Evidence map›Paper›PMID 26083430›Full record

Trial reportPloS one2015

Autoantibody-Targeted Treatments for Acute Exacerbations of Idiopathic Pulmonary Fibrosis.

Michael Donahoe, Vincent G Valentine, Nydia Chien, Kevin F Gibson, Jay S Raval, Melissa Saul, Jianmin Xue, Yingze Zhang, Steven R Duncan

Erratum issued 3 registry-linked trialsOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 3 registered trials, which are not on this map. Cited by 59 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 2 pooled it
11.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01266317 phase1 / phase2completednot on this map

Open-Label, Feasibility Study of Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids in Patients With Acute Idiopathic Pulmonary Fibrosis Exacerbations

TypeinterventionalSponsorMichael DonahoeRan2011 to 2015Enrolled9ConditionsIPFArmsCombined Plasma Exchange (PEX), Rituximab, and Corticosteroids
NCT03286556 phase2completednot on this mapstarted 2018, after this paper: background citation

Study of Therapeutic Plasma Exchange, Rituximab and Intravenous Immunoglobulin for Acute Exacerbations of Idiopathic Pulmonary Fibrosis (STRIVE-IPF)

TypeinterventionalSponsorUniversity of Alabama at BirminghamRan2018 to 2024Enrolled82ConditionsIdiopathic Pulmonary Fibrosis, Acute Fatal FormArmsAutoantibody Reductive Therapy, Treatment as Usual (TAU)
NCT07674745 phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Study of Therapeutic Plasma Exchange, Rituximab, and Intravenous Immunoglobulin for Progressive Idiopathic Pulmonary Fibrosis (STRIVE II)

TypeinterventionalSponsorUniversity of Alabama at BirminghamRan2026 to 2031Enrolled52ConditionsIdiopathic Pulmonary FibrosisArmsTherapeutic Plasma Exchange, Rituximab, Intravenous immunoglobulin, Treatment as Usual
3 · Its place in the literature

Who cites it

59 citing papers in PubMed, 2 syntheses or guidelines pooled it, 126 citations in OpenAlex.

  1. Pooled it
  2. Risk factors for mortality and mortality rates in interstitial lung disease patients in the intensive care unit.European respiratory review : an official journal of the European Respiratory Society · 2018
    Pooled it
  3. Acute exacerbation in fibrotic interstitial lung disease: an international working group report.American journal of respiratory and critical care medicine · 2026
    Review
  4. Review
  5. Review
  6. Article
  7. TheJournal of clinical medicine · 2024
    Review
  8. Review
  9. Article
  10. Review
  11. Review
  12. Article
  13. Article
  14. Persistent microbial infections and idiopathic pulmonary fibrosis - an insight intoFrontiers in cellular and infection microbiology · 2024
    Review
  15. Article
  16. Review
  17. Intravenous immunoglobulin for acute exacerbation of fibrotic idiopathic interstitial pneumonias.Sarcoidosis, vasculitis, and diffuse lung diseases : official journal of WASOG · 2022
    Article
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 1 country.

Michael DonahoeDepartment of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States of America.
Vincent G ValentineDepartment of Medicine, University of Texas Medical Branch, Galveston, Texas, 77555, United States of America.
Nydia ChienDepartment of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States of America.
Kevin F GibsonDepartment of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States of America.
Jay S RavalDepartment of Pathology and Laboratory Medicine, University of North Carolina, Chapel Hill, North Carolina, 27599, United States of America.
Melissa SaulDepartment of Biomedical Informatics, University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States of America.
Jianmin XueDepartment of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States of America.
Yingze ZhangDepartment of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States of America.
Steven R DuncanDepartment of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States of America.
University of Pittsburgh · USThe University of Texas Medical Branch at Galveston · USUniversity of North Carolina at Chapel Hill · US

Funding

Rituximab Therapy in Patients with IPFR01HL119960 · NHLBI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI DUNCAN, STEVEN R, KASS, DANIEL J · 2013 to 2018
$3.4M
The Role of Humoral Autoimmunity in Idiopathic Pulmonary FibrosisP50HL107172 · NHLBI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI DUNCAN, STEVEN R · 2011 to 2012
$859k
NHLBI NIH HHS HL107172NHLBI NIH HHS HL119960NHLBI NIH HHS P50 HL107172NHLBI NIH HHS R01 HL119960
6 · The paper itself

Abstract

backgroundSevere acute exacerbations (AE) of idiopathic pulmonary fibrosis (IPF) are medically untreatable and often fatal within days. Recent evidence suggests autoantibodies may be involved in IPF progression. Autoantibody-mediated lung diseases are typically refractory to glucocorticoids and nonspecific medications, but frequently respond to focused autoantibody reduction treatments. We conducted a pilot trial to test the hypothesis that autoantibody-targeted therapies may also benefit AE-IPF patients.

methodsEleven (11) critically-ill AE-IPF patients with no evidence of conventional autoimmune diseases were treated with therapeutic plasma exchanges (TPE) and rituximab, supplemented in later cases with intravenous immunoglobulin (IVIG). Plasma anti-epithelial (HEp-2) autoantibodies and matrix metalloproteinase-7 (MMP7) were evaluated by indirect immunofluorescence and ELISA, respectively. Outcomes among the trial subjects were compared to those of 20 historical control AE-IPF patients treated with conventional glucocorticoid therapy prior to this experimental trial.

resultsNine (9) trial subjects (82%) had improvements of pulmonary gas exchange after treatment, compared to one (5%) historical control. Two of the three trial subjects who relapsed after only five TPE responded again with additional TPE. The three latest subjects who responded to an augmented regimen of nine TPE plus rituximab plus IVIG have had sustained responses without relapses after 96-to-237 days. Anti-HEp-2 autoantibodies were present in trial subjects prior to therapy, and were reduced by TPE among those who responded to treatment. Conversely, plasma MMP7 levels were not systematically affected by therapy nor correlated with clinical responses. One-year survival of trial subjects was 46+15% vs. 0% among historical controls. No serious adverse events were attributable to the experimental medications.

conclusionThis pilot trial indicates specific treatments that reduce autoantibodies might benefit some severely-ill AE-IPF patients. These findings have potential implications regarding mechanisms of IPF progression, and justify considerations for incremental trials of autoantibody-targeted therapies in AE-IPF patients.

trial registrationClinicalTrials.gov NCT01266317.

Indexed as

Plasma ExchangeAgedAged, 80 and overAutoantibodiesCase-Control StudiesDisease ProgressionFemaleGlucocorticoidsHumansIdiopathic Pulmonary FibrosisImmunoglobulins, IntravenousImmunologic FactorsLungMaleMiddle AgedPilot ProjectsAutoantibodiesGlucocorticoidsImmunoglobulins, IntravenousImmunologic FactorsRituximab

Identifiers

PMID26083430
PMCPMC4470587
OpenAlexW567581979

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.