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In placebo-controlled randomized clinical trials and observational studies, both intravenous (IV) and oral (PO) cyclophosphamide (CYC) have shown beneficial effects on skin and lungs of systemic sclerosis (SSc).
study aims to compare the relative efficacy and safety of PO-CYC in treating interstitiotic lung disease and/or skin-affected SSc, the results of this study have been published online in Clin Exp Rheumatol.
patients from the EUSTAR Center and stethosis lung studies III and II.
need at least 6 months of CYC treatment and 12 months of follow-up.
analyze severity (SAEs) and non-critical adverse events and efficacy data (FVC, DLCO, mRSS changes) at the end of CYC therapy (EoT) and follow-up (FU).
analysis includes descriptive statistics and linear regression.
results, differences in race, previous DMALD exposure, prior and accompanying steroid exposure/dose were observed in the CYC groups of PO (n=149) and IV (n=153).
FVC, DLCO% and MSSS are similar to unaldished changes regardless of the method of dosing.
patients with EOT had more lecytosis (p.lt;0.001), hemorrhagic cystitis (p-0.011) and hair loss (p-lt;0.001), while IV group IV had more SAE (p-0.025) and oxygen rehydration requirements (p-0.049) at FU.
, comparing PO-and IV-CYC treatment with SSc, we found no difference in lung function and skin hardening after one year.
there are some differences in side effects.
these results need to be considered preliminary; however, since we need to use a combination of RCT and registry data, there are some demographic and accompanying drug differences, so good control studies are needed.
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