PMID- 35199968
OWN - NLM
STAT- MEDLINE
DCOM- 20220602
LR  - 20220731
IS  - 2326-5205 (Electronic)
IS  - 2326-5191 (Print)
IS  - 2326-5191 (Linking)
VI  - 74
IP  - 6
DP  - 2022 Jun
TI  - Nintedanib in Patients With Autoimmune Disease-Related Progressive Fibrosing 
      Interstitial Lung Diseases: Subgroup Analysis of the INBUILD Trial.
PG  - 1039-1047
LID - 10.1002/art.42075 [doi]
AB  - OBJECTIVE: To analyze the efficacy and safety of nintedanib in patients with 
      fibrosing autoimmune disease-related interstitial lung diseases (ILDs) with a 
      progressive phenotype. METHODS: The INBUILD trial enrolled patients with a 
      fibrosing ILD other than idiopathic pulmonary fibrosis, with diffuse fibrosing 
      lung disease of >10% extent on high-resolution computed tomography, forced vital 
      capacity percent predicted (FVC%) >/=45%, and diffusing capacity of the lungs for 
      carbon monoxide percent predicted >/=30% to <80%. Patients fulfilled 
      protocol-defined criteria for progression of ILD within the 24 months before 
      screening, despite management deemed appropriate in clinical practice. Subjects 
      were randomized to receive nintedanib or placebo. We assessed the rate of decline 
      in FVC (ml/year) and adverse events (AEs) over 52 weeks in the subgroup with 
      autoimmune disease-related ILDs. RESULTS: Among 170 patients with autoimmune 
      disease-related ILDs, the rate of decline in FVC over 52 weeks was -75.9 ml/year 
      with nintedanib versus -178.6 ml/year with placebo (difference 102.7 ml/year [95% 
      confidence interval 23.2, 182.2]; nominal P = 0.012). No heterogeneity was 
      detected in the effect of nintedanib versus placebo across subgroups based on ILD 
      diagnosis (P = 0.91). The most frequent AE was diarrhea, reported in 63.4% and 
      27.3% of subjects in the nintedanib and placebo groups, respectively. AEs led to 
      permanent discontinuation of trial drug in 17.1% and 10.2% of subjects in the 
      nintedanib and placebo groups, respectively. CONCLUSION: In the INBUILD trial, 
      nintedanib slowed the rate of decline in FVC in patients with progressive 
      fibrosing autoimmune disease-related ILDs, with AEs that were manageable for most 
      patients.
CI  - (c) 2022 The Authors. Arthritis & Rheumatology published by Wiley Periodicals LLC 
      on behalf of American College of Rheumatology.
FAU - Matteson, Eric L
AU  - Matteson EL
AUID- ORCID: 0000-0002-9866-0124
AD  - Mayo Clinic College of Medicine and Science, Rochester, Minnesota.
FAU - Kelly, Clive
AU  - Kelly C
AD  - Newcastle University, Newcastle-upon-Tyne, UK.
FAU - Distler, Jorg H W
AU  - Distler JHW
AUID- ORCID: 0000-0001-7408-9333
AD  - Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany.
FAU - Hoffmann-Vold, Anna-Maria
AU  - Hoffmann-Vold AM
AD  - Oslo University Hospital, Oslo, Norway.
FAU - Seibold, James R
AU  - Seibold JR
AD  - Scleroderma Research Consultants LLC, Aiken, South Carolina.
FAU - Mittoo, Shikha
AU  - Mittoo S
AD  - University of Toronto, Toronto, Ontario, Canada.
FAU - Dellaripa, Paul F
AU  - Dellaripa PF
AD  - Brigham and Women's Hospital, Boston, Massachusetts.
FAU - Aringer, Martin
AU  - Aringer M
AUID- ORCID: 0000-0003-4471-8375
AD  - Technical University of Dresden, Dresden, Germany.
FAU - Pope, Janet
AU  - Pope J
AUID- ORCID: 0000-0003-1479-5302
AD  - University of Western Ontario, London, Ontario, Canada.
FAU - Distler, Oliver
AU  - Distler O
AUID- ORCID: 0000-0002-0546-8310
AD  - University of Zurich, Zurich, Switzerland.
FAU - James, Alexandra
AU  - James A
AD  - elderbrook solutions GmbH, Bietigheim-Bissingen, Germany.
FAU - Schlenker-Herceg, Rozsa
AU  - Schlenker-Herceg R
AD  - Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, Connecticut.
FAU - Stowasser, Susanne
AU  - Stowasser S
AD  - Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
FAU - Quaresma, Manuel
AU  - Quaresma M
AD  - Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
FAU - Flaherty, Kevin R
AU  - Flaherty KR
AD  - University of Michigan, Ann Arbor.
CN  - INBUILD Trial Investigators
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20220502
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
MH  - *Autoimmune Diseases/chemically induced/complications/drug therapy
MH  - Disease Progression
MH  - Humans
MH  - *Idiopathic Pulmonary Fibrosis/complications/drug therapy
MH  - Indoles
MH  - *Lung Diseases, Interstitial/diagnosis
MH  - Protein Kinase Inhibitors/therapeutic use
MH  - Vital Capacity
PMC - PMC9321107
EDAT- 2022/02/25 06:00
MHDA- 2022/06/03 06:00
PMCR- 2022/07/26
CRDT- 2022/02/24 08:44
PHST- 2021/11/26 00:00 [revised]
PHST- 2021/03/11 00:00 [received]
PHST- 2022/01/21 00:00 [accepted]
PHST- 2022/02/25 06:00 [pubmed]
PHST- 2022/06/03 06:00 [medline]
PHST- 2022/02/24 08:44 [entrez]
PHST- 2022/07/26 00:00 [pmc-release]
AID - ART42075 [pii]
AID - 10.1002/art.42075 [doi]
PST - ppublish
SO  - Arthritis Rheumatol. 2022 Jun;74(6):1039-1047. doi: 10.1002/art.42075. Epub 2022 
      May 2.