Infliximab Biosimilar for Intravenous Drip Infusion 100 mg Pfizer Drug Use Investigation (Psoriasis)

An adverse drug reaction (ADR) was a treatment-related adverse event, and any untoward medical occurrence attributed to Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] in a participant who received this drug. A serious ADR was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] was assessed by the physician.

Time frame: 30 weeks from the day of initial dose

Population: The safety analysis set (8 participants) comprised of participants who satisfied the inclusion criteria and had received Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\]. Participants with no informed consent for publication of study results were excluded.

Summary statistics of the BSA at baseline, at study completion date, and the change in BSA from baseline to study completion date was presented. BSA was calculated from the percentage of skin rash to body surface area from baseline to study completion date, and change in severity of disease was evaluated.

Time frame: 30 weeks from the day of initial dose

Population: The efficacy analysis set (4 participants) comprised of participants in the safety analysis set who had effectiveness evaluation. Of the 4 participants, summary statistics and change from baseline in BSA as of the study completion date was calculated for the 1 participant whose BSA both at baseline and study completion date were available.

Percentage of participants with a PASI75 response was presented along with the two-sided 95% confidence interval (exact method). The PASI quantifies the severity of lesions and the percentage of lesion area. It is the total score of the degree of erythema, infiltration/thickening, and scaling (evaluated for each skin finding) in each of the 4 body regions evaluated by the physician. The score was adjusted for the percentage of lesion area of skin rash in each body region and the percentage of the area of each body region to the whole body. The percent change (%) in PASI score from baseline to the study completion date was calculated for each participant, and the number and proportion of participants with ≥ 75% improvement were calculated as PASI75.

Time frame: 30 weeks from the day of initial dose

Population: The efficacy analysis set (4 participants) comprised of participants in the safety analysis set who had effectiveness evaluation. Of the 4 participants, percentage of participants with a PASI75 response as of the study completion date was calculated for the 3 participants whose PASI scores both at baseline and study completion date were available.

Percentage of participants with a PASI90 response was presented along with the two-sided 95% confidence interval (exact method). The PASI quantifies the severity of lesions and the percentage of lesion area. It is the total score of the degree of erythema, infiltration/thickening, and scaling (evaluated for each skin finding) in each of the 4 body regions evaluated by the physician. The score was adjusted for the percentage of lesion area of skin rash in each body region and the percentage of the area of each body region to the whole body. The percent change (%) in PASI score from baseline to the study completion date was calculated for each participant, and the number and proportion of participants with ≥ 90% improvement were calculated as PASI90.

Time frame: 30 weeks from the day of initial dose

Population: The efficacy analysis set (4 participants) comprised of participants in the safety analysis set who had effectiveness evaluation. Of the 4 participants, percentage of participants with a PASI90 response as of the study completion date was calculated for the 3 participants whose PASI scores both at baseline and study completion date were available.