PMID- 33142016
OWN - NLM
STAT- MEDLINE
DCOM- 20210427
LR  - 20240331
IS  - 2326-5205 (Electronic)
IS  - 2326-5191 (Print)
IS  - 2326-5191 (Linking)
VI  - 73
IP  - 4
DP  - 2021 Apr
TI  - Effect of Nintedanib on Lung Function in Patients With Systemic 
      Sclerosis-Associated Interstitial Lung Disease: Further Analyses of a Randomized, 
      Double-Blind, Placebo-Controlled Trial.
PG  - 671-676
LID - 10.1002/art.41576 [doi]
AB  - OBJECTIVE: In the SENSCIS trial in subjects with systemic sclerosis-associated 
      interstitial lung disease (SSc-ILD), nintedanib reduced the rate of decline in 
      forced vital capacity (FVC) over 52 weeks by 44% versus placebo. This study was 
      undertaken to investigate the effects of nintedanib on categorical changes in FVC 
      and other measures of ILD progression. METHODS: In post hoc analyses, we assessed 
      the proportions of subjects with categorical changes in FVC % predicted at week 
      52 and the time to absolute decline in FVC of >/=5% predicted or death and absolute 
      decline in FVC of >/=10% predicted or death. RESULTS: A total of 288 subjects 
      received nintedanib and 288 subjects received placebo. At week 52, in subjects 
      treated with nintedanib and placebo, respectively, 55.7% and 66.3% had any 
      decline in FVC % predicted, 13.6% and 20.1% had a decline in FVC of >5% to </=10% 
      predicted, and 3.5% and 5.2% had a decline in FVC of >10% to </=15% predicted; 
      34.5% and 43.8% had a decrease in FVC of >/=3.3% predicted (proposed minimal 
      clinically important difference [MCID] for worsening of FVC), while 23.0% and 
      14.9% had an increase in FVC of >/=3.0% predicted (proposed MCID for improvement in 
      FVC). Over 52 weeks, the hazard ratio (HR) for an absolute decline in FVC of >/=5% 
      predicted or death with nintedanib versus placebo was 0.83 (95% confidence 
      interval [95% CI] 0.66-1.06) (P = 0.14), and the HR for an absolute decline in 
      FVC of >/=10% predicted was 0.64 (95% CI 0.43-0.95) (P = 0.029). CONCLUSION: These 
      results suggest that nintedanib has a clinically relevant benefit on the 
      progression of SSc-ILD.
CI  - (c) 2020 The Authors. Arthritis & Rheumatology published by Wiley Periodicals LLC 
      on behalf of American College of Rheumatology.
FAU - Maher, Toby M
AU  - Maher TM
AUID- ORCID: 0000-0001-7192-9149
AD  - National Heart and Lung Institute, Imperial College London and NIHR Clinical 
      Research Facility, Royal Brompton Hospital, London, UK, and Keck School of 
      Medicine, University of Southern California, Los Angeles.
FAU - Mayes, Maureen D
AU  - Mayes MD
AD  - University of Texas McGovern Medical School, Houston.
FAU - Kreuter, Michael
AU  - Kreuter M
AD  - Thoraxklinik, University of Heidelberg, and the German Center for Lung Research, 
      Heidelberg, Germany.
FAU - Volkmann, Elizabeth R
AU  - Volkmann ER
AUID- ORCID: 0000-0003-3750-6569
AD  - University of California, David Geffen School of Medicine, Los Angeles.
FAU - Aringer, Martin
AU  - Aringer M
AUID- ORCID: 0000-0003-4471-8375
AD  - University Medical Center and Faculty of Medicine Carl Gustav Carus, TU Dresden, 
      Dresden, Germany.
FAU - Castellvi, Ivan
AU  - Castellvi I
AUID- ORCID: 0000-0002-5410-5807
AD  - Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
FAU - Cutolo, Maurizio
AU  - Cutolo M
AUID- ORCID: 0000-0002-5396-0932
AD  - University of Genova, IRCCS San Martino Polyclinic Hospital, Genova, Italy.
FAU - Stock, Christian
AU  - Stock C
AD  - Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.
FAU - Schoof, Nils
AU  - Schoof N
AD  - Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
FAU - Alves, Margarida
AU  - Alves M
AD  - Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
FAU - Raghu, Ganesh
AU  - Raghu G
AD  - University of Washington, Seattle.
CN  - SENSCIS Trial Investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT02597933
GR  - CS-2013-13-017/DH_/Department of Health/United Kingdom
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20210308
PL  - United States
TA  - Arthritis Rheumatol
JT  - Arthritis & rheumatology (Hoboken, N.J.)
JID - 101623795
RN  - 0 (Indoles)
RN  - 0 (Protein Kinase Inhibitors)
RN  - G6HRD2P839 (nintedanib)
SB  - IM
CIN - Arthritis Rheumatol. 2021 Dec;73(12):2353-2354. PMID: 34105307
CIN - Arthritis Rheumatol. 2021 Dec;73(12):2354-2355. PMID: 34105317
MH  - Adult
MH  - Aged
MH  - Disease Progression
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Indoles/pharmacology/*therapeutic use
MH  - Lung/*drug effects/physiopathology
MH  - Lung Diseases, Interstitial/*drug therapy/etiology/physiopathology
MH  - Male
MH  - Middle Aged
MH  - Protein Kinase Inhibitors/pharmacology/*therapeutic use
MH  - Scleroderma, Systemic/*complications/physiopathology
MH  - Treatment Outcome
PMC - PMC8048624
EDAT- 2020/11/04 06:00
MHDA- 2021/04/28 06:00
PMCR- 2021/04/15
CRDT- 2020/11/03 17:13
PHST- 2020/10/08 00:00 [revised]
PHST- 2020/03/17 00:00 [received]
PHST- 2020/10/29 00:00 [accepted]
PHST- 2020/11/04 06:00 [pubmed]
PHST- 2021/04/28 06:00 [medline]
PHST- 2020/11/03 17:13 [entrez]
PHST- 2021/04/15 00:00 [pmc-release]
AID - ART41576 [pii]
AID - 10.1002/art.41576 [doi]
PST - ppublish
SO  - Arthritis Rheumatol. 2021 Apr;73(4):671-676. doi: 10.1002/art.41576. Epub 2021 
      Mar 8.