Trial Outcomes & Findings for Dose Reduction and Discontinuation With Anti-Fibrotic Medications (NCT NCT05779007)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

2778 participants

Primary outcome timeframe

From individual index date up to 12 months.

Results posted on

2025-07-28

Participant Flow

This was a retrospective cohort study to assess the dose reduction/interruption and discontinuation with nintedanib and pirfenidone initiators among patients with Idiopathic Pulmonary Fibrosis (IPF) from the Optum Research Database (ORD) who initiated either pirfenidone or nintedanib between October 2014 and December 2021.

Patients with IPF who presented at least one pirfenidone or nintedanib prescription during the identification period and with at least 12 months of continuous enrollment in the health plan during pre- and post-index period. A total of 1,389 new users of nintedanib were matched to equal number of new pirfenidone users.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	4972	3398
Overall Study Propensity Score Matched Patients	1389	1389
Overall Study COMPLETED	1455	1389
Overall Study NOT COMPLETED	3517	2009

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study not meeting eligibility criteria	3517	2009

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nintedanib Initiators Cohort n=1389 Participants 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.	Pirfenidone Initiators Cohort n=1389 Participants 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.	Total n=2778 Participants Total of all reporting groups
Age, Continuous	73.4 years STANDARD_DEVIATION 7.6 • n=1389 Participants	73.9 years STANDARD_DEVIATION 7.6 • n=1389 Participants	73.52 years STANDARD_DEVIATION 7.54 • n=2778 Participants
Sex: Female, Male Female	534 Participants n=1389 Participants	549 Participants n=1389 Participants	1083 Participants n=2778 Participants
Sex: Female, Male Male	855 Participants n=1389 Participants	840 Participants n=1389 Participants	1695 Participants n=2778 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: From individual index date up to 12 months.

Population: Propensity score matched (PSM) cohorts of IPF patients between the nintedanib and pirfenidone initiators groups (1:1). Patients \>= 18 years old and registered in Optum Research Database (ORD) between October 2014 and December 2021.

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.

Outcome measures

Outcome measures
Measure	Nintedanib Initiators Cohort n=1389 Participants 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.	Pirfenidone Initiators Cohort n=1389 Participants 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.
Number of Patients With Dose Reduction and/or Temporary Dose Reduction (Sub-optimal Dose) by 12 Months	301 Participants	373 Participants

SECONDARY outcome

Timeframe: From individual index date up to 12 months.

Population: Propensity score matched (PSM) cohorts of IPF patients between the nintedanib and pirfenidone initiators groups (1:1). Patients \>= 18 years old and registered in Optum Research Database (ORD) between October 2014 and December 2021. Only IPF patients with event were included in the analysis.

Treatment discontinuation was defined as presence of ninety or more days gap in refilling a prescription of the drug (pirfenidone or nintedanib)

Outcome measures

Outcome measures
Measure	Nintedanib Initiators Cohort n=1389 Participants 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.	Pirfenidone Initiators Cohort n=1389 Participants 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.
Time to Treatment Discontinuation	257.47 Days Standard Deviation 130.29	246.56 Days Standard Deviation 134.55

Adverse Events

Nintedanib Initiators Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pirfenidone Initiators Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 018002430127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place