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.
Study Type
OBSERVATIONAL
Enrollment
2,207
Pfizer
Tokyo, Japan
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
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
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
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
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
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