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Peer-reviewedCC BY-NCERJ open research

Multimodal investigation of the association between bevacizumab and pulmonary arterial hypertension

  • Simon Valentin1
  • Alex Hlavaty2
  • Coline Brossat2
  • Marie-Camille Chaumais3
  • Élise Artaud-Macari4
  • Pierre Mauran5
  • Arnaud Maurac6
  • Laurent Savale7
  • Olivier Sitbon7
  • Marc Humbert7
  • Ari Chaouat1
  • Charles Khouri2
1 more authors
  • David Montani7
7 affiliations
  1. 1Université de Lorraine, CHRU de Nancy, Pôle des Spécialités Médicales/Département de Pneumologie, Nancy, France
  2. 2Univ. Grenoble Alpes, Inserm U1300, HP2, Grenoble, France
  3. 3Department of Pharmacy, Hôpital Bicêtre, AP-HP, Le Kremlin-Bicêtre, France
  4. 4Université Rouen Normandie, GRHVN UR 3830, CHU Rouen, Department of Pulmonary, Thoracic Oncology and Respiratory Intensive Care, Rouen, France
  5. 5CCMR PulmoTension, Hôpital Robert Debré, CHU Reims, Reims, France
  6. 6Service des Maladies Respiratoires, Hôpital Haut Leveque CHU de Bordeaux Pessac, Pessac, France
  7. 7INSERM UMR_S1358, Pulmonary Hypertension: Pathophysiology and Novel Therapies, Hôpital Marie-Lannelongue and Hôpital Bicêtre, Le Kremlin-Bicêtre, France
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Abstract

Background Pulmonary arterial hypertension (PAH) is a rare and severe condition that may be associated with exposure to certain drugs. Bevacizumab, a monoclonal antibody targeting vascular endothelial growth factor, has been classified as having a possible association with PAH, but data remain scarce. This study aimed to assess the potential link between bevacizumab exposure and PAH through complementary clinical, medico-administrative and pharmacovigilance databases. Methods We performed a multimodal investigation combining: 1) case identification from the French Pulmonary Hypertension (PH) Registry, 2) a population-based cohort analysis using the French National Health Data System (Système National des Données de Santé (SNDS)) and 3) a disproportionality analysis in the World Health Organization pharmacovigilance database (VigiBase). Clinical, haemodynamic and exposure data were reviewed in the French PH Registry; prevalence of PAH in patients exposed to bevacizumab was computed in the SNDS; and disproportionality analyses (information component (IC) values) were calculated in VigiBase. Results Seven cases of PAH temporally associated with bevacizumab were identified in the French PH Registry, most displaying predisposing conditions ( BMPR2 mutation, portal hypertension or COPD). In the SNDS cohort of 9964 PAH patients, 30 had prior bevacizumab exposure, with no increased incidence compared to the general population. In VigiBase, 21 PAH cases were reported with bevacizumab, yielding a modest disproportionality signal only under broad definitions (IC 0.4 (95% credibility interval 0.1–0.6)). Conclusions Across complementary data sources, there was no evidence of a causal association between exposure to bevacizumab and the development of PAH in adults. However, the effect of bevacizumab as a secondary trigger in predisposed individuals cannot be definitely or completely excluded.

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Cite

BibTeXRIS
BibTeX
@article{valentin2026multimodal,
  title = {{Multimodal investigation of the association between bevacizumab and pulmonary arterial hypertension}},
  author = {Simon Valentin and Alex Hlavaty and Coline Brossat and Marie-Camille Chaumais and Élise Artaud-Macari and Pierre Mauran and Arnaud Maurac and Laurent Savale and Olivier Sitbon and Marc Humbert and Ari Chaouat and Charles Khouri and David Montani},
  journal = {ERJ open research},
  year = {2026},
  month = sep,
  doi = {10.1183/23120541.00209-2026},
  url = {https://europepmc.org/article/PMC/PMC13656190},
  note = {CC BY-NC},
}
RIS
TY  - JOUR
TI  - Multimodal investigation of the association between bevacizumab and pulmonary arterial hypertension
AU  - Simon Valentin
AU  - Alex Hlavaty
AU  - Coline Brossat
AU  - Marie-Camille Chaumais
AU  - Élise Artaud-Macari
AU  - Pierre Mauran
AU  - Arnaud Maurac
AU  - Laurent Savale
AU  - Olivier Sitbon
AU  - Marc Humbert
AU  - Ari Chaouat
AU  - Charles Khouri
AU  - David Montani
PY  - 2026
DA  - 2026/09/01
JO  - ERJ open research
DO  - 10.1183/23120541.00209-2026
UR  - https://europepmc.org/article/PMC/PMC13656190
AB  - Background Pulmonary arterial hypertension (PAH) is a rare and severe condition that may be associated with exposure to certain drugs. Bevacizumab, a monoclonal antibody targeting vascular endothelial growth factor, has been classified as having a possible association with PAH, but data remain scarce. This study aimed to assess the potential link between bevacizumab exposure and PAH through complementary clinical, medico-administrative and pharmacovigilance databases. Methods We performed a multimodal investigation combining: 1) case identification from the French Pulmonary Hypertension (PH) Registry, 2) a population-based cohort analysis using the French National Health Data System (Système National des Données de Santé (SNDS)) and 3) a disproportionality analysis in the World Health Organization pharmacovigilance database (VigiBase). Clinical, haemodynamic and exposure data were reviewed in the French PH Registry; prevalence of PAH in patients exposed to bevacizumab was computed in the SNDS; and disproportionality analyses (information component (IC) values) were calculated in VigiBase. Results Seven cases of PAH temporally associated with bevacizumab were identified in the French PH Registry, most displaying predisposing conditions ( BMPR2 mutation, portal hypertension or COPD). In the SNDS cohort of 9964 PAH patients, 30 had prior bevacizumab exposure, with no increased incidence compared to the general population. In VigiBase, 21 PAH cases were reported with bevacizumab, yielding a modest disproportionality signal only under broad definitions (IC 0.4 (95% credibility interval 0.1–0.6)). Conclusions Across complementary data sources, there was no evidence of a causal association between exposure to bevacizumab and the development of PAH in adults. However, the effect of bevacizumab as a secondary trigger in predisposed individuals cannot be definitely or completely excluded.
SN  - 2312-0541
ER  -