Safety and efficacy of nintedanib in idiopathic pulmonary fibrosis: A real-life observational study in Greece

Tzouvelekis, Argyrios; Karampitsakos, Theodoros; Kontou, Maria; Granitsas, A. N.; Malliou, Ioanna; Anagnostopoulos, Aris; Ntolios, Paschalis; Tzilas, Vasilios; Bouros, Evangelos; Steiropoulos, Paschalis; Chrysikos, Serafeim; Dimakou, Katerina; Koulouris, Nikolaos; Bouros, Demosthenes

doi:10.1016/j.pupt.2018.01.006

Cited by 53 publications

(71 citation statements)

References 33 publications

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“…In accordance with the findings of clinical trials, the most frequent AE in our case series was diarrhea, but the percentage of patients (25%) presenting the condition was lower with respect to that reported by other real-life studies (between 50% and 63%) [13][14][15]. In line with our results, another retrospective study examining the records of 64 IPF patients, nearly half of whom originally treated with pirfenidone, showed that diarrhea, which was generally considered manageable, was reported by only 33% of the patients [11].…”

Section: Discussionsupporting

confidence: 91%

Nintedanib Treatment for Idiopathic Pulmonary Fibrosis Patients Who Have Been Switched from Pirfenidone Therapy: A Retrospective Case Series Study

Vianello

Salton

Molena

et al. 2020

JCM

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Background: The efficacy and effectiveness of nintedanib as a first-line therapy in idiopathic pulmonary fibrosis (IPF) patients have been demonstrated by clinical trials and real-life studies. Our aim was to examine the safety profile and effectiveness of nintedanib when it is utilized as a second-line treatment in subjects who have discontinued pirfenidone. Methods: The medical charts of 12 patients who were switched from pirfenidone to nintedanib were examined retrospectively. The drug’s safety was defined by the number of adverse events (AEs) that were reported; disease progression was evaluated based on the patient’s vital status and changes in forced vital capacity (FVC) at 12-month follow-up. Results: The numbers of patients experiencing AEs and of the AEs per patient in our study group didn’t significantly differ with respect to a group of 56 individuals who were taking nintedanib as a first-line therapy during the study period (5/12 vs. 22/56; p = 0.9999, and 0.00 (0.00–1.00) vs. 0.00 (0.00–3.00); p = 0.517, respectively). Two out of the 3 patients who had been switched to nintedanib due to a rapid disease progression showed stabilized FVC values. Conclusions: Nintedanib was found to have an acceptable safety profile in the majority of the IPF patients switched from pirfenidone. Prospective studies are warranted to determine if the drug can effectively delay disease progression in these patients.

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Section: Discussionsupporting

confidence: 91%

Nintedanib Treatment for Idiopathic Pulmonary Fibrosis Patients Who Have Been Switched from Pirfenidone Therapy: A Retrospective Case Series Study

Vianello

Salton

Molena

et al. 2020

JCM

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“…The study complements data from the open-label large extension trial INPULSIS-ON that demonstrates similar therapeutic effects of nintedanib in patients with IPF, irrespective of disease severity [6]. It also validates other real-world observational studies based on compassionate use programs including a recent one from our study group, which demonstrated similar therapeutic profiles in patients with IPF of all severity groups [7-11]. …”

supporting

confidence: 81%

Nintedanib in Severe Idiopathic Pulmonary Fibrosis: Effectiveness through Compassion

Tzouvelekis

Bouros

2018

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“…The panel agreed that hepatic transaminase and bilirubin levels should be measured before initiating treatment but would advocate repeating these measures every 4 weeks for the first 6 months of treatment, and every 3 months or as clinical needed thereafter. In a recent retrospective, observational real-world study conducted in Greece ( n = 94) liver toxicity was reported in 5.3% of subjects [21], while real-world studies in Germany ( n = 64) and the United Kingdom ( n = 187) have reported hepatic enzyme elevations in 1.6 and 9.6% of nintedanib-treated subjects respectively [22, 23]. In the majority of patients, these elevations are reversible with a dose reduction or short treatment interruption [15, 17].…”

Section: Hepatic Side Effects In Patients On Nintedanibmentioning

confidence: 99%

Nintedanib in Idiopathic Pulmonary Fibrosis: Practical Management Recommendations for Potential Adverse Events

et al. 2018

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Idiopathic pulmonary fibrosis (IPF) is a fatal lung disease with a dismal survival rate of only 3 years and no curative pharmacological therapy. The recent approval of 2 anti-fibrotic drugs (nintedanib and pirfenidone) that slow disease progression has provided some hope for patients. However, effectively managing anti-fibrotic treatment can be a challenge due to tolerability issues, the presence of pulmonary and extra-pulmonary comorbidities, and the need for concomitant medications in many patients. In general, making clear evidence-based decisions can be difficult for physicians because patients with comorbidities are often excluded from clinical trials. Since currently anti-fibrotic drugs are the only effective therapeutics capable of slowing disease progression, it is imperative that all treatment options are thoroughly evaluated and exhausted in each individual, irrespective of complicating factors, to permit the best outcome for the patient. In this review, we present data from clinical trials, post hoc analyses, post-marketing surveillance, and real-world studies that are relevant to the management of nintedanib treatment. In addition, we also provide practical recommendations developed by a multidisciplinary panel of experts for the management of nintedanib treatment in patients with IPF associated complications and those experiencing gastrointestinal side effects.

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Safety and efficacy of nintedanib in idiopathic pulmonary fibrosis: A real-life observational study in Greece

Cited by 53 publications

References 33 publications

Nintedanib Treatment for Idiopathic Pulmonary Fibrosis Patients Who Have Been Switched from Pirfenidone Therapy: A Retrospective Case Series Study

Nintedanib Treatment for Idiopathic Pulmonary Fibrosis Patients Who Have Been Switched from Pirfenidone Therapy: A Retrospective Case Series Study

Nintedanib in Severe Idiopathic Pulmonary Fibrosis: Effectiveness through Compassion

Nintedanib in Idiopathic Pulmonary Fibrosis: Practical Management Recommendations for Potential Adverse Events

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