Infliximab Biosimilar Pfizer Drug Use Investigation (Crohn's Disease or Ulcerative Colitis)

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. 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 (371 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 and contract violation/deficiency were excluded.

Summary statistics of the Mayo score at baseline, at study completion date, and the change in Mayo score from baseline to study completion date in participants with Ulcerative colitis. The Mayo score consists of 4 domains, each scored as a 0- to 3-point subscore, with higher scores indicating more severe disease activity. The 4 domains are the number of bowel movements subscore (0 to 3), rectal bleeding subscore (0 to 3), endoscopic finding subscore (0 to 3), and physician's global assessment subscore (0 to 3). The method of calculating the Mayo score is the sum of all subscores in the 4 domains, with a range of 0 to 12 points.

Time frame: Baseline, Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period.

Population: The efficacy analysis set (348 participants) comprised of participants in the safety analysis set who had effectiveness evaluation. Of the 348 participants, summary statistics and change of the Mayo score was calculated for the 15 participants with Ulcerative colitis whose effectiveness was evaluated by the Mayo score.

Percentage of participants with improvement of Ulcerative colitis was presented using the partial Mayo score along with the two-sided 95% confidence interval (exact method). The partial Mayo score is the sum of the subscores for the following 3 domains with a range of 0 to 9 points; the number of bowel movements subscore (0 to 3), rectal bleeding subscore (0 to 3), and physician's global assessment subscore (0 to 3). Partial Mayo score improvement was defined as 2 points or more reduction from baseline.

Time frame: Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period.

Population: The efficacy analysis set (348 participants) comprised of participants in the safety analysis set who had effectiveness evaluation. Of the 348 participants, percentage of remission and improvement of Ulcerative colitis as of the end date of the study was calculated for the 87 participants whose effectiveness was evaluated by the partial Mayo score.

Percentage of participants with improvement of Crohn's disease was presented using the Crohn's Disease Activity Index score along with the two-sided 95% confidence interval (exact method). The Crohn's Disease Activity Index score is calculated from the following 8 items:(1) the number of watery or mushy stools, (2) abdominal pain (0 to 3), (3) general condition (0 to 4), (4) symptoms and signs considered to be related to Crohn's disease (0 to6), (5) use of Lomotil/Opiate for diarrhea (0 to 1), (6) abdominal mass (0 to 5), (7) hematocrit(%), and (8) score derived from body weight, that is the sum of 2x(1)+5x(2)+7x(3)+20x(4)+30x(5)+10x(6)+6x(7)+(8). The Crohn's Disease Activity Index improvement was defined as a decrease of 25% or more and 70 points or more in Crohn's Disease Activity Index score after treatment with Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] compared with the Crohn's Disease Activity Index score before treatment.

Time frame: Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period.

Population: The efficacy analysis set (348 participants) comprised of participants in the safety analysis set who had effectiveness evaluation. Of the 348 participants, percentage of remission and improvement of Crohn's disease as of the end date of the study was calculated for the 151 participants whose effectiveness was evaluated by the CDAI score.

Percentage of participants with remission of Crohn's disease was presented using the Crohn's Disease Activity Index score along with the two-sided 95% confidence interval (exact method). The Crohn's Disease Activity Index score is calculated from the following 8 items: (1) the number of watery or mushy stools, (2) abdominal pain (0 to 3), (3) general condition (0 to 4), (4) symptoms and signs considered to be related to Crohn's disease (0 to6), (5) use of Lomotil/Opiate for diarrhea (0 to 1), (6) abdominal mass (0 to 5), (7) hematocrit(%), and (8) score derived from body weight, that is the sum of 2x(1)+5x(2)+7x(3)+20x(4)+30x(5)+10x(6)+6x(7)+(8). A Crohn's Disease Activity IndexI score of \<150 was considered remission.

Time frame: Baseline, Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period.

Population: The efficacy analysis set (348 participants) comprised of participants in the safety analysis set who had effectiveness evaluation. Of the 348 participants, percentage of remission and improvement of Crohn's disease as of the end date of the study was calculated for the 151 participants whose effectiveness was evaluated by the CDAI score.

Percentage of participants with remission of Ulcerative colitis was presented using the partial Mayo score along with the two-sided 95% confidence interval (exact method). The partial Mayo score is the sum of the subscores for the following 3 domains with a range of 0 to 9 points; the number of bowel movements subscore (0 to 3), rectal bleeding subscore (0 to 3), and physician's global assessment subscore (0 to 3). Partial Mayo score of \<2 was considered partial Mayo score remission.

Time frame: Baseline, Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period.

Population: The efficacy analysis set (348 participants) comprised of participants in the safety analysis set who had effectiveness evaluation. Of the 348 participants, percentage of remission and improvement of Ulcerative colitis as of the end date of the study was calculated for the 87 participants whose effectiveness was evaluated by the partial Mayo score.