Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade

PERSIST: PROSPECTIVE OBSERVATIONAL COHORT STUDY TO ASSESS PERSISTENCE OF CT-P13 (INFLIXIMAB) IN PATIENTS WITH RHEUMATOID DISEASES WHO ARE EITHER NAIVE TO BIOLOGICS OR SWITCHED FROM STABLE REMICADE(R) (INFLIXIMAB)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02605642

Acronym

PERSIST

Enrollment

351

Registered

2015-11-16

Start date

2015-09-10

Completion date

2018-12-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Diseases, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis

Keywords

CT-P13, Inflectra, Remsima, Remicade, Infliximab, Observational, Follow-up, Safety

Brief summary

To assess persistence of CT-P13 in patients with Rheumatoid Diseases (Rheumatoid arthritis \[RA\], ankylosing spondylitis \[AS\], and psoriatic arthritis \[PsA\]) who are naïve to biologics or are switching from stable Remicade to CT-P13. The main objectives of the study are: * To evaluate real-life drug persistence in RA, AS, and PsA patients who are either initiated with CT-P13 as their first biologic, or who are switched from stable Remicade * To characterise the patient populations and drug usage patterns of RA, AS, and PsA patients who are either initiated with CT-P13 as their first biologic, or who are switched from stable Remicade * To assess the safety of CT-P13 in RA, AS, and PsA patients who are either initiated with CT-P13 as their first biologic, or who are switched from stable Remicade for up to 2 years

Detailed description

The study will be conducted in accordance with legal and regulatory requirements with scientific purpose, value and rigor following generally accepted research practices described in Guidelines for Good Pharmacoepidemiology Practices (GPP), Good Epidemiological Practice (GEP), Good Practices for Outcomes Research, International Ethical Guidelines for Epidemiological Research, European Medicines Agency (EMA) European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Guide on Methodological Standards in Pharmacoepidemiology, and FDA Guidance for Industry. Data sources will be validated and will consist of the hospital medical records and monitoring will be organized on a regular basis. Data sources will be validated. The source data will consist of medical records, physician questionnaires, and patient questionnaires. Data for the study will be entered into an electronic data capture system. Questionnaires will be completed on electronic tablets. The study is a one year enrollment period with a two year follow-up period. The study plans to enroll patients throughout Canada and Europe.

Interventions

DRUGCT-P13

biosimilar infliximab

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients aged ≥18 years old at the time of enrollment 2. Patients who are prescribed CT-P13 or Remicade for the treatment of rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis prescribed according to the corresponding summary of product characteristics (SmPC and Product Monograph) as determined by the investigator

Exclusion criteria

1. Any reported contraindications for Inflectra according to the SmPC or Product Monograph 2. Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its excipients or other murine proteins, at the time of enrollment

Design outcomes

Primary

Measure	Time frame	Description
Treatment Persistence With CT-P13 in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA)	During the observation period of 2 years	Persistence (in days) was defined as a continuous variable measured in time from index date until date of drug discontinuation. Drug discontinuation was defined as either switching to another non infliximab BDMARD or elapsing of a drug free interval of 16 weeks from CT-P13. For participants undergoing a switch to CT-P13 from Remicade, the index date was considered the date from which Remicade was originally commenced and for participants who initiated treatment with CT-P13 as their first biologic, the index date was considered the date from which CT-P13 was initiated.
Disease Duration in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA), as Recorded on the Day of Inclusion in Study	At Day 1 of 2 year observation period	Disease duration was defined as the number of months from initial diagnosis of rheumatoid disease (RA, AS or PsA) to the date of informed consent, which was recorded at the time of inclusion in the study (Day 1).
Initial Dose of CT-P13 Infusion Administered to Participants	At Day 1 of 2 year observation period	Initial dose of CT-P13 infusion (dose at the time of CT-P13 treatment initiation) was reported in this outcome measure.
Number of Participants by Initial Frequency of CT-P13 Infusion Received	Baseline (Day 1) of 2 year observation period	Initial frequency of CT-P13 infusion was categorized as: once every 4, 6, 8 weeks and other. 'Other' included all other frequencies other than specified. Number of participants by baseline infusion frequency (in weeks) were reported.
Total Dose of CT-P13 Infusion Received During Observation Period	During the observation period of 2 years	Total dose of infusion received by the participants were evaluated.
Number of Participants With Change in CT-P13 Infusion Dose	During the observation period of 2 years	Participants who had change in the dose of infusion (either dose reduction or increase in dose) during the observation period were reported.
Number of Participants Who Had At Least One Concomitant Medication Related to the Treatment of Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA)	During the observation period of 2 years	Concomitant medications included corticosteroids, non-steroidal anti- inflammatory drugs (NSAID'S) and immunosuppressant. Participants were counted in more than one categories. 'Others' included DMARDS and other medications apart from the categories specified.
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)	During the observation period of 2 years	An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent were events between first dose of infusion up to 2 years, that were absent before treatment or that worsened relative to pretreatment state. Serious infections including sepsis (excluding opportunistic infections and tuberculosis) were the pre-defined TEAE of special Interest for this study. AEs included both serious and non-serious adverse events.

Secondary

Measure	Time frame	Description
Change From Baseline in Physical Component Summary (PCS) Score of Short Form 12 Version 2 (SF-12v2) Health Survey at Months 6, 12, 18 and 24	Baseline, Months 6, 12, 18 and 24	The SF-12v2 is a self-administered, validated, multipurpose SF questionnaire to measure generic health status. It consists of 12 items, which are categorized into eight domains (subscales) of functioning and well-being: physical function, role limitations due to physical problems, bodily pain, general health perceptions, energy and vitality, social functioning, role limitations due to emotional problems, and mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. These eight domains are further summarized into PCS and mental component summary (MCS). The score range for each of these 2 summary scores was from 0 (poor health) to 100 (better health). Higher scores indicated a better health-related quality of life.
Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Rheumatoid Arthritis (RA) at Months 6, 12, 18 and 24	Baseline, Months 6, 12, 18 and 24	DAS28 calculated from the number of tender joint count (TJC) and swollen joint count (SJC) using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeters per hour; ranged from 0 to 150), and a participant's general health assessment (GH) on a 100 millimeter (mm) visual analog scale (VAS) (ranging from 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicated worsening of health condition). Total DAS28 score ranged from 0 (none) to 9.4 (extreme disease activity), higher scores indicated more disease activity. DAS28 less than or equal to (\<=) 3.2 implied low, greater than (\>) 3.2 to \<=5.1 implied moderate, and \>5.1 implied high disease activity. DAS28=0.56\sqrt(28TJC)+0.28\sqrt(28SJC)+0.70\ln(ESR)+0.014\GH; where ln = natural logarithm and sqrt = square root of.
Change From Baseline in Physician Global Assessment (PGA) of Rheumatoid Diseases Activity at Months 6, 12, 18 and 24	Baseline, Months 6, 12, 18 and 24	PGA of disease activity was measured on a 0 to 100 mm VAS, where 0 mm = no disease activity and 100 mm = extremely active. Higher scores indicated worsening of condition.
Change From Baseline in Mental Component Summary (MCS) Score of Short Form 12 Version 2 (SF-12v2) Health Survey at Months 6, 12, 18 and 24	Baseline, Months 6, 12, 18 and 24	The SF-12v2 is a self-administered, validated, multipurpose SF questionnaire to measure generic health status. It consists of 12 items, which are categorized into eight domains (subscales) of functioning and well-being: physical function, role limitations due to physical problems, bodily pain, general health perceptions, energy and vitality, social functioning, role limitations due to emotional problems, and mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. These eight domains are further summarized into PCS and mental component summary (MCS). The score range for each of these 2 summary scores was from 0 (poor health) to 100 (better health). Higher scores indicated a better health-related quality of life.
Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Psoriatic Arthritis (PsA) at Months 6, 12, 18 and 24	Baseline, Months 6, 12, 18 and 24	DAS28 calculated from the number of TJC and SJC using 28 joints count, ESR (millimeters per hour; ranged from 0 to 150), and participant's GH on a 100 mm VAS (ranging from 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicated worsening of health condition). Total DAS28 score ranged from 0 (none) to 9.4 (extreme disease activity), higher scores indicated more disease activity. DAS28 \<= 3.2 implied low, \> 3.2 to \<=5.1 implied moderate, and \>5.1 implied high disease activity. DAS28=0.56\sqrt(28TJC)+0.28\sqrt(28SJC)+0.70\ln(ESR)+0.014\GH; where ln = natural logarithm and sqrt = square root of.
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24	Baseline, Weeks 6, 12, 18 and 24	BASDAI is a self-reported measure of disease activity in participants with AS. Participants answered 6 questions measuring symptoms of AS (fatigue, spinal pain, joint pain or swelling, areas of localized tenderness, morning stiffness duration and severity). The BASDAI total score was calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score was then divided by 5. BASDAI=Q1+Q2+Q3+Q4+\[Q5+Q6/2\]/5. The total BASDAI score ranges from 1=none to 10=severe, where lower score indicated less disease activity. The level of AS disease activity was interpreted as low (BASDAI \< 4) or high (BASDAI \> 4).
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis (AS) at Months 6,12,18 and 24	Baseline, Weeks 6, 12, 18 and 24	ASDAS is used to assess disease activity in participants with AS. It is a score combining the assessment of overall pain (Q1), duration of morning stiffness (Q2), peripheral pain/swelling (Q3), PtGA (assessed on a sale of 0 to 10, where 0 = not active and 10=very active), and C-reactive protein (CRP) in milligrams per liter (mg/L). ASDAS total score was derived using the following formula: ASDAS=0.12\Q1+0.06\Q2+0.11\GH+0.07\Q3+0.58\*ln (CRP+1). The level of AS disease activity was interpreted as inactive disease (ASDAS\< 1.3), moderate disease activity (1.3 \<= ASDAS \< 2.1), high disease activity (2.1\<= ASDAS \<=3.5) and very high disease activity (ASDAS \> 3.5).
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24	Baseline, Weeks 6, 12, 18 and 24	BASFI is a validated self assessment tool to determine the degree of functional limitation in participants with AS. It is comprised of 10 questions which were answered by participants using a VAS ranging from 0 (being easy) to 10 (impossible). BASFI total score was calculated as the average score of the 10 questions, and ranges from 0 (no functional impairment) to 10 (maximal impairment), higher scores indicated more impairment.
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Months 6, 12, 18 and 24	Baseline, Months 6, 12, 18 and 24	HAQ-DI assesses the degree of difficulty a participant had experienced in 8 domains of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale from 0 to 3 with 0 =no difficulty, 1 =some difficulty, 2 = much difficulty, and 3 =unable to do. Overall score was computed as the sum of scores divided by the number of domains answered. Total possible score range was 0-3 with 0 = no difficulty to 3 =unable to do. Higher score indicate more difficulty in performing daily living activities.
Change From Baseline in European Quality of Life- 5 Dimensions 3 Level Version (EQ-5D-3L) Visual Analog Scale (VAS) Score at Months 6, 12, 18 and 24	Baseline, Months 6, 12, 18 and 24	EQ-5D-3L is a standardized, participant-administered measure of health outcomes. It consists of two parts: EQ-5D descriptive system (Part I) and the EQ-VAS (Part II). EQ-5D-3L Part II uses a vertical graduated VAS to measure health status on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicating a better health state.
Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Index Score at Months 6, 12, 18 and 24	Baseline, Months 6, 12, 18 and 24	EQ-5D-3L is a standardized, participant-administered measure of self-reported health outcomes. It consists of two parts: EQ-5D descriptive system (Part I) and the EQ-VAS (Part II). For Part I, i.e. EQ-5D-3L index score, participants rated their current health state on 5 single-item dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with each dimension having three levels of function:. 1=no problems, 2=some problems and 3=extreme problems. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score was transformed and results in a total score range of -0.074 to 1.00; higher scores indicating a better health state.

Countries

Bulgaria, Canada, Czechia, Germany, Greece, Spain, United Kingdom

Participant flow

Recruitment details

351 participants were included in this study, however, 17 participants were excluded from all analysis (they were neither BDMARD naive nor switched from Remicade). They switched to CT-P13 from a BDMARD other than Remicade, therefore not considered for any analysis.

Participants by arm

Arm	Count
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive BDMARD naive participants who were receiving CT-P13 according to the summary of product characteristics (SmPC and Product Monograph) as determined by the investigator, were included in this group and observed in this study for a duration of up to 2 years.	221
Participants Who Switched From Remicade to CT-P13 Participants who were previously treated with Remicade, switched to CT-P13 and started receiving CT-P13 (according to the SmPC and Product Monograph; as determined by the investigator) from stable treatment with Remicade, were included in this group and observed for a duration of up to 2 years.	107
Total	328

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	14	2
Overall Study	Lack of response	24	11
Overall Study	Lost to Follow-up	12	1
Overall Study	Other	11	1
Overall Study	Participant non-compliance	2	4
Overall Study	Physician Decision	10	0
Overall Study	Withdrawal by Subject	23	2

Baseline characteristics

Characteristic	Total	Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Participants Who Switched From Remicade to CT-P13
Age, Continuous	53.1 years STANDARD_DEVIATION 13.23	53.3 years STANDARD_DEVIATION 13.54	52.5 years STANDARD_DEVIATION 12.61
Body Mass Index	28.26 kilogram per meter square STANDARD_DEVIATION 5.672	28.51 kilogram per meter square STANDARD_DEVIATION 5.521	27.74 kilogram per meter square STANDARD_DEVIATION 5.968
Body Weight	81.59 kilograms STANDARD_DEVIATION 17.592	80.80 kilograms STANDARD_DEVIATION 16.613	83.21 kilograms STANDARD_DEVIATION 19.442
Height	169.98 centimeter STANDARD_DEVIATION 10.08	168.44 centimeter STANDARD_DEVIATION 9.467	173.19 centimeter STANDARD_DEVIATION 10.592
Participants with Medical History	328 Participants	221 Participants	107 Participants
Race/Ethnicity, Customized Asian	6 Participants	6 Participants	0 Participants
Race/Ethnicity, Customized Black or African American	2 Participants	2 Participants	0 Participants
Race/Ethnicity, Customized Other	2 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized White	318 Participants	212 Participants	106 Participants
Sex: Female, Male Female	166 Participants	118 Participants	48 Participants
Sex: Female, Male Male	162 Participants	103 Participants	59 Participants
Surgery Status No	296 Participants	201 Participants	95 Participants
Surgery Status Yes	32 Participants	20 Participants	12 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 221	0 / 107
other Total, other adverse events	88 / 221	24 / 107
serious Total, serious adverse events	19 / 221	10 / 107

Outcome results

Primary

Disease Duration in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA), as Recorded on the Day of Inclusion in Study

Disease duration was defined as the number of months from initial diagnosis of rheumatoid disease (RA, AS or PsA) to the date of informed consent, which was recorded at the time of inclusion in the study (Day 1).

Time frame: At Day 1 of 2 year observation period

Population: The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified rows.

Arm	Measure	Group	Value (MEDIAN)
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Disease Duration in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA), as Recorded on the Day of Inclusion in Study	Disease Type: RA	52.928 months
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Disease Duration in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA), as Recorded on the Day of Inclusion in Study	Disease Type: AS	35.039 months
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Disease Duration in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA), as Recorded on the Day of Inclusion in Study	Disease Type: PsA	33.084 months
Participants Who Switched From Remicade to CT-P13	Disease Duration in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA), as Recorded on the Day of Inclusion in Study	Disease Type: RA	189.142 months
Participants Who Switched From Remicade to CT-P13	Disease Duration in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA), as Recorded on the Day of Inclusion in Study	Disease Type: AS	159.376 months
Participants Who Switched From Remicade to CT-P13	Disease Duration in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA), as Recorded on the Day of Inclusion in Study	Disease Type: PsA	133.979 months

Primary

Initial Dose of CT-P13 Infusion Administered to Participants

Initial dose of CT-P13 infusion (dose at the time of CT-P13 treatment initiation) was reported in this outcome measure.

Time frame: At Day 1 of 2 year observation period

Population: The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period. Here Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

Arm	Measure	Value (MEDIAN)
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Initial Dose of CT-P13 Infusion Administered to Participants	3.00 milligram per kilogram
Participants Who Switched From Remicade to CT-P13	Initial Dose of CT-P13 Infusion Administered to Participants	4.00 milligram per kilogram

Primary

Number of Participants by Initial Frequency of CT-P13 Infusion Received

Initial frequency of CT-P13 infusion was categorized as: once every 4, 6, 8 weeks and other. 'Other' included all other frequencies other than specified. Number of participants by baseline infusion frequency (in weeks) were reported.

Time frame: Baseline (Day 1) of 2 year observation period

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Number of Participants by Initial Frequency of CT-P13 Infusion Received	Once every 4 weeks	3 Participants
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Number of Participants by Initial Frequency of CT-P13 Infusion Received	Once every 6 weeks	79 Participants
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Number of Participants by Initial Frequency of CT-P13 Infusion Received	Once every 8 weeks	73 Participants
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Number of Participants by Initial Frequency of CT-P13 Infusion Received	Other	52 Participants
Participants Who Switched From Remicade to CT-P13	Number of Participants by Initial Frequency of CT-P13 Infusion Received	Other	15 Participants
Participants Who Switched From Remicade to CT-P13	Number of Participants by Initial Frequency of CT-P13 Infusion Received	Once every 4 weeks	1 Participants
Participants Who Switched From Remicade to CT-P13	Number of Participants by Initial Frequency of CT-P13 Infusion Received	Once every 8 weeks	44 Participants
Participants Who Switched From Remicade to CT-P13	Number of Participants by Initial Frequency of CT-P13 Infusion Received	Once every 6 weeks	42 Participants

Primary

Number of Participants Who Had At Least One Concomitant Medication Related to the Treatment of Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA)

Concomitant medications included corticosteroids, non-steroidal anti- inflammatory drugs (NSAID'S) and immunosuppressant. Participants were counted in more than one categories. 'Others' included DMARDS and other medications apart from the categories specified.

Time frame: During the observation period of 2 years

Population: The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Number of Participants Who Had At Least One Concomitant Medication Related to the Treatment of Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA)	Other	26 Participants
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Number of Participants Who Had At Least One Concomitant Medication Related to the Treatment of Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA)	Corticosteroids	28 Participants
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Number of Participants Who Had At Least One Concomitant Medication Related to the Treatment of Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA)	NSAID's	27 Participants
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Number of Participants Who Had At Least One Concomitant Medication Related to the Treatment of Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA)	Immunosuppressants	48 Participants
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Number of Participants Who Had At Least One Concomitant Medication Related to the Treatment of Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA)	Missing	7 Participants
Participants Who Switched From Remicade to CT-P13	Number of Participants Who Had At Least One Concomitant Medication Related to the Treatment of Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA)	Missing	5 Participants
Participants Who Switched From Remicade to CT-P13	Number of Participants Who Had At Least One Concomitant Medication Related to the Treatment of Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA)	Immunosuppressants	12 Participants
Participants Who Switched From Remicade to CT-P13	Number of Participants Who Had At Least One Concomitant Medication Related to the Treatment of Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA)	Corticosteroids	2 Participants
Participants Who Switched From Remicade to CT-P13	Number of Participants Who Had At Least One Concomitant Medication Related to the Treatment of Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA)	Other	2 Participants
Participants Who Switched From Remicade to CT-P13	Number of Participants Who Had At Least One Concomitant Medication Related to the Treatment of Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA)	NSAID's	5 Participants

Primary

Number of Participants With Change in CT-P13 Infusion Dose

Participants who had change in the dose of infusion (either dose reduction or increase in dose) during the observation period were reported.

Time frame: During the observation period of 2 years

Population: The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Number of Participants With Change in CT-P13 Infusion Dose	40 Participants
Participants Who Switched From Remicade to CT-P13	Number of Participants With Change in CT-P13 Infusion Dose	8 Participants

Primary

Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)

An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent were events between first dose of infusion up to 2 years, that were absent before treatment or that worsened relative to pretreatment state. Serious infections including sepsis (excluding opportunistic infections and tuberculosis) were the pre-defined TEAE of special Interest for this study. AEs included both serious and non-serious adverse events.

Time frame: During the observation period of 2 years

Population: The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)	TEAEs	97 Participants
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)	SAEs	19 Participants
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)	TEAEs of Special Interest	24 Participants
Participants Who Switched From Remicade to CT-P13	Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)	TEAEs	29 Participants
Participants Who Switched From Remicade to CT-P13	Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)	SAEs	10 Participants
Participants Who Switched From Remicade to CT-P13	Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)	TEAEs of Special Interest	8 Participants

Primary

Total Dose of CT-P13 Infusion Received During Observation Period

Total dose of infusion received by the participants were evaluated.

Time frame: During the observation period of 2 years

Population: The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period.

Arm	Measure	Value (MEDIAN)
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Total Dose of CT-P13 Infusion Received During Observation Period	35.00 milligram per kilogram
Participants Who Switched From Remicade to CT-P13	Total Dose of CT-P13 Infusion Received During Observation Period	46.50 milligram per kilogram

Primary

Treatment Persistence With CT-P13 in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA)

Persistence (in days) was defined as a continuous variable measured in time from index date until date of drug discontinuation. Drug discontinuation was defined as either switching to another non infliximab BDMARD or elapsing of a drug free interval of 16 weeks from CT-P13. For participants undergoing a switch to CT-P13 from Remicade, the index date was considered the date from which Remicade was originally commenced and for participants who initiated treatment with CT-P13 as their first biologic, the index date was considered the date from which CT-P13 was initiated.

Time frame: During the observation period of 2 years

Population: The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period.

Arm	Measure	Value (MEAN)	Dispersion
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Treatment Persistence With CT-P13 in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA)	404.10 days	Standard Deviation 291.33
Participants Who Switched From Remicade to CT-P13	Treatment Persistence With CT-P13 in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA)	542.30 days	Standard Deviation 268.55

Secondary

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis (AS) at Months 6,12,18 and 24

ASDAS is used to assess disease activity in participants with AS. It is a score combining the assessment of overall pain (Q1), duration of morning stiffness (Q2), peripheral pain/swelling (Q3), PtGA (assessed on a sale of 0 to 10, where 0 = not active and 10=very active), and C-reactive protein (CRP) in milligrams per liter (mg/L). ASDAS total score was derived using the following formula: ASDAS=0.12\*Q1+0.06\*Q2+0.11\*GH+0.07\*Q3+0.58\*ln (CRP+1). The level of AS disease activity was interpreted as inactive disease (ASDAS\< 1.3), moderate disease activity (1.3 \<= ASDAS \< 2.1), high disease activity (2.1\<= ASDAS \<=3.5) and very high disease activity (ASDAS \> 3.5).

Time frame: Baseline, Weeks 6, 12, 18 and 24

Population: Analysis performed on participants who had received at least one dose of CT-P13 and had at least one post-dose assessment for ASDAS. 'Overall number of participants analyzed': participants who were evaluable for this outcome measure. 'Number analyzed' = Participants evaluable for this outcome measure at specified rows.

Arm	Measure	Group	Value (MEAN)	Dispersion
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis (AS) at Months 6,12,18 and 24	Change at Month 6	-0.875 units on a scale	Standard Deviation 1.3108
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis (AS) at Months 6,12,18 and 24	Change at Month 18	-0.603 units on a scale	Standard Deviation 2.7745
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis (AS) at Months 6,12,18 and 24	Change at Month 12	-0.379 units on a scale	Standard Deviation 0.9905
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis (AS) at Months 6,12,18 and 24	Change at Month 24	-1.154 units on a scale	Standard Deviation 1.2293
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis (AS) at Months 6,12,18 and 24	Baseline	3.153 units on a scale	Standard Deviation 1.1082
Participants Who Switched From Remicade to CT-P13	Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis (AS) at Months 6,12,18 and 24	Change at Month 24	-0.356 units on a scale	Standard Deviation 1.708
Participants Who Switched From Remicade to CT-P13	Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis (AS) at Months 6,12,18 and 24	Baseline	2.151 units on a scale	Standard Deviation 1.0456
Participants Who Switched From Remicade to CT-P13	Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis (AS) at Months 6,12,18 and 24	Change at Month 6	-0.023 units on a scale	Standard Deviation 1.1017
Participants Who Switched From Remicade to CT-P13	Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis (AS) at Months 6,12,18 and 24	Change at Month 12	-0.452 units on a scale	Standard Deviation 0.8156
Participants Who Switched From Remicade to CT-P13	Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis (AS) at Months 6,12,18 and 24	Change at Month 18	-0.002 units on a scale	Standard Deviation 0.363

Secondary

Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24

BASDAI is a self-reported measure of disease activity in participants with AS. Participants answered 6 questions measuring symptoms of AS (fatigue, spinal pain, joint pain or swelling, areas of localized tenderness, morning stiffness duration and severity). The BASDAI total score was calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score was then divided by 5. BASDAI=Q1+Q2+Q3+Q4+\[Q5+Q6/2\]/5. The total BASDAI score ranges from 1=none to 10=severe, where lower score indicated less disease activity. The level of AS disease activity was interpreted as low (BASDAI \< 4) or high (BASDAI \> 4).

Time frame: Baseline, Weeks 6, 12, 18 and 24

Population: Analysis performed on participants who had received at least one dose of CT-P13 and had at least one post-dose assessment for BASDAI. 'Overall number of participants analyzed': participants who were evaluable for this outcome measure. 'Number analyzed' = Participants evaluable for this outcome measure at specified rows.

Arm	Measure	Group	Value (MEAN)	Dispersion
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24	Change at Month 6	-1.00 units on a scale	Standard Deviation 1.911
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24	Change at Month 18	-0.55 units on a scale	Standard Deviation 2.153
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24	Change at Month 12	-0.87 units on a scale	Standard Deviation 1.816
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24	Change at Month 24	-1.14 units on a scale	Standard Deviation 2.167
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24	Baseline	4.63 units on a scale	Standard Deviation 2.263
Participants Who Switched From Remicade to CT-P13	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24	Change at Month 24	-1.32 units on a scale	Standard Deviation 2.875
Participants Who Switched From Remicade to CT-P13	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24	Baseline	3.06 units on a scale	Standard Deviation 2.313
Participants Who Switched From Remicade to CT-P13	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24	Change at Month 6	0.01 units on a scale	Standard Deviation 1.47
Participants Who Switched From Remicade to CT-P13	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24	Change at Month 12	0.06 units on a scale	Standard Deviation 2.304
Participants Who Switched From Remicade to CT-P13	Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24	Change at Month 18	-0.24 units on a scale	Standard Deviation 2.015

Secondary

Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24

BASFI is a validated self assessment tool to determine the degree of functional limitation in participants with AS. It is comprised of 10 questions which were answered by participants using a VAS ranging from 0 (being easy) to 10 (impossible). BASFI total score was calculated as the average score of the 10 questions, and ranges from 0 (no functional impairment) to 10 (maximal impairment), higher scores indicated more impairment.

Time frame: Baseline, Weeks 6, 12, 18 and 24

Population: Analysis performed on participants who had received at least one dose of CT-P13 and had at least one post-dose assessment for BASFI. 'Overall number of participants analyzed': participants who were evaluable for this outcome measure. 'Number analyzed' = Participants evaluable for this outcome measure at specified rows.

Arm	Measure	Group	Value (MEAN)	Dispersion
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24	Change at Month 6	-0.72 units on a scale	Standard Deviation 2.107
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24	Change at Month 18	-0.43 units on a scale	Standard Deviation 2.194
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24	Change at Month 12	-1.01 units on a scale	Standard Deviation 2.085
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24	Change at Month 24	-1.18 units on a scale	Standard Deviation 2.379
Biologic Disease Modifying Anti-Rheumatic Drugs (BDMARD) Naive	Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24	Baseline	4.17 units on a scale	Standard Deviation 2.804
Participants Who Switched From Remicade to CT-P13	Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24	Change at Month 24	-0.42 units on a scale	Standard Deviation 3.012
Participants Who Switched From Remicade to CT-P13	Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24	Baseline	2.89 units on a scale	Standard Deviation 2.492
Participants Who Switched From Remicade to CT-P13	Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24	Change at Month 6	0.20 units on a scale	Standard Deviation 1.146
Participants Who Switched From Remicade to CT-P13	Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24	Change at Month 12	0.18 units on a scale	Standard Deviation 2.228
Participants Who Switched From Remicade to CT-P13	Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24	Change at Month 18	0.23 units on a scale	Standard Deviation 2.257

Secondary

Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Psoriatic Arthritis (PsA) at Months 6, 12, 18 and 24

DAS28 calculated from the number of TJC and SJC using 28 joints count, ESR (millimeters per hour; ranged from 0 to 150), and participant's GH on a 100 mm VAS (ranging from 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicated worsening of health condition). Total DAS28 score ranged from 0 (none) to 9.4 (extreme disease activity), higher scores indicated more disease activity. DAS28 \<= 3.2 implied low, \> 3.2 to \<=5.1 implied moderate, and \>5.1 implied high disease activity. DAS28=0.56\*sqrt(28TJC)+0.28\*sqrt(28SJC)+0.70\*ln(ESR)+0.014\*GH; where ln = natural logarithm and sqrt = square root of.