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Original research
Interstitial lung disease in patients treated with poly (ADP-ribose) polymerase inhibitors (PARPi): analysis of results from clinical trials and the FDA Adverse Events Reporting System database
  1. Zhichao He1,2,
  2. Jiayao Mo3,
  3. Wei Jiang1,2,
  4. Jianhong Zhu1,2,
  5. Shan Yang1,2,
  6. Siyuan Gao1,2,
  7. Kakei Lam3,
  8. Yu Li3,
  9. Kaifeng Qiu1,2,
  10. Min Huang3 and
  11. Junyan Wu1,2
  1. 1Department of Pharmacy, Sun Yat-Sen Memorial Hospital, Guangzhou, China
  2. 2Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Guangzhou, China
  3. 3School of Pharmaceutical Sciences, Sun Yat-Sen University, Guangzhou, China
  1. Correspondence to Professor Junyan Wu, Department of Pharmacy, Sun Yat-Sen Memorial Hospital, Guangzhou, Guangdong, China; wujunyan{at}mail.sysu.edu.cn

Abstract

Objective To evaluate the risk of interstitial lung disease associated with poly (ADP-ribose) polymerase inhibitors (PARPi) and characterize its clinical features.

Methods We systematically reviewed phase III randomized clinical trials of interstitial lung disease related to PARPi and calculated Peto odds ratios (ORs) with 95% confidence intervals (CIs). Pharmacovigilance studies were conducted by collecting cases of PARPi-related interstitial lung disease from the FDA Adverse Events Reporting System and assessing disproportionalities by reporting ORs and information components.

Results A total of five randomized clinical trials involving 2980 patients were included. Although PARPi showed a tendency to increase the risk of interstitial lung disease compared with controls, this difference was not significant (Peto OR: 4.92; 95% CI: 0.92 to 26.35). A total of 170 cases of interstitial lung disease related to PARPi were included, with a median latency of 99 days. PARPi had a significantly increased reporting of interstitial lung disease (reporting OR: 2.86; 95% CI: 2.46 to 3.33; information component (IC): 1.49; 95% CI: 1.28 to 1.74). Our sensitivity analyses showed strong robustness of the disproportionalities between PARPi as a class, olaparib, and interstitial lung disease. Some 91.9% of patients experienced discontinuation, 51.6% achieved remission, and no deaths were reported.

Conclusion Our pharmacovigilance study suggested increased reporting of interstitial lung disease related to PARPi particularly olaparib.

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Data availability statement

Data are available in a public, open access repository.

https://doi.org/10.1136/ijgc-2022-004042

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    Data availability statement

    Data are available in a public, open access repository.

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    Footnotes

    • ZH, JM, WJ, JZ and SY contributed equally.

    • Contributors JW had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: ZH, JM, WJ, JZ, SY, and JW. Data acquisition: ZH, JM, WJ, JZ, and SY. Data analysis and interpretation: all authors. Data curation: SG, KL, and YL. Manuscript drafting: ZH, JM, WJ, JZ, SY, KQ, MH, and JW. Study administration and supervision: KQ, MH, and JW.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.