Role of 'dual Antifibrotic combination' Nintedanib plus Pirfenidone in Idiopathic Pulmonary Fibrosis: A favourable outcome & recommendation to change from monotherapy to combination regimen in a single center experience of 105 IPF cases

Methods: Prospective, observational study, included 105 cases of idiopathic pulmonary fibrosis diagnosed by ATS/ERS consensus for clinical-radiological criteria and divided into three treatment groups of 35 patients in each group. First group received Pirfenidone with dose of 1800 mg to 2400 mf per day as per tolerance, second group received Nintedanib with doe of 100 mg three times and third group with combination of Nintedanib 100 mg three times and Pirfenidone 400 mg three times. All cases were followed for 36 months. All cases received influenza, pneumococcal vaccine and other similar features in all study cases is FVC>50% at baseline at entry point. We have performed analysis in all three groups for 36 months. Statistical analysis done by chi-test, Anova test and paired t-test Results: Clinical assessment & 6-minute walk distance parameters (P<0.0004 & p<0.0053) & Radiological disease progression, worsening of grading and honeycombing at 36 months (p<0.00009, p<0.0022 & p<0.0035) showed significant association. Lung function assessment, FVC % showed significant association(p<0.00003) Exacerbation risk with and without hospitalization has significant association(p<0.00005). Nausea, vomiting and weight loss were significant in the first group as compared to two groups Conclusion: Nintedanib and Nintedanib plus low dose Pirfenidone is superior to Pirfenidone therapy. Low dose Pirfenidone is complementary to Nintedanib and found an important role in stabilising lung functions, improving 6-minute walk distance and recovery time, and preventing radiological progression of disease