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McMaster Textbook of Internal Medicine

Nintedanib and pirfenidone in patients with FVC <50%

2017-03-02
Luca Richeldi

What is your opinion on using nintedanib and pirfenidone in patients with forced vital capacity (FVC) <50%? Are there any data available to support such treatment?

Luca Richeldi: Patients with an FVC below 50% have not been enrolled in clinical trials, so this population has not been tested for the safety and efficacy of these drugs. That is the first message. As far as we know, we do not have a reassuring answer for these patients.

However, we have a reassuring answer for patients with an FVC above 50%. Idiopathic pulmonary fibrosis (IPF) is a progressive disease, so every patient that achieved an FVC below 50% before had been on an FVC above 50%. There are no reasons to think that a patient with an FVC below 50% will be different in terms of efficacy, but we are not sure about the safety. That is why most guidelines do not recommend treatment for patients with an FVC below 50%. It is also true that in countries like the US, the Food and Drug Administration (FDA) approved a drug for patients with any FVC value.

It is still an area in which there is debate. It is an evolving concept. We hope to have more placebo-controlled [trials] in the severe population, but for the time being, we cannot give a definitive answer to that question in the case of patients with severe disease.

See also
  • Noninvasive ventilation in asthma exacerbations The use of noninvasive ventilation in asthma exacerbations is often discussed but rarely applied in daily practice. Which patients may benefit from this intervention?
  • Treatment of CAP and resistant pathogens There is a tendency to keep the duration of antibiotic treatment for community-acquired pneumonia as short as possible. Treatment of 5 days is safe and effective but is it associated with an increased risk of selection of resistant pathogens?
  • Treatment based on changes in the bacterial load in the lungs in IPF Some recently published papers reported changes in the bacterial load in the lungs of patients with idiopathic pulmonary fibrosis. Are there any ongoing trials on antibiotics or other treatments based on these findings?
  • Use of full-face masks and helmets Full-face masks or helmets are not used universally in everyday practice. What is your experience with using such devices? Do you use them often in your practice? Which patients would benefit most from this type of intervention?
  • Treatment of latent TB infection in patients with rheumatoid arthritis The WHO advocates several regimens for the treatment of latent tuberculosis (TB) infection. Are there any new data comparing different treatments that suggest which regimen would be optimal for adults with rheumatoid arthritis (RA) who have been treated for latent TB infection before starting biologic therapy for RA?
  • Treatment of IPF without nintedanib or pirfenidone What treatment would you recommend in a patient with idiopathic pulmonary fibrosis who cannot be treated with nintedanib or pirfenidone?

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