Drug updated on 9/4/2024
Dosage Form | Capsule (oral: 100 mg, 150 mg) |
Drug Class | Kinase inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
- Indicated for the treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.
- Indicated for the slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
Latest News
Summary
- Ofev (nintedanib) is indicated for the treatment of idiopathic pulmonary fibrosis (IPF), the treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype, and for slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
- This summary is based on the review of 18 systematic reviews/meta-analyses. [1-18]
- Forced Vital Capacity (FVC) Outcomes: Nintedanib significantly slows FVC decline in patients with IPF, SSc-ILD, and other progressive ILDs. Both Nintedanib and Pirfenidone improve the proportion of patients with a decline in FVC ≤10% predicted compared to placebo.
- Combination therapy of Nintedanib with mycophenolate shows further improvement in FVC compared to placebo.
- Mortality and Disease Progression: Antifibrotic treatment, including Nintedanib, is associated with a decreased risk of all-cause mortality and acute exacerbations in patients with IPF.
- Rheumatoid Arthritis-Associated ILD (RA-ILD): Nintedanib and Pirfenidone reduce disease progression in RA-ILD, demonstrated by significant reductions in FVC decline compared to placebo.
- Comparative Effectiveness: Nintedanib and Pirfenidone both effectively slow lung function decline in IPF, with no significant differences in effectiveness between the two drugs.
- Nintedanib is associated with gastrointestinal side effects, including diarrhea, nausea, vomiting, and weight loss, which frequently result in treatment discontinuation. Pirfenidone similarly causes gastrointestinal side effects and is also linked to photosensitivity and skin rashes.
- The incidence of serious adverse events (SAEs) with Nintedanib is not significantly different from placebo, although combination therapy with mycophenolate increases gastrointestinal side effects and leads to higher rates of treatment discontinuation.
- Nintedanib is associated with a lower risk of cough and dyspnea compared to placebo in patients with IPF and fibrotic ILD but shows a higher overall risk of adverse events, with a trend toward fewer fatal adverse events.
- The effectiveness of Nintedanib and Pirfenidone in improving Forced Vital Capacity (FVC) outcomes does not differ significantly across age, gender, and ethnicity. Patients with systemic sclerosis-associated ILD (SSc-ILD), rheumatoid arthritis-associated ILD (RA-ILD), and those with a progressive phenotype of ILDs respond to antifibrotic treatments. However, patients with lower BMI values in IPF are associated with higher mortality and adverse outcomes.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Ofev (nintedanib) prescribing information. | 2022 | Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Idiopathic pulmonary fibrosis (an update) and progressive pulmonary fibrosis in adults: an official ATS/ERS/JRS/ALAT clinical practice guideline. | 2024 | American Journal of Respiratory and Critical Care Medicine |
Treatment of systemic sclerosis-associated interstitial lung disease: evidence-based recommendations. An official American Thoracic Society clinical practice guideline. | 2024 | American Journal of Respiratory and Critical Care Medicine |
Idiopathic pulmonary fibrosis (an update) and progressive pulmonary fibrosis in adults. | 2022 | American Journal of Respiratory and Critical Care Medicine |
Brazilian guidelines for the pharmacological treatment of idiopathic pulmonary fibrosis. Official document of the Brazilian Thoracic Association based on the GRADE methodology. | 2020 | Brazilian Journal of Pulmonology |
Overview of idiopathic pulmonary fibrosis, evidence-based guidelines, and recent developments in the treatment landscape. | 2019 | The American Journal of Managed Care |