Trial Outcomes & Findings for To Evaluate the Safety and Efficacy of Remsima™ in Patients With Crohn's Disease (CD) or Ulcerative Colitis (UC) (NCT NCT02326155)

Last Updated: 2022-02-21

Results Overview

Including Hepatitis B virus (HBV) reactivation, congestive heart failure, opportunistic infections (excluding tuberculosis), serious infections including sepsis (excluding opportunistic infections and tuberculosis), tuberculosis (TB), serum sickness (delayed hypersensitivity reactions), haematologic reactions, systemic lupus erythematosus/lupus-like syndrome, demyelinating disorders, lymphoma (not hepatosplenic T cell lymphoma), hepatobiliary events, hepatosplenic T cell lymphoma, intestinal or perianal abscess (in Crohn's disease), serious infusion reactions during a re-induction regimen following disease flare, sarcoidosis/sarcoid-like reactions, paediatric malignancy, leukaemia, malignancy (excluding lymphoma), colon carcinoma/dysplasia (in Ulcerative Colitis), skin cancer, pregnancy exposure, bowel stenosis/stricture/obstruction (in Crohn's disease) and infusion related reaction (IRR)/ hypersensitivity/anaphylactic reaction.

Recruitment status

TERMINATED

Target enrollment

470 participants

Primary outcome timeframe

Up to 5 years for each patient

Results posted on

2022-02-21

Participant Flow

Participant milestones

Participant milestones
Measure	Remsima (CT-P13) Patients were not treated with infliximab before enrollment. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.	Switched to Remsima (CT-P13) Patients were treated with infliximab prior to enrollment of the study. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.
Overall Study STARTED	407	63
Overall Study COMPLETED	13	1
Overall Study NOT COMPLETED	394	62

Reasons for withdrawal

Reasons for withdrawal
Measure	Remsima (CT-P13) Patients were not treated with infliximab before enrollment. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.	Switched to Remsima (CT-P13) Patients were treated with infliximab prior to enrollment of the study. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.
Overall Study Adverse Event	21	5
Overall Study Death	3	0
Overall Study Lack of Efficacy	49	5
Overall Study Lost to Follow-up	14	3
Overall Study Protocol Violation	2	0
Overall Study Withdrawal by Subject	34	11
Overall Study Disease progression	37	4
Overall Study Study close	188	21
Overall Study except for study close	46	13

Baseline Characteristics

To Evaluate the Safety and Efficacy of Remsima™ in Patients With Crohn's Disease (CD) or Ulcerative Colitis (UC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Remsima (CT-P13) n=407 Participants Patients were not treated with infliximab before enrollment. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.	Switched to Remsima (CT-P13) n=63 Participants Patients were treated with infliximab prior to enrollment of the study. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.	Total n=470 Participants Total of all reporting groups
Age, Categorical <=18 years	52 Participants n=5 Participants	18 Participants n=7 Participants	70 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	334 Participants n=5 Participants	44 Participants n=7 Participants	378 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants	1 Participants n=7 Participants	22 Participants n=5 Participants
Age, Continuous	33 years n=5 Participants	27 years n=7 Participants	32 years n=5 Participants
Sex: Female, Male Female	169 Participants n=5 Participants	21 Participants n=7 Participants	190 Participants n=5 Participants
Sex: Female, Male Male	238 Participants n=5 Participants	42 Participants n=7 Participants	280 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	186 Participants n=5 Participants	30 Participants n=7 Participants	216 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	220 Participants n=5 Participants	33 Participants n=7 Participants	253 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 years for each patient

Population: Safety analysis set, all patients who received at least one dose of study treatment. Intestinal or perianal abscess and bowel stenosis/stricture/obstruction events are only applicable for patients with moderate to severe active CD, fistulising active CD and paediatric severe active CD. Colon carcinoma/dysplasia is only applicable for patients with moderate to severe active UC and paediatric severe active UC. Paediatric malignancy is only applicable for paediatric patients.

Outcome measures

Outcome measures
Measure	Remsima (CT-P13) n=407 Participants Patients were not treated with infliximab before enrollment. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.	Switched to Remsima (CT-P13) n=63 Participants Patients were treated with infliximab prior to enrollment of the study. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.
Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) Treatment-emergent Adverse Events of demyelinating disorders	0 Participants	0 Participants
Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) Treatment-emergent Adverse Events (TEAEs) of Hepatitis B virus reactivation	0 Participants	0 Participants
Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) Treatment-emergent Adverse Events of congestive heart failure	0 Participants	0 Participants
Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) Treatment-emergent Adverse Events of opportunistic infections (excluding tuberculosis)	0 Participants	0 Participants
Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) TEAEs of serious infections including sepsis (excl. opportunistic infections and TB	15 Participants	2 Participants
Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) Treatment-emergent Adverse Events of tuberculosis (TB)	4 Participants	0 Participants
Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) Treatment-emergent Adverse Events of serum sickness (delayed hypersensitivity reactions)	0 Participants	0 Participants
Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) Treatment-emergent Adverse Events of haematologic reactions	36 Participants	8 Participants
Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) Treatment-emergent Adverse Events of systemic lupus erythematosus/lupus-like syndrome	0 Participants	0 Participants
Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) Treatment-emergent Adverse Events of lymphoma (not hepatosplenic T cell lymphoma)	1 Participants	0 Participants
Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) Treatment-emergent Adverse Events of hepatobiliary events	14 Participants	5 Participants
Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) Treatment-emergent Adverse Events of hepatosplenic T cell lymphoma	0 Participants	0 Participants
Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) Treatment-emergent Adverse Events of intestinal or perianal abscess (in Crohn's disease)	7 Participants	1 Participants
Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) TEAEs of serious infusion reactions during a re-induction regimen following disease flare	0 Participants	0 Participants
Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) Treatment-emergent Adverse Events of sarcoidosis/sarcoid-like reactions	0 Participants	1 Participants
Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) Treatment-emergent Adverse Events of paediatric malignancy	0 Participants	0 Participants
Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) Treatment-emergent Adverse Events of leukaemia	0 Participants	0 Participants
Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) Treatment-emergent Adverse Events of malignancy (excluding lymphoma)	3 Participants	2 Participants
Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) Treatment-emergent Adverse Events of colon carcinoma/dysplasia (in Ulcerative Colitis)	0 Participants	0 Participants
Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) Treatment-emergent Adverse Events of skin cancer	0 Participants	0 Participants
Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) Treatment-emergent Adverse Events of pregnancy exposure	3 Participants	1 Participants
Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) Treatment-emergent Adverse Events of bowel stenosis/stricture/obstruction (in Crohn's disease)	8 Participants	2 Participants
Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) TEAEs of infusion related reaction (IRR)/ hypersensitivity/anaphylactic reaction	39 Participants	4 Participants

SECONDARY outcome

Timeframe: Every 6 months (months 6 -60)

Population: Efficacy analysis set, consist of all moderate-severe active Crohn's Disease patients who received at least one dose of the study treatment during any dosing period and had at least one efficacy result corresponding to indication used for analysis after treatment. The denominators of proportions are the number of patients with non-missing efficacy result at each time point and baseline. Some rows have 0 participants analyzed because there were no patients applicable for analysis on this visit.

A patient is considered as achieving clinical response according to CDAI-70 (or CDAI-100) if the patient has a reduction on CDAI score of 70 (or 100) points or more from the baseline value.

Outcome measures

Outcome measures
Measure	Remsima (CT-P13) n=124 Participants Patients were not treated with infliximab before enrollment. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.	Switched to Remsima (CT-P13) n=23 Participants Patients were treated with infliximab prior to enrollment of the study. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.
Number and Percentage of Patients Achieving Clinical Response, Decrease of ≥70 Points From Baseline Scores in Crohn's Disease Activity Index-70 (CDAI-70) and Decrease of ≥100 Points From Baseline Scores in CDAI-100 Clinical response according to CDAI-70 at 18 months	39 Participants	3 Participants
Number and Percentage of Patients Achieving Clinical Response, Decrease of ≥70 Points From Baseline Scores in Crohn's Disease Activity Index-70 (CDAI-70) and Decrease of ≥100 Points From Baseline Scores in CDAI-100 Clinical response according to CDAI-70 at 24 months	27 Participants	4 Participants
Number and Percentage of Patients Achieving Clinical Response, Decrease of ≥70 Points From Baseline Scores in Crohn's Disease Activity Index-70 (CDAI-70) and Decrease of ≥100 Points From Baseline Scores in CDAI-100 Clinical response according to CDAI-70 at 48 months	8 Participants	0 Participants
Number and Percentage of Patients Achieving Clinical Response, Decrease of ≥70 Points From Baseline Scores in Crohn's Disease Activity Index-70 (CDAI-70) and Decrease of ≥100 Points From Baseline Scores in CDAI-100 Clinical response according to CDAI-70 at 6 months	36 Participants	2 Participants
Number and Percentage of Patients Achieving Clinical Response, Decrease of ≥70 Points From Baseline Scores in Crohn's Disease Activity Index-70 (CDAI-70) and Decrease of ≥100 Points From Baseline Scores in CDAI-100 Clinical response according to CDAI-70 at 12 months	42 Participants	4 Participants
Number and Percentage of Patients Achieving Clinical Response, Decrease of ≥70 Points From Baseline Scores in Crohn's Disease Activity Index-70 (CDAI-70) and Decrease of ≥100 Points From Baseline Scores in CDAI-100 Clinical response according to CDAI-70 at 30 months	24 Participants	0 Participants
Number and Percentage of Patients Achieving Clinical Response, Decrease of ≥70 Points From Baseline Scores in Crohn's Disease Activity Index-70 (CDAI-70) and Decrease of ≥100 Points From Baseline Scores in CDAI-100 Clinical response according to CDAI-70 at 36 months	22 Participants	0 Participants
Number and Percentage of Patients Achieving Clinical Response, Decrease of ≥70 Points From Baseline Scores in Crohn's Disease Activity Index-70 (CDAI-70) and Decrease of ≥100 Points From Baseline Scores in CDAI-100 Clinical response according to CDAI-70 at 42 months	13 Participants	0 Participants
Number and Percentage of Patients Achieving Clinical Response, Decrease of ≥70 Points From Baseline Scores in Crohn's Disease Activity Index-70 (CDAI-70) and Decrease of ≥100 Points From Baseline Scores in CDAI-100 Clinical response according to CDAI-70 at 54 months	12 Participants	0 Participants
Number and Percentage of Patients Achieving Clinical Response, Decrease of ≥70 Points From Baseline Scores in Crohn's Disease Activity Index-70 (CDAI-70) and Decrease of ≥100 Points From Baseline Scores in CDAI-100 Clinical response according to CDAI-70 at 60 months	2 Participants	—
Number and Percentage of Patients Achieving Clinical Response, Decrease of ≥70 Points From Baseline Scores in Crohn's Disease Activity Index-70 (CDAI-70) and Decrease of ≥100 Points From Baseline Scores in CDAI-100 Clinical response according to CDAI-100 at 6 months	33 Participants	2 Participants
Number and Percentage of Patients Achieving Clinical Response, Decrease of ≥70 Points From Baseline Scores in Crohn's Disease Activity Index-70 (CDAI-70) and Decrease of ≥100 Points From Baseline Scores in CDAI-100 Clinical response according to CDAI-100 at 12 months	36 Participants	3 Participants
Number and Percentage of Patients Achieving Clinical Response, Decrease of ≥70 Points From Baseline Scores in Crohn's Disease Activity Index-70 (CDAI-70) and Decrease of ≥100 Points From Baseline Scores in CDAI-100 Clinical response according to CDAI-100 at 18 months	34 Participants	3 Participants
Number and Percentage of Patients Achieving Clinical Response, Decrease of ≥70 Points From Baseline Scores in Crohn's Disease Activity Index-70 (CDAI-70) and Decrease of ≥100 Points From Baseline Scores in CDAI-100 Clinical response according to CDAI-100 at 24 months	24 Participants	2 Participants
Number and Percentage of Patients Achieving Clinical Response, Decrease of ≥70 Points From Baseline Scores in Crohn's Disease Activity Index-70 (CDAI-70) and Decrease of ≥100 Points From Baseline Scores in CDAI-100 Clinical response according to CDAI-100 at 30 months	24 Participants	0 Participants
Number and Percentage of Patients Achieving Clinical Response, Decrease of ≥70 Points From Baseline Scores in Crohn's Disease Activity Index-70 (CDAI-70) and Decrease of ≥100 Points From Baseline Scores in CDAI-100 Clinical response according to CDAI-100 at 36 months	18 Participants	0 Participants
Number and Percentage of Patients Achieving Clinical Response, Decrease of ≥70 Points From Baseline Scores in Crohn's Disease Activity Index-70 (CDAI-70) and Decrease of ≥100 Points From Baseline Scores in CDAI-100 Clinical response according to CDAI-100 at 42 months	12 Participants	0 Participants
Number and Percentage of Patients Achieving Clinical Response, Decrease of ≥70 Points From Baseline Scores in Crohn's Disease Activity Index-70 (CDAI-70) and Decrease of ≥100 Points From Baseline Scores in CDAI-100 Clinical response according to CDAI-100 at 48 months	12 Participants	0 Participants
Number and Percentage of Patients Achieving Clinical Response, Decrease of ≥70 Points From Baseline Scores in Crohn's Disease Activity Index-70 (CDAI-70) and Decrease of ≥100 Points From Baseline Scores in CDAI-100 Clinical response according to CDAI-100 at 54 months	8 Participants	0 Participants
Number and Percentage of Patients Achieving Clinical Response, Decrease of ≥70 Points From Baseline Scores in Crohn's Disease Activity Index-70 (CDAI-70) and Decrease of ≥100 Points From Baseline Scores in CDAI-100 Clinical response according to CDAI-100 at 60 months	2 Participants	—

SECONDARY outcome

Timeframe: Every 6 months (months 6 -42)

Population: Efficacy analysis set, consist of all Pediatric severe active Crohn's Disease patients who received at least one dose of the study treatment during any dosing period and had at least one efficacy result corresponding to indication used for analysis after treatment. The denominators of proportions are the number of patients with non-missing efficacy result at each timepoint and baseline.

A patient is considered as achieving clinical response according to PCDAI if the patient has a PCDAI score less than or equal to 30 points and a reduction on PCDAI score of 15 points or more from the baseline value.

Outcome measures

Outcome measures
Measure	Remsima (CT-P13) n=41 Participants Patients were not treated with infliximab before enrollment. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.	Switched to Remsima (CT-P13) n=15 Participants Patients were treated with infliximab prior to enrollment of the study. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.
Number and Percentage of Patients Achieving Clinical Response, Decrease From Baseline in the Paediatric Crohn's Disease Activity Index (PCDAI) ≥15 Points; Total Score ≤30 Clinical response at 36 months	2 Participants	1 Participants
Number and Percentage of Patients Achieving Clinical Response, Decrease From Baseline in the Paediatric Crohn's Disease Activity Index (PCDAI) ≥15 Points; Total Score ≤30 Clinical response at 6 months	15 Participants	2 Participants
Number and Percentage of Patients Achieving Clinical Response, Decrease From Baseline in the Paediatric Crohn's Disease Activity Index (PCDAI) ≥15 Points; Total Score ≤30 Clinical response at 12 months	18 Participants	2 Participants
Number and Percentage of Patients Achieving Clinical Response, Decrease From Baseline in the Paediatric Crohn's Disease Activity Index (PCDAI) ≥15 Points; Total Score ≤30 Clinical response at 18 months	17 Participants	0 Participants
Number and Percentage of Patients Achieving Clinical Response, Decrease From Baseline in the Paediatric Crohn's Disease Activity Index (PCDAI) ≥15 Points; Total Score ≤30 Clinical response at 24 months	10 Participants	0 Participants
Number and Percentage of Patients Achieving Clinical Response, Decrease From Baseline in the Paediatric Crohn's Disease Activity Index (PCDAI) ≥15 Points; Total Score ≤30 Clinical response at 30 months	0 Participants	0 Participants
Number and Percentage of Patients Achieving Clinical Response, Decrease From Baseline in the Paediatric Crohn's Disease Activity Index (PCDAI) ≥15 Points; Total Score ≤30 Clinical response at 42 months	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Every 6 months (months 6 -48)

Population: Efficacy analysis set, consist of all Fistulizing Active Crohn's Disease patients who received at least one dose of the study treatment during any dosing period and had at least one efficacy result corresponding to indication used for analysis after treatment. The denominators of proportions are the number of patients with non-missing efficacy result at each timepoint and baseline.

A patient is considered as achieving clinical response according to the number of draining fistulas if the patient has a reduction on the number of draining fistulas from the baseline value (over a period of ≥ 4 weeks) ≥ 50%.

Outcome measures

Outcome measures
Measure	Remsima (CT-P13) n=19 Participants Patients were not treated with infliximab before enrollment. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.	Switched to Remsima (CT-P13) n=6 Participants Patients were treated with infliximab prior to enrollment of the study. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.
Number and Percentage of Patients Achieving Clinical Response, a ≥50% Reduction From Baseline in the Number of Draining Fistulas Over a Period of ≥4 Weeks Compared to Baseline Clinical response at 18 months	4 Participants	0 Participants
Number and Percentage of Patients Achieving Clinical Response, a ≥50% Reduction From Baseline in the Number of Draining Fistulas Over a Period of ≥4 Weeks Compared to Baseline Clinical response at 24 months	2 Participants	0 Participants
Number and Percentage of Patients Achieving Clinical Response, a ≥50% Reduction From Baseline in the Number of Draining Fistulas Over a Period of ≥4 Weeks Compared to Baseline Clinical response at 6 months	2 Participants	1 Participants
Number and Percentage of Patients Achieving Clinical Response, a ≥50% Reduction From Baseline in the Number of Draining Fistulas Over a Period of ≥4 Weeks Compared to Baseline Clinical response at 12 months	3 Participants	1 Participants
Number and Percentage of Patients Achieving Clinical Response, a ≥50% Reduction From Baseline in the Number of Draining Fistulas Over a Period of ≥4 Weeks Compared to Baseline Clinical response at 30 months	2 Participants	0 Participants
Number and Percentage of Patients Achieving Clinical Response, a ≥50% Reduction From Baseline in the Number of Draining Fistulas Over a Period of ≥4 Weeks Compared to Baseline Clinical response at 36 months	1 Participants	0 Participants
Number and Percentage of Patients Achieving Clinical Response, a ≥50% Reduction From Baseline in the Number of Draining Fistulas Over a Period of ≥4 Weeks Compared to Baseline Clinical response at 42 months	0 Participants	1 Participants
Number and Percentage of Patients Achieving Clinical Response, a ≥50% Reduction From Baseline in the Number of Draining Fistulas Over a Period of ≥4 Weeks Compared to Baseline Clinical response at 48 months	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Every 6 months (months 6 - 60)

A patient is considered as achieving clinical response according to total Mayo score if the patient has a reduction from baseline in total mayo score at least 3 points and at least 30%, with an accompanying reduction in the subscore for rectal bleeding of at least 1 point, or an absolute subscore for rectal bleeding of 0 or 1. A patient is considered as achieving clinical response according to partial Mayo score if the patient has a reduction from baseline in partial mayo score at least 2 points, with an accompanying reduction in the subscore for rectal bleeding of at least 1 point, or an absolute subscore for rectal bleeding of 0 or 1.

Outcome measures

Outcome measures
Measure	Remsima (CT-P13) n=103 Participants Patients were not treated with infliximab before enrollment. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.	Switched to Remsima (CT-P13) n=6 Participants Patients were treated with infliximab prior to enrollment of the study. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.
Decrease in Mayo Scores From Baseline at Least 3 Points and 30% for Total or Decrease in Scores From Baseline at Least 2 Points for Partial, With Accompanying Decrease in Subscore for Rectal Bleeding of at Least 1 Point, or Absolute Subscore 0 or 1. Clinical response according to total mayo score at 18 months	13 Participants	—
Decrease in Mayo Scores From Baseline at Least 3 Points and 30% for Total or Decrease in Scores From Baseline at Least 2 Points for Partial, With Accompanying Decrease in Subscore for Rectal Bleeding of at Least 1 Point, or Absolute Subscore 0 or 1. Clinical response according to partial mayo score at 30 months	23 Participants	1 Participants
Decrease in Mayo Scores From Baseline at Least 3 Points and 30% for Total or Decrease in Scores From Baseline at Least 2 Points for Partial, With Accompanying Decrease in Subscore for Rectal Bleeding of at Least 1 Point, or Absolute Subscore 0 or 1. Clinical response according to total mayo score at 6 months	18 Participants	—
Decrease in Mayo Scores From Baseline at Least 3 Points and 30% for Total or Decrease in Scores From Baseline at Least 2 Points for Partial, With Accompanying Decrease in Subscore for Rectal Bleeding of at Least 1 Point, or Absolute Subscore 0 or 1. Clinical response according to total mayo score at 12 months	19 Participants	—
Decrease in Mayo Scores From Baseline at Least 3 Points and 30% for Total or Decrease in Scores From Baseline at Least 2 Points for Partial, With Accompanying Decrease in Subscore for Rectal Bleeding of at Least 1 Point, or Absolute Subscore 0 or 1. Clinical response according to total mayo score at 24 months	12 Participants	—
Decrease in Mayo Scores From Baseline at Least 3 Points and 30% for Total or Decrease in Scores From Baseline at Least 2 Points for Partial, With Accompanying Decrease in Subscore for Rectal Bleeding of at Least 1 Point, or Absolute Subscore 0 or 1. Clinical response according to total mayo score at 30 months	15 Participants	—
Decrease in Mayo Scores From Baseline at Least 3 Points and 30% for Total or Decrease in Scores From Baseline at Least 2 Points for Partial, With Accompanying Decrease in Subscore for Rectal Bleeding of at Least 1 Point, or Absolute Subscore 0 or 1. Clinical response according to total mayo score at 36 months	5 Participants	0 Participants
Decrease in Mayo Scores From Baseline at Least 3 Points and 30% for Total or Decrease in Scores From Baseline at Least 2 Points for Partial, With Accompanying Decrease in Subscore for Rectal Bleeding of at Least 1 Point, or Absolute Subscore 0 or 1. Clinical response according to total mayo score at 42 months	7 Participants	—
Decrease in Mayo Scores From Baseline at Least 3 Points and 30% for Total or Decrease in Scores From Baseline at Least 2 Points for Partial, With Accompanying Decrease in Subscore for Rectal Bleeding of at Least 1 Point, or Absolute Subscore 0 or 1. Clinical response according to total mayo score at 48 months	6 Participants	—
Decrease in Mayo Scores From Baseline at Least 3 Points and 30% for Total or Decrease in Scores From Baseline at Least 2 Points for Partial, With Accompanying Decrease in Subscore for Rectal Bleeding of at Least 1 Point, or Absolute Subscore 0 or 1. Clinical response according to total mayo score at 54 months	4 Participants	—
Decrease in Mayo Scores From Baseline at Least 3 Points and 30% for Total or Decrease in Scores From Baseline at Least 2 Points for Partial, With Accompanying Decrease in Subscore for Rectal Bleeding of at Least 1 Point, or Absolute Subscore 0 or 1. Clinical response according to total mayo score at 60 months	1 Participants	—
Decrease in Mayo Scores From Baseline at Least 3 Points and 30% for Total or Decrease in Scores From Baseline at Least 2 Points for Partial, With Accompanying Decrease in Subscore for Rectal Bleeding of at Least 1 Point, or Absolute Subscore 0 or 1. Clinical response according to partial mayo score at 6 months	35 Participants	1 Participants
Decrease in Mayo Scores From Baseline at Least 3 Points and 30% for Total or Decrease in Scores From Baseline at Least 2 Points for Partial, With Accompanying Decrease in Subscore for Rectal Bleeding of at Least 1 Point, or Absolute Subscore 0 or 1. Clinical response according to partial mayo score at 12 months	30 Participants	1 Participants
Decrease in Mayo Scores From Baseline at Least 3 Points and 30% for Total or Decrease in Scores From Baseline at Least 2 Points for Partial, With Accompanying Decrease in Subscore for Rectal Bleeding of at Least 1 Point, or Absolute Subscore 0 or 1. Clinical response according to partial mayo score at 18 months	28 Participants	1 Participants
Decrease in Mayo Scores From Baseline at Least 3 Points and 30% for Total or Decrease in Scores From Baseline at Least 2 Points for Partial, With Accompanying Decrease in Subscore for Rectal Bleeding of at Least 1 Point, or Absolute Subscore 0 or 1. Clinical response according to partial mayo score at 24 months	22 Participants	1 Participants
Decrease in Mayo Scores From Baseline at Least 3 Points and 30% for Total or Decrease in Scores From Baseline at Least 2 Points for Partial, With Accompanying Decrease in Subscore for Rectal Bleeding of at Least 1 Point, or Absolute Subscore 0 or 1. Clinical response according to partial mayo score at 36 months	19 Participants	1 Participants
Decrease in Mayo Scores From Baseline at Least 3 Points and 30% for Total or Decrease in Scores From Baseline at Least 2 Points for Partial, With Accompanying Decrease in Subscore for Rectal Bleeding of at Least 1 Point, or Absolute Subscore 0 or 1. Clinical response according to partial mayo score at 42 months	15 Participants	1 Participants
Decrease in Mayo Scores From Baseline at Least 3 Points and 30% for Total or Decrease in Scores From Baseline at Least 2 Points for Partial, With Accompanying Decrease in Subscore for Rectal Bleeding of at Least 1 Point, or Absolute Subscore 0 or 1. Clinical response according to partial mayo score at 48 months	14 Participants	1 Participants
Decrease in Mayo Scores From Baseline at Least 3 Points and 30% for Total or Decrease in Scores From Baseline at Least 2 Points for Partial, With Accompanying Decrease in Subscore for Rectal Bleeding of at Least 1 Point, or Absolute Subscore 0 or 1. Clinical response according to partial mayo score at 54 months	10 Participants	—
Decrease in Mayo Scores From Baseline at Least 3 Points and 30% for Total or Decrease in Scores From Baseline at Least 2 Points for Partial, With Accompanying Decrease in Subscore for Rectal Bleeding of at Least 1 Point, or Absolute Subscore 0 or 1. Clinical response according to partial mayo score at 60 months	2 Participants	—

SECONDARY outcome

Timeframe: Every 6 months (months 6 - 18)

A patient is considered as achieving clinical response according to PUCAI if the patient has a reduction on PUCAI score of 20 points or more from the baseline value.

Outcome measures

Outcome measures
Measure	Remsima (CT-P13) n=2 Participants Patients were not treated with infliximab before enrollment. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.	Switched to Remsima (CT-P13) Patients were treated with infliximab prior to enrollment of the study. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.
Number and Percentage of Patients Achieving Clinical Response, Decrease From Baseline in the Paediatric Ulcerative Colitis Activity Index (PUCAI) ≥20 Score Clinical response at 6 months	1 Participants	—
Number and Percentage of Patients Achieving Clinical Response, Decrease From Baseline in the Paediatric Ulcerative Colitis Activity Index (PUCAI) ≥20 Score Clinical response at 12 months	1 Participants	—
Number and Percentage of Patients Achieving Clinical Response, Decrease From Baseline in the Paediatric Ulcerative Colitis Activity Index (PUCAI) ≥20 Score Clinical response at 18 months	1 Participants	—

Adverse Events

Remsima (CT-P13)

Serious events: 53 serious events

Other events: 221 other events

Deaths: 5 deaths

Switched to Remsima (CT-P13)

Serious events: 10 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

JiWoong Lim

Celltrion Inc

Phone: 82-32-850-5702

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Remsima (CT-P13) n=407 participants at risk Patients were not treated with infliximab before enrollment. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.	Switched to Remsima (CT-P13) n=63 participants at risk Patients were treated with infliximab prior to enrollment of the study. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.
Blood and lymphatic system disorders Anaemia	0.49% 2/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	1.6% 1/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Blood and lymphatic system disorders Pancytopenia	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Blood and lymphatic system disorders Thrombocytopenia	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Abdominal pain	0.49% 2/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Abdominal pain lower	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Anal fistula	0.49% 2/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Colitis	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Crohn's disease	0.74% 3/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Diarrhoea	0.00% 0/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	3.2% 2/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Haematochezia	0.00% 0/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	1.6% 1/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Ileal stenosis	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Ileus	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	1.6% 1/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Impaired gastric emptying	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Intestinal obstruction	0.49% 2/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Intestinal perforation	0.49% 2/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Large intestinal stenosis	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Large intestinal perforation	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Mechanical ileus	0.00% 0/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	1.6% 1/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Oesophageal achalasia	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Pneumoperitoneum	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Vomiting	0.00% 0/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	1.6% 1/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
General disorders Death	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
General disorders Gait disturbance	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
General disorders Generalised Oedema	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
General disorders Localised Oedema	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
General disorders Pyrexia	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Hepatobiliary disorders Cholelithiasis	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Hepatobiliary disorders Hepatitis alcoholic	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Infections and infestations Abdominal abscess	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Infections and infestations Anal abscess	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Infections and infestations Cellulitis	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Infections and infestations Chronic Hepatitis B	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Infections and infestations Clostridium difficile colitis	0.00% 0/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	3.2% 2/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Infections and infestations Cystitis	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Infections and infestations Gastroenteritis	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Infections and infestations Influenza	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Infections and infestations Otitis media chronic	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Infections and infestations Pneumonia	0.74% 3/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Infections and infestations Post procedural infection	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Infections and infestations Pulmonary tuberculosis	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .

Other adverse events
Measure	Remsima (CT-P13) n=407 participants at risk Patients were not treated with infliximab before enrollment. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.	Switched to Remsima (CT-P13) n=63 participants at risk Patients were treated with infliximab prior to enrollment of the study. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.
Blood and lymphatic system disorders Anaemia	4.2% 17/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	1.6% 1/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Blood and lymphatic system disorders Eosinophilia	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	3.2% 2/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Eye disorders Vision blurred	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	3.2% 2/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Abdominal pain	13.8% 56/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	14.3% 9/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Abdominal pain upper	3.2% 13/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	1.6% 1/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Anal fissure	0.74% 3/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	3.2% 2/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Anal fistula	1.5% 6/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	4.8% 3/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Anal inflammation	0.00% 0/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	4.8% 3/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Anal skin tags	0.00% 0/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	4.8% 3/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Aphthous ulcer	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	9.5% 6/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Cheilosis	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	3.2% 2/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Colitis ulcerative	3.9% 16/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	0.00% 0/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Crohn's disease	11.8% 48/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	17.5% 11/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Diarrhoea	9.1% 37/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	17.5% 11/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Diarrhoea haemorrhagic	0.98% 4/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	3.2% 2/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Dyspepsia	2.7% 11/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	4.8% 3/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Gastritis	2.5% 10/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	3.2% 2/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Gastrooesophagel reflux disease	1.2% 5/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	3.2% 2/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Haematochezia	5.2% 21/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	9.5% 6/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Ileal stenosis	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	3.2% 2/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Mucous stools	0.74% 3/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	4.8% 3/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Nausea	4.2% 17/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	6.3% 4/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Gastrointestinal disorders Vomiting	4.4% 18/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	4.8% 3/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
General disorders Asthenia	3.2% 13/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	6.3% 4/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
General disorders Pyrexia	4.4% 18/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	6.3% 4/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Hepatobiliary disorders Hypertransaminaesaemia	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	3.2% 2/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Infections and infestations Bacteriuria	0.25% 1/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	3.2% 2/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Infections and infestations Nasopharyngitis	10.1% 41/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	11.1% 7/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Infections and infestations Oral herpes	2.9% 12/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	3.2% 2/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Infections and infestations Pharyngitis	4.2% 17/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	9.5% 6/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Infections and infestations Rhinitis	3.2% 13/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	7.9% 5/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Infections and infestations Upper respiratory tract infection	5.9% 24/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	11.1% 7/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Infections and infestations Urinary tract infection	1.5% 6/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	3.2% 2/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Infections and infestations Varicella zoster virus infection	0.00% 0/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	3.2% 2/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Injury, poisoning and procedural complications Infusion related reaction	7.9% 32/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	6.3% 4/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Investigations Bone density decreased	1.2% 5/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	7.9% 5/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Investigations Faecal calprotectin increased	0.74% 3/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	9.5% 6/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Investigations Hepatic enzyme increased	0.49% 2/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	3.2% 2/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Investigations Red blood cell sedimentation rate increased	0.98% 4/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	3.2% 2/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .
Musculoskeletal and connective tissue disorders Arthralgia	7.4% 30/407 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .	3.2% 2/63 • Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .