PMID- 38033836 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20231202 IS - 2251-6093 (Electronic) IS - 2251-6085 (Print) IS - 2251-6085 (Linking) VI - 52 IP - 9 DP - 2023 Sep TI - Efficacy and Safety of Nintedanib in Patients with Interstitial Lung Disease with or without Systemic Sclerosis: A Meta-Analysis. PG - 1781-1787 LID - 10.18502/ijph.v52i9.13561 [doi] AB - BACKGROUND: Nintedanib is a potent intracellular inhibitor of tyrosine kinases and modulates the pathways involved in the development of fibrosis. We assessed nintedanib efficacy and safety in interstitial lung disease (ILD) patients. METHODS: We searched MEDLINE, EMBASE, and the Cochrane Controlled Trials Register to identify available articles (up to April 2022). We conducted a meta-analysis of randomized controlled trials (RCTs) examining nintedanib efficacy and safety in patients with ILD with or without systemic sclerosis (SSc). RESULTS: Meta-analysis of five RCTs including 2,470 patients with ILD (1,343 nintedanib group and 1,127 controls) revealed that the annual rate of change in forced vital capacity (FVC) was significantly lower in the ILD group than in the control group (standardized mean difference [SMD] = 0.336; 95% confidence interval (CI) = 0.256-0.416, P<0.001). Stratification by disease type showed a low annual rate of change in FVC in patients with and without SSc (SMD = 0.389, 95% CI=0.294-0.478, P<0.001; SMD=0.177, 95% CI=0.013-0.340, P<0.00). The incidence of serious adverse events did not differ between the nintedanib and placebo groups; however, adverse events (AEs) and withdrawals due to AEs were significantly higher in the nintedanib group than in the placebo group (SMD =2.365, 95% CI=1.673-3.343, P<0.001; SMD =1.740, 95% CI= 1.385-2.185, P<0.001). CONCLUSION: Nintedanib is effective for ILD with or without SSc. However, it increased the incidence of AEs and withdrawals due to AEs. CI - Copyright(c) 2023 Lee et al. Published by Tehran University of Medical Sciences. FAU - Lee, Young Ho AU - Lee YH AD - Department of Rheumatology, Korea University College of Medicine, Seoul, Korea. FAU - Song, Gwan Gyu AU - Song GG AD - Department of Rheumatology, Korea University College of Medicine, Seoul, Korea. LA - eng PT - Journal Article PT - Review PL - Iran TA - Iran J Public Health JT - Iranian journal of public health JID - 7505531 PMC - PMC10682577 OTO - NOTNLM OT - Efficacy OT - Interstitial lung disease OT - Nintedanib OT - Safety EDAT- 2023/11/30 18:45 MHDA- 2023/11/30 18:46 PMCR- 2023/09/01 CRDT- 2023/11/30 17:24 PHST- 2022/07/20 00:00 [received] PHST- 2022/10/18 00:00 [accepted] PHST- 2023/11/30 18:46 [medline] PHST- 2023/11/30 18:45 [pubmed] PHST- 2023/11/30 17:24 [entrez] PHST- 2023/09/01 00:00 [pmc-release] AID - IJPH-52-1781 [pii] AID - 10.18502/ijph.v52i9.13561 [doi] PST - ppublish SO - Iran J Public Health. 2023 Sep;52(9):1781-1787. doi: 10.18502/ijph.v52i9.13561.