Note: link to the survey https://redcap.uchicago.edu/surveys/?s=D97TYC4XRHPMRDE4
Dear Members of EUSTAR,
We are aiming to evaluate the safety and effectiveness of mycophenolate vs tocilizumab/mycophenolate (TCZ/MMF) combination therapy in systemic sclerosis-associated interstitial lung disease. As part of this, we have created a survey, with link below, to better understand patterns of combination therapy treatment at member institutions. The results of this survey will be submitted to the 2024 ACR meeting as an abstract. Based on the results of this survey, we plan to invite institutions to collaborate by sharing their deidentified patient data for this important and clinically relevant project. Authorship on resulting manuscripts from this project will be offered to collaborators that are able to provide their institution’s deidentified data, as is needed for this analysis. A list of respondents will be acknowledged for this initial survey project.
The focuSSed trial evaluated TCZ vs placebo in early cutaneous diffuse SSc with elevated acute phase reactants. Most notably, TCZ led to stabilization of FVC compared with placebo across baseline ILD severity, improved CT ILD lung involvement scores, and led to stabilization of CT fibrosis involvement scores in 48 weeks. The data from the focuSSed trial led to the FDA approval of TCZ for SSc-ILD in 2021. We plan to compare effectiveness and safety outcomes of MMF vs TCZ vs combination therapy with MMF/TCZ when used for SSc-ILD using multicenter patient outcome data in a retrospective observational study.
Purpose of the Study:
1. Investigate the differences in the evolution of pulmonary functional tests (FVC and DLCO) in patients with SSc-ILD treated with MMF monotherapy, TCZ monotherapy, and MMF/TCZ combination therapy.
2. Compare the safety profile of MMF monotherapy, TCZ monotherapy, and MMF/TCZ combination therapy.
1. MMF/TCZ combination therapy is superior to mycophenolate and TCZ alone for stabilization of FVC and DLCO in SSc-ILD.
2. MMF/TCZ combination therapy has a similar adverse effect profile compared to TCZ and MMF alone.
Link to survey:
Michael Macklin MD, PharmD; Iazsmin Ventura MD; Dinesh Khanna, MD, MSc