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

An 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; and congenital anomaly/birth defect. Relatedness to Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] was assessed.

Time frame: 30 weeks from the day of initial dose

Population: The safety analysis set (61 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 protocol violation were excluded.

The Disease Activity Score based on 28-joint count and C-reactive protein (DAS28 \[4/CRP\]) was calculated using four variables: Tender Joint Count (TJC28) and Swollen Joint Count (SJC28), both scored from 0 to 28; participant's overall activity assessed by the Visual Analog Scale (VAS, 0-100 mm); and C-reactive protein (CRP, ≥0 mg/dL). Higher scores indicate increased disease activity. The formula is: DAS28 (4/CRP) = 0.56 × √(TJC28) + 0.28 × √(SJC28) + 0.36 × LN((CRP) × 10 + 1) + 0.014 × (VAS) + 0.96. Changes in DAS28 (4/CRP) from baseline to study completion were summarized as mean ± standard deviation, overall, as well as separately based on prior infliximab use before the initial dose of this drug. Greater negative changes reflect larger reductions in disease activity.

Time frame: 30 weeks from the day of initial dose

Population: The efficacy analysis set (54 participants) comprised of participants in the safety analysis set who had effectiveness evaluation. Of the 54 participants, 41 participants who had DAS28 (4/CRP) available both at baseline and study completion were evaluated the disease activity at the time of study completion.~Among the 41 participants, 28 had no prior use of infliximab products, while 13 had used them before.

Percentage of participants with a remission based on DAS28 (4/CRP) was presented along with the two-sided 95% confidence interval (exact method). For participants with available DAS28 (4/CRP) values both at baseline and study completion, the number and proportion of those who achieved remission (\<2.3) at both time points were calculated overall, as well as separately based on prior infliximab use before the initial dose of this drug.

Time frame: 30 weeks from the day of initial dose

Population: The efficacy analysis set (54 participants) comprised of participants in the safety analysis set who had effectiveness evaluation. Of the 54 participants, the percentage of participants who achieved remission (\< 2.3) as of the study completion date was calculated for the 41 participants whose DAS28 (4/CRP) were available both at baseline and study completion.~Among the 41 participants, 28 had no prior use of infliximab products, while 13 had used them before.