P6 Early Clinical Experience With Nintedanib – a two centre review

Abstract

IntroductionClinical trials of pirfenidone and nintedanib have shown similar reduced rates of lung function decline in patients with idiopathic pulmonary fibrosis (IPF). In 2013 NICE approved pirfenidone for use in IPF patients with forced vital capacity (FVC) between 50% and 80% predicted. More recently, nintedanib has been available on an individual patient supply program (IPSP).AimsReporting early experience of nintedanib in two tertiary referral centres, focussing on characterising the treated population, assessing the indications for use, and evaluating adverse effects.MethodAll IPF patients attending two tertiary referral centre ILD clinics who were commenced on nintedanib as part of the IPSP were included. Data were collected retrospectively from clinical records and local clinical databases. Data are presented as mean (range).Results75 patients (mean age 70.8 years (50–85), 76% male). The FVC was 79.2% predicted (35% - 123%) and transfer factor (DLCO) 45.8% predicted (13% - 74%) prior to commencing treatment. 54% of patients were prescribed nintedanib because they did not meet FVC criteria for pirfenidone (FVC >80% in 41% of patients and FVC <50% in 13%). Other indications included refusal of pirfenidone due to the side effect profile (15%) or adverse effects requiring pirfenidone discontinuation (13%). 39 patients (52%) experienced adverse effects on nintedanib, the most common being diarrhoea (25%), nausea (13%), abnormal liver function tests (8%) and lethargy (11%). Adverse effects required nintedanib to be discontinued in 7 (9%) patients (diarrhoea (n = 3), abnormal LFTs (n = 2) and patient choice (n = 2)), dose reduction in 13 (17%) patients, and temporarily stopped and restarted in 9 (12%) patients.ConclusionNintedanib is a relatively new medication and although there are modest numbers in this review only 9% had to discontinue treatment. Diarrhoea is the most quoted side effect from trial data (63% of patients in INPULSIS-2), but in our observational data only one quarter suffered diarrhoea and only 3 patients stopping due to this. Although the data is from early experience the discontinuation rate is favourable compared with published and local data on pirfenidone (drop out rate 15%). This needs continued review to further evaluate drug tolerability and real world efficacy.