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SLS II Trial — SCE Rheumatology MCQ

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HardSystemic SclerosisSLS II TrialSCE Rheumatology

In Scleroderma Lung Study II (SLS II), patients with symptomatic systemic sclerosis-associated interstitial lung disease were randomized to mycophenolate mofetil for 24 months or oral cyclophosphamide for 12 months followed by placebo. Which statement most accurately describes the trial findings?

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Correct answer: BThe 24-month FVC course did not differ significantly between groups; lung function improved in both, while MMF was better tolerated and less toxic.

SLS II found no significant difference in the prespecified course of percentage-predicted FVC between MMF and cyclophosphamide over 24 months (p=0.24); thus, it was a negative superiority trial and did not formally establish equivalence or non-inferiority. Lung function improved in both treatment groups. MMF was favoured because it caused substantially less leucopenia and thrombocytopenia and fewer patients discontinued treatment prematurely. Therefore D is the most precise interpretation. A and B incorrectly claim superiority, C incorrectly states that lung function did not improve, and E mischaracterizes the trial as a successful non-inferiority study. These findings support, but did not alone establish, the current UK preference for MMF as first-line treatment for SSc-ILD.

Reference: Tashkin DP et al. Mycophenolate mofetil versus oral cyclophosphamide in scleroderma-related interstitial lung disease (SLS II): a randomised controlled, double-blind, parallel group trial. Lancet Respiratory Medicine. 2016;4:708–719. https://pubmed.ncbi.nlm.nih.gov/27469583/