Real world experiences: Pirfenidone is well tolerated in patients with idiopathic pulmonary fibrosis

Chaudhuri, Nazia; Duck, Annette; Frank, Rebecca; Holme, Jayne; Leonard, Colm

doi:10.1016/j.rmed.2013.11.005

Cited by 59 publications

(44 citation statements)

References 2 publications

(2 reference statements)

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“…In addition to long-term observational studies, a number of recent single-centre studies have been published reporting the efficacy and tolerability of pirfenidone in a real-world setting (table 3) [13][14][15][16][17][18][19][20]. Generally, these single-centre observational studies demonstrate that in daily clinical practice the tolerability of pirfenidone is comparable to the literature with a positive effect in terms of clinical efficacy in the majority of patients treated, particularly regarding disease stabilisation and prevention of pulmonary function decline.…”

Section: Single-centre Real-world Experience With Pirfenidonementioning

confidence: 99%

Long-term clinical and real-world experience with pirfenidone in the treatment of idiopathic pulmonary fibrosis

2015

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Idiopathic pulmonary fibrosis (IPF) is a chronic, irreversible, progressively destructive lung disease that culminates in respiratory failure and death. Randomised controlled trials have demonstrated that treatment of IPF patients with pirfenidone reduces lung function decline, improves progression-free survival and significantly reduces the risk of all-cause mortality at 1 year. Pirfenidone has been shown to have a favourable safety profile and was generally well tolerated over the long term in clinical trials and realworld experience. However, side-effect management is critical to help some patients remain on treatment over the long term. The primary treatment-related adverse events associated with pirfenidone therapy are gastrointestinal upset, rash and photosensitivity. Gastrointestinal events may be mitigated by ensuring that pirfenidone is taken with food, while skin symptoms may be reduced by avoiding sun exposure and frequent use of sunblock. Educating patients about the potential for these adverse events to occur and providing instructions prior to treatment to avoid adverse drug reactions are an important means of ensuring patients may derive the important benefits provided by long-term treatment with pirfenidone. @ERSpublications Patient education is critical to help IPF patients manage side-effects of pirfenidone and remain on treatment http://ow.ly/HaPak

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Section: Single-centre Real-world Experience With Pirfenidonementioning

confidence: 99%

Long-term clinical and real-world experience with pirfenidone in the treatment of idiopathic pulmonary fibrosis

2015

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“…GI events, such as nausea, vomiting and diarrhoea, typically occur early in the course of pirfenidone treatment and decline after the first 6 months, whereas skin-related AEs, such as rash and photosensitivity, exhibit more variability in their time course [16,30]. The median time to any first AE in the pooled pirfenidone phase III trials was 15.0 days (interquartile range (IQR) 6.0-49.0 days) [31].…”

Section: Prevention and Management Of Common Pirfenidone-related Aesmentioning

confidence: 99%

“…Providing patient education on the timing of these events is a proactive method to improve pirfenidone adherence. One real-world study found that after the occurrence of a GI-related AE within the first 8 weeks and subsequent consultation with a nurse specialist for the following 3 months, pirfenidone adherence was improved by reinforcing necessary management techniques [16].…”

Section: Gi-related Aesmentioning

confidence: 99%

Pirfenidone safety and adverse event management in idiopathic pulmonary fibrosis

et al. 2017

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Pirfenidone is one of two approved therapies for the treatment of idiopathic pulmonary fibrosis (IPF). Randomised controlled clinical trials and subsequent post hoc analyses have demonstrated that pirfenidone reduces lung function decline, decreases mortality and improves progression-free survival. Long-term extension trials, registries and real-world studies have also shown similar treatment effects with pirfenidone. However, for patients with IPF to obtain the maximum benefits of pirfenidone treatment, the potential adverse events (AEs) associated with pirfenidone need to be managed. This review highlights the well-known and established safety profile of pirfenidone based on randomised controlled clinical trials and real-world data. Key strategies for preventing and managing the most common pirfenidone-related AEs are described, with the goal of maximising adherence to pirfenidone with minimal AEs.

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“…Pirfenidone has a well-characterized long-term safety profile, a favorable benefit-risk profile, and manageable tolerability [8,9]. Evidence from postmarketing surveillance and real-world studies supports the safety profile observed in large randomized clinical trials [5,6,[8][9][10].…”

Section: Introductionmentioning

confidence: 89%

An Open-Label, Phase II Study of the Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (PIPF-002)

et al. 2018

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Introduction PIPF-002 was a phase 2, multicenter, open-label study of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF) or other types of pulmonary fibrosis (PF). PIPF-002 terminated after pirfenidone became commercially available in the United States. The goal of PIPF-002 was to characterize the long-term safety of pirfenidone in these patients. Methods Between August 2003 and September 2006, 83 patients (IPF: 81, PF: 2) enrolled. Patients received pirfenidone in three divided doses daily, with the maintenance dose and schedule determined by enrollment group assignment. Treatment continued until patient withdrawal or study termination (2015). Treatment-emergent adverse events (TEAEs) were assessed by descriptive statistics. Results At baseline, median age was 70 years, mean percent predicted forced vital capacity was 67.7%, 33.7% of patients had cardiac disorders, 51.8% had gastroesophageal reflux disease, and 63.9% were receiving concomitant prednisone. Median pirfenidone dose and exposure duration were 2400 mg/day and 3.0 years, respectively. Cumulative total exposure was 279.7 patient-exposure years (PEY). Most patients (98.8%) reported ≥ 1 TEAE, with an overall incidence rate of 460.5 per 100 PEY. The most frequent TEAEs (incidence rate per 100 PEY) were nausea (23.6), IPF progression (16.1), fatigue (11.8), dyspnea (11.4), upper respiratory tract infection (11.4), and cough (10.7). Serious TEAEs were reported in 49 patients; the most frequent serious TEAEs were IPF progression and pneumonia. The most common reason for discontinuation was TEAEs (35 patients; 12.5 patients per 100 PEY), most frequently IPF progression and nausea. Overall, 21 patients died (7.5 per 100 PEY); 16 deaths were IPF-related. Conclusions Long-term safety and tolerability of pirfenidone findings in this study were consistent with the known safety profile of pirfenidone; no new safety signals were identified. These data support the continued use of pirfenidone in patients with IPF. Funding F. Hoffmann-La Roche Ltd./Genentech, Inc. Trial Registration ClinicalTrials.gov identifier, NCT00080223. Plain Language Summary Plain language summary available for this article.

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Real world experiences: Pirfenidone is well tolerated in patients with idiopathic pulmonary fibrosis

Cited by 59 publications

References 2 publications

Long-term clinical and real-world experience with pirfenidone in the treatment of idiopathic pulmonary fibrosis

Long-term clinical and real-world experience with pirfenidone in the treatment of idiopathic pulmonary fibrosis

Pirfenidone safety and adverse event management in idiopathic pulmonary fibrosis

An Open-Label, Phase II Study of the Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (PIPF-002)

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