Source: International Congress 2014 – ILDs 6
Disease area: Interstitial lung diseases

Abstract

BACKGROUND: PIONEER is an observational, PractIce based, Open label, Non-comparative, multicEnter study to Evaluate the efficacy, toleRability and safety of pirfenidone in idiopathic pulmonary fibrosis (IPF) patients from India.OBJECTIVES: To understand the clinical profile of patients prescribed pirfenidone therapy.METHODS: In this interim analysis, clinical profile of 90 patients on pirfenidone treatment is reported.RESULTS: Mean age was 60.95±11.13 years (46 males). Mean dose and duration of treatment on pirfenidone was 1031.06±360.2 mg and 29.26±20.00 weeks. Clinical features at baseline were dry cough 70 (77.78%), dyspnea on exertion 65 (72.22%), desaturation on exercise 26 (28.89%), clubbing 12 (13.33%), crackles 13 (14.44%) and crepitations/rales in 39 (43.33%) patients. High resolution computed tomography (HRCT) data was available in 88 patients, 62(70.45%) patients showed usual interstitial pneumonia (UIP)-IPF pattern and the rest had an “off-label prescription” of pirfenidone for non UIP-IPF pattern. Mean± SD baseline values of forced vital capacity (FVC) (n=74), six minute walk test (6MWT) (n=36) and diffusion capacity DL_CO (n=36) were 1.58± 0.663 L, 365.79±130.65 meters and 48.32±26.76 %. Mean change± SD in FVC (n=13 with FVC data for 48 weeks) was 0.09±0.27 L. Most common adverse events reported (5 each) were gastrointestinal, skin-related and respiratory.CONCLUSION: We present the baseline data for patients on pirfenidone in the PIONEER study. In a small subgroup of patients who had FVC data at 24 and 48 weeks, pirfenidone appears to stabilize lung function. Further results from the study are awaited.

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R. Dhar, K. S. Satish, S. Rajan, R. Vijai Kumar, Z. Udwadia, H. Dumra, M. Mohan, R. Namjoshi, N. Ghag, J. Gogtay (Kolkata, Bengaluru, Mumbai, Hyderabad, Ahmedabad, India). Clinical profile and early follow-up of patients receiving pirfenidone in the PIONEER observational study. Eur Respir J 2014; 44: Suppl. 58, 3792

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