2
views
0
recommends
+1 Recommend
1 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Utility of nintedanib for severe idiopathic pulmonary fibrosis: a single-center retrospective study [Response to letter]

      1 , 1 , 2 , 1

      Drug Design, Development and Therapy

      Dove

      Read this article at

      ScienceOpenPublisherPMC
      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Dear editor In our study, we observed that even in Severe Group of patients with interstitial pulmonary fibrosis (IPF), nintedanib administration suppressed the reduction in the forced vital capacity (FVC) (Figure 3).1 However, the frequency of side effects tended to be more (Table 2) and the prognosis was significantly worse in Severe Group than in Mild Group (Figure 5). Orsatti et al pointed out three limitations of our research.2 First, the two study groups presented clinically meaningful differences at baseline. However, we found that even in Severe Group, FVC reduction was suppressed by nintedanib administration (p=0.029) (Figure 3). The INPULSIS-ON trial revealed that nintedanib administration in IPF patients with a more advanced functional impairment may have the same beneficial effect on FVC reduction as among patients with less severe impairment. However, we believe that it is important to demonstrate a beneficial effect among patients with severe IPF in the real world. Second, a higher mortality rate among patients with severe IPF is expected independent of the pharmacological intervention; lower FVC and diffusing capacity of the lungs for carbon monoxide (DLCO) seen at baseline among patients with severe IPF were associated with a worse prognosis. Clearly, patients with more severe disease have a worse prognosis. We suggested in our paper that patients with severe disease should start treatment earlier considering the poor prognosis. Furthermore, our study revealed that patients with severe IPF had a greater FVC decline than those with mild-to-moderate IPF in the year preceding nintedanib administration. A more severe decline in FVC over time has also been associated with a worse prognosis. Hence, even in patients with severe IPF who experienced a more severe decline in FVC, we believe that it is important to clarify the usefulness of nintedanib in the real world. We agree that it is important to conduct a multi-center prospective clinical trial. However, it may not often be feasible to compare treatment effect with a control group in the real world; retrospective research is also important in such circumstances.

          Related collections

          Most cited references 1

          • Record: found
          • Abstract: found
          • Article: found
          Is Open Access

          Utility of nintedanib for severe idiopathic pulmonary fibrosis: a single-center retrospective study

          Introduction The INPULSIS-ON trial demonstrated that nintedanib reduced decline in forced vital capacity (FVC) and low pulmonary function (%FVC < 50%) of patients with idiopathic pulmonary fibrosis (IPF). However, there is no sufficient evidence in real world. Objectives Reveal the utility and adverse events of nintedanib for severe IPF patients. Methods This was a single-center retrospective study. Patients who met the eligibility criteria of the INPULSIS trial (%FVC ≥ 50%; %DLCO [diffusing capacity of the lung carbon monoxide % predicted] ≥ 30%) were classified as Mild to Moderate Group (n = 34); patients who did not meet the criteria were classified as Severe Group (n=17). Results The body mass index (24.7 ± 3.4 vs 22.4 ± 3.6 kg/m2; P = 0.021) were significantly low in Severe Group. Main adverse events (diarrhea, nausea, liver disorder, and acute exacerbation) tended to be more in Severe Group than in Mild to Moderate Group; however, the difference was not significant (P = 0.76, 0.14, 0.18, and 0.67, respectively). The continuation rates over 12 months tended to be higher in Mild to Moderate Group than in Severe Group (77% vs 44%; P = 0.027). Log-rank test revealed that the prognosis was significantly better in Mild to Moderate Group than in Severe Group (P = 0.014). In the Severe Group, patients who were able to continue nintedanib for more than 3 months had significantly better prognosis compared to those who could not (P = 0.007). Conclusion The benefit from nintedanib was reduced in patients in Severe Group when compared to those in Mild to Moderate Group; however, the prognosis is expected to improve with control of side effects and long-term administration. It is more important to control the side effects in Severe Group.
            Bookmark

            Author and article information

            Journal
            Drug Des Devel Ther
            Drug Des Devel Ther
            DDDT
            dddt
            Drug Design, Development and Therapy
            Dove
            1177-8881
            14 May 2019
            2019
            : 13
            : 1687-1688
            Affiliations
            [1 ]Department of Respirology, Graduate School of Medicine, Chiba University , Chuo-ku, Chiba city, Chiba 260-8670, Japan
            [2 ]Department of Pulmonary Medicine, International University of Health and Welfare, School of Medicine , Narita city, Chiba 286-8686, Japan
            Author notes
            Correspondence: Mitsuhiro AbeDepartment of Respirology, Graduate School of Medicine, Chiba University , 1-8-1 Inohana, Chuo-ku, Chiba260-8670, JapanTel +8 143 226 2576Email mthrsgnm@ 123456chiba-u.jp
            Article
            207537
            10.2147/DDDT.S207537
            6526187
            31190746
            © 2019 Abe et al.

            This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

            Page count
            Pages: 2
            Categories
            Response to Letter

            Pharmacology & Pharmaceutical medicine

            Comments

            Comment on this article