We hypothesised that a 2 year course of mycophenolate mofetil would be safer, better tolerated, and produce longer lasting improvements than cyclophosphamide. Methods: This randomised, double-blind, parallel group trial enrolled patients from 14 US medical centres with scleroderma-related interstitial lung disease meeting defined dyspnoea ...

2016年7月25日 · Using a double-blind, randomised controlled clinical trial approach, SLS II compared a continuous 24 month course of MMF with a 12 month course of oral cyclophosphamide (followed by 12 months of placebo) for the treatment of symptomatic scleroderma-related interstitial lung disease.

SLS I randomized participants to receive either oral cyclophosphamide (CYC) or placebo for 1 year, while SLS II randomized participants to receive either MMF for 2 years or oral CYC for 1 year followed by 1 year of placebo. Eligibility criteria for SLS I and SLS II were nearly identical.

2020年2月27日 · The SLS-2 trial 109 was designed to address concerns regarding the tolerance and toxicity of cyclophosphamide by comparing 12 months of oral cyclosphosphamide (up to 2 mg/kg) followed by 12 months of placebo, with 24 months of mycophenolate mofetil (maximum daily dose 3 g). FVC increased by 2–3% at the end of the study, with no medication ...

Scleroderma Lung Study (SLS) II, the fi rst randomised controlled trial to compare MMF and cyclophosphamide for the treatment of symptomatic scleroderma-related interstitial lung disease. Cyclophosphamide was included as an active comparator because it is the only drug that has been found in previous

Methods: An investigator-initiated multi-center, double-blind, placebo (PLA)-controlled Phase II trial evaluated combination therapy (MMF+PFD vs MMF+PLA) in those with SSc-ILD. Key inclusion criteria were age≥18, SSc-ILD with symptoms (Mahler dyspnea index), FVC% ≤ 85% predicted, disease duration ≤7 yrs, and any ground glass opacity on HRCT.

Objective: To compare safety and efficacy outcomes between the cyclophosphamide (CYC) arms of Scleroderma Lung Study (SLS) I and II. Methods: Participants enrolled in the CYC arms of SLS I (n = 79) and II (n = 69) were included. SLS I and II randomized participants to oral CYC for 1 year and followed patients for an additional year off therapy ...

2006年6月22日 · We conducted a double-blind, randomized, placebo-controlled trial to determine the effects of oral cyclophosphamide on lung function and health-related symptoms in patients with evidence of...

The Scleroderma Lung Study II (SLS II) Shows That Both Oral Cyclophosphamide (CYC) and Mycophenolate Mofitil (MMF) Are Efficacious in Treating Progressive Interstitial Lung Disease (ILD) in Patients with Systemic Sclerosis (SSc) [abstract].

In the SLS-II trial, 2 years of daily MMF and 1-year of CYC were each associated with clinically meaningful and statistically significant improvements in mRSS vs. placebo arm in patients with dcSSc over a 24-month period.