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SLS II Trial — SCE Rheumatology MCQ

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HardSystemic SclerosisSLS II TrialSCE Rheumatology

Which trial–outcome pairing most directly provides the evidence underlying the preference for mycophenolate mofetil over cyclophosphamide as initial immunosuppressive therapy for systemic sclerosis-associated interstitial lung disease?

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Correct answer: E — SLS II: mycophenolate for 24 months and oral cyclophosphamide for 12 months had no significant difference in FVC course, but mycophenolate had fewer toxic effects and withdrawals

SLS II directly compared mycophenolate mofetil for 24 months with oral cyclophosphamide for 12 months followed by placebo. The prespecified analysis found no significant difference between groups in the course of percentage-predicted FVC, so the study should not be described as a formal non-inferiority trial. Both groups improved, but mycophenolate caused substantially less leucopenia and thrombocytopenia and fewer participants discontinued treatment, supporting its clinical preference. SLS I established a modest benefit of cyclophosphamide over placebo rather than testing mycophenolate. SENSCIS evaluated nintedanib, focuSSced evaluated tocilizumab, and RECITAL compared rituximab with intravenous cyclophosphamide across connective tissue disease-associated ILD. Current BSR and EULAR guidance is consistent with using mycophenolate as a principal first-line immunosuppressive option 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/