Trial Outcomes & Findings for A Study to Learn About the Study Medicine Called Infliximab (Genetical Recombination)[Infliximab Biosimilar 3] in People With Rheumatoid Arthritis, Ulcerative Colitis, Crohn's Disease, or Psoriasis (NCT NCT05796245)

Last Updated: 2025-06-04

Results Overview

The observation of serious infections was expected to occur in an acute time period following any exposure. An incident event occurring during the 60-day risk window was counted in the numerator for the analysis and the person-time accrued until the first occurrence of an event, the end of the 60-day risk window, date of switch treatment, death, or the end of study period. Additionally, two types of analyses based on propensity score were conducted. For the full analysis set, 9 and 232 events occurred with a total of 151.9 and 2609.9 person-years in the Infliximab-Pfizer Biosimilar group and Remicade group, respectively. For the comparative analysis set, 5 and 232 events occurred with a total of 22.8 and 2609.9 person-years. For the comparative analysis set (IPTW weighted), 0.5 and 230.7 events occurred with a total of 3.6 and 2598.5 person-years. For the comparative matched analysis set, 5 and 6 events occurred with a total of 22.8 and 46.7 person-years.

Recruitment status

COMPLETED

Target enrollment

2207 participants

Primary outcome timeframe

From index date up to 60 days after last dose

Results posted on

2025-06-04

Participant Flow

Data of study patients were extracted from the Medical Data Vision (MDV) database according to the study entry criteria. MDV database is a hospital-based claims database in Japan that consists of outpatient and inpatient data from hospitals using the diagnosis procedure combination system. The study period was from December 1, 2018 through November 30, 2023.

Participant milestones

Participant milestones
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] Patients treated with Infliximab-Pfizer Biosimilar who meet the inclusion/exclusion criteria.	Remicade (Infliximab [Genetical Recombination]) Patients treated with Remicade who meet the inclusion/exclusion criteria.
Overall Study STARTED	92	2115
Overall Study Full Analysis Set	92	2115
Overall Study Comparative Analysis Set	28	2115
Overall Study COMPLETED	92	2115
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] (Full Analysis Set) n=92 Participants Patients treated with Infliximab-Pfizer Biosimilar who meet the inclusion/exclusion criteria.	Remicade (Infliximab [Genetical Recombination]) (Full Analysis Set) n=2115 Participants Patients treated with Remicade who meet the inclusion/exclusion criteria.	Total n=2207 Participants Total of all reporting groups
Age, Customized ≥18 and <65 years (Comparative analysis set)	18 Participants n=28 Participants • The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.	1615 Participants n=2115 Participants • The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.	1633 Participants n=2143 Participants • The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.
Age, Customized ≥65 years (Comparative analysis set)	9 Participants n=28 Participants • The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.	412 Participants n=2115 Participants • The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.	421 Participants n=2143 Participants • The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.
Age, Customized <18 years (Full analysis set)	1 Participants n=92 Participants • The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.	88 Participants n=2115 Participants • The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.	89 Participants n=2207 Participants • The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.
Age, Customized ≥18 and <65 years (Full analysis set)	52 Participants n=92 Participants • The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.	1615 Participants n=2115 Participants • The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.	1667 Participants n=2207 Participants • The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.
Age, Customized ≥65 years (Full analysis set)	39 Participants n=92 Participants • The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.	412 Participants n=2115 Participants • The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.	451 Participants n=2207 Participants • The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.
Age, Customized <18 years (Comparative analysis set)	1 Participants n=28 Participants • The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.	88 Participants n=2115 Participants • The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.	89 Participants n=2143 Participants • The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.
Sex: Female, Male Full analysis set · Female	49 Participants n=92 Participants • The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.	827 Participants n=2115 Participants • The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.	876 Participants n=2207 Participants • The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.
Sex: Female, Male Full analysis set · Male	43 Participants n=92 Participants • The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.	1288 Participants n=2115 Participants • The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.	1331 Participants n=2207 Participants • The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.
Sex: Female, Male Comparative analysis set · Female	17 Participants n=28 Participants • The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.	827 Participants n=2115 Participants • The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.	844 Participants n=2143 Participants • The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.
Sex: Female, Male Comparative analysis set · Male	11 Participants n=28 Participants • The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.	1288 Participants n=2115 Participants • The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.	1299 Participants n=2143 Participants • The full analysis set included all patients who were considered eligible by the inclusion and exclusion criteria. The comparative analysis set was a subset of the full analysis set who were new users.
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: From index date up to 60 days after last dose

Population: For the analysis of each outcome event, those patients experiencing the same outcome event during the 90-day look-back period prior to the index date were excluded. For serious infections, this resulted in Full analysis set (Infliximab-Pfizer Biosimilar, n=86; Remicade, n=1909), Comparative analysis set (Infliximab-Pfizer Biosimilar, n=23; Remicade, n=1909).

Outcome measures

Outcome measures
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] n=92 Participants Patients treated with Infliximab-Pfizer Biosimilar who meet the inclusion/exclusion criteria.	Remicade (Infliximab [Genetical Recombination]) n=2115 Participants Patients treated with Remicade who meet the inclusion/exclusion criteria.
Incidence Rate of Serious Infections Incidence rate of serious infections (Full analysis set)	0.06 serious infections per 1 person-year	0.09 serious infections per 1 person-year
Incidence Rate of Serious Infections Incidence rate of serious infections (Comparative analysis set)	0.22 serious infections per 1 person-year	0.09 serious infections per 1 person-year
Incidence Rate of Serious Infections Incidence rate of serious infections (Comparative analysis set, IPTW weighted)	0.13 serious infections per 1 person-year	0.09 serious infections per 1 person-year
Incidence Rate of Serious Infections Incidence rate of serious infections (Comparative matched analysis set)	0.22 serious infections per 1 person-year	0.13 serious infections per 1 person-year

SECONDARY outcome

Timeframe: From index date up to 60 days after last dose

Population: For the analysis of each outcome event, those patients experiencing the same outcome event during the 90-day look-back period prior to the index date were excluded. For tuberculosis, this resulted in Full analysis set (Infliximab-Pfizer Biosimilar, n=91; Remicade, n=2100), Comparative analysis set (Infliximab-Pfizer Biosimilar, n=28; Remicade, n=2100).

The observation of tuberculosis was expected to occur in an acute time period following any exposure. An incident event occurring during the 60-day risk window was counted in the numerator for the analysis and the person-time accrued until the first occurrence of an event, the end of the 60-day risk window, date of switch treatment, death, or the end of study period. Additionally, two types of analyses based on propensity score were conducted. For the full analysis set, 0 and 14 events occurred with a total of 161.8 and 2904.1 person-years in the Infliximab-Pfizer Biosimilar group and Remicade group, respectively. For the comparative analysis set, 0 and 14 events occurred with a total of 27.2 and 2904.1 person-years. For the comparative analysis set (IPTW weighted), 0.0 and 14.3 events occurred with a total of 10.4 and 2889.7 person-years. For the comparative matched analysis set, 0 and 1 event occurred with a total of 27.2 and 50.1 person-years.

Outcome measures

Outcome measures
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] n=92 Participants Patients treated with Infliximab-Pfizer Biosimilar who meet the inclusion/exclusion criteria.	Remicade (Infliximab [Genetical Recombination]) n=2115 Participants Patients treated with Remicade who meet the inclusion/exclusion criteria.
Incidence Rate of Tuberculosis Incidence rate of tuberculosis (Full analysis set)	0.00 tuberculosis per 1 person-year	0.00 tuberculosis per 1 person-year
Incidence Rate of Tuberculosis Incidence rate of tuberculosis (Comparative analysis set)	0.00 tuberculosis per 1 person-year	0.00 tuberculosis per 1 person-year
Incidence Rate of Tuberculosis Incidence rate of tuberculosis (Comparative analysis set, IPTW weighted)	0.00 tuberculosis per 1 person-year	0.00 tuberculosis per 1 person-year
Incidence Rate of Tuberculosis Incidence rate of tuberculosis (Comparative matched analysis set)	0.00 tuberculosis per 1 person-year	0.02 tuberculosis per 1 person-year

SECONDARY outcome

Timeframe: From index date up to 60 days after last dose

Population: For the analysis of each outcome event, those patients experiencing the same outcome event during the 90-day look-back period prior to the index date were excluded. For serious blood disorder, this resulted in Full analysis set (Infliximab-Pfizer Biosimilar, n=92; Remicade, n=2093), Comparative analysis set (Infliximab-Pfizer Biosimilar, n=28; Remicade, n=2093).

The observation of serious blood disorder was expected to occur in an acute time period following any exposure. An incident event occurring during the 60-day risk window was counted in the numerator for the analysis and the person-time accrued until the first occurrence of an event, the end of the 60-day risk window, date of switch treatment, death, or the end of study period. Additionally, two types of analyses based on propensity score were conducted. For the full analysis set, 1 and 15 events occurred with a total of 163.5 and 2913.5 person-years in the Infliximab-Pfizer Biosimilar group and Remicade group, respectively. For the comparative analysis set, 1 and 15 events occurred with a total of 27.5 and 2913.5 person-years. For the comparative analysis set (IPTW weighted), 0.1 and 14.9 events occurred with a total of 10.4 and 2899.6 person-years. For the comparative matched analysis set, 1 and 0 events occurred with a total of 27.5 and 52.5 person-years.

Outcome measures

Outcome measures
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] n=92 Participants Patients treated with Infliximab-Pfizer Biosimilar who meet the inclusion/exclusion criteria.	Remicade (Infliximab [Genetical Recombination]) n=2115 Participants Patients treated with Remicade who meet the inclusion/exclusion criteria.
Incidence Rate of Serious Blood Disorder Incidence rate of serious blood disorder (Full analysis set)	0.01 serious blood disorder per 1 person-year	0.01 serious blood disorder per 1 person-year
Incidence Rate of Serious Blood Disorder Incidence rate of serious blood disorder (Comparative analysis set)	0.04 serious blood disorder per 1 person-year	0.01 serious blood disorder per 1 person-year
Incidence Rate of Serious Blood Disorder Incidence rate of serious blood disorder (Comparative analysis set, IPTW weighted)	0.01 serious blood disorder per 1 person-year	0.01 serious blood disorder per 1 person-year
Incidence Rate of Serious Blood Disorder Incidence rate of serious blood disorder (Comparative matched analysis set)	0.04 serious blood disorder per 1 person-year	0.00 serious blood disorder per 1 person-year

SECONDARY outcome

Timeframe: From index date up to 60 days after last dose

Population: For the analysis of each outcome event, those patients experiencing the same outcome event during the 90-day look-back period prior to the index date were excluded. For interstitial pneumonia, this resulted in Full analysis set (Infliximab-Pfizer Biosimilar, n=91; Remicade, n=2092), Comparative analysis set (Infliximab-Pfizer Biosimilar, n=27; Remicade, n=2092).

The observation of interstitial pneumonia was expected to occur in an acute time period following any exposure. An incident event occurring during the 60-day risk window was counted in the numerator for the analysis and the person-time accrued until the first occurrence of an event, the end of the 60-day risk window, date of switch treatment, death, or the end of study period. Additionally, two types of analyses based on propensity score were conducted. For the full analysis set, 5 and 42 events occurred with a total of 157.1 and 2918.8 person-years in the Infliximab-Pfizer Biosimilar group and Remicade group, respectively. For the comparative analysis set, 1 and 42 events occurred with a total of 26.2 and 2918.8 person-years. For the comparative analysis set (IPTW weighted), 0.3 and 42.1 events occurred with a total of 10.1 and 2905.0 person-years. For the comparative matched analysis set, 1 and 1 event occurred with a total of 26.2 and 52.5 person-years.

Outcome measures

Outcome measures
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] n=92 Participants Patients treated with Infliximab-Pfizer Biosimilar who meet the inclusion/exclusion criteria.	Remicade (Infliximab [Genetical Recombination]) n=2115 Participants Patients treated with Remicade who meet the inclusion/exclusion criteria.
Incidence Rate of Interstitial Pneumonia Incidence rate of interstitial pneumonia (Comparative analysis set)	0.04 interstitial pneumonia per 1 person-year	0.01 interstitial pneumonia per 1 person-year
Incidence Rate of Interstitial Pneumonia Incidence rate of interstitial pneumonia (Full analysis set)	0.03 interstitial pneumonia per 1 person-year	0.01 interstitial pneumonia per 1 person-year
Incidence Rate of Interstitial Pneumonia Incidence rate of interstitial pneumonia (Comparative analysis set, IPTW weighted)	0.03 interstitial pneumonia per 1 person-year	0.01 interstitial pneumonia per 1 person-year
Incidence Rate of Interstitial Pneumonia Incidence rate of interstitial pneumonia (Comparative matched analysis set)	0.04 interstitial pneumonia per 1 person-year	0.02 interstitial pneumonia per 1 person-year

SECONDARY outcome

Timeframe: From index date up to the first incident event, death, end of the study period, or loss to follow-up

Population: For the analysis of each outcome event, those patients experiencing the same outcome event during the 90-day look-back period prior to the index date were excluded. For malignancy, this resulted in Full analysis set (Infliximab-Pfizer Biosimilar, n=89; Remicade, n=2094), Comparative analysis set (Infliximab-Pfizer Biosimilar, n=26; Remicade, n=2094).

This study analyzed malignancy by extending follow-up time until the first incident event, death, end of the study period, or loss to follow-up. The primary analysis utilized an ever-exposed approach whereby a person always was considered exposed to the initial treatment. All malignancies were reported in the primary analysis even those that occur after the day of initial treatment. Additionally, two types of analyses based on propensity score were conducted. For the full analysis set, 7 and 77 events occurred with a total of 172.5 and 4480.2 person-years in the Infliximab-Pfizer Biosimilar group and Remicade group, respectively. For the comparative analysis set, 1 and 77 events occurred with a total of 27.7 and 4480.2 person-years. For the comparative analysis set (IPTW weighted), 0.0 and 76.7 events occurred with a total of 10.5 and 4458.5 person-years. For the comparative matched analysis set, 1 and 4 events occurred with a total of 27.7 and 78.4 person-years.

Outcome measures

Outcome measures
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] n=92 Participants Patients treated with Infliximab-Pfizer Biosimilar who meet the inclusion/exclusion criteria.	Remicade (Infliximab [Genetical Recombination]) n=2115 Participants Patients treated with Remicade who meet the inclusion/exclusion criteria.
Incidence Rate of Malignancy Incidence rate of malignancy (Comparative analysis set)	0.04 malignancy per 1 person-year	0.02 malignancy per 1 person-year
Incidence Rate of Malignancy Incidence rate of malignancy (Full analysis set)	0.04 malignancy per 1 person-year	0.02 malignancy per 1 person-year
Incidence Rate of Malignancy Incidence rate of malignancy (Comparative analysis set, IPTW weighted)	0.00 malignancy per 1 person-year	0.02 malignancy per 1 person-year
Incidence Rate of Malignancy Incidence rate of malignancy (Comparative matched analysis set)	0.04 malignancy per 1 person-year	0.05 malignancy per 1 person-year

Adverse Events

Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3]

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Remicade (Infliximab [Genetical Recombination])

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

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER