Dose Reduction and Discontinuation With Anti-Fibrotic Medications

Assessment of the Dose Reduction and Discontinuation Associated With Anti-Fibrotic Medications in Patients With Idiopathic Pulmonary Fibrosis

The overarching aim of our study is to assess the incidence of dose reduction and discontinuations for pirfenidone and nintedanib.

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: Nintedanib; Drug: Pirfenidone

• Study Type: Observational
• Enrollment (Actual): 2778

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Ridgefield, Connecticut, United States, 06877
      • Boehringer Ingelheim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with idiopathic pulmonary fibrosis (IPF) who initiated either pirfenidone or nintedanib between October 2014 and September 2021.

Description

Inclusion Criteria:

• Presence of at least one pirfenidone or nintedanib prescription during the identification period (0/01/2014 to 09/30/2021; the date of first prescription for pirfenidone/nintedanib is the index date)
• Evidence of IPF: patient with at least one inpatient or two outpatient claims (>14 days apart) with a diagnosis code for IPF during the study period (10/01/2013 to 09/30/2022)
• At least 18 years old at the index date
• Have at least 12 months of continuous enrollment in the health plan during pre-index period, and at least 6 months of continuous enrollment in post-index period

Exclusion Criteria:

• Any history of lung transplant during the 12-months pre-index/baseline period
• Any claims for a skilled nursing facility, a long-term care facility or hospice care during the 12-month pre-index period
• Evidence of non-IPF chronic fibrosis Interstitial Lung Disease (ILD) or connective tissue diseases during the 12-months pre-index period. The following conditions will be excluded: autoimmune, or connective tissue diseases (i.e., rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), dermatopolymyositis, systemic sclerosis, Sjogren's syndrome, and mixed connective tissue disease (CTD), sarcoidosis, and hypersensitivity pneumonitis).
• Missing demographic information (i.e., age or sex)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pirfenidone initiators cohort; IPF patients from the Optum Research Database (ORD) who presented at least one pirfenidone prescription during the identification period (the date of first prescription for pirfenidone was considered the index date, between October 2014 up to December 2021) and with at least 12 months of continuous enrollment in the health plan during pre-and post-index period.	Drug: Pirfenidone; Pirfenidone
Nintedanib initiators cohort; IPF patients from the Optum Research Database (ORD) who presented at least one nintedanib prescription during the identification period (the date of first prescription for nintedanib was considered the index date, between October 2014 up to December 2021) and with at least 12 months of continuous enrollment in the health plan during pre-and post-index period.	Drug: Nintedanib; Nintedanib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Dose Reduction and/or Temporary Dose Reduction (Sub-optimal Dose) by 12 Months	Number of patients with sub-optimal dose was be defined as patients with an average daily dose not following the prescribing information of nintedanib and pirfenidone for at least 90 consecutive days, corresponding to ≤ 66.67% dose strength for pirfenidone and ≤ 66.67% dose strength for nintedanib. Number of patients with sub-optimal dosing by month 12 is reported.	From individual index date up to 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Treatment Discontinuation	Treatment discontinuation was defined as presence of ninety or more days gap in refilling a prescription of the drug (pirfenidone or nintedanib)	From individual index date up to 12 months.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2023
• Primary Completion (Actual): July 14, 2023
• Study Completion (Actual): July 14, 2023

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: March 9, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 8, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Protein Kinase Inhibitors; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Pirfenidone; Nintedanib
• Other Study ID Numbers: 1199-0526

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No