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.

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.

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.