Speaker's Highlight

• Don Sin University of British Columbia, St. Paul Hospital (Canada)
  Kenneth R. Chapman Toronto General Hospital Research Institute (Canada)
• Parameswaran Nair McMaster University (Canada)
  Carolyn Calfee UCSF (U.S.A.)
• Gregory P. Downey University of Colorado School of Medicine (U.S.A.)
  David A. Schwartz University of Colorado School of Medicine (U.S.A.)
• Neil Schluger Tuberculosis Control Branch, California Department of Public Health (U.S.A.)
  Nick Kim Critical Care & Sleep Medicine, University of California San Diego (U.S.A.)
• Nicola Hananiah Baylor College of Medicine (U.S.A.)
  Jae-Joon Yim Seoul National University College of Medicine (Republic of Korea)
• Koichiro Asano Tokai University School of Medicine (Japan)
  Diahn-Warng Perng Taipei Veterans General Hospital (Taiwan)
• Konstantinos Kostikas University of Ioannina (Greece)
  Karin Klooster University Medical Center Groningen (Kingdom of the Netherlands)

• Nintedanib In Practice For Idiopathic Pulmonary Fibrosis

  Idiopathic pulmonary fibrosis (IPF) is a progressive interstitial lung disease marked by scarring of the lung tissue, worsening breathlessness and declining forced vital capacity (FVC). The real-world effectiveness of nintedanib in idiopathic pulmonary fibrosis is best understood through routine clinical practice, where patients may be older, have several comorbidities and require dose adjustments that were less prominent in controlled trials.

  Nintedanib is an intracellular tyrosine kinase inhibitor that targets pathways involved in fibrotic activity. It does not reverse established scarring, but clinical trials and observational studies show that it can slow the annual rate of FVC decline. Australian respiratory physicians assess this benefit alongside tolerability, access through the Pharmaceutical Benefits Scheme (PBS), liver function, patient priorities and the practical demands of long-term treatment.

  What Real-World Evidence Shows

  Randomised trials established the central role of nintedanib in slowing lung function loss. Real-world registries and hospital-based cohorts broadly support this finding, with many patients showing a flatter decline in FVC during treatment than would be expected from the natural history of untreated IPF. The magnitude of benefit varies, and an individual patient may still experience worsening symptoms or an acute exacerbation.

  Routine-care data are valuable because they include people often under-represented in trials, including those with cardiovascular disease, diabetes, gastro-oesophageal reflux or reduced baseline lung function. These studies generally suggest that treatment persistence and clinical monitoring influence outcomes as much as the initial prescription. Survival comparisons are harder to interpret because observational studies can contain selection bias and differences in access to specialist care.

  For patients attending interstitial lung disease services in Sydney, Melbourne, Brisbane or Perth, the practical message is that stable disease is not evidence that the medicine has failed. Preserving lung function over time can maintain walking capacity, independence and eligibility for future options such as transplantation assessment.

  Tolerability Shapes Treatment Success

  Diarrhoea is the most familiar adverse effect of nintedanib and the main reason some patients interrupt or discontinue therapy. Nausea, reduced appetite, weight loss and fatigue can also affect adherence. In everyday care, clinicians commonly respond with early dietary advice, hydration, antidiarrhoeal treatment and temporary interruption, followed by reintroduction at a lower dose when appropriate.

  Liver enzyme abnormalities require particular attention. Baseline liver function testing and periodic review are important, especially during the first months of therapy or when other medicines may affect hepatic function. A patient’s alcohol intake, nutritional status and use of complementary products should be discussed without judgement. Australian prescribing decisions must remain consistent with the Therapeutic Goods Administration-approved product information.

  Medication management also needs to fit ordinary life. A person commuting across Melbourne, travelling from a regional town to a respiratory clinic or planning a long drive along the Queensland coast may struggle with urgent bowel symptoms. Practical planning, including access to toilets, repeat prescriptions and clear instructions about missed doses, can make continued treatment more realistic.

  Measuring Benefit Beyond FVC

  FVC remains a key objective measure, but it does not capture every meaningful treatment outcome. Six-minute walk distance, oxygen requirements, cough severity, breathlessness, weight, exacerbations and the ability to perform household activities can reveal changes that spirometry misses. Patient-reported outcomes are especially useful when FVC appears stable but daily function is declining.

  Australian conditions add relevant environmental considerations. Bushfire smoke affecting communities around Canberra, New South Wales or Victoria can temporarily worsen cough and breathlessness, making it important to distinguish exposure-related deterioration from progression of fibrosis. Air-quality alerts, indoor filtration and avoidance of strenuous outdoor activity during severe smoke events may support symptom control, although these measures do not replace antifibrotic treatment.

  Follow-up should also account for pulmonary rehabilitation, vaccination, smoking cessation and management of reflux or sleep-related breathing problems. Medicare-supported care pathways vary by location, and people in rural and remote regions may rely on telehealth combined with periodic specialist appointments. Consistent collection of lung function and symptom data helps the treating team judge whether the overall plan is working.

  Access, Cost And Shared Decisions

  Nintedanib access in Australia is influenced by PBS authority requirements, specialist assessment and the clinical documentation needed to demonstrate eligibility. The medicine’s list price is not the same as the patient’s final cost under a subsidised pathway, so patients should discuss dispensing arrangements, safety-net thresholds and travel supplies with their pharmacist or treatment team.

  The local market also affects continuity. Hospital pharmacies, community pharmacies and specialist clinics may have different ordering processes, while supply interruptions can be particularly difficult for people travelling from regional Western Australia or northern Queensland. Planning repeats before holidays and confirming stock availability can prevent avoidable gaps.

  Digital information requires similar care. Conference attendees reviewing respiratory medicine resources alongside unrelated web content should verify the purpose and safety of every page, including this external access link, rather than assuming that a conference-associated domain makes a page clinically relevant. Reliable information should come from the TGA, PBS, recognised respiratory societies and the treating specialist.

  Practical Monitoring Priorities

  A structured plan can help clinicians and patients preserve treatment exposure while responding early to adverse effects:

  • Record baseline FVC, diffusing capacity where available, oxygen needs, weight and functional limitations.
  • Check liver function before treatment and at clinically appropriate intervals, with closer review when symptoms or interacting medicines are present.
  • Discuss diarrhoea prevention, hydration, diet, antidiarrhoeal options and the circumstances requiring medical review.
  • Review weight, appetite, fatigue and medication adherence at every appointment rather than waiting for a major decline.
  • Reassess symptoms alongside spirometry, six-minute walk performance, exacerbations and quality of life.
  • Confirm PBS arrangements, pharmacy supply, repeat prescriptions and travel plans before treatment gaps occur.
  • Coordinate respiratory, primary care, pulmonary rehabilitation, palliative care and transplant services when appropriate.

  The best response is rarely defined by a single spirometry result. A patient who maintains function, avoids hospitalisation and continues therapy with manageable side effects may be achieving a clinically important benefit even when the disease remains visible on imaging.

  Nintedanib is therefore most effective as part of sustained, individualised IPF care rather than as an isolated prescription. In Australian practice, the practical takeaway is to pair early adverse-effect management with regular lung function, symptom and access reviews so that treatment can be maintained safely for as long as it remains beneficial.

  Richard Russell Nuffield Department of Clinical Medicine, University of Oxford (United Kingdom)
• Mona Bafadhel King’s College London (United Kingdom)
  David Jackson Guy’s and St Thomas’ Hospital, King’s College London (United Kingdom)
• James Chalmers University of Dundee (United Kingdom)
  David Price University of Aberdeen (United Kingdom)