Arthritis, Rheumatoid, Colitis, Ulcerative, Crohn Disease, Psoriasis
Conditions
Keywords
Tumor Necrosis Factor, TNF, Infliximab, Biosimilar
Brief summary
The purpose of this study is to learn about the safety of the safety of the study medicine called infliximab for the possible treatment of rheumatoid arthritis (RA), ulcerative colitis (UC, Crohn's disease, or psoriasis. RA is a kind of joint disease that causes pain and swelling. UC causes inflammation and sores (also called ulcers), in the lining of the rectum and colon. Chron's disease is a disease that lasts for a long time and causes severe irritation in your digestive tract. Psoriasis is a skin disease that gives you a dry, scaly rash. The study includes patient's data from the database who: * Have at least 90 days of look-back period * Have any of these diseases (RA, UC, Crohn's disease, or Psoriasis) in the 90-day look back period * Are 15 years of age or older at the time of first dosing All the patient's data included in this study would have received infliximab as intravenous (into veins) injection.
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have at least 90 days of look-back period 2. Have diagnostic code of indicated diseases (rheumatoid arthritis, ulcerative colitis, Crohn's disease, or psoriasis) in the 90-day look-back period. Patients with \>1 indication will be summarized as a separate group from each sub-cohort. An inpatient or outpatient visit assigned a diagnosis code consistent with either rheumatoid arthritis, ulcerative colitis, Crohn's disease, or psoriasis using ICD-10 coding. 3. 15 years of age or older at the time of index date
Exclusion criteria
1\. Patients with pre-existing safety outcome event during the 90-day look-back period will be excluded from the study cohort for that specific outcome event as this study is observing incident cases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of Serious Infections | From index date up to 60 days after last dose | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of Tuberculosis | From index date up to 60 days after last dose | 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. |
| Incidence Rate of Serious Blood Disorder | From index date up to 60 days after last dose | 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. |
| Incidence Rate of Interstitial Pneumonia | From index date up to 60 days after last dose | 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. |
| Incidence Rate of Malignancy | From index date up to the first incident event, death, end of the study period, or loss to follow-up | 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. |
Countries
Japan
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] (Full Analysis Set) Patients treated with Infliximab-Pfizer Biosimilar who meet the inclusion/exclusion criteria. | 92 |
| Remicade (Infliximab [Genetical Recombination]) (Full Analysis Set) Patients treated with Remicade who meet the inclusion/exclusion criteria. | 2,115 |
| Total | 2,207 |
Baseline characteristics
| Characteristic | Total | Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] (Full Analysis Set) | Remicade (Infliximab [Genetical Recombination]) (Full Analysis Set) |
|---|---|---|---|
| Age, Customized ≥18 and <65 years (Comparative analysis set) | 1633 Participants | 18 Participants | 1615 Participants |
| Age, Customized ≥18 and <65 years (Full analysis set) | 1667 Participants | 52 Participants | 1615 Participants |
| Age, Customized <18 years (Comparative analysis set) | 89 Participants | 1 Participants | 88 Participants |
| Age, Customized <18 years (Full analysis set) | 89 Participants | 1 Participants | 88 Participants |
| Age, Customized ≥65 years (Comparative analysis set) | 421 Participants | 9 Participants | 412 Participants |
| Age, Customized ≥65 years (Full analysis set) | 451 Participants | 39 Participants | 412 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Sex: Female, Male Comparative analysis set Female | 844 Participants | 17 Participants | 827 Participants |
| Sex: Female, Male Comparative analysis set Male | 1299 Participants | 11 Participants | 1288 Participants |
| Sex: Female, Male Full analysis set Female | 876 Participants | 49 Participants | 827 Participants |
| Sex: Female, Male Full analysis set Male | 1331 Participants | 43 Participants | 1288 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Incidence Rate of Serious Infections
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.
Time frame: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] | Incidence Rate of Serious Infections | Incidence rate of serious infections (Comparative analysis set, IPTW weighted) | 0.13 serious infections per 1 person-year |
| Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] | Incidence Rate of Serious Infections | Incidence rate of serious infections (Comparative matched analysis set) | 0.22 serious infections per 1 person-year |
| Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] | Incidence Rate of Serious Infections | Incidence rate of serious infections (Full analysis set) | 0.06 serious infections per 1 person-year |
| Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] | Incidence Rate of Serious Infections | Incidence rate of serious infections (Comparative analysis set) | 0.22 serious infections per 1 person-year |
| Remicade (Infliximab [Genetical Recombination]) | Incidence Rate of Serious Infections | Incidence rate of serious infections (Comparative analysis set) | 0.09 serious infections per 1 person-year |
| Remicade (Infliximab [Genetical Recombination]) | Incidence Rate of Serious Infections | Incidence rate of serious infections (Comparative analysis set, IPTW weighted) | 0.09 serious infections per 1 person-year |
| Remicade (Infliximab [Genetical Recombination]) | Incidence Rate of Serious Infections | Incidence rate of serious infections (Full analysis set) | 0.09 serious infections per 1 person-year |
| Remicade (Infliximab [Genetical Recombination]) | Incidence Rate of Serious Infections | Incidence rate of serious infections (Comparative matched analysis set) | 0.13 serious infections per 1 person-year |
Comparison: Comparative analysis set, IPTW weighted95% CI: [0.39, 5.2]
Comparison: Comparative analysis set, IPTW weighted95% CI: [0.38, 5.34]
Comparison: Comparative analysis set, IPTW weighted95% CI: [-0.2, 0.11]
Comparison: Comparative matched analysis set95% CI: [0.54, 4.9]
Comparison: Comparative matched analysis set95% CI: [0.55, 5.26]
Comparison: Comparative matched analysis set95% CI: [-0.1, 0.39]
Comparison: Comparative analysis set95% CI: [1.05, 5.67]
Comparison: Comparative analysis set95% CI: [1.02, 5.99]
Comparison: Comparative analysis set95% CI: [-0.06, 0.32]
Secondary
Incidence Rate of Interstitial Pneumonia
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.
Time frame: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] | Incidence Rate of Interstitial Pneumonia | Incidence rate of interstitial pneumonia (Full analysis set) | 0.03 interstitial pneumonia per 1 person-year |
| Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] | Incidence Rate of Interstitial Pneumonia | Incidence rate of interstitial pneumonia (Comparative analysis set) | 0.04 interstitial pneumonia per 1 person-year |
| Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] | Incidence Rate of Interstitial Pneumonia | Incidence rate of interstitial pneumonia (Comparative matched analysis set) | 0.04 interstitial pneumonia per 1 person-year |
| Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] | Incidence Rate of Interstitial Pneumonia | Incidence rate of interstitial pneumonia (Comparative analysis set, IPTW weighted) | 0.03 interstitial pneumonia per 1 person-year |
| Remicade (Infliximab [Genetical Recombination]) | Incidence Rate of Interstitial Pneumonia | Incidence rate of interstitial pneumonia (Comparative analysis set, IPTW weighted) | 0.01 interstitial pneumonia per 1 person-year |
| Remicade (Infliximab [Genetical Recombination]) | Incidence Rate of Interstitial Pneumonia | Incidence rate of interstitial pneumonia (Full analysis set) | 0.01 interstitial pneumonia per 1 person-year |
| Remicade (Infliximab [Genetical Recombination]) | Incidence Rate of Interstitial Pneumonia | Incidence rate of interstitial pneumonia (Comparative matched analysis set) | 0.02 interstitial pneumonia per 1 person-year |
| Remicade (Infliximab [Genetical Recombination]) | Incidence Rate of Interstitial Pneumonia | Incidence rate of interstitial pneumonia (Comparative analysis set) | 0.01 interstitial pneumonia per 1 person-year |
Comparison: Comparative analysis set, IPTW weighted95% CI: [0.16, 17.61]
Comparison: Comparative analysis set, IPTW weighted95% CI: [0.17, 19.79]
Comparison: Comparative analysis set, IPTW weighted95% CI: [-0.12, 0.03]
Comparison: Comparative matched analysis set95% CI: [0.15, 45.68]
Comparison: Comparative matched analysis set95% CI: [0.12, 34.94]
Comparison: Comparative matched analysis set95% CI: [-0.1, 0.26]
Comparison: Comparative analysis set95% CI: [0.37, 19.93]
Comparison: Comparative analysis set95% CI: [0.37, 19.31]
Comparison: Comparative analysis set95% CI: [-0.05, 0.1]
Secondary
Incidence Rate of Malignancy
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.
Time frame: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] | Incidence Rate of Malignancy | Incidence rate of malignancy (Full analysis set) | 0.04 malignancy per 1 person-year |
| Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] | Incidence Rate of Malignancy | Incidence rate of malignancy (Comparative analysis set, IPTW weighted) | 0.00 malignancy per 1 person-year |
| Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] | Incidence Rate of Malignancy | Incidence rate of malignancy (Comparative matched analysis set) | 0.04 malignancy per 1 person-year |
| Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] | Incidence Rate of Malignancy | Incidence rate of malignancy (Comparative analysis set) | 0.04 malignancy per 1 person-year |
| Remicade (Infliximab [Genetical Recombination]) | Incidence Rate of Malignancy | Incidence rate of malignancy (Comparative matched analysis set) | 0.05 malignancy per 1 person-year |
| Remicade (Infliximab [Genetical Recombination]) | Incidence Rate of Malignancy | Incidence rate of malignancy (Comparative analysis set) | 0.02 malignancy per 1 person-year |
| Remicade (Infliximab [Genetical Recombination]) | Incidence Rate of Malignancy | Incidence rate of malignancy (Comparative analysis set, IPTW weighted) | 0.02 malignancy per 1 person-year |
| Remicade (Infliximab [Genetical Recombination]) | Incidence Rate of Malignancy | Incidence rate of malignancy (Full analysis set) | 0.02 malignancy per 1 person-year |
Comparison: Comparative analysis set, IPTW weighted95% CI: [0.02, 1.85]
Comparison: Comparative analysis set, IPTW weighted95% CI: [0.02, 1.99]
Comparison: Comparative analysis set, IPTW weighted95% CI: [-0.17, 0]
Comparison: Comparative matched analysis set95% CI: [0.07, 6]
Comparison: Comparative matched analysis set95% CI: [0.08, 6.61]
Comparison: Comparative matched analysis set95% CI: [-0.1, 0.21]
Comparison: Comparative analysis set95% CI: [0.28, 15.22]
Comparison: Comparative analysis set95% CI: [0.29, 15.08]
Comparison: Comparative analysis set95% CI: [-0.05, 0.09]
Secondary
Incidence Rate of Serious Blood Disorder
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.
Time frame: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] | Incidence Rate of Serious Blood Disorder | Incidence rate of serious blood disorder (Comparative analysis set) | 0.04 serious blood disorder per 1 person-year |
| Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] | 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 |
| Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] | 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 |
| Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] | Incidence Rate of Serious Blood Disorder | Incidence rate of serious blood disorder (Full analysis set) | 0.01 serious blood disorder per 1 person-year |
| Remicade (Infliximab [Genetical Recombination]) | Incidence Rate of Serious Blood Disorder | Incidence rate of serious blood disorder (Comparative matched analysis set) | 0.00 serious blood disorder per 1 person-year |
| Remicade (Infliximab [Genetical Recombination]) | Incidence Rate of Serious Blood Disorder | Incidence rate of serious blood disorder (Comparative analysis set) | 0.01 serious blood disorder per 1 person-year |
| Remicade (Infliximab [Genetical Recombination]) | 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 |
| Remicade (Infliximab [Genetical Recombination]) | Incidence Rate of Serious Blood Disorder | Incidence rate of serious blood disorder (Full analysis set) | 0.01 serious blood disorder per 1 person-year |
Comparison: Comparative analysis set, IPTW weighted95% CI: [0.12, 12.49]
Comparison: Comparative analysis set, IPTW weighted95% CI: [0.12, 17.14]
Comparison: Comparative analysis set, IPTW weighted95% CI: [-0.05, 0.01]
Comparison: Comparative analysis set Note: Hazard ratio, risk ratio, and risk difference for the comparative matched analysis set could not be calculated.95% CI: [0.81, 45.94]
Comparison: Comparative analysis set95% CI: [0.93, 53.51]
Comparison: Comparative analysis set95% CI: [-0.04, 0.1]
Secondary
Incidence Rate of Tuberculosis
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.
Time frame: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] | Incidence Rate of Tuberculosis | Incidence rate of tuberculosis (Full analysis set) | 0.00 tuberculosis per 1 person-year |
| Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] | Incidence Rate of Tuberculosis | Incidence rate of tuberculosis (Comparative analysis set) | 0.00 tuberculosis per 1 person-year |
| Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] | Incidence Rate of Tuberculosis | Incidence rate of tuberculosis (Comparative analysis set, IPTW weighted) | 0.00 tuberculosis per 1 person-year |
| Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3] | Incidence Rate of Tuberculosis | Incidence rate of tuberculosis (Comparative matched analysis set) | 0.00 tuberculosis per 1 person-year |
| Remicade (Infliximab [Genetical Recombination]) | Incidence Rate of Tuberculosis | Incidence rate of tuberculosis (Comparative matched analysis set) | 0.02 tuberculosis per 1 person-year |
| Remicade (Infliximab [Genetical Recombination]) | Incidence Rate of Tuberculosis | Incidence rate of tuberculosis (Full analysis set) | 0.00 tuberculosis per 1 person-year |
| Remicade (Infliximab [Genetical Recombination]) | Incidence Rate of Tuberculosis | Incidence rate of tuberculosis (Comparative analysis set, IPTW weighted) | 0.00 tuberculosis per 1 person-year |
| Remicade (Infliximab [Genetical Recombination]) | Incidence Rate of Tuberculosis | Incidence rate of tuberculosis (Comparative analysis set) | 0.00 tuberculosis per 1 person-year |
Comparison: Comparative analysis set Note: Hazard ratio, risk ratio, and risk difference for the Comparative analysis set (IPTW weighted) and for the Comparative matched analysis set could not be calculated. Also, crude hazard ratio and crude risk ratio could not be calculated.95% CI: [-0.01, 0]