Bexotegrast in Patients with Idiopathic Pulmonary Fibrosis: The INTEGRIS-IPF Clinical Trial Article Swipe
Lisa Lancaster
,
Vincent Cottin
,
Murali Ramaswamy
,
Wim Wuyts
,
Gísli Jenkins
,
Mary Beth Scholand
,
Michael Kreuter
,
Claudia Valenzuela
,
Christopher J. Ryerson
,
Jonathan Goldin
,
Grace Hyun J. Kim
,
Marzena Jurek
,
Martin Decaris
,
Annie Clark
,
Scott Turner
,
Chris N. Barnes
,
Hardean E. Achneck
,
Gregory P. Cosgrove
,
Éric Lefebvre
,
Kevin R. Flaherty
,
David Baratz
,
Neil Ettinger
,
Daniel Layish
,
Matthew D. Epstein
,
Srihari Veeraraghavan
,
Jeffrey A. Golden
,
Murali Ramaswamy
,
Rebecca Bascom
,
Lisa Lancaster
,
Mary Beth Scholand
,
Amy Hajari Case
,
Tanzira Zaman
,
Alan Betensley
,
Danielle Antin‐Ozerkis
,
Sydney Montessi
,
Evans R. Fernández Pérez
,
R. Boente
,
Jeffrey S. Sager
,
Gary M. Hunninghake
,
Kevin F. Gibson
,
Nadim Srour
,
Anil Dhar
,
Wim Wuyts
,
Pascal Wielders
,
Marcel Veltkamp
,
Rémy L.M. Mostard
,
Robert Janssen
,
Anton Vonk Noordegraaf
,
Ian Glaspole
,
Tamera J. Corte
,
Lutz Beckert
,
Benedict Brockway
,
Andrew G. Veale
,
Luca Richeldi
,
Sergio Harari
·
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1164/rccm.202403-0636oc
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1164/rccm.202403-0636oc
Rationale: Idiopathic pulmonary fibrosis (IPF) is a rare and progressive disease that causes progressive cough, exertional dyspnea, impaired quality of life, and death. Objectives: Bexotegrast (PLN-74809) is an oral, once-daily, investigational drug in development for the treatment of IPF. Methods: This Phase-2a multicenter, clinical trial randomized participants with IPF to receive, orally and once daily, bexotegrast at 40 mg, 80 mg, 160 mg, or 320 mg, or placebo, with or without background IPF therapy (pirfenidone or nintedanib), in an approximately 3:1 ratio in each bexotegrast dose cohort, for at least 12 weeks. The primary endpoint was incidence of treatment-emergent adverse events (TEAEs). Exploratory efficacy endpoints included change from baseline in FVC, quantitative lung fibrosis (QLF) extent (%), and changes from baseline in fibrosis-related biomarkers. Measurements and Main Results: Bexotegrast was well tolerated, with similar rates of TEAEs in the pooled bexotegrast and placebo groups (62/89 [69.7%] and 21/31 [67.7%], respectively). Diarrhea was the most common TEAE; most participants with diarrhea also received nintedanib. Participants who were treated with bexotegrast experienced a reduction in FVC decline over 12 weeks compared with those who received placebo, with or without background therapy. A dose-dependent antifibrotic effect of bexotegrast was observed with QLF imaging, and a decrease in fibrosis-associated biomarkers was observed with bexotegrast versus placebo. Conclusions: Bexotegrast demonstrated a favorable safety and tolerability profile, up to 12 weeks for the doses studied. Exploratory analyses suggest an antifibrotic effect according to FVC, QLF imaging, and circulating levels of fibrosis biomarkers. Clinical trial registered with www.clinicaltrials.gov (NCT04396756).
Related Topics
Concepts
Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1164/rccm.202403-0636oc
- OA Status
- green
- Cited By
- 43
- References
- 51
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4399393072
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4399393072Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1164/rccm.202403-0636ocDigital Object Identifier
- Title
-
Bexotegrast in Patients with Idiopathic Pulmonary Fibrosis: The INTEGRIS-IPF Clinical TrialWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2024Year of publication
- Publication date
-
2024-06-06Full publication date if available
- Authors
-
Lisa Lancaster, Vincent Cottin, Murali Ramaswamy, Wim Wuyts, Gísli Jenkins, Mary Beth Scholand, Michael Kreuter, Claudia Valenzuela, Christopher J. Ryerson, Jonathan Goldin, Grace Hyun J. Kim, Marzena Jurek, Martin Decaris, Annie Clark, Scott Turner, Chris N. Barnes, Hardean E. Achneck, Gregory P. Cosgrove, Éric Lefebvre, Kevin R. Flaherty, David Baratz, Neil Ettinger, Daniel Layish, Matthew D. Epstein, Srihari Veeraraghavan, Jeffrey A. Golden, Murali Ramaswamy, Rebecca Bascom, Lisa Lancaster, Mary Beth Scholand, Amy Hajari Case, Tanzira Zaman, Alan Betensley, Danielle Antin‐Ozerkis, Sydney Montessi, Evans R. Fernández Pérez, R. Boente, Jeffrey S. Sager, Gary M. Hunninghake, Kevin F. Gibson, Nadim Srour, Anil Dhar, Wim Wuyts, Pascal Wielders, Marcel Veltkamp, Rémy L.M. Mostard, Robert Janssen, Anton Vonk Noordegraaf, Ian Glaspole, Tamera J. Corte, Lutz Beckert, Benedict Brockway, Andrew G. Veale, Luca Richeldi, Sergio HarariList of authors in order
- Landing page
-
https://doi.org/10.1164/rccm.202403-0636ocPublisher landing page
- Open access
-
YesWhether a free full text is available
- OA status
-
greenOpen access status per OpenAlex
- OA URL
-
https://hdl.handle.net/2434/1090323Direct OA link when available
- Concepts
-
Medicine, Idiopathic pulmonary fibrosis, Exertional dyspnea, Pulmonary fibrosis, Quality of life (healthcare), Clinical trial, Internal medicine, Fibrosis, Intensive care medicine, Lung, NursingTop concepts (fields/topics) attached by OpenAlex
- Cited by
-
43Total citation count in OpenAlex
- Citations by year (recent)
-
2025: 35, 2024: 8Per-year citation counts (last 5 years)
- References (count)
-
51Number of works referenced by this work
- Related works (count)
-
10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.an | 27, 78, 232 |
| abstract_inverted_index.at | 56, 88 |
| abstract_inverted_index.in | 32, 77, 82, 109, 121, 137, 172, 203 |
| abstract_inverted_index.is | 5, 26 |
| abstract_inverted_index.of | 19, 37, 97, 135, 193, 243 |
| abstract_inverted_index.or | 63, 66, 69, 75, 185 |
| abstract_inverted_index.to | 49, 222, 236 |
| abstract_inverted_index.up | 221 |
| abstract_inverted_index.160 | 61 |
| abstract_inverted_index.320 | 64 |
| abstract_inverted_index.3:1 | 80 |
| abstract_inverted_index.FVC | 173 |
| abstract_inverted_index.IPF | 48, 72 |
| abstract_inverted_index.QLF | 198, 238 |
| abstract_inverted_index.The | 92 |
| abstract_inverted_index.and | 8, 21, 52, 117, 125, 141, 146, 200, 218, 240 |
| abstract_inverted_index.for | 34, 87, 225 |
| abstract_inverted_index.mg, | 58, 60, 62, 65 |
| abstract_inverted_index.the | 35, 138, 152, 226 |
| abstract_inverted_index.was | 95, 129, 151, 195, 206 |
| abstract_inverted_index.who | 164, 181 |
| abstract_inverted_index.(%), | 116 |
| abstract_inverted_index.FVC, | 110, 237 |
| abstract_inverted_index.IPF. | 38 |
| abstract_inverted_index.Main | 126 |
| abstract_inverted_index.This | 40 |
| abstract_inverted_index.also | 160 |
| abstract_inverted_index.dose | 85 |
| abstract_inverted_index.drug | 31 |
| abstract_inverted_index.each | 83 |
| abstract_inverted_index.from | 107, 119 |
| abstract_inverted_index.lung | 112 |
| abstract_inverted_index.most | 153, 156 |
| abstract_inverted_index.once | 53 |
| abstract_inverted_index.over | 175 |
| abstract_inverted_index.rare | 7 |
| abstract_inverted_index.that | 11 |
| abstract_inverted_index.well | 130 |
| abstract_inverted_index.were | 165 |
| abstract_inverted_index.with | 47, 68, 132, 158, 167, 179, 184, 197, 208, 249 |
| abstract_inverted_index.(IPF) | 4 |
| abstract_inverted_index.(QLF) | 114 |
| abstract_inverted_index.21/31 | 147 |
| abstract_inverted_index.TEAE; | 155 |
| abstract_inverted_index.TEAEs | 136 |
| abstract_inverted_index.doses | 227 |
| abstract_inverted_index.least | 89 |
| abstract_inverted_index.life, | 20 |
| abstract_inverted_index.oral, | 28 |
| abstract_inverted_index.rates | 134 |
| abstract_inverted_index.ratio | 81 |
| abstract_inverted_index.those | 180 |
| abstract_inverted_index.trial | 44, 247 |
| abstract_inverted_index.weeks | 177, 224 |
| abstract_inverted_index.(62/89 | 144 |
| abstract_inverted_index.causes | 12 |
| abstract_inverted_index.change | 106 |
| abstract_inverted_index.common | 154 |
| abstract_inverted_index.cough, | 14 |
| abstract_inverted_index.daily, | 54 |
| abstract_inverted_index.death. | 22 |
| abstract_inverted_index.effect | 192, 234 |
| abstract_inverted_index.events | 100 |
| abstract_inverted_index.extent | 115 |
| abstract_inverted_index.groups | 143 |
| abstract_inverted_index.levels | 242 |
| abstract_inverted_index.orally | 51 |
| abstract_inverted_index.pooled | 139 |
| abstract_inverted_index.safety | 217 |
| abstract_inverted_index.versus | 210 |
| abstract_inverted_index.weeks. | 91 |
| abstract_inverted_index.[69.7%] | 145 |
| abstract_inverted_index.adverse | 99 |
| abstract_inverted_index.changes | 118 |
| abstract_inverted_index.cohort, | 86 |
| abstract_inverted_index.decline | 174 |
| abstract_inverted_index.disease | 10 |
| abstract_inverted_index.placebo | 142 |
| abstract_inverted_index.primary | 93 |
| abstract_inverted_index.quality | 18 |
| abstract_inverted_index.similar | 133 |
| abstract_inverted_index.suggest | 231 |
| abstract_inverted_index.therapy | 73 |
| abstract_inverted_index.treated | 166 |
| abstract_inverted_index.without | 70, 186 |
| abstract_inverted_index.(TEAEs). | 101 |
| abstract_inverted_index.Clinical | 246 |
| abstract_inverted_index.Diarrhea | 150 |
| abstract_inverted_index.Phase-2a | 41 |
| abstract_inverted_index.[67.7%], | 148 |
| abstract_inverted_index.analyses | 230 |
| abstract_inverted_index.baseline | 108, 120 |
| abstract_inverted_index.clinical | 43 |
| abstract_inverted_index.compared | 178 |
| abstract_inverted_index.decrease | 202 |
| abstract_inverted_index.diarrhea | 159 |
| abstract_inverted_index.dyspnea, | 16 |
| abstract_inverted_index.efficacy | 103 |
| abstract_inverted_index.endpoint | 94 |
| abstract_inverted_index.fibrosis | 3, 113, 244 |
| abstract_inverted_index.imaging, | 199, 239 |
| abstract_inverted_index.impaired | 17 |
| abstract_inverted_index.included | 105 |
| abstract_inverted_index.observed | 196, 207 |
| abstract_inverted_index.placebo, | 67, 183 |
| abstract_inverted_index.placebo. | 211 |
| abstract_inverted_index.profile, | 220 |
| abstract_inverted_index.receive, | 50 |
| abstract_inverted_index.received | 161, 182 |
| abstract_inverted_index.studied. | 228 |
| abstract_inverted_index.therapy. | 188 |
| abstract_inverted_index.according | 235 |
| abstract_inverted_index.endpoints | 104 |
| abstract_inverted_index.favorable | 216 |
| abstract_inverted_index.incidence | 96 |
| abstract_inverted_index.pulmonary | 2 |
| abstract_inverted_index.reduction | 171 |
| abstract_inverted_index.treatment | 36 |
| abstract_inverted_index.Idiopathic | 1 |
| abstract_inverted_index.background | 71, 187 |
| abstract_inverted_index.biomarkers | 205 |
| abstract_inverted_index.exertional | 15 |
| abstract_inverted_index.randomized | 45 |
| abstract_inverted_index.registered | 248 |
| abstract_inverted_index.tolerated, | 131 |
| abstract_inverted_index.(PLN-74809) | 25 |
| abstract_inverted_index.Bexotegrast | 24, 128, 213 |
| abstract_inverted_index.Exploratory | 102, 229 |
| abstract_inverted_index.bexotegrast | 55, 84, 140, 168, 194, 209 |
| abstract_inverted_index.biomarkers. | 123, 245 |
| abstract_inverted_index.circulating | 241 |
| abstract_inverted_index.development | 33 |
| abstract_inverted_index.experienced | 169 |
| abstract_inverted_index.nintedanib. | 162 |
| abstract_inverted_index.once-daily, | 29 |
| abstract_inverted_index.progressive | 9, 13 |
| abstract_inverted_index.(pirfenidone | 74 |
| abstract_inverted_index.Participants | 163 |
| abstract_inverted_index.Results:</b> | 127 |
| abstract_inverted_index.antifibrotic | 191, 233 |
| abstract_inverted_index.demonstrated | 214 |
| abstract_inverted_index.multicenter, | 42 |
| abstract_inverted_index.nintedanib), | 76 |
| abstract_inverted_index.participants | 46, 157 |
| abstract_inverted_index.quantitative | 111 |
| abstract_inverted_index.tolerability | 219 |
| abstract_inverted_index.approximately | 79 |
| abstract_inverted_index.(NCT04396756). | 251 |
| abstract_inverted_index.dose-dependent | 190 |
| abstract_inverted_index.respectively). | 149 |
| abstract_inverted_index.<b>Measurements | 124 |
| abstract_inverted_index.<b>Methods:</b> | 39 |
| abstract_inverted_index.investigational | 30 |
| abstract_inverted_index.fibrosis-related | 122 |
| abstract_inverted_index.<b>Rationale:</b> | 0 |
| abstract_inverted_index.<b>Objectives:</b> | 23 |
| abstract_inverted_index.treatment-emergent | 98 |
| abstract_inverted_index.<b>Conclusions:</b> | 212 |
| abstract_inverted_index.fibrosis-associated | 204 |
| abstract_inverted_index.www.clinicaltrials.gov | 250 |
| cited_by_percentile_year.max | 100 |
| cited_by_percentile_year.min | 99 |
| countries_distinct_count | 7 |
| institutions_distinct_count | 55 |
| citation_normalized_percentile.value | 0.99741413 |
| citation_normalized_percentile.is_in_top_1_percent | True |
| citation_normalized_percentile.is_in_top_10_percent | True |