Abstract
Introduction. IPF is a chronic, progressive interstitial lung disease. Pirfenidone and nintedanib are both licensed and approved for use in patients with an FVC of 50-80% in the UK.
Aim. To report our early clinical experience using nintedanib in IPF patients who commenced treatment as part of a manufacturer funded patient in need scheme prior to NICE approval.
Methods. All IPF patients seen at 3 UK centres started on nintedanib between Dec14-Jan16 were included. Data was retrospectively collected from clinical letters and is presented as mean+/-SD(range).
Results. N=188(76% males) with average age of 70 years±8(50-89). Average FVC was 81.1±19.7(35-135). Patients were started on nintedanib because their FVC>80%(50%,n=94),intolerable adverse events(AEs) on pirfenidone(22%,42),refusing pirfenidone based on AE profile (17%,32),FVC<50%(6%,12) and decline in FVC>10% on pirfenidone(2%,4). There were a total of 274 AEs in 116 patients. The majority of patients experienced>1AE(62%,116). The commonest were diarrhoea(22%),nausea/vomiting(19%),appetite loss(11%),lethargy(10%),abdominal pain(9%),GOR(8%) and abnormal LFTs(8%). Only 39 AEs(14%) necessitated treatment discontinuation with the majority having no change in treatment(57%,157) or reductions in dosage(25%,69). To date,71%(133) of patients were continuing full dose treatment,11%(20) were taking a reduced dose,14%(27) had stopped and 4%(8) had died.
Conclusion. The AE profile of nintedanib in this review is comparable to the findings of the INPULSIS trials with comparably lower diarrhoea rates in our study(22% vs 63%). Our early data shows that 1 in 7 patients discontinue treatment due to AEs and is better than that experienced with pirfenidone.
Aim. To report our early clinical experience using nintedanib in IPF patients who commenced treatment as part of a manufacturer funded patient in need scheme prior to NICE approval.
Methods. All IPF patients seen at 3 UK centres started on nintedanib between Dec14-Jan16 were included. Data was retrospectively collected from clinical letters and is presented as mean+/-SD(range).
Results. N=188(76% males) with average age of 70 years±8(50-89). Average FVC was 81.1±19.7(35-135). Patients were started on nintedanib because their FVC>80%(50%,n=94),intolerable adverse events(AEs) on pirfenidone(22%,42),refusing pirfenidone based on AE profile (17%,32),FVC<50%(6%,12) and decline in FVC>10% on pirfenidone(2%,4). There were a total of 274 AEs in 116 patients. The majority of patients experienced>1AE(62%,116). The commonest were diarrhoea(22%),nausea/vomiting(19%),appetite loss(11%),lethargy(10%),abdominal pain(9%),GOR(8%) and abnormal LFTs(8%). Only 39 AEs(14%) necessitated treatment discontinuation with the majority having no change in treatment(57%,157) or reductions in dosage(25%,69). To date,71%(133) of patients were continuing full dose treatment,11%(20) were taking a reduced dose,14%(27) had stopped and 4%(8) had died.
Conclusion. The AE profile of nintedanib in this review is comparable to the findings of the INPULSIS trials with comparably lower diarrhoea rates in our study(22% vs 63%). Our early data shows that 1 in 7 patients discontinue treatment due to AEs and is better than that experienced with pirfenidone.
| Original language | English |
|---|---|
| Article number | OA4961 |
| Journal | European Respiratory Journal |
| Volume | 48 |
| Issue number | Suppl 60 |
| DOIs | |
| Publication status | Published online - 8 Nov 2016 |
