Observational, multicentre, prospective, real-world post-authorization safety study describing the achievement of nintedanib-associated DIArrhoea control after 12 weeks of follow-up in patients with idiopathic puLmonary FIBrosis (IPF) and progressive pulmonary fibrosis (other than IPF) in Spain: the DIALFIB study

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation

  Other
• If ‘other’, further details on the scope of the study:
  Nintedanib associated diarrhoea control
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  OFEV
• Study drug International non-proprietary name (INN) or common name:
  NINTEDANIB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01EX09) nintedanib

  nintedanib
• Medical condition to be studied:
  Diarrhoea

Population studied

• Short description of the study population:
  All patients diagnosed with IPF and PPFs who reported a first episode of diarrhoea while being treated with nintedanib optimal dose (150 mg twice per day [bid])
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  100

Study design details

• Study design:
  Observational, non-interventional, multicentre, and prospective, real-world post authorization safety study (PASS)
• Main study objective:
  To describe the proportion of patients who achieve diarrhea control while taking a nintedanib dose of 150 mg bid at 12-week follow up in patients with IPF and other PPF reporting a first episode of nintedanib-associated diarrhea at study baseline.
• Setting:
  Hospital settings in Spain
• Outcomes:
  Achievement of diarrhea control (yes/no), defined as the passage of less than 3 loose or liquid stools in a 24-hour period (loose or liquid stools defined as stools with a BSFS of 6 or 7 points (17))while being treated with 150 mg bid of nintedanib, at 12-week follow-up. ; 1. Absolute change in the proportion of patients taking optimal nintedanib dose (150 mg bid) at 12-week follow-up referent to baseline ; 2. Absolute change in BSFS score at week 12 follow-up referent to baseline ; 3. Absolute change in number of stools per day at 12-week follow-up referent to baseline ; 4. Absolute change in current body weight (in kilograms) at 12-week And 6 more
• Data analysis plan:
  Descriptive statistics will be presented as absolute (counts) and relative frequencies (proportions) for categorical variables, and mean, standard deviation, median, 25 and 75 quartiles, and minimum, and maximum values for continuous variables.
• Summary results:
  During the recruitment period, 18 patients were included in the study. One patient was subsequently excluded due to not fulfilling the eligibility criteria, resulting in a final analysed population of 17 patients. ; ; At baseline, the mean (SD) age of the included population (n=18) was 70.28 (6.88) years, and 14 patients (77.78%) were male. Most patients were White 16 (88.89%), followed by Latino 1 (5.56%) and Black 1 ; (5.56%). Mean (SD) body mass index (BMI) was 28.97 (5.67) kg/m² and mean (SD) body weight was 80.84 (16.68) kg. Regarding smoking status, 13 (72.22%) were ex-smokers, 4 (22.22%) non-smokers, and 1 (5.56%) ; smoker. ; ; 17 patients were finally eligible and finished the study. Among these eligible patients, the most common comorbidities were arterial hypertension (suffered by 47.06% of patients), sleep apnoea (29.41%), emphysema (29.41%), diabetes (23.53%) and coronary heart disease (23.53%). ; ; Of the 17 eligible patients, 70.59 % achieved diarrhoea control while taking a nintedanib dose of 150 mg twice daily (bid) at the 12-week follow-up. 76.47% of patients were taking the optimal nintedanib dose at the 12-week follow-up. BSFS score in the 12-week follow-up, as compared to the baseline visit, presented a mean (SD) difference of 1.76 (1.60). During this period, mean (SD) change for number of stools was -2.09 ; (1.27) stools per day. Mean body weight in kilograms presented a mean