (FVC), change in diffusion lung capacity for CO (DLCO), serious adverse events (SAEs), discontinuation for adverse events and mortality in SSc-ILD. Standardized mean difference (SMD) and log odds ratio were estimated using NMA with fixed effects. Results: Nine randomized clinical trials (926 participants) comparing eight interventions and the placebo for an average follow-up of one year were included. Compared to the placebo, only rituximab significantly reduced FVC decline (SMD (95% CI) = 1.00 (0.39 to 1.61)). Suitable data on FVC outcome for nintedanib were not available for the analysis. No treatments influenced DLCO. Safety and mortality were also not different across treatments and the placebo, although there were few reported events. Cyclophosphamide and pomalidomide were less tolerated than the placebo, mycophenolate, and nintedanib. Conclusion: Only rituximab significantly reduced lung function decline compared to the placebo. However, direct head-to-head comparison studies are required to confirm these findings and to better determine the safety profile of various treatments.

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Section: Resultsmentioning

confidence: 85%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Efficacy, Safety, and Tolerability of Treatments for Systemic Sclerosis-Related Interstitial Lung Disease: A Systematic Review and Network Meta-Analysis

Erre

Sebastiani

Fenu

et al. 2020

JCM

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2023 American College of Rheumatology (ACR)/American College of Chest Physicians (CHEST) Guideline for the Treatment of Interstitial Lung Disease in People with Systemic Autoimmune Rheumatic Diseases

Johnson,

Bernstein,

Bolster

et al. 2024

Arthritis Care & Research

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ObjectiveWe provide evidence‐based recommendations regarding the treatment of interstitial lung disease (ILD) in adults with systemic autoimmune rheumatic diseases (SARDs).MethodsWe developed clinically relevant population, intervention, comparator, and outcomes questions. A systematic literature review was then performed, and the available evidence was rated using the Grading of Recommendations, Assessment, Development, and Evaluation methodology. A panel of clinicians and patients reached consensus on the direction and strength of the recommendations.ResultsThirty‐five recommendations were generated (including two strong recommendations) for first‐line SARD‐ILD treatment, treatment of SARD‐ILD progression despite first‐line ILD therapy, and treatment of rapidly progressive ILD. The strong recommendations were against using glucocorticoids in systemic sclerosis–ILD as a first‐line ILD therapy and after ILD progression. Otherwise, glucocorticoids are conditionally recommended for first‐line ILD treatment in all other SARDs.ConclusionThis clinical practice guideline presents the first recommendations endorsed by the American College of Rheumatology and American College of Chest Physicians for the treatment of ILD in people with SARDs.

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Detection and Management of Interstitial Lung Diseases Associated With Connective Tissue Diseases

Castelino

Moua

2021

ACR Open Rheumatology

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Interstitial lung disease (ILD) is a common manifestation of connective tissue diseases (CTDs). A proportion of patients with CTD‐ILDs develop progressive fibrosing ILD, which is characterized by worsening fibrotic abnormalities on high‐resolution computed tomography scan, decline in lung function, worsening symptoms, and early mortality. Here, we review the impact of ILD in patients with CTDs, the importance of prompt diagnosis and close monitoring, and the evidence available to guide the management of CTD‐ILDs. Management of patients with CTD‐ILDs should be individualized and involve close collaboration between rheumatologists and pulmonologists. Immunosuppression is the mainstay of therapy for CTDs, but evidence for its effectiveness in slowing the progression of ILD is limited. Recently, nintedanib has been approved to slow decline in lung function in patients with systemic sclerosis–associated ILD and chronic fibrosing ILDs with a progressive phenotype. The results of ongoing clinical trials will help clinicians take a more evidence‐based approach to the treatment of CTD‐ILDs.

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Effect of mycophenolate mofetil (MMF) on systemic sclerosis-related interstitial lung disease with mildly impaired lung function: a double-blind, placebo-controlled, randomized trial

Cited by 37 publications

References 35 publications

Efficacy, Safety, and Tolerability of Treatments for Systemic Sclerosis-Related Interstitial Lung Disease: A Systematic Review and Network Meta-Analysis

Efficacy, Safety, and Tolerability of Treatments for Systemic Sclerosis-Related Interstitial Lung Disease: A Systematic Review and Network Meta-Analysis

2023 American College of Rheumatology (ACR)/American College of Chest Physicians (CHEST) Guideline for the Treatment of Interstitial Lung Disease in People with Systemic Autoimmune Rheumatic Diseases

Detection and Management of Interstitial Lung Diseases Associated With Connective Tissue Diseases

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