Pirfenidone in real life : A retrospective observational multicentre study in Italian patients with idiopathic pulmonary fibrosis
Articolo
Data di Pubblicazione:
2019
Citazione:
Pirfenidone in real life : A retrospective observational multicentre study in Italian patients with idiopathic pulmonary fibrosis / C. Vancheri, A. Sebastiani, S. Tomassetti, A. Pesci, P. Rogliani, L. Tavanti, F. Luppi, S. Harari, P. Rottoli, A. Ghirardini, K.U. Kirchgaessler, C. Albera. - In: RESPIRATORY MEDICINE. - ISSN 0954-6111. - 156(2019 Sep), pp. 78-84. [10.1016/j.rmed.2019.08.006]
Abstract:
Rationale: Real-world data on pirfenidone treatment of patients with idiopathic pulmonary fibrosis (IPF) are limited. This study assessed the effectiveness of pirfenidone in a large real-life Italian IPF cohort. Methods: IRENE was an observational, retrospective study of patients with IPF treated with pirfenidone in routine clinical practice (18 centres). At Month 6, a mandatory re-evaluation of forced vital capacity (FVC) decline (absolute change < 10%) was required to continue pirfenidone. The primary effectiveness outcomes were absolute change from baseline in FVC and the percentage of patients with ≥ 10% absolute decline in % predicted FVC at Month 12. Safety was described by adverse event (AE) occurrence. Prespecified subgroups included sex, age, presence/absence of emphysema, usual interstitial pneumonia (UIP) pattern on high-resolution computed tomography, and baseline lung function. Results: The study included 379 patients (mean age, 67.6 years; 78.1% male). Mean change from baseline in FVC and the percentage of patients with ≥ 10% absolute decline in % predicted FVC at Month 12 were −81.8 mL (SD, 419.6 mL; P = 0.002) and 16.0% (95% CI, 12.2–20.9%), respectively. Disease progression was similar across prespecified subgroups, including patients with definite vs possible UIP. Overall, 211 AEs occurred in 149 patients (39.3%), with serious AEs in 31 patients (8.2%) and 9 discontinuations due to AEs. Skin and gastrointestinal AEs were most frequent. Fifteen patients (4.0%) died. Conclusions: The decline in FVC and the safety profile observed in this real-world IPF cohort were consistent with the findings of the Phase III pirfenidone trials.
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
Antifibrotic therapy; Disease progression; Effectiveness; Interstitial lung disease; Pirfenidone; Aged; Female; Humans; Idiopathic Pulmonary Fibrosis; Male; Pyridones; Retrospective Studies; Vital Capacity
Elenco autori:
C. Vancheri, A. Sebastiani, S. Tomassetti, A. Pesci, P. Rogliani, L. Tavanti, F. Luppi, S. Harari, P. Rottoli, A. Ghirardini, K.U. Kirchgaessler, C. Albera
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