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Impact of Adding Tacrolimus to Initial Treatment of Interstitial Pneumonitis in Polymyositis/dermatomyositis: a Single-arm Clinical Trial by Kazuki Takada; Yoshinori Katada; Satoshi Ito; Taichi Hayashi; Jun Kishi; Kenji Itoh; Hiroyuki Yamashita; Michito Hirakata; Kimito Kawahata; Atsushi Kawakami; Norihiko Watanabe; Tatsuya Atsumi; Yoshinari Takasaki; Nobuyuki Miyasaka is a Medicine article available to read on EtoBox.
What is Impact of Adding Tacrolimus to Initial Treatment of Interstitial Pneumonitis in Polymyositis/dermatomyositis: a Single-arm Clinical Trial about?
## Abstract ## Objective Interstitial pneumonia is common and has high short-term mortality in patients with PM and DM despite glucocorticoid (GC) treatment. Retrospective studies suggested that the early use of immunosuppressive drugs with GCs might improve its short-term mortality. ## Methods A multicentre, single-arm, 52-week-long clinical trial was performed to test whether the initial combination treatment with tacrolimus (0.075 mg/kg/day, adjusted for the target whole-blood trough levels between 5 and 10 ng/ml) and GCs (0.6–1.0 mg/kg/day of prednisolone followed by a slow taper) improves short-term mortality of PM/DM-interstitial pneumonia patients. The primary outcome was overall survival. We originally intended to compare, by using propensity-score matching, the outcome data of clinical trial patients with that of historical control patients who were initially treated with GCs alone. ## Results The 52-week survival rate with the combination treatment (__N__ = 26) was 88.0% (95% CI, 67.3, 96.0). Safety profiles of the combination treatment were consistent with those known for tacrolimus and high-dose GCs individually. Serious adverse events occurred in 11 patients (44.0%), w
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- Author
- Kazuki Takada; Yoshinori Katada; Satoshi Ito; Taichi Hayashi; Jun Kishi; Kenji Itoh; Hiroyuki Yamashita; Michito Hirakata; Kimito Kawahata; Atsushi Kawakami; Norihiko Watanabe; Tatsuya Atsumi; Yoshinari Takasaki; Nobuyuki Miyasaka
- Publisher
- Oxford University Press (OUP)
- Published
- 2019
- Language
- EN
- Field
- Medicine (Health Sciences)