1. Real World Experiences: Pirfenidone is well tolerated and reduces decline in FVC and TLCO at 9 months in Idiopathic Pulmonary Fibrosis (IPF).
Nazia Chaudhuri*, Annette Duck*,and Colm Leonard*.
Department of Respiratory Medicine, University Hospital of South Manchester, North West Lung Centre, Wythenshawe Hospital, Southmoor Road, Manchester. M23 9LT. United Kingdom.
INTRODUCTION
RESULTS
IPF is a debilitating condition with life expectancy of 2-5years. .
Pirfenidone is the only licensed drug in Europe shown to reduce the decline in FVC at 6 months (1).
Clinical trials with pirfenidone have demonstrated an excess of adverse effects (98%) culminating in an 15% drop out rate (1).
Here we demonstrate that improved adherence and compliance can be achieved by specialist nurse and clinician review, support and education of the patient.
LTOT
Ambulatory O2
No O2
8 (16%)
8 (17%)
32 (67%)
NAC
Prednisolone
Both
5 (10%)
9 (19%)
2. 22% of Patients Discontinued Pirfenidone Due To Adverse Effects.
3. The Majority Of Adverse Effects Are Self Limiting.
1. 88% of Patients Experience >1 Adverse Effects (AE) – Similar to Clinical Trials.
4. There Is A Reduction In The Decline Of Mean % Change In FVC and DLCO After Commencement Of Pirfenidone.
SUMMARY
We demonstrate that adherence and compliance can be achieved by specialist nurse and clinician review, support and education of the patient.
Pirfenidone is well tolerated and the majority of adverse effects are self limiting.
Although our numbers are small we demonstrate a reduction in the decline of FVC and TLCO at 9 months.
Further longitudinal follow-up is required to ascertain the benefits of pirfenidone long-term.
METHODS
This was a single centre observational study of patients involved in the Named Patient Programme.
We retrospectively analysed the data from 48 IPF patients (as per ATS/ERS Criteria) treated with pirfenidone from September 2011 to July 2013.
2. 60% Of Adverse Effects Are Gastrointestinal In Nature.
Start of Treatment:
Mean Age = 65.5 years (range 47-80) 71% males.
Average FVC 78.8% and DLCO 43.7% .
20 (42%) had DLCO<35%
REFERENCES
1. Noble P, Albera C, Bradford W et al, for the CAPACITY Study Group. Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY): two randomised trials. Lancet 2011;377:1760–69.
Pulmonary function tests were performed at 3, 6 and 9 months pre and post pirfenidone commencement as described in the methods. The percentage change in FVC and DLCO was calculated from baseline values at commencement of pirfenidone. Data shown are mean ± SEM at 3, 6 and 9 months pre and post pirfenidone commencement (n=14, 14 and 11 pre pirfenidone and n=26, 23 and 15 post pirfenidone respectively). The gradients of the slopes were calculated using linear regression analysis using Prismv5 software.
Figure 4. There is a reduction in FVC (A) and DLCO (B) decline after commencement of pirfenidone.