RT Journal Article
SR Electronic
T1 Clinical profile and early follow-up of patients receiving pirfenidone in the PIONEER observational study
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP P3792
VO 44
IS Suppl 58
A1 Raja Dhar
A1 K.S. Satish
A1 Sujeet Rajan
A1 R. Vijai Kumar
A1 Zarir Udwadia
A1 Harjit Dumra
A1 Murali Mohan
A1 Rahul Namjoshi
A1 Namita Ghag
A1 Jaideep Gogtay
YR 2014
UL http://erj.ersjournals.com/content/44/Suppl_58/P3792.abstract
AB 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 DLCO (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.