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

Abstract

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

Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis: Experience from 92 Sites in an Open-Label US Expanded Access Program

“…Real-world data on pirfenidone are limited; the data presented here are reassuring and consistent with data from the ongoing PASSPORT registry study [13]. Similar to the findings here, the most common ADRs reported in PASSPORT were nausea (15.7%) and fatigue (15.3%) over a mean of 6.3 months of exposure.…”

Pirfenidone safety and adverse event management in idiopathic pulmonary fibrosis

“…Interim analyses from PASSPORT (n=1009), a safety registry study initiated in Europe in 2011, indicated that the safety profile of pirfenidone in routine clinical practice was consistent with that seen in the phase III trials, with no new or unexpected safety signals [22,29]. The most common ADRs were nausea (20.4 per 100 PEY) and fatigue (17.9 per 100 PEY).…”

Idiopathic pulmonary fibrosis: from clinical trials to real-life experiences

“…Treatment with pirfenidone in this large cohort of IPF patients seemed to be safe and generally well tolerated. In the ERR, COTTIN and MAHER [25] recently reviewed the long-term clinical and real-world experience with pirfenidone in the treatment of IPF and concluded their overview by affirming that in clinical trials, observational studies and real-world use, pirfenidone has proved to have a favourable safety profile and has been generally well tolerated over the long term. However, management of adverse events is critical for some patients in order to help them remain on treatment.…”