PMID- 36119045
OWN - NLM
STAT- MEDLINE
DCOM- 20220920
LR  - 20220926
IS  - 1664-3224 (Electronic)
IS  - 1664-3224 (Linking)
VI  - 13
DP  - 2022
TI  - The efficacy and safety of tacrolimus on top of glucocorticoids in the management 
      of IIM-ILD: A retrospective and prospective study.
PG  - 978429
LID - 10.3389/fimmu.2022.978429 [doi]
LID - 978429
AB  - OBJECTIVE: To examine the efficacy of tacrolimus on top of glucocorticoids (GCs) 
      in the management of idiopathic inflammatory myopathies-associated interstitial 
      lung disease (IIM-ILD) and further assess the therapeutic benefit and safety of 
      low-dose pirfenidone followed above treatments. METHODS: The retrospective study 
      comprised 250 patients with IIM-ILD hospitalized in Tongji Hospital from 2014 to 
      2020. Demographic data, survival outcomes, and recurrence rates over the 1-year 
      follow-up period were retrospectively analyzed. These patients were divided into 
      two groups based on treatment with tacrolimus alone or other conventional 
      immunosuppressants. Endpoints were compared by adjusted Cox regression model 
      using inverse probability of treatment weighting to minimize treatment bias and 
      potential confounders. For the prospective study, IIM-ILD patients treated with 
      tacrolimus alone or tacrolimus combined with low-dose pirfenidone were enrolled 
      from 2018 to 2020. Clinical characteristics, survival outcomes and multifarious 
      assessment scales were followed up at baseline, 3, 6 and 12 months. The primary 
      endpoint was 12-month survival rate and the secondary endpoints included 
      respiratory-related events, adverse events, exacerbation in HRCT findings and 
      laboratory parameters during therapy courses, and changes in respiratory 
      function. RESULTS: For the retrospective study, tacrolimus group (n=93) had a 
      significantly higher survival rate (weighted HR=0.330, p=0.002) and a lower 
      relapse rate (weighted HR=0.548, p=0.003) compared with patients treated with 
      other types of immunosuppressant (n=157) after adjustment. The prospectively 
      enrolled 34 IIM-ILD patients were treated with tacrolimus (n=12) or tacrolimus 
      combined with low-dose pirfenidone (n=22). After 12 months of treatment with 
      tacrolimus, patients in the prospective cohort showed significant improvements in 
      cardio-pulmonary function, disease activity, muscle strength, and mental scale 
      from baseline. Subgroup analysis indicated that patients with tacrolimus and 
      pirfenidone combination therapy showed lower chest HRCT scores (p=0.021) and 
      lower respiratory-related relapse rates than those in tacrolimus monotherapy 
      group (log-rank p=0.0029). The incidence rate of drug-associated adverse events 
      (AEs) was comparable between two groups and none of the patients discontinued the 
      treatment due to severe AEs. CONCLUSION: Tacrolimus is well-tolerated and 
      effective in the treatment of IIM-ILD. Furthermore, low-dose pirfenidone add-on 
      treatment seems result in favorable improvements in pulmonary involvements for 
      IIM-ILD patients. CLINICAL TRIAL REGISTRATION: http://www.chictr.org.cn, 
      identifier ChiCTR2100043595.
CI  - Copyright (c) 2022 Chen, Bai, Zhang, Hu, Zhong and Dong.
FAU - Chen, Yuxue
AU  - Chen Y
AD  - Department of Rheumatology and Immunology, Tongji Hospital, Tongji Medical 
      College, Huazhong University of Science and Technology, Wuhan, China.
FAU - Bai, Zhiqian
AU  - Bai Z
AD  - Department of Rheumatology and Immunology, Tongji Hospital, Tongji Medical 
      College, Huazhong University of Science and Technology, Wuhan, China.
FAU - Zhang, Ziyun
AU  - Zhang Z
AD  - Department of Rheumatology and Immunology, Tongji Hospital, Tongji Medical 
      College, Huazhong University of Science and Technology, Wuhan, China.
FAU - Hu, Qiongjie
AU  - Hu Q
AD  - Department of Radiology, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, China.
FAU - Zhong, Jixin
AU  - Zhong J
AD  - Department of Rheumatology and Immunology, Tongji Hospital, Tongji Medical 
      College, Huazhong University of Science and Technology, Wuhan, China.
FAU - Dong, Lingli
AU  - Dong L
AD  - Department of Rheumatology and Immunology, Tongji Hospital, Tongji Medical 
      College, Huazhong University of Science and Technology, Wuhan, China.
LA  - eng
SI  - ChiCTR/ChiCTR2100043595
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20220902
PL  - Switzerland
TA  - Front Immunol
JT  - Frontiers in immunology
JID - 101560960
RN  - 0 (Glucocorticoids)
RN  - 0 (Immunosuppressive Agents)
RN  - WM0HAQ4WNM (Tacrolimus)
SB  - IM
MH  - Glucocorticoids/adverse effects
MH  - Humans
MH  - Immunosuppressive Agents/adverse effects
MH  - *Lung Diseases, Interstitial/etiology
MH  - Prospective Studies
MH  - Recurrence
MH  - Retrospective Studies
MH  - *Tacrolimus/adverse effects
PMC - PMC9479328
OTO - NOTNLM
OT  - glucocorticoids
OT  - idiopathic inflammatory myopathies (IIM)
OT  - interstitial lung diseases (ILD)
OT  - pirfenidone
OT  - tacrolimus
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2022/09/20 06:00
MHDA- 2022/09/21 06:00
PMCR- 2022/01/01
CRDT- 2022/09/19 04:21
PHST- 2022/06/26 00:00 [received]
PHST- 2022/08/16 00:00 [accepted]
PHST- 2022/09/19 04:21 [entrez]
PHST- 2022/09/20 06:00 [pubmed]
PHST- 2022/09/21 06:00 [medline]
PHST- 2022/01/01 00:00 [pmc-release]
AID - 10.3389/fimmu.2022.978429 [doi]
PST - epublish
SO  - Front Immunol. 2022 Sep 2;13:978429. doi: 10.3389/fimmu.2022.978429. eCollection 
      2022.