Trial Outcomes & Findings for National Observational Study On The Use Of Inflectra™ An Infliximab Biosimilar In Real Life (NCT NCT02925338)

Last Updated: 2023-01-25

Results Overview

Treatment failure was defined as permanent discontinuation of the Inflectra treatment due to intolerance and/or permanent discontinuation of treatment due to absence of response according to the physician's assessment, or death of the participant related to Inflectra. In this outcome measure percentage of participants without treatment failure and whose data were missing are reported.

Recruitment status

COMPLETED

Target enrollment

1431 participants

Primary outcome timeframe

2 years post inclusion in the study

Results posted on

2023-01-25

Participant Flow

Participants who were being treated with Inflectra or who initiated Inflectra or switched from infliximab reference to Inflectra in real world practice for following indications, in conformity to summary of product characteristics (SmPC): adult participants with crohn's disease (CD), ulcerative colitis (UC), rheumatoid arthritis (RA), ankylosing spondylitis (SpA) or psoriatic arthritis (PA); pediatric participants with CD or UC, were observed for 2 years post inclusion in this study.

Total 1431 participants were enrolled in this study, however only 1426 participants received the treatment. 5 participants did not receive the treatment due to major protocol deviations.

Participant milestones

Participant milestones
Measure	Crohn's Disease (CD) Adult participants diagnosed with moderately to fistulizing active CD received 5 milligrams per kilogram (mg/kg) of Inflectra as an intravenous (IV) infusion followed by additional 5 mg/kg infusion at 2 weeks (for moderate to severely active CD) and at 2 weeks and 6 weeks (for fistulizing active) after the first infusion. Participants who responded to the treatment received additional infusion of 5 mg/kg at 6 weeks after the initial dose, followed by infusions every 8 weeks or infusion of 5 mg/kg if signs and symptoms of the disease. Pediatric participants diagnosed with CD received 5 mg/kg given as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Ulcerative Colitis (UC) Adult and pediatric participants included in this arm were diagnosed with UC and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Rheumatoid Arthritis (RA) Adult participants included in this arm were diagnosed with RA and received 3 mg/kg of Inflectra as an IV infusion followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Inflectra was administered in combination with methotrexate. Participants were observed for 2 years in this study.	Ankylosing Spondylitis (SpA) Adult participants included in this arm were diagnosed with SpA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks. Participants were observed for 2 years in this study.	Psoriatic Arthritis (PA) Adult participants included in this arm were diagnosed with PA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.
Overall Study STARTED	547	230	142	411	96
Overall Study Adult Population	530	221	142	411	96
Overall Study Pediatric Population	17	9	0	0	0
Overall Study COMPLETED	321	119	78	251	66
Overall Study NOT COMPLETED	226	111	64	160	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Crohn's Disease (CD) Adult participants diagnosed with moderately to fistulizing active CD received 5 milligrams per kilogram (mg/kg) of Inflectra as an intravenous (IV) infusion followed by additional 5 mg/kg infusion at 2 weeks (for moderate to severely active CD) and at 2 weeks and 6 weeks (for fistulizing active) after the first infusion. Participants who responded to the treatment received additional infusion of 5 mg/kg at 6 weeks after the initial dose, followed by infusions every 8 weeks or infusion of 5 mg/kg if signs and symptoms of the disease. Pediatric participants diagnosed with CD received 5 mg/kg given as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Ulcerative Colitis (UC) Adult and pediatric participants included in this arm were diagnosed with UC and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Rheumatoid Arthritis (RA) Adult participants included in this arm were diagnosed with RA and received 3 mg/kg of Inflectra as an IV infusion followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Inflectra was administered in combination with methotrexate. Participants were observed for 2 years in this study.	Ankylosing Spondylitis (SpA) Adult participants included in this arm were diagnosed with SpA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks. Participants were observed for 2 years in this study.	Psoriatic Arthritis (PA) Adult participants included in this arm were diagnosed with PA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.
Overall Study Death	0	2	1	0	0
Overall Study Lost to Follow-up	30	10	1	16	3
Overall Study Withdrawal by Subject	3	0	3	2	2
Overall Study Missing	38	27	0	3	2
Overall Study Participant's Decision	11	7	3	8	1
Overall Study Treatment Discontinuation	144	65	56	131	22

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Crohn's Disease (CD) n=547 Participants Adult participants diagnosed with moderately to fistulizing active CD received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion at 2 weeks (for moderate to severely active CD) and at 2 weeks and 6 weeks (for fistulizing active) after the first infusion. Participants who responded to the treatment received additional infusion of 5 mg/kg at 6 weeks after the initial dose, followed by infusions every 8 weeks or infusion of 5 mg/kg if signs and symptoms of the disease. Pediatric participants diagnosed with CD received 5 mg/kg given as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Ulcerative Colitis (UC) n=230 Participants Adult and pediatric participants included in this arm were diagnosed with UC and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Rheumatoid Arthritis (RA) n=142 Participants Adult participants included in this arm were diagnosed with RA and received 3 mg/kg of Inflectra as an IV infusion followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Inflectra was administered in combination with methotrexate. Participants were observed for 2 years in this study.	Ankylosing Spondylitis (SpA) n=411 Participants Adult participants included in this arm were diagnosed with SpA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks. Participants were observed for 2 years in this study.	Psoriatic Arthritis (PA) n=96 Participants Adult participants included in this arm were diagnosed with PA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Total n=1426 Participants Total of all reporting groups
Age, Continuous	37.4 Years STANDARD_DEVIATION 14.2 • n=547 Participants	42.3 Years STANDARD_DEVIATION 17.9 • n=230 Participants	61.5 Years STANDARD_DEVIATION 10.9 • n=142 Participants	48.1 Years STANDARD_DEVIATION 13.1 • n=411 Participants	53.4 Years STANDARD_DEVIATION 14.1 • n=96 Participants	44.8 Years STANDARD_DEVIATION 16.2 • n=1426 Participants
Sex: Female, Male Female	281 Participants n=547 Participants	103 Participants n=230 Participants	107 Participants n=142 Participants	169 Participants n=411 Participants	56 Participants n=96 Participants	716 Participants n=1426 Participants
Sex: Female, Male Male	266 Participants n=547 Participants	127 Participants n=230 Participants	35 Participants n=142 Participants	242 Participants n=411 Participants	40 Participants n=96 Participants	710 Participants n=1426 Participants
Race and Ethnicity Not Collected	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Body Mass Index (BMI)	24.01 Kg/m^2 STANDARD_DEVIATION 5.52 • n=541 Participants • Here, "Overall Number of Participants Analyzed" signifies participants analyzed for this baseline measure.	24.29 Kg/m^2 STANDARD_DEVIATION 4.72 • n=224 Participants • Here, "Overall Number of Participants Analyzed" signifies participants analyzed for this baseline measure.	27.12 Kg/m^2 STANDARD_DEVIATION 5.68 • n=132 Participants • Here, "Overall Number of Participants Analyzed" signifies participants analyzed for this baseline measure.	26.52 Kg/m^2 STANDARD_DEVIATION 5.44 • n=393 Participants • Here, "Overall Number of Participants Analyzed" signifies participants analyzed for this baseline measure.	29.26 Kg/m^2 STANDARD_DEVIATION 6.71 • n=95 Participants • Here, "Overall Number of Participants Analyzed" signifies participants analyzed for this baseline measure.	25.42 Kg/m^2 STANDARD_DEVIATION 5.71 • n=1385 Participants • Here, "Overall Number of Participants Analyzed" signifies participants analyzed for this baseline measure.

PRIMARY outcome

Timeframe: 2 years post inclusion in the study

Population: Analysis population included all enrolled participants treated with Inflectra.

Outcome measures

Outcome measures
Measure	Ankylosing Spondylitis (SpA) n=411 Participants Adult participants included in this arm were diagnosed with SpA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks. Participants were observed for 2 years in this study.	Psoriatic Arthritis (PA) n=96 Participants Adult participants included in this arm were diagnosed with PA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Crohn's Disease (CD) n=547 Participants Adult participants diagnosed with moderately to fistulizing active CD received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion at 2 weeks (for moderate to severely active CD) and at 2 weeks and 6 weeks (for fistulizing active) after the first infusion. Participants who responded to the treatment received additional infusion of 5 mg/kg at 6 weeks after the initial dose, followed by infusions every 8 weeks or infusion of 5 mg/kg if signs and symptoms of the disease. Pediatric participants diagnosed with CD received 5 mg/kg given as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Ulcerative Colitis (UC) n=230 Participants Adult and pediatric participants included in this arm were diagnosed with UC and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Rheumatoid Arthritis (RA) n=142 Participants Adult participants included in this arm were diagnosed with RA and received 3 mg/kg of Inflectra as an IV infusion followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Inflectra was administered in combination with methotrexate. Participants were observed for 2 years in this study.
Percentage of Participants Without Treatment Failure During 2-Years of Observation Without Treatment Failure	61.1 Percentage of participants Interval 56.4 to 65.8	64.6 Percentage of participants Interval 55.0 to 74.2	59.2 Percentage of participants Interval 55.1 to 63.4	53.5 Percentage of participants Interval 47.0 to 59.9	53.5 Percentage of participants Interval 45.3 to 61.7
Percentage of Participants Without Treatment Failure During 2-Years of Observation Missing Data	14.4 Percentage of participants Interval 11.0 to 17.7	9.4 Percentage of participants Interval 3.5 to 15.2	19.2 Percentage of participants Interval 15.9 to 22.5	21.3 Percentage of participants Interval 16.0 to 26.6	7.7 Percentage of participants Interval 3.3 to 12.1

PRIMARY outcome

Timeframe: Data collected and recorded at study inclusion visit

Population: Analysis population included all enrolled participants treated with Inflectra.

Pre-treatment assessment was a check-list with the set of measures determined by the physician to check the eligibility of a participant before initiation of treatment. Physician recorded as "Yes" if a participant was eligible for initiation of treatment and "No" if a participant was not eligible to initiate a treatment. In this outcome measure, number of participants whose pre-treatment assessment were performed prior to initiation of Inflectra are reported and whose data were missing are reported.

Outcome measures

Outcome measures
Measure	Ankylosing Spondylitis (SpA) n=411 Participants Adult participants included in this arm were diagnosed with SpA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks. Participants were observed for 2 years in this study.	Psoriatic Arthritis (PA) n=96 Participants Adult participants included in this arm were diagnosed with PA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Crohn's Disease (CD) n=547 Participants Adult participants diagnosed with moderately to fistulizing active CD received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion at 2 weeks (for moderate to severely active CD) and at 2 weeks and 6 weeks (for fistulizing active) after the first infusion. Participants who responded to the treatment received additional infusion of 5 mg/kg at 6 weeks after the initial dose, followed by infusions every 8 weeks or infusion of 5 mg/kg if signs and symptoms of the disease. Pediatric participants diagnosed with CD received 5 mg/kg given as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Ulcerative Colitis (UC) n=230 Participants Adult and pediatric participants included in this arm were diagnosed with UC and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Rheumatoid Arthritis (RA) n=142 Participants Adult participants included in this arm were diagnosed with RA and received 3 mg/kg of Inflectra as an IV infusion followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Inflectra was administered in combination with methotrexate. Participants were observed for 2 years in this study.
Number of Participants With Pre-treatment Assessment Prior to Initiation of Inflectra Treatment (Anti-Tumor Necrosis Factor [TNF] Aplha) Therapy Had Pre-treatment Assessment	355 Participants	86 Participants	458 Participants	177 Participants	118 Participants
Number of Participants With Pre-treatment Assessment Prior to Initiation of Inflectra Treatment (Anti-Tumor Necrosis Factor [TNF] Aplha) Therapy Missing Data	2 Participants	0 Participants	5 Participants	4 Participants	2 Participants

PRIMARY outcome

Timeframe: Data collected and recorded at study inclusion visit

Outcome measures

Outcome measures
Measure	Ankylosing Spondylitis (SpA) n=407 Participants Adult participants included in this arm were diagnosed with SpA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks. Participants were observed for 2 years in this study.	Psoriatic Arthritis (PA) n=95 Participants Adult participants included in this arm were diagnosed with PA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Crohn's Disease (CD) n=546 Participants Adult participants diagnosed with moderately to fistulizing active CD received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion at 2 weeks (for moderate to severely active CD) and at 2 weeks and 6 weeks (for fistulizing active) after the first infusion. Participants who responded to the treatment received additional infusion of 5 mg/kg at 6 weeks after the initial dose, followed by infusions every 8 weeks or infusion of 5 mg/kg if signs and symptoms of the disease. Pediatric participants diagnosed with CD received 5 mg/kg given as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Ulcerative Colitis (UC) n=230 Participants Adult and pediatric participants included in this arm were diagnosed with UC and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Rheumatoid Arthritis (RA) n=142 Participants Adult participants included in this arm were diagnosed with RA and received 3 mg/kg of Inflectra as an IV infusion followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Inflectra was administered in combination with methotrexate. Participants were observed for 2 years in this study.
Time Between Diagnosis and Inclusion in Study	13.58 Years Standard Deviation 10.26	11.50 Years Standard Deviation 8.42	10.05 Years Standard Deviation 9.51	8.77 Years Standard Deviation 8.56	15.18 Years Standard Deviation 10.13

PRIMARY outcome

Timeframe: Data collected and recorded at study inclusion visit

Outcome measures

Outcome measures
Measure	Ankylosing Spondylitis (SpA) n=402 Participants Adult participants included in this arm were diagnosed with SpA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks. Participants were observed for 2 years in this study.	Psoriatic Arthritis (PA) n=93 Participants Adult participants included in this arm were diagnosed with PA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Crohn's Disease (CD) n=535 Participants Adult participants diagnosed with moderately to fistulizing active CD received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion at 2 weeks (for moderate to severely active CD) and at 2 weeks and 6 weeks (for fistulizing active) after the first infusion. Participants who responded to the treatment received additional infusion of 5 mg/kg at 6 weeks after the initial dose, followed by infusions every 8 weeks or infusion of 5 mg/kg if signs and symptoms of the disease. Pediatric participants diagnosed with CD received 5 mg/kg given as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Ulcerative Colitis (UC) n=224 Participants Adult and pediatric participants included in this arm were diagnosed with UC and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Rheumatoid Arthritis (RA) n=142 Participants Adult participants included in this arm were diagnosed with RA and received 3 mg/kg of Inflectra as an IV infusion followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Inflectra was administered in combination with methotrexate. Participants were observed for 2 years in this study.
Time Between Diagnosis and the First Inflectra Infusion	12.80 Years Standard Deviation 10.29	10.78 Years Standard Deviation 8.42	9.37 Years Standard Deviation 9.67	8.22 Years Standard Deviation 8.66	14.39 Years Standard Deviation 10.11

PRIMARY outcome

Timeframe: Data collected and recorded at study inclusion visit

Population: Analysis population included all enrolled participants treated with Inflectra.

Type of biotherapies received by participants before inclusion in the study were: anti-TNF alpha (remicade/ adalimumab/ golimumab / etanercept/ rituximab); anti-integrin (vedolizumab); immunosuppressant (abatacept); interleukin inhibitor (anakinra / tocilizumab); anti interleukin (IL) 12 and anti IL-23 (ustekinumab); and other. In this outcome measure number of participants who received biotherapies other than Inflectra and whose data were missing are reported.

Outcome measures

Outcome measures
Measure	Ankylosing Spondylitis (SpA) n=411 Participants Adult participants included in this arm were diagnosed with SpA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks. Participants were observed for 2 years in this study.	Psoriatic Arthritis (PA) n=96 Participants Adult participants included in this arm were diagnosed with PA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Crohn's Disease (CD) n=547 Participants Adult participants diagnosed with moderately to fistulizing active CD received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion at 2 weeks (for moderate to severely active CD) and at 2 weeks and 6 weeks (for fistulizing active) after the first infusion. Participants who responded to the treatment received additional infusion of 5 mg/kg at 6 weeks after the initial dose, followed by infusions every 8 weeks or infusion of 5 mg/kg if signs and symptoms of the disease. Pediatric participants diagnosed with CD received 5 mg/kg given as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Ulcerative Colitis (UC) n=230 Participants Adult and pediatric participants included in this arm were diagnosed with UC and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Rheumatoid Arthritis (RA) n=142 Participants Adult participants included in this arm were diagnosed with RA and received 3 mg/kg of Inflectra as an IV infusion followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Inflectra was administered in combination with methotrexate. Participants were observed for 2 years in this study.
Number of Participants Who Received Biotherapy Other Than Inflectra Before Inclusion in the Study Received Biotherapy	344 Participants	81 Participants	347 Participants	146 Participants	116 Participants
Number of Participants Who Received Biotherapy Other Than Inflectra Before Inclusion in the Study Missing Data	0 Participants	0 Participants	4 Participants	2 Participants	0 Participants

PRIMARY outcome

Timeframe: Data collected and recorded at study inclusion visit

Type of previous biotherapies included were: anti-TNF alpha (infliximab/adalimumab/etanercept/golimumab), selective immuno-suppressant (vedolizumab/abatacept), interleukin inhibitor (anakinra/ustekinumab/tocilizumab), and other. In this outcome measure, number of participants who discontinued previous biotherapy are reported according to reason of discontinuations.

Outcome measures

Outcome measures
Measure	Ankylosing Spondylitis (SpA) n=344 Participants Adult participants included in this arm were diagnosed with SpA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks. Participants were observed for 2 years in this study.	Psoriatic Arthritis (PA) n=81 Participants Adult participants included in this arm were diagnosed with PA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Crohn's Disease (CD) n=347 Participants Adult participants diagnosed with moderately to fistulizing active CD received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion at 2 weeks (for moderate to severely active CD) and at 2 weeks and 6 weeks (for fistulizing active) after the first infusion. Participants who responded to the treatment received additional infusion of 5 mg/kg at 6 weeks after the initial dose, followed by infusions every 8 weeks or infusion of 5 mg/kg if signs and symptoms of the disease. Pediatric participants diagnosed with CD received 5 mg/kg given as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Ulcerative Colitis (UC) n=146 Participants Adult and pediatric participants included in this arm were diagnosed with UC and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Rheumatoid Arthritis (RA) n=116 Participants Adult participants included in this arm were diagnosed with RA and received 3 mg/kg of Inflectra as an IV infusion followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Inflectra was administered in combination with methotrexate. Participants were observed for 2 years in this study.
Number of Participants With Reasons for Discontinuation of Previous Biotherapy Primary Non-response	49 Participants	10 Participants	25 Participants	40 Participants	16 Participants
Number of Participants With Reasons for Discontinuation of Previous Biotherapy Missing	29 Participants	6 Participants	13 Participants	5 Participants	5 Participants
Number of Participants With Reasons for Discontinuation of Previous Biotherapy Loss of Efficacy	52 Participants	14 Participants	80 Participants	35 Participants	19 Participants
Number of Participants With Reasons for Discontinuation of Previous Biotherapy Intolerance	23 Participants	9 Participants	42 Participants	5 Participants	9 Participants
Number of Participants With Reasons for Discontinuation of Previous Biotherapy Remission	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Reasons for Discontinuation of Previous Biotherapy Switch Inflectra	166 Participants	32 Participants	164 Participants	52 Participants	57 Participants
Number of Participants With Reasons for Discontinuation of Previous Biotherapy Other	25 Participants	9 Participants	23 Participants	9 Participants	10 Participants

PRIMARY outcome

Timeframe: Data collected and recorded at study inclusion visit

Outcome measures

Outcome measures
Measure	Ankylosing Spondylitis (SpA) n=338 Participants Adult participants included in this arm were diagnosed with SpA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks. Participants were observed for 2 years in this study.	Psoriatic Arthritis (PA) n=79 Participants Adult participants included in this arm were diagnosed with PA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Crohn's Disease (CD) n=339 Participants Adult participants diagnosed with moderately to fistulizing active CD received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion at 2 weeks (for moderate to severely active CD) and at 2 weeks and 6 weeks (for fistulizing active) after the first infusion. Participants who responded to the treatment received additional infusion of 5 mg/kg at 6 weeks after the initial dose, followed by infusions every 8 weeks or infusion of 5 mg/kg if signs and symptoms of the disease. Pediatric participants diagnosed with CD received 5 mg/kg given as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Ulcerative Colitis (UC) n=143 Participants Adult and pediatric participants included in this arm were diagnosed with UC and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Rheumatoid Arthritis (RA) n=116 Participants Adult participants included in this arm were diagnosed with RA and received 3 mg/kg of Inflectra as an IV infusion followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Inflectra was administered in combination with methotrexate. Participants were observed for 2 years in this study.
Duration of Previous Biotherapies	73.1 Months Standard Deviation 51.2	70.4 Months Standard Deviation 60.7	51.3 Months Standard Deviation 43.1	33.2 Months Standard Deviation 38.2	81.0 Months Standard Deviation 55.8

PRIMARY outcome

Timeframe: Data collected and recorded at study inclusion visit

Type of previous biotherapies included were: anti-TNF alpha (infliximab/adalimumab/etanercept/golimumab), selective immuno-suppressant (vedolizumab/abatacept), interleukin inhibitor (anakinra/ustekinumab/tocilizumab), and other. In this outcome measure mean of number of doses administered in previous biotherapy is reported.

Outcome measures

Outcome measures
Measure	Ankylosing Spondylitis (SpA) n=127 Participants Adult participants included in this arm were diagnosed with SpA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks. Participants were observed for 2 years in this study.	Psoriatic Arthritis (PA) n=37 Participants Adult participants included in this arm were diagnosed with PA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Crohn's Disease (CD) n=197 Participants Adult participants diagnosed with moderately to fistulizing active CD received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion at 2 weeks (for moderate to severely active CD) and at 2 weeks and 6 weeks (for fistulizing active) after the first infusion. Participants who responded to the treatment received additional infusion of 5 mg/kg at 6 weeks after the initial dose, followed by infusions every 8 weeks or infusion of 5 mg/kg if signs and symptoms of the disease. Pediatric participants diagnosed with CD received 5 mg/kg given as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Ulcerative Colitis (UC) n=75 Participants Adult and pediatric participants included in this arm were diagnosed with UC and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Rheumatoid Arthritis (RA) n=55 Participants Adult participants included in this arm were diagnosed with RA and received 3 mg/kg of Inflectra as an IV infusion followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Inflectra was administered in combination with methotrexate. Participants were observed for 2 years in this study.
Mean of Number of Doses Administered in Previous Biotherapy	39.2 Dose Standard Deviation 55.6	24.3 Dose Standard Deviation 26.6	38.2 Dose Standard Deviation 48.1	26.5 Dose Standard Deviation 24.5	33.5 Dose Standard Deviation 30.1

PRIMARY outcome

Timeframe: Data collected and recorded at study inclusion visit

Type of previous biotherapies included were: anti-TNF alpha (infliximab/adalimumab/etanercept/golimumab), selective immuno-suppressant (vedolizumab/abatacept), interleukin inhibitor (anakinra/ustekinumab/tocilizumab), and other. In this outcome measure mean of last dosage (in units) of previous biotherapy administered dose is reported.

Outcome measures

Outcome measures
Measure	Ankylosing Spondylitis (SpA) n=275 Participants Adult participants included in this arm were diagnosed with SpA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks. Participants were observed for 2 years in this study.	Psoriatic Arthritis (PA) n=59 Participants Adult participants included in this arm were diagnosed with PA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Crohn's Disease (CD) n=299 Participants Adult participants diagnosed with moderately to fistulizing active CD received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion at 2 weeks (for moderate to severely active CD) and at 2 weeks and 6 weeks (for fistulizing active) after the first infusion. Participants who responded to the treatment received additional infusion of 5 mg/kg at 6 weeks after the initial dose, followed by infusions every 8 weeks or infusion of 5 mg/kg if signs and symptoms of the disease. Pediatric participants diagnosed with CD received 5 mg/kg given as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Ulcerative Colitis (UC) n=124 Participants Adult and pediatric participants included in this arm were diagnosed with UC and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Rheumatoid Arthritis (RA) n=94 Participants Adult participants included in this arm were diagnosed with RA and received 3 mg/kg of Inflectra as an IV infusion followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Inflectra was administered in combination with methotrexate. Participants were observed for 2 years in this study.
Last Dosage Administered of a Previous Biotherapy	216.7 Units Standard Deviation 218.0	238.4 Units Standard Deviation 227.9	104.4 Units Standard Deviation 193.3	86.8 Units Standard Deviation 127.2	204.8 Units Standard Deviation 255.5

PRIMARY outcome

Timeframe: Data collected and recorded at study inclusion visit

Population: Analysis population included all enrolled participants treated with Inflectra.

Following concomitant treatments were received by participants before initiation of Inflectra: 1) Corticosteroids, 2) Salicylates, and 3) Azathioprine/6-MP, Methotrexate, and Cyclosporine.

Outcome measures

Outcome measures
Measure	Ankylosing Spondylitis (SpA) n=411 Participants Adult participants included in this arm were diagnosed with SpA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks. Participants were observed for 2 years in this study.	Psoriatic Arthritis (PA) n=96 Participants Adult participants included in this arm were diagnosed with PA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Crohn's Disease (CD) n=547 Participants Adult participants diagnosed with moderately to fistulizing active CD received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion at 2 weeks (for moderate to severely active CD) and at 2 weeks and 6 weeks (for fistulizing active) after the first infusion. Participants who responded to the treatment received additional infusion of 5 mg/kg at 6 weeks after the initial dose, followed by infusions every 8 weeks or infusion of 5 mg/kg if signs and symptoms of the disease. Pediatric participants diagnosed with CD received 5 mg/kg given as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Ulcerative Colitis (UC) n=230 Participants Adult and pediatric participants included in this arm were diagnosed with UC and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Rheumatoid Arthritis (RA) n=142 Participants Adult participants included in this arm were diagnosed with RA and received 3 mg/kg of Inflectra as an IV infusion followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Inflectra was administered in combination with methotrexate. Participants were observed for 2 years in this study.
Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra Azathioprine/6-MP; Methotrexate; Cyclosporine · Yes	187 Participants	74 Participants	398 Participants	167 Participants	125 Participants
Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra Salicylates · No	359 Participants	90 Participants	339 Participants	70 Participants	131 Participants
Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra Corticosteroids · Missing	0 Participants	0 Participants	5 Participants	1 Participants	0 Participants
Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra Corticosteroids · No	373 Participants	82 Participants	440 Participants	162 Participants	83 Participants
Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra Corticosteroids · Yes	38 Participants	14 Participants	102 Participants	67 Participants	59 Participants
Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra Salicylates · Missing	1 Participants	0 Participants	6 Participants	1 Participants	0 Participants
Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra Salicylates · Yes	51 Participants	6 Participants	202 Participants	159 Participants	11 Participants
Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra Azathioprine/6-MP; Methotrexate; Cyclosporine · Missing	0 Participants	0 Participants	5 Participants	1 Participants	0 Participants
Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra Azathioprine/6-MP; Methotrexate; Cyclosporine · No	224 Participants	22 Participants	144 Participants	62 Participants	17 Participants

SECONDARY outcome

Timeframe: 24 months

Population: Analysis population included all enrolled participants treated with Inflectra. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Analysis for this outcome measure was planned for participants with indications RA, SpA and PA and not for participants with CD and UC.

PGA was evaluated in participants with RA, SpA and PA on a 0 to 10 centimeter (cm) visual analog scale (VAS), with 0 cm = no disease activity and 10 cm = worst disease activity possible. Higher scores indicated worse condition.

Outcome measures

Outcome measures
Measure	Ankylosing Spondylitis (SpA) Adult participants included in this arm were diagnosed with SpA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks. Participants were observed for 2 years in this study.	Psoriatic Arthritis (PA) Adult participants included in this arm were diagnosed with PA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Crohn's Disease (CD) n=116 Participants Adult participants diagnosed with moderately to fistulizing active CD received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion at 2 weeks (for moderate to severely active CD) and at 2 weeks and 6 weeks (for fistulizing active) after the first infusion. Participants who responded to the treatment received additional infusion of 5 mg/kg at 6 weeks after the initial dose, followed by infusions every 8 weeks or infusion of 5 mg/kg if signs and symptoms of the disease. Pediatric participants diagnosed with CD received 5 mg/kg given as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Ulcerative Colitis (UC) n=322 Participants Adult and pediatric participants included in this arm were diagnosed with UC and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Rheumatoid Arthritis (RA) n=76 Participants Adult participants included in this arm were diagnosed with RA and received 3 mg/kg of Inflectra as an IV infusion followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Inflectra was administered in combination with methotrexate. Participants were observed for 2 years in this study.
Physician Global Assessment (PGA) of Disease for RA, SpA and PA	—	—	3.5 cm Standard Deviation 2.6	3.2 cm Standard Deviation 2.4	3.2 cm Standard Deviation 2.3

SECONDARY outcome

Timeframe: Inclusion visit up to 6-Month visit, 6-Month visit to 12-Month visit, 12-Month visit up to 18-Month visit, and 18-Month visit up to 24-Month visit

Mean dose (in milligrams \[mg\]) administered was sum of dose of all infusions administered divided by total number of doses administered.

Outcome measures

Outcome measures
Measure	Ankylosing Spondylitis (SpA) n=352 Participants Adult participants included in this arm were diagnosed with SpA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks. Participants were observed for 2 years in this study.	Psoriatic Arthritis (PA) n=88 Participants Adult participants included in this arm were diagnosed with PA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Crohn's Disease (CD) n=486 Participants Adult participants diagnosed with moderately to fistulizing active CD received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion at 2 weeks (for moderate to severely active CD) and at 2 weeks and 6 weeks (for fistulizing active) after the first infusion. Participants who responded to the treatment received additional infusion of 5 mg/kg at 6 weeks after the initial dose, followed by infusions every 8 weeks or infusion of 5 mg/kg if signs and symptoms of the disease. Pediatric participants diagnosed with CD received 5 mg/kg given as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Ulcerative Colitis (UC) n=201 Participants Adult and pediatric participants included in this arm were diagnosed with UC and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Rheumatoid Arthritis (RA) n=119 Participants Adult participants included in this arm were diagnosed with RA and received 3 mg/kg of Inflectra as an IV infusion followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Inflectra was administered in combination with methotrexate. Participants were observed for 2 years in this study.
Mean Administered Dose of Inflectra (in mg) Month 6 to Month 12	411.3 mg Standard Deviation 123.0	441.2 mg Standard Deviation 152.2	473.4 mg Standard Deviation 195.6	534.0 mg Standard Deviation 213.2	313.4 mg Standard Deviation 127.3
Mean Administered Dose of Inflectra (in mg) Month 12 to Month 18	414.8 mg Standard Deviation 120.6	437.7 mg Standard Deviation 155.1	503.1 mg Standard Deviation 211.7	520.8 mg Standard Deviation 212.7	313.1 mg Standard Deviation 121.7
Mean Administered Dose of Inflectra (in mg) Inclusion to Month 6	406.9 mg Standard Deviation 113.4	440.8 mg Standard Deviation 142.5	451.0 mg Standard Deviation 184.5	493.9 mg Standard Deviation 202.1	313.7 mg Standard Deviation 125.4
Mean Administered Dose of Inflectra (in mg) Month 18 to Month 24	417.3 mg Standard Deviation 127.0	433.7 mg Standard Deviation 155.6	515.6 mg Standard Deviation 223.6	533.6 mg Standard Deviation 218.5	317.5 mg Standard Deviation 109.2

SECONDARY outcome

Timeframe: Inclusion visit up to 6-Month visit, 6-Month visit to 12-Month visit, 12-Month visit up to 18-Month visit, and 18-Month visit up to 24-Month visit

Mean posology administered was sum of posology of all infusions administered divided by total number of infusions administered. Posology = dose (mg) / weight (kg).

Outcome measures

Outcome measures
Measure	Ankylosing Spondylitis (SpA) n=334 Participants Adult participants included in this arm were diagnosed with SpA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks. Participants were observed for 2 years in this study.	Psoriatic Arthritis (PA) n=82 Participants Adult participants included in this arm were diagnosed with PA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Crohn's Disease (CD) n=486 Participants Adult participants diagnosed with moderately to fistulizing active CD received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion at 2 weeks (for moderate to severely active CD) and at 2 weeks and 6 weeks (for fistulizing active) after the first infusion. Participants who responded to the treatment received additional infusion of 5 mg/kg at 6 weeks after the initial dose, followed by infusions every 8 weeks or infusion of 5 mg/kg if signs and symptoms of the disease. Pediatric participants diagnosed with CD received 5 mg/kg given as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Ulcerative Colitis (UC) n=201 Participants Adult and pediatric participants included in this arm were diagnosed with UC and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Rheumatoid Arthritis (RA) n=114 Participants Adult participants included in this arm were diagnosed with RA and received 3 mg/kg of Inflectra as an IV infusion followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Inflectra was administered in combination with methotrexate. Participants were observed for 2 years in this study.
Mean Administered Posology of Inflectra (in mg/kg) Inclusion to Month 6	5.3 mg/kg Standard Deviation 1.1	5.4 mg/kg Standard Deviation 1.1	6.6 mg/kg Standard Deviation 2.2	7.0 mg/kg Standard Deviation 2.2	4.3 mg/kg Standard Deviation 1.4
Mean Administered Posology of Inflectra (in mg/kg) Month 6 to Month 12	5.4 mg/kg Standard Deviation 1.3	5.5 mg/kg Standard Deviation 1.3	6.8 mg/kg Standard Deviation 2.2	7.3 mg/kg Standard Deviation 2.3	4.4 mg/kg Standard Deviation 1.4
Mean Administered Posology of Inflectra (in mg/kg) Month 12 to Month 18	5.5 mg/kg Standard Deviation 1.3	5.4 mg/kg Standard Deviation 1.3	7.1 mg/kg Standard Deviation 2.3	7.2 mg/kg Standard Deviation 2.4	4.4 mg/kg Standard Deviation 1.4
Mean Administered Posology of Inflectra (in mg/kg) Month 18 to Month 24	5.5 mg/kg Standard Deviation 1.3	5.4 mg/kg Standard Deviation 1.3	7.3 mg/kg Standard Deviation 2.3	7.4 mg/kg Standard Deviation 2.4	4.5 mg/kg Standard Deviation 1.3

SECONDARY outcome

Timeframe: Inclusion visit up to 6-Month visit, Inclusion visit up to 12-Month visit, Inclusion visit up to 18-Month visit, and Inclusion visit up to 24-Month visit

Cumulative dose is the sum of doses administered during inclusion visit to month 6, 12, 18, and 24.

Outcome measures

Outcome measures
Measure	Ankylosing Spondylitis (SpA) n=352 Participants Adult participants included in this arm were diagnosed with SpA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks. Participants were observed for 2 years in this study.	Psoriatic Arthritis (PA) n=88 Participants Adult participants included in this arm were diagnosed with PA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Crohn's Disease (CD) n=486 Participants Adult participants diagnosed with moderately to fistulizing active CD received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion at 2 weeks (for moderate to severely active CD) and at 2 weeks and 6 weeks (for fistulizing active) after the first infusion. Participants who responded to the treatment received additional infusion of 5 mg/kg at 6 weeks after the initial dose, followed by infusions every 8 weeks or infusion of 5 mg/kg if signs and symptoms of the disease. Pediatric participants diagnosed with CD received 5 mg/kg given as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Ulcerative Colitis (UC) n=201 Participants Adult and pediatric participants included in this arm were diagnosed with UC and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Rheumatoid Arthritis (RA) n=119 Participants Adult participants included in this arm were diagnosed with RA and received 3 mg/kg of Inflectra as an IV infusion followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Inflectra was administered in combination with methotrexate. Participants were observed for 2 years in this study.
Cumulative Dose Inclusion to Month 6	986.1 mg Standard Deviation 589.4	1015.4 mg Standard Deviation 832.1	1028.9 mg Standard Deviation 782.1	1071.6 mg Standard Deviation 810.0	630.7 mg Standard Deviation 449.0
Cumulative Dose Inclusion to Month 12	1202.0 mg Standard Deviation 755.0	1251.4 mg Standard Deviation 914.9	1353.9 mg Standard Deviation 1057.4	1437.6 mg Standard Deviation 1118.1	804.5 mg Standard Deviation 603.3
Cumulative Dose Inclusion to Month 18	1159.5 mg Standard Deviation 726.7	1258.2 mg Standard Deviation 965.2	1445.2 mg Standard Deviation 1116.0	1433.6 mg Standard Deviation 1090.3	762.8 mg Standard Deviation 592.4
Cumulative Dose Inclusion to Month 24	1405.8 mg Standard Deviation 892.1	1502.0 mg Standard Deviation 1213.7	1718.0 mg Standard Deviation 1305.8	1616.9 mg Standard Deviation 1229.6	929.6 mg Standard Deviation 668.2

SECONDARY outcome

Timeframe: Inclusion visit up to 6-Month visit, 6-Month visit to 12-Month visit, 12-Month visit up to 18-Month visit, and 18-Month visit up to 24-Month visit

Mean infusion time was sum of duration of all infusions administered divided by total number of infusion times administered.

Outcome measures

Outcome measures
Measure	Ankylosing Spondylitis (SpA) n=337 Participants Adult participants included in this arm were diagnosed with SpA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks. Participants were observed for 2 years in this study.	Psoriatic Arthritis (PA) n=85 Participants Adult participants included in this arm were diagnosed with PA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Crohn's Disease (CD) n=447 Participants Adult participants diagnosed with moderately to fistulizing active CD received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion at 2 weeks (for moderate to severely active CD) and at 2 weeks and 6 weeks (for fistulizing active) after the first infusion. Participants who responded to the treatment received additional infusion of 5 mg/kg at 6 weeks after the initial dose, followed by infusions every 8 weeks or infusion of 5 mg/kg if signs and symptoms of the disease. Pediatric participants diagnosed with CD received 5 mg/kg given as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Ulcerative Colitis (UC) n=183 Participants Adult and pediatric participants included in this arm were diagnosed with UC and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Rheumatoid Arthritis (RA) n=113 Participants Adult participants included in this arm were diagnosed with RA and received 3 mg/kg of Inflectra as an IV infusion followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Inflectra was administered in combination with methotrexate. Participants were observed for 2 years in this study.
Mean Infusion Time Month 18 to Month 24	87.4 Minutes Standard Deviation 24.9	95.1 Minutes Standard Deviation 24.1	71.9 Minutes Standard Deviation 24.7	69.9 Minutes Standard Deviation 25.0	86.9 Minutes Standard Deviation 26.2
Mean Infusion Time Inclusion to Month 6	92.7 Minutes Standard Deviation 27.4	100.1 Minutes Standard Deviation 26.4	75.3 Minutes Standard Deviation 25.2	79.7 Minutes Standard Deviation 28.0	94.8 Minutes Standard Deviation 30.3
Mean Infusion Time Month 6 to Month 12	89.3 Minutes Standard Deviation 25.9	96.8 Minutes Standard Deviation 29.3	73.2 Minutes Standard Deviation 25.1	73.9 Minutes Standard Deviation 29.4	88.4 Minutes Standard Deviation 28.1
Mean Infusion Time Month 12 to Month 18	87.6 Minutes Standard Deviation 25.7	94.9 Minutes Standard Deviation 30.9	72.7 Minutes Standard Deviation 25.6	70.5 Minutes Standard Deviation 26.4	86.1 Minutes Standard Deviation 26.3

SECONDARY outcome

Timeframe: Inclusion visit up to 6-Month visit, 6-Month visit to 12-Month visit, 12-Month visit up to 18-Month visit, and 18-Month visit up to 24-Month visit

Outcome measures

Outcome measures
Measure	Ankylosing Spondylitis (SpA) n=302 Participants Adult participants included in this arm were diagnosed with SpA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks. Participants were observed for 2 years in this study.	Psoriatic Arthritis (PA) n=73 Participants Adult participants included in this arm were diagnosed with PA and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Crohn's Disease (CD) n=422 Participants Adult participants diagnosed with moderately to fistulizing active CD received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion at 2 weeks (for moderate to severely active CD) and at 2 weeks and 6 weeks (for fistulizing active) after the first infusion. Participants who responded to the treatment received additional infusion of 5 mg/kg at 6 weeks after the initial dose, followed by infusions every 8 weeks or infusion of 5 mg/kg if signs and symptoms of the disease. Pediatric participants diagnosed with CD received 5 mg/kg given as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Ulcerative Colitis (UC) n=160 Participants Adult and pediatric participants included in this arm were diagnosed with UC and received 5 mg/kg of Inflectra as an IV infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Participants were observed for 2 years in this study.	Rheumatoid Arthritis (RA) n=101 Participants Adult participants included in this arm were diagnosed with RA and received 3 mg/kg of Inflectra as an IV infusion followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Inflectra was administered in combination with methotrexate. Participants were observed for 2 years in this study.
Mean Time Between Infusions Inclusion to Month 6	7.0 Weeks Standard Deviation 1.7	7.2 Weeks Standard Deviation 1.6	7.5 Weeks Standard Deviation 3.5	7.7 Weeks Standard Deviation 3.5	7.5 Weeks Standard Deviation 2.0
Mean Time Between Infusions Month 6 to Month 12	10.7 Weeks Standard Deviation 6.9	11.7 Weeks Standard Deviation 7.8	11.9 Weeks Standard Deviation 8.0	13.3 Weeks Standard Deviation 10.3	12.7 Weeks Standard Deviation 7.3
Mean Time Between Infusions Month 12 to Month 18	12.7 Weeks Standard Deviation 8.9	13.0 Weeks Standard Deviation 8.7	12.8 Weeks Standard Deviation 9.0	13.8 Weeks Standard Deviation 9.8	13.7 Weeks Standard Deviation 8.6
Mean Time Between Infusions Month 18 to Month 24	13.8 Weeks Standard Deviation 10.4	13.3 Weeks Standard Deviation 8.9	8.7 Weeks Standard Deviation 6.2	14.4 Weeks Standard Deviation 11.6	15.4 Weeks Standard Deviation 9.9

SECONDARY outcome

Timeframe: Inclusion visit up to 6-Month visit, 6-Month visit to 12-Month visit, 12-Month visit up to 18-Month visit, and 18-Month visit up to 24-Month visit

Mean post-infusion monitoring at hospital was sum of duration of all monitoring at hospital divided by total number monitoring times.