Ankylosing Spondylitis, Crohn Disease, Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis
Conditions
Brief summary
National, prospective, multicentre observational study designed for eligible patients treated with Inflectra. Its objectives are to describe under real conditions of use, the profile of patients treated with Inflectra and the response to treatment.
Interventions
OTHERQOL questionaire
Health assessment questionnaire disability index for rheumatoid polyarthritis questionnaire
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients treated with Inflectra™ regardless of treatment phase in one of the following indications consistent with the SPC: Crohn's Disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis. * Paediatric patients (children and adolescents between 6 and 17 years old) treated with Inflectra™, regardless of treatment phase from the time when Inflectra™ is prescribed in accordance with the indications listed in the SPC Crohn's Disease or ulcerative colitis Patients (or their legal representatives) who have received information (verbally and in writing) about the study and agreed to take part in it. * Patients who have given their agreement for their clinical data and their medical file to be accessed by signing the information leaflet.
Exclusion criteria
* Patients who refuse access to their medical file for collection of: their medical data * Patients not treated with Inflectra™. * Patients treated with Inflectra™ for psoriasis. * Patients with a past history of hypersensitivity to infliximab, to other murine proteins or to one of the excipients in Inflectra™. * Patients with tuberculosis or any other severe infection such as sepsis, abscess or opportunistic infection . * Patients with moderate to severe heart failure (NYHA III/IV)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Without Treatment Failure During 2-Years of Observation | 2 years post inclusion in the study | 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. |
| Number of Participants With Pre-treatment Assessment Prior to Initiation of Inflectra Treatment (Anti-Tumor Necrosis Factor [TNF] Aplha) Therapy | Data collected and recorded at study inclusion visit | 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. |
| Time Between Diagnosis and Inclusion in Study | Data collected and recorded at study inclusion visit | — |
| Time Between Diagnosis and the First Inflectra Infusion | Data collected and recorded at study inclusion visit | — |
| Number of Participants Who Received Biotherapy Other Than Inflectra Before Inclusion in the Study | Data collected and recorded at study inclusion visit | 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. |
| Number of Participants With Reasons for Discontinuation of Previous Biotherapy | 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. |
| Duration of Previous Biotherapies | 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. |
| Mean of Number of Doses Administered in Previous Biotherapy | 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. |
| Last Dosage Administered of a Previous Biotherapy | 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. |
| Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Data collected and recorded at study inclusion visit | Following concomitant treatments were received by participants before initiation of Inflectra: 1) Corticosteroids, 2) Salicylates, and 3) Azathioprine/6-MP, Methotrexate, and Cyclosporine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Variation in Mean Mayo Score Compared With Baseline at Month 6, 12, 18, and 24 | Baseline (Inclusion Visit), Month 6, 12, 18, and 24 | Mayo score was evaluated in participants with UC. Mayo score consists of 4 items (stool frequency, rectal bleeding, findings of endoscopy, physician global assessment), each graded from 0 (no severity) to 3 (maximum severity), with higher scores indicating more severe disease. Total score was sum of 4 items resulting in a score range of 0 (no severity) to 12 (maximum severity), where higher score indicated increased severity. Score \<=2 indicated UC inactive, score between \>=3 and \<=5 indicated mild UC, score between \>=6 and \<=10 indicated moderate UC, and score \>11 indicated severe UC. Absolute variation = mean result of laboratory test during period in question - result of laboratory test at baseline. |
| Absolute Variation in Mean Pediatric Ulcerative Colitis Activity Index (PUCAI) Score Compared With Baseline at Month 6, 12, 18, and 24 | Baseline (Inclusion Visit), Month 6, 12, 18, and 24 | PUCAI score was intended for pediatric participants with UC. PUCAI had 6 items with scores as: abdominal pain (no pain =0, pain can be ignored =5, pain cannot be ignored =10); rectal bleeding (none =0, small amount only \[in less than 50% of stools\] =10, small amount with most stools =20, large amount \[\>50% of the stool content\] =30); stool consistency of most stools (formed =0, partially formed =5, completely unformed =10); number of stools per 24 hours (0-2 =0, 3-5 =5, 6-8 =10, \>8 =15); nocturnal stools (no =0, yes =10); activity level (no limitation of activity =0, occasional limitation of activity =5, severely restricted activity =10). PUCAI score = sum of scores of 6 items; score range of 0= no severity to 85= extreme severity. PUCAI score \<10: UC in remission, score between \>=10 and \<35: mild UC, score between \>=35 and \<65: moderate UC, and score \>=65: severe UC. Absolute variation = mean result of laboratory test during period in question - result of laboratory test at baseline. |
| Absolute Variation in Mean Colitis Endoscopic Index of Severity (UCEIS) Score Compared With Baseline at Month 6, 12, 18, and 24 | Baseline (Inclusion Visit), Month 6, 12, 18, and 24 | UCEIS score was evaluated in participants with indication UC. It had 3 sub-scales: endoscopic vascular pattern (scored 0 \[normal pattern\] to 2 \[complete obliteration of vascular pattern\]), bleeding (scored 0 \[none\] to 3 \[luminal moderate or severe\]), erosions and ulcerations (scored 0 \[none\] to 3 \[deep ulcers\]). UCEIS total score was calculated by sum of all 3 sub-scale scores. Total score ranged from 0 (remission in disease) to 8 (extreme severity of disease), with higher scores indicating more severe disease. Absolute variation = mean result of laboratory test during period in question - result of laboratory test at baseline. |
| Absolute Variation in Mean Harvey-Bradshaw Score Compared With Baseline at Month 6, 12, 18, and 24 | Baseline (Inclusion Visit), Month 6, 12, 18, and 24 | Harvey-Bradshaw score was evaluated for indication CD. Harvey-Bradshaw measures 5 parameters; general well-being (0= very well to 4= terrible), abdominal pain (0= none to 3= severe), number of liquid stools per day (0 to no maximum score), presence of an abdominal mass on physical exam (0= none to 3= definite and tender), and whether there are any complications (0= no complications, 1= arthralgia, 2= uveitis, 3= erythema nodosum, 4= aphthous ulcer, 5= pyoderma gangrenosum, 6= anal fissure, 7= new fistula, 8= abscess). Total HBI score: sum of all 5 individual parameters, minimum score is 0 and there was no pre-specified maximum score as it depended on number of liquids stools. Higher HBI scores = greater disease activity score \<4 indicated Inactive disease, score \>=4 and/or \<=12 indicated Active disease, and score \>12 indicated Very active disease. Absolute variation = mean result of laboratory test during period in question - result of laboratory test at baseline. |
| Absolute Variation in Mean Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Compared With Baseline at Month 6, 12, 18, and 24 | Baseline (Inclusion Visit), Month 6, 12, 18, and 24 | CDEIS is an index for determining the severity of CD with endoscopic localization to ileum and colon. CDEIS considered 4 parameters: deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis. These 4 parameters were evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). CDEIS score ranged from 0 (no lesions) to 44 (severe lesions) where higher scores indicate more severity. CDEIS score \<=7 indicated Endoscopic remission, and score \>7 indicated Absence of endoscopic remission. Absolute variation = mean result of laboratory test during period in question - result of laboratory test at baseline. |
| Absolute Variation of Mean Global Disease Assessment Compared With Baseline at Month 6, 12, 18, and 24 | Baseline (Inclusion Visit), Month 6, 12, 18, and 24 | The global disease assessment by the physician for participants with RA, SpA and PA was evaluated on a 0 to 10 cm VAS, with 0 cm = no disease activity and 10 cm = worst disease activity. Higher scores indicated worse condition. Absolute variation = mean result of laboratory test during period in question - result of laboratory test at baseline. |
| Absolute Variation of Mean Fatigue Score Compared With Baseline at Month 6, 12, 18, and 24 | Baseline (Inclusion Visit), Month 6, 12, 18, and 24 | Fatigue score was evaluated among participants with RA, SpA, and PA. Participants' fatigue severity was measured on a VAS with a score range of 0 (no fatigue) to 10 (highest level of fatigue). Higher score signifies more severity. Absolute variation = mean result of laboratory test during period in question - result of laboratory test at baseline. |
| Absolute Variation in Mean Simple Disease Activity Index (SDAI) Score Compared With Baseline at Month 6, 12, 18, and 24 | Baseline (Inclusion Visit), Month 6, 12, 18, and 24 | SDAI was evaluated in participants with indication RA. SDAI is the numerical sum of 5 parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0 (very well) -10 cm (worst) VAS; higher scores = greater affection due to disease activity, and C-reactive protein (CRP) (mg/dL). SDAI total score =0 (no disease) to 86 (extreme severity of disease), where higher scores indicated higher disease activity. SDAI score \<=3.3 indicated achievement of remission state, score \>3.3 and/or \<=11 indicated mildly active state, score \>11 and/or \<=26 indicated moderately active state, and score \>26 indicated very active state. Absolute variation = mean result of laboratory test during period in question - result of laboratory test at baseline. |
| Absolute Variation in Mean Health Assessment Questionnaire (HAQ) Score Compared With Baseline at Month 6, 12, 18, and 24 | Baseline (Inclusion Visit), Month 6, 12, 18, and 24 | HAQ score was evaluated for indication RA. HAQ assesses degree of difficulty participant had experienced during past week in 8 domains of daily activities: dressing & grooming, arising, eating, walking, hygiene, reach, grip and other activities. For each question in questionnaire, level of difficulty was scored from 0 (no difficulty) to 3 (unable to do). Any activity requiring assistance from another individual or required use of assistive device would adjust to minimum score of 2 to represent more limited functional status. Overall score = sum of scores divided by number of domains answered. Total possible score range was 0 (no difficulty) to 3 (unable to do). Higher score = more difficulty in performing daily living activities. HAQ score \>0.5 indicated Existence of functional disability & HAQ score \<=0.5 indicated Absence of functional disability. Absolute variation = mean result of laboratory test during period in question - result of laboratory test at baseline. |
| Absolute Variation in Mean Ankylosing Spondylitis Disease Activity Score (ASDAS) Score Compared With Baseline at Month 6, 12, 18, and 24 | Baseline (Inclusion Visit), Month 6, 12, 18, and 24 | ASDAS score was evaluated for indication SpA. 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 \[not active\] to 10 \[very active\]), and CRP in mg/L. ASDAS total score ranged from 0 (no disease) to 10 (maximum severity), higher score indicates greater severity of disease and was derived using the following formula: ASDAS =0.12\*Q1 + 0.06\*Q2 + 0.11\* PtGA + 0.07\*Q3 + 0.58\*ln (CRP+1). ASDAS score \<1.3 indicated SpA inactive, ASDAS score \>=1.3 and/or \<2.1 indicated SpA mildly active, ASDAS score \>=2.1 and/or \<=3.5 indicated SpA moderately active, and ASDAS score \>3.5 indicated SpA very active. Absolute variation = mean result of laboratory test during period in question - result of laboratory test at baseline. |
| Cook and Medley Score at Baseline | Baseline (data recorded at inclusion visit) | Cook-Medley questionnaire, also called cynical distrust scale, contained 8 items, scoring from 0 (trust) to 4 (no trust). The total score of the questionnaire was calculated by adding together the scores for the 8 items. Total possible score range was from 0 (trust) to 32 (no trust), higher score signifies greater cynical distrust. This outcome measure was evaluated in participants who were informed of a switch from infliximab reference to Inflectra. |
| Stress Score | Baseline (inclusion visit) up to Month 12 | The questionnaire on stress after the switch to the biosimilar contained 3 items (emotional reactivity, repetition syndrome and tendency to avoid), each scored from 0 (no stress) to 4 (extreme stress). The overall score of stress was calculated by adding together the scores for the 3 items, ranged from 0 (no stress) to 12 (highest level of stress), higher scores indicated greater levels of stress. This outcome measure was evaluated in participants who were informed of a switch from infliximab reference to Inflectra. |
| General Anxiety Disorder (GAD7) Score | Baseline (inclusion visit) through post each infusion (during 2 years) | GAD7: questionnaire of anxiety with 7 items, scoring from 0 (no anxiety) to 3 (extreme anxiety). The total GAD7 score was calculated by adding together the scores for the 7 items, ranged from 0 (no anxiety) to 21 (extreme anxiety), higher scores indicated severe anxiety. This outcome measure was evaluated in participants who were informed of a switch from infliximab reference to Inflectra. |
| Number of Participants With Immunogenicity Assay at Inclusion Visit | Baseline (data recorded at inclusion visit) | — |
| Number of Participants With Anti-Infliximab Antibody Assay Assessment at Inclusion Visit | Baseline (data recorded at inclusion visit) | — |
| Physician Global Assessment (PGA) of Disease for RA, SpA and PA | 24 months | 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. |
| Number of Participants With Infliximab Trough Level (IFX-TL) Assay at Inclusion Visit | Baseline (data recorded at inclusion visit) | Trough level was plasma concentration of drug before infusion. |
| Infliximab Trough Level (IFX-TL) at Inclusion Visit | Before infusion at baseline (data recorded at inclusion visit) | Trough level was plasma concentration of drug before infusion. |
| Mean of Number of Immunogenicity Assays Done (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Inclusion visit up to 6-Month visit, 6-Month visit up to 12-Month visit, 12-Month visit up to 18-Month visit, and 18-Month visit up to 24-Month visit | — |
| Number of Participants With Presence of At-least 1 Anti-Infliximab Antibodies (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Inclusion visit up to 6-Month visit, 6-Month visit up to 12-Month visit, 12-Month visit up to 18-Month visit, and 18-Month visit up to 24-Month visit | — |
| Mean Inflectra Trough Level (IFX-TL) (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Before every infusion occurred during: inclusion visit up to 6-Month visit; 6-Month visit up to 12-Month visit; 12-Month visit up to 18-Month visit, and 18-Month visit up to 24-Month visit | Trough level was plasma concentration of drug before infusion. In this outcome measure mean of all IFX-TLs for all infusions occurring during specified duration is reported. |
| Number of Participants With Presence of Anti-infliximab Antibodies at Inclusion Visit | Baseline (data recorded at inclusion visit) | — |
| Mean Administered Dose of Inflectra (in mg) | 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. |
| Mean Time Between Infusions | 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 Administered Posology of Inflectra (in mg/kg) | 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). |
| Cumulative Dose | 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. |
| Mean Infusion Time | 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. |
| Mean Duration of Post-infusion Monitoring at the Hospital | 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. |
| Absolute Variation in Mean Disease Activity Score (DAS) 28 Compared With Baseline at Month 6, 12, 18, and 24 | Baseline (Inclusion Visit), Month 6, 12, 18, and 24 | DAS28 score was evaluated in participants with RA and PA. DAS28 is calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (in millimeters per hour \[mm/hour\]) and participant's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with scores ranging 0 to 10; higher scores indicated high disease activity). DAS28 was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR \[mm/first hour\] + 0.014 (PtGA \[mm\]). Total score range: 0-9.4. DAS 28 score \<=2.6 indicated remission in disease, score between \>2.6 and \<=3.2 indicated mildly active disease, score between \>3.2 and \<=2.6 indicated moderately active disease, and score \>5.1 indicated very active disease. Absolute variation = mean result of laboratory test during period in question - result of laboratory test at baseline. |
| Absolute Variation in Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score Compared With Baseline at Month 6, 12, 18, and 24 | Baseline (Inclusion Visit), Month 6, 12, 18, and 24 | BASDAI is a set of 6 questions to determine disease activity in participant with SpA. Participants answered each 6 questions on a scale of 0 (no problem) to 10 (the worst problem). The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score is then divided by 5. BASDAI score = (Q1 + Q2 + Q3+ Q4+ \[Q5 + Q6/2\])/5. BASDAI score ranges from 0 (best) to 10 (worst), where higher scores meant worse condition. BASDAI score \>4 indicated SpA active, and score \<=4 indicated SpA inactive. Absolute variation = mean result of laboratory test during period in question - result of laboratory test at baseline. |
| Absolute Variation in Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Score Compared With Baseline at Month 6, 12, 18, and 24 | Baseline (Inclusion Visit), Month 6, 12, 18, and 24 | BASFI is a set of 10 questions to determine degree of functional limitation in participants with SpA. Participants answered each 10 questions on a scale of 0 (no functional impairment) to 10 (maximal impairment). BASFI score was calculated as mean of scores from 10 questions. BASFI score ranged from 0 (no functional impairment) to 10 (maximal impairment), where higher scores meant worse condition. Score \>4 indicated significant functional impairment, and score \<=4 indicated mild functional impairment. Absolute variation = mean result of laboratory test during period in question - result of laboratory test at baseline. |
Countries
France
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Crohn's Disease (CD) 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. | 547 |
| 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. | 230 |
| 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. | 142 |
| 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. | 411 |
| 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. | 96 |
| Total | 1,426 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 2 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 30 | 10 | 1 | 16 | 3 |
| 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 |
| Overall Study | Withdrawal by Subject | 3 | 0 | 3 | 2 | 2 |
Baseline characteristics
| Characteristic | Crohn's Disease (CD) | Ulcerative Colitis (UC) | Rheumatoid Arthritis (RA) | Ankylosing Spondylitis (SpA) | Psoriatic Arthritis (PA) | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 37.4 Years STANDARD_DEVIATION 14.2 | 42.3 Years STANDARD_DEVIATION 17.9 | 61.5 Years STANDARD_DEVIATION 10.9 | 48.1 Years STANDARD_DEVIATION 13.1 | 53.4 Years STANDARD_DEVIATION 14.1 | 44.8 Years STANDARD_DEVIATION 16.2 |
| Body Mass Index (BMI) | 24.01 Kg/m^2 STANDARD_DEVIATION 5.52 | 24.29 Kg/m^2 STANDARD_DEVIATION 4.72 | 27.12 Kg/m^2 STANDARD_DEVIATION 5.68 | 26.52 Kg/m^2 STANDARD_DEVIATION 5.44 | 29.26 Kg/m^2 STANDARD_DEVIATION 6.71 | 25.42 Kg/m^2 STANDARD_DEVIATION 5.71 |
| Race and Ethnicity Not Collected | — | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 281 Participants | 103 Participants | 107 Participants | 169 Participants | 56 Participants | 716 Participants |
| Sex: Female, Male Male | 266 Participants | 127 Participants | 35 Participants | 242 Participants | 40 Participants | 710 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 547 | 2 / 230 | 1 / 142 | 0 / 411 | 0 / 96 |
| other Total, other adverse events | 252 / 547 | 91 / 230 | 62 / 142 | 219 / 411 | 49 / 96 |
| serious Total, serious adverse events | 73 / 547 | 28 / 230 | 20 / 142 | 47 / 411 | 10 / 96 |
Outcome results
Primary
Duration of Previous Biotherapies
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.
Time frame: Data collected and recorded at study inclusion visit
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 with non-missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crohn's Disease (CD) | Duration of Previous Biotherapies | 51.3 Months | Standard Deviation 43.1 |
| Ulcerative Colitis (UC) | Duration of Previous Biotherapies | 33.2 Months | Standard Deviation 38.2 |
| Rheumatoid Arthritis (RA) | Duration of Previous Biotherapies | 81.0 Months | Standard Deviation 55.8 |
| Ankylosing Spondylitis (SpA) | Duration of Previous Biotherapies | 73.1 Months | Standard Deviation 51.2 |
| Psoriatic Arthritis (PA) | Duration of Previous Biotherapies | 70.4 Months | Standard Deviation 60.7 |
Primary
Last Dosage Administered of a Previous Biotherapy
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.
Time frame: Data collected and recorded at study inclusion visit
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 with non-missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crohn's Disease (CD) | Last Dosage Administered of a Previous Biotherapy | 104.4 Units | Standard Deviation 193.3 |
| Ulcerative Colitis (UC) | Last Dosage Administered of a Previous Biotherapy | 86.8 Units | Standard Deviation 127.2 |
| Rheumatoid Arthritis (RA) | Last Dosage Administered of a Previous Biotherapy | 204.8 Units | Standard Deviation 255.5 |
| Ankylosing Spondylitis (SpA) | Last Dosage Administered of a Previous Biotherapy | 216.7 Units | Standard Deviation 218 |
| Psoriatic Arthritis (PA) | Last Dosage Administered of a Previous Biotherapy | 238.4 Units | Standard Deviation 227.9 |
Primary
Mean of Number of Doses Administered in Previous Biotherapy
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.
Time frame: Data collected and recorded at study inclusion visit
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 with non-missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crohn's Disease (CD) | Mean of Number of Doses Administered in Previous Biotherapy | 38.2 Dose | Standard Deviation 48.1 |
| Ulcerative Colitis (UC) | Mean of Number of Doses Administered in Previous Biotherapy | 26.5 Dose | Standard Deviation 24.5 |
| Rheumatoid Arthritis (RA) | Mean of Number of Doses Administered in Previous Biotherapy | 33.5 Dose | Standard Deviation 30.1 |
| Ankylosing Spondylitis (SpA) | Mean of Number of Doses Administered in Previous Biotherapy | 39.2 Dose | Standard Deviation 55.6 |
| Psoriatic Arthritis (PA) | Mean of Number of Doses Administered in Previous Biotherapy | 24.3 Dose | Standard Deviation 26.6 |
Primary
Number of Participants Who Received Biotherapy Other Than Inflectra Before Inclusion in the Study
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.
Time frame: Data collected and recorded at study inclusion visit
Population: Analysis population included all enrolled participants treated with Inflectra.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crohn's Disease (CD) | Number of Participants Who Received Biotherapy Other Than Inflectra Before Inclusion in the Study | Missing Data | 4 Participants |
| Crohn's Disease (CD) | Number of Participants Who Received Biotherapy Other Than Inflectra Before Inclusion in the Study | Received Biotherapy | 347 Participants |
| Ulcerative Colitis (UC) | Number of Participants Who Received Biotherapy Other Than Inflectra Before Inclusion in the Study | Missing Data | 2 Participants |
| Ulcerative Colitis (UC) | Number of Participants Who Received Biotherapy Other Than Inflectra Before Inclusion in the Study | Received Biotherapy | 146 Participants |
| Rheumatoid Arthritis (RA) | Number of Participants Who Received Biotherapy Other Than Inflectra Before Inclusion in the Study | Received Biotherapy | 116 Participants |
| Rheumatoid Arthritis (RA) | Number of Participants Who Received Biotherapy Other Than Inflectra Before Inclusion in the Study | Missing Data | 0 Participants |
| Ankylosing Spondylitis (SpA) | Number of Participants Who Received Biotherapy Other Than Inflectra Before Inclusion in the Study | Received Biotherapy | 344 Participants |
| Ankylosing Spondylitis (SpA) | Number of Participants Who Received Biotherapy Other Than Inflectra Before Inclusion in the Study | Missing Data | 0 Participants |
| Psoriatic Arthritis (PA) | Number of Participants Who Received Biotherapy Other Than Inflectra Before Inclusion in the Study | Missing Data | 0 Participants |
| Psoriatic Arthritis (PA) | Number of Participants Who Received Biotherapy Other Than Inflectra Before Inclusion in the Study | Received Biotherapy | 81 Participants |
Primary
Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra
Following concomitant treatments were received by participants before initiation of Inflectra: 1) Corticosteroids, 2) Salicylates, and 3) Azathioprine/6-MP, Methotrexate, and Cyclosporine.
Time frame: Data collected and recorded at study inclusion visit
Population: Analysis population included all enrolled participants treated with Inflectra.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Crohn's Disease (CD) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Azathioprine/6-MP; Methotrexate; Cyclosporine | No | 144 Participants |
| Crohn's Disease (CD) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Salicylates | Yes | 202 Participants |
| Crohn's Disease (CD) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Azathioprine/6-MP; Methotrexate; Cyclosporine | Missing | 5 Participants |
| Crohn's Disease (CD) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Corticosteroids | No | 440 Participants |
| Crohn's Disease (CD) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Azathioprine/6-MP; Methotrexate; Cyclosporine | Yes | 398 Participants |
| Crohn's Disease (CD) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Corticosteroids | Yes | 102 Participants |
| Crohn's Disease (CD) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Salicylates | Missing | 6 Participants |
| Crohn's Disease (CD) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Corticosteroids | Missing | 5 Participants |
| Crohn's Disease (CD) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Salicylates | No | 339 Participants |
| Ulcerative Colitis (UC) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Corticosteroids | No | 162 Participants |
| Ulcerative Colitis (UC) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Azathioprine/6-MP; Methotrexate; Cyclosporine | Yes | 167 Participants |
| Ulcerative Colitis (UC) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Azathioprine/6-MP; Methotrexate; Cyclosporine | No | 62 Participants |
| Ulcerative Colitis (UC) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Corticosteroids | Missing | 1 Participants |
| Ulcerative Colitis (UC) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Corticosteroids | Yes | 67 Participants |
| Ulcerative Colitis (UC) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Salicylates | No | 70 Participants |
| Ulcerative Colitis (UC) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Salicylates | Missing | 1 Participants |
| Ulcerative Colitis (UC) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Salicylates | Yes | 159 Participants |
| Ulcerative Colitis (UC) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Azathioprine/6-MP; Methotrexate; Cyclosporine | Missing | 1 Participants |
| Rheumatoid Arthritis (RA) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Azathioprine/6-MP; Methotrexate; Cyclosporine | Missing | 0 Participants |
| Rheumatoid Arthritis (RA) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Corticosteroids | No | 83 Participants |
| Rheumatoid Arthritis (RA) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Salicylates | Missing | 0 Participants |
| Rheumatoid Arthritis (RA) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Salicylates | No | 131 Participants |
| Rheumatoid Arthritis (RA) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Salicylates | Yes | 11 Participants |
| Rheumatoid Arthritis (RA) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Corticosteroids | Missing | 0 Participants |
| Rheumatoid Arthritis (RA) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Corticosteroids | Yes | 59 Participants |
| Rheumatoid Arthritis (RA) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Azathioprine/6-MP; Methotrexate; Cyclosporine | Yes | 125 Participants |
| Rheumatoid Arthritis (RA) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Azathioprine/6-MP; Methotrexate; Cyclosporine | No | 17 Participants |
| Ankylosing Spondylitis (SpA) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Azathioprine/6-MP; Methotrexate; Cyclosporine | No | 224 Participants |
| Ankylosing Spondylitis (SpA) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Azathioprine/6-MP; Methotrexate; Cyclosporine | Missing | 0 Participants |
| Ankylosing Spondylitis (SpA) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Corticosteroids | Missing | 0 Participants |
| Ankylosing Spondylitis (SpA) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Corticosteroids | No | 373 Participants |
| Ankylosing Spondylitis (SpA) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Corticosteroids | Yes | 38 Participants |
| Ankylosing Spondylitis (SpA) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Salicylates | Missing | 1 Participants |
| Ankylosing Spondylitis (SpA) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Salicylates | No | 359 Participants |
| Ankylosing Spondylitis (SpA) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Salicylates | Yes | 51 Participants |
| Ankylosing Spondylitis (SpA) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Azathioprine/6-MP; Methotrexate; Cyclosporine | Yes | 187 Participants |
| Psoriatic Arthritis (PA) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Salicylates | No | 90 Participants |
| Psoriatic Arthritis (PA) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Salicylates | Missing | 0 Participants |
| Psoriatic Arthritis (PA) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Corticosteroids | Yes | 14 Participants |
| Psoriatic Arthritis (PA) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Corticosteroids | Missing | 0 Participants |
| Psoriatic Arthritis (PA) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Azathioprine/6-MP; Methotrexate; Cyclosporine | No | 22 Participants |
| Psoriatic Arthritis (PA) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Corticosteroids | No | 82 Participants |
| Psoriatic Arthritis (PA) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Azathioprine/6-MP; Methotrexate; Cyclosporine | Missing | 0 Participants |
| Psoriatic Arthritis (PA) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Azathioprine/6-MP; Methotrexate; Cyclosporine | Yes | 74 Participants |
| Psoriatic Arthritis (PA) | Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra | Salicylates | Yes | 6 Participants |
Primary
Number of Participants With Pre-treatment Assessment Prior to Initiation of Inflectra Treatment (Anti-Tumor Necrosis Factor [TNF] Aplha) Therapy
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.
Time frame: Data collected and recorded at study inclusion visit
Population: Analysis population included all enrolled participants treated with Inflectra.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crohn's Disease (CD) | Number of Participants With Pre-treatment Assessment Prior to Initiation of Inflectra Treatment (Anti-Tumor Necrosis Factor [TNF] Aplha) Therapy | Missing Data | 5 Participants |
| Crohn's Disease (CD) | Number of Participants With Pre-treatment Assessment Prior to Initiation of Inflectra Treatment (Anti-Tumor Necrosis Factor [TNF] Aplha) Therapy | Had Pre-treatment Assessment | 458 Participants |
| Ulcerative Colitis (UC) | Number of Participants With Pre-treatment Assessment Prior to Initiation of Inflectra Treatment (Anti-Tumor Necrosis Factor [TNF] Aplha) Therapy | Missing Data | 4 Participants |
| Ulcerative Colitis (UC) | Number of Participants With Pre-treatment Assessment Prior to Initiation of Inflectra Treatment (Anti-Tumor Necrosis Factor [TNF] Aplha) Therapy | Had Pre-treatment Assessment | 177 Participants |
| Rheumatoid Arthritis (RA) | Number of Participants With Pre-treatment Assessment Prior to Initiation of Inflectra Treatment (Anti-Tumor Necrosis Factor [TNF] Aplha) Therapy | Had Pre-treatment Assessment | 118 Participants |
| Rheumatoid Arthritis (RA) | Number of Participants With Pre-treatment Assessment Prior to Initiation of Inflectra Treatment (Anti-Tumor Necrosis Factor [TNF] Aplha) Therapy | Missing Data | 2 Participants |
| Ankylosing Spondylitis (SpA) | 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 |
| Ankylosing Spondylitis (SpA) | Number of Participants With Pre-treatment Assessment Prior to Initiation of Inflectra Treatment (Anti-Tumor Necrosis Factor [TNF] Aplha) Therapy | Missing Data | 2 Participants |
| Psoriatic Arthritis (PA) | Number of Participants With Pre-treatment Assessment Prior to Initiation of Inflectra Treatment (Anti-Tumor Necrosis Factor [TNF] Aplha) Therapy | Missing Data | 0 Participants |
| Psoriatic Arthritis (PA) | Number of Participants With Pre-treatment Assessment Prior to Initiation of Inflectra Treatment (Anti-Tumor Necrosis Factor [TNF] Aplha) Therapy | Had Pre-treatment Assessment | 86 Participants |
Primary
Number of Participants With Reasons for Discontinuation of Previous Biotherapy
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.
Time frame: Data collected and recorded at study inclusion visit
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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crohn's Disease (CD) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Intolerance | 42 Participants |
| Crohn's Disease (CD) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Remission | 0 Participants |
| Crohn's Disease (CD) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Missing | 13 Participants |
| Crohn's Disease (CD) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Other | 23 Participants |
| Crohn's Disease (CD) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Loss of Efficacy | 80 Participants |
| Crohn's Disease (CD) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Switch Inflectra | 164 Participants |
| Crohn's Disease (CD) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Primary Non-response | 25 Participants |
| Ulcerative Colitis (UC) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Remission | 0 Participants |
| Ulcerative Colitis (UC) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Loss of Efficacy | 35 Participants |
| Ulcerative Colitis (UC) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Intolerance | 5 Participants |
| Ulcerative Colitis (UC) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Other | 9 Participants |
| Ulcerative Colitis (UC) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Missing | 5 Participants |
| Ulcerative Colitis (UC) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Primary Non-response | 40 Participants |
| Ulcerative Colitis (UC) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Switch Inflectra | 52 Participants |
| Rheumatoid Arthritis (RA) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Missing | 5 Participants |
| Rheumatoid Arthritis (RA) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Loss of Efficacy | 19 Participants |
| Rheumatoid Arthritis (RA) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Primary Non-response | 16 Participants |
| Rheumatoid Arthritis (RA) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Intolerance | 9 Participants |
| Rheumatoid Arthritis (RA) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Remission | 0 Participants |
| Rheumatoid Arthritis (RA) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Switch Inflectra | 57 Participants |
| Rheumatoid Arthritis (RA) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Other | 10 Participants |
| Ankylosing Spondylitis (SpA) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Primary Non-response | 49 Participants |
| Ankylosing Spondylitis (SpA) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Remission | 0 Participants |
| Ankylosing Spondylitis (SpA) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Loss of Efficacy | 52 Participants |
| Ankylosing Spondylitis (SpA) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Other | 25 Participants |
| Ankylosing Spondylitis (SpA) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Switch Inflectra | 166 Participants |
| Ankylosing Spondylitis (SpA) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Missing | 29 Participants |
| Ankylosing Spondylitis (SpA) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Intolerance | 23 Participants |
| Psoriatic Arthritis (PA) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Loss of Efficacy | 14 Participants |
| Psoriatic Arthritis (PA) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Other | 9 Participants |
| Psoriatic Arthritis (PA) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Switch Inflectra | 32 Participants |
| Psoriatic Arthritis (PA) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Remission | 1 Participants |
| Psoriatic Arthritis (PA) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Intolerance | 9 Participants |
| Psoriatic Arthritis (PA) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Missing | 6 Participants |
| Psoriatic Arthritis (PA) | Number of Participants With Reasons for Discontinuation of Previous Biotherapy | Primary Non-response | 10 Participants |
Primary
Percentage of Participants Without Treatment Failure During 2-Years of Observation
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.
Time frame: 2 years post inclusion in the study
Population: Analysis population included all enrolled participants treated with Inflectra.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Crohn's Disease (CD) | Percentage of Participants Without Treatment Failure During 2-Years of Observation | Missing Data | 19.2 Percentage of participants |
| Crohn's Disease (CD) | Percentage of Participants Without Treatment Failure During 2-Years of Observation | Without Treatment Failure | 59.2 Percentage of participants |
| Ulcerative Colitis (UC) | Percentage of Participants Without Treatment Failure During 2-Years of Observation | Without Treatment Failure | 53.5 Percentage of participants |
| Ulcerative Colitis (UC) | Percentage of Participants Without Treatment Failure During 2-Years of Observation | Missing Data | 21.3 Percentage of participants |
| Rheumatoid Arthritis (RA) | Percentage of Participants Without Treatment Failure During 2-Years of Observation | Without Treatment Failure | 53.5 Percentage of participants |
| Rheumatoid Arthritis (RA) | Percentage of Participants Without Treatment Failure During 2-Years of Observation | Missing Data | 7.7 Percentage of participants |
| Ankylosing Spondylitis (SpA) | Percentage of Participants Without Treatment Failure During 2-Years of Observation | Missing Data | 14.4 Percentage of participants |
| Ankylosing Spondylitis (SpA) | Percentage of Participants Without Treatment Failure During 2-Years of Observation | Without Treatment Failure | 61.1 Percentage of participants |
| Psoriatic Arthritis (PA) | Percentage of Participants Without Treatment Failure During 2-Years of Observation | Without Treatment Failure | 64.6 Percentage of participants |
| Psoriatic Arthritis (PA) | Percentage of Participants Without Treatment Failure During 2-Years of Observation | Missing Data | 9.4 Percentage of participants |
Primary
Time Between Diagnosis and Inclusion in Study
Time frame: Data collected and recorded at study inclusion visit
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 with non-missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crohn's Disease (CD) | Time Between Diagnosis and Inclusion in Study | 10.05 Years | Standard Deviation 9.51 |
| Ulcerative Colitis (UC) | Time Between Diagnosis and Inclusion in Study | 8.77 Years | Standard Deviation 8.56 |
| Rheumatoid Arthritis (RA) | Time Between Diagnosis and Inclusion in Study | 15.18 Years | Standard Deviation 10.13 |
| Ankylosing Spondylitis (SpA) | Time Between Diagnosis and Inclusion in Study | 13.58 Years | Standard Deviation 10.26 |
| Psoriatic Arthritis (PA) | Time Between Diagnosis and Inclusion in Study | 11.50 Years | Standard Deviation 8.42 |
Primary
Time Between Diagnosis and the First Inflectra Infusion
Time frame: Data collected and recorded at study inclusion visit
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 with non-missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crohn's Disease (CD) | Time Between Diagnosis and the First Inflectra Infusion | 9.37 Years | Standard Deviation 9.67 |
| Ulcerative Colitis (UC) | Time Between Diagnosis and the First Inflectra Infusion | 8.22 Years | Standard Deviation 8.66 |
| Rheumatoid Arthritis (RA) | Time Between Diagnosis and the First Inflectra Infusion | 14.39 Years | Standard Deviation 10.11 |
| Ankylosing Spondylitis (SpA) | Time Between Diagnosis and the First Inflectra Infusion | 12.80 Years | Standard Deviation 10.29 |
| Psoriatic Arthritis (PA) | Time Between Diagnosis and the First Inflectra Infusion | 10.78 Years | Standard Deviation 8.42 |
Secondary
Absolute Variation in Mean Ankylosing Spondylitis Disease Activity Score (ASDAS) Score Compared With Baseline at Month 6, 12, 18, and 24
ASDAS score was evaluated for indication SpA. 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 \[not active\] to 10 \[very active\]), and CRP in mg/L. ASDAS total score ranged from 0 (no disease) to 10 (maximum severity), higher score indicates greater severity of disease and was derived using the following formula: ASDAS =0.12\*Q1 + 0.06\*Q2 + 0.11\* PtGA + 0.07\*Q3 + 0.58\*ln (CRP+1). ASDAS score \<1.3 indicated SpA inactive, ASDAS score \>=1.3 and/or \<2.1 indicated SpA mildly active, ASDAS score \>=2.1 and/or \<=3.5 indicated SpA moderately active, and ASDAS score \>3.5 indicated SpA very active. Absolute variation = mean result of laboratory test during period in question - result of laboratory test at baseline.
Time frame: Baseline (Inclusion Visit), Month 6, 12, 18, and 24
Population: Analysis population included all enrolled participants treated with Inflectra. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows. Analysis for this outcome measure was planned for participants with indication SpA, and not for participants with RA, PA, CD, UC.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease (CD) | Absolute Variation in Mean Ankylosing Spondylitis Disease Activity Score (ASDAS) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 6 | -0.1 Units on a scale | Standard Deviation 0.7 |
| Crohn's Disease (CD) | Absolute Variation in Mean Ankylosing Spondylitis Disease Activity Score (ASDAS) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 12 | -0.1 Units on a scale | Standard Deviation 0.7 |
| Crohn's Disease (CD) | Absolute Variation in Mean Ankylosing Spondylitis Disease Activity Score (ASDAS) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 18 | -0.2 Units on a scale | Standard Deviation 0.9 |
| Crohn's Disease (CD) | Absolute Variation in Mean Ankylosing Spondylitis Disease Activity Score (ASDAS) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 24 | -0.2 Units on a scale | Standard Deviation 0.8 |
Secondary
Absolute Variation in Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score Compared With Baseline at Month 6, 12, 18, and 24
BASDAI is a set of 6 questions to determine disease activity in participant with SpA. Participants answered each 6 questions on a scale of 0 (no problem) to 10 (the worst problem). The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score is then divided by 5. BASDAI score = (Q1 + Q2 + Q3+ Q4+ \[Q5 + Q6/2\])/5. BASDAI score ranges from 0 (best) to 10 (worst), where higher scores meant worse condition. BASDAI score \>4 indicated SpA active, and score \<=4 indicated SpA inactive. Absolute variation = mean result of laboratory test during period in question - result of laboratory test at baseline.
Time frame: Baseline (Inclusion Visit), Month 6, 12, 18, and 24
Population: Analysis population included all enrolled participants treated with Inflectra. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows. Analysis for this outcome measure was planned for participants with indications SpA and not for participants with RA, PA, CD and UC.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease (CD) | Absolute Variation in Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 6 | -0.1 Units on a scale | Standard Deviation 1.7 |
| Crohn's Disease (CD) | Absolute Variation in Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 12 | -0.2 Units on a scale | Standard Deviation 1.7 |
| Crohn's Disease (CD) | Absolute Variation in Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 18 | -0.2 Units on a scale | Standard Deviation 1.8 |
| Crohn's Disease (CD) | Absolute Variation in Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 24 | -0.3 Units on a scale | Standard Deviation 2 |
Secondary
Absolute Variation in Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Score Compared With Baseline at Month 6, 12, 18, and 24
BASFI is a set of 10 questions to determine degree of functional limitation in participants with SpA. Participants answered each 10 questions on a scale of 0 (no functional impairment) to 10 (maximal impairment). BASFI score was calculated as mean of scores from 10 questions. BASFI score ranged from 0 (no functional impairment) to 10 (maximal impairment), where higher scores meant worse condition. Score \>4 indicated significant functional impairment, and score \<=4 indicated mild functional impairment. Absolute variation = mean result of laboratory test during period in question - result of laboratory test at baseline.
Time frame: Baseline (Inclusion Visit), Month 6, 12, 18, and 24
Population: Analysis population included all enrolled participants treated with Inflectra. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows. Analysis for this outcome measure was planned for participants with indications SpA and not for participants with RA, PA, CD and UC.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease (CD) | Absolute Variation in Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 12 | -0.2 Units on a scale | Standard Deviation 1.6 |
| Crohn's Disease (CD) | Absolute Variation in Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 18 | -0.0 Units on a scale | Standard Deviation 1.8 |
| Crohn's Disease (CD) | Absolute Variation in Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 6 | -0.1 Units on a scale | Standard Deviation 1.4 |
| Crohn's Disease (CD) | Absolute Variation in Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 24 | 0.1 Units on a scale | Standard Deviation 1.9 |
Secondary
Absolute Variation in Mean Colitis Endoscopic Index of Severity (UCEIS) Score Compared With Baseline at Month 6, 12, 18, and 24
UCEIS score was evaluated in participants with indication UC. It had 3 sub-scales: endoscopic vascular pattern (scored 0 \[normal pattern\] to 2 \[complete obliteration of vascular pattern\]), bleeding (scored 0 \[none\] to 3 \[luminal moderate or severe\]), erosions and ulcerations (scored 0 \[none\] to 3 \[deep ulcers\]). UCEIS total score was calculated by sum of all 3 sub-scale scores. Total score ranged from 0 (remission in disease) to 8 (extreme severity of disease), with higher scores indicating more severe disease. Absolute variation = mean result of laboratory test during period in question - result of laboratory test at baseline.
Time frame: Baseline (Inclusion Visit), Month 6, 12, 18, and 24
Population: Analysis population included all enrolled participants treated with Inflectra. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows. Analysis for this outcome measure was planned for participants with indications UC and not for participants with RA, SpA, PA and CD.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease (CD) | Absolute Variation in Mean Colitis Endoscopic Index of Severity (UCEIS) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 12 | -0.80 Units on a scale | Standard Deviation 3.71 |
| Crohn's Disease (CD) | Absolute Variation in Mean Colitis Endoscopic Index of Severity (UCEIS) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 6 | 0.25 Units on a scale | Standard Deviation 4.2 |
| Crohn's Disease (CD) | Absolute Variation in Mean Colitis Endoscopic Index of Severity (UCEIS) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 18 | 0.00 Units on a scale | Standard Deviation 2.62 |
| Crohn's Disease (CD) | Absolute Variation in Mean Colitis Endoscopic Index of Severity (UCEIS) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 24 | -2.50 Units on a scale | Standard Deviation 2.38 |
Secondary
Absolute Variation in Mean Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Compared With Baseline at Month 6, 12, 18, and 24
CDEIS is an index for determining the severity of CD with endoscopic localization to ileum and colon. CDEIS considered 4 parameters: deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis. These 4 parameters were evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). CDEIS score ranged from 0 (no lesions) to 44 (severe lesions) where higher scores indicate more severity. CDEIS score \<=7 indicated Endoscopic remission, and score \>7 indicated Absence of endoscopic remission. Absolute variation = mean result of laboratory test during period in question - result of laboratory test at baseline.
Time frame: Baseline (Inclusion Visit), Month 6, 12, 18, and 24
Population: Analysis population included all enrolled participants treated with Inflectra. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows. Analysis for this outcome measure was planned for participants with indications CD and not for participants with RA, SpA, PA, UC.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease (CD) | Absolute Variation in Mean Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 6 | -2.35 Units on a scale | Standard Deviation 4.03 |
| Crohn's Disease (CD) | Absolute Variation in Mean Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 12 | -5.98 Units on a scale | Standard Deviation 7.4 |
| Crohn's Disease (CD) | Absolute Variation in Mean Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 18 | -1.37 Units on a scale | Standard Deviation 1.5 |
Secondary
Absolute Variation in Mean Disease Activity Score (DAS) 28 Compared With Baseline at Month 6, 12, 18, and 24
DAS28 score was evaluated in participants with RA and PA. DAS28 is calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (in millimeters per hour \[mm/hour\]) and participant's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with scores ranging 0 to 10; higher scores indicated high disease activity). DAS28 was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR \[mm/first hour\] + 0.014 (PtGA \[mm\]). Total score range: 0-9.4. DAS 28 score \<=2.6 indicated remission in disease, score between \>2.6 and \<=3.2 indicated mildly active disease, score between \>3.2 and \<=2.6 indicated moderately active disease, and score \>5.1 indicated very active disease. Absolute variation = mean result of laboratory test during period in question - result of laboratory test at baseline.
Time frame: Baseline (Inclusion Visit), Month 6, 12, 18, and 24
Population: Analysis population included all enrolled participants treated with Inflectra. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows. Analysis for this outcome measure was planned for participants with indications RA, PA and not for participants with SpA, CD, UC.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease (CD) | Absolute Variation in Mean Disease Activity Score (DAS) 28 Compared With Baseline at Month 6, 12, 18, and 24 | Month 6 | -0.1 Units on a scale | Standard Deviation 0.9 |
| Crohn's Disease (CD) | Absolute Variation in Mean Disease Activity Score (DAS) 28 Compared With Baseline at Month 6, 12, 18, and 24 | Month 12 | -0.2 Units on a scale | Standard Deviation 1.1 |
| Crohn's Disease (CD) | Absolute Variation in Mean Disease Activity Score (DAS) 28 Compared With Baseline at Month 6, 12, 18, and 24 | Month 18 | -0.2 Units on a scale | Standard Deviation 1.3 |
| Crohn's Disease (CD) | Absolute Variation in Mean Disease Activity Score (DAS) 28 Compared With Baseline at Month 6, 12, 18, and 24 | Month 24 | -0.1 Units on a scale | Standard Deviation 1.3 |
| Ulcerative Colitis (UC) | Absolute Variation in Mean Disease Activity Score (DAS) 28 Compared With Baseline at Month 6, 12, 18, and 24 | Month 24 | -0.1 Units on a scale | Standard Deviation 1.4 |
| Ulcerative Colitis (UC) | Absolute Variation in Mean Disease Activity Score (DAS) 28 Compared With Baseline at Month 6, 12, 18, and 24 | Month 6 | -0.2 Units on a scale | Standard Deviation 1.1 |
| Ulcerative Colitis (UC) | Absolute Variation in Mean Disease Activity Score (DAS) 28 Compared With Baseline at Month 6, 12, 18, and 24 | Month 18 | -0.2 Units on a scale | Standard Deviation 1.2 |
| Ulcerative Colitis (UC) | Absolute Variation in Mean Disease Activity Score (DAS) 28 Compared With Baseline at Month 6, 12, 18, and 24 | Month 12 | -0.3 Units on a scale | Standard Deviation 1.1 |
Secondary
Absolute Variation in Mean Harvey-Bradshaw Score Compared With Baseline at Month 6, 12, 18, and 24
Harvey-Bradshaw score was evaluated for indication CD. Harvey-Bradshaw measures 5 parameters; general well-being (0= very well to 4= terrible), abdominal pain (0= none to 3= severe), number of liquid stools per day (0 to no maximum score), presence of an abdominal mass on physical exam (0= none to 3= definite and tender), and whether there are any complications (0= no complications, 1= arthralgia, 2= uveitis, 3= erythema nodosum, 4= aphthous ulcer, 5= pyoderma gangrenosum, 6= anal fissure, 7= new fistula, 8= abscess). Total HBI score: sum of all 5 individual parameters, minimum score is 0 and there was no pre-specified maximum score as it depended on number of liquids stools. Higher HBI scores = greater disease activity score \<4 indicated Inactive disease, score \>=4 and/or \<=12 indicated Active disease, and score \>12 indicated Very active disease. Absolute variation = mean result of laboratory test during period in question - result of laboratory test at baseline.
Time frame: Baseline (Inclusion Visit), Month 6, 12, 18, and 24
Population: Analysis population included all enrolled participants treated with Inflectra. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows. Analysis for this outcome measure was planned for participants with indications CD and not for participants with RA, SpA, PA, UC.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease (CD) | Absolute Variation in Mean Harvey-Bradshaw Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 6 | -0.1 Units on a scale | Standard Deviation 2.4 |
| Crohn's Disease (CD) | Absolute Variation in Mean Harvey-Bradshaw Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 12 | -0.2 Units on a scale | Standard Deviation 2.3 |
| Crohn's Disease (CD) | Absolute Variation in Mean Harvey-Bradshaw Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 18 | -0.4 Units on a scale | Standard Deviation 2.2 |
| Crohn's Disease (CD) | Absolute Variation in Mean Harvey-Bradshaw Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 24 | -0.6 Units on a scale | Standard Deviation 2.5 |
Secondary
Absolute Variation in Mean Health Assessment Questionnaire (HAQ) Score Compared With Baseline at Month 6, 12, 18, and 24
HAQ score was evaluated for indication RA. HAQ assesses degree of difficulty participant had experienced during past week in 8 domains of daily activities: dressing & grooming, arising, eating, walking, hygiene, reach, grip and other activities. For each question in questionnaire, level of difficulty was scored from 0 (no difficulty) to 3 (unable to do). Any activity requiring assistance from another individual or required use of assistive device would adjust to minimum score of 2 to represent more limited functional status. Overall score = sum of scores divided by number of domains answered. Total possible score range was 0 (no difficulty) to 3 (unable to do). Higher score = more difficulty in performing daily living activities. HAQ score \>0.5 indicated Existence of functional disability & HAQ score \<=0.5 indicated Absence of functional disability. Absolute variation = mean result of laboratory test during period in question - result of laboratory test at baseline.
Time frame: Baseline (Inclusion Visit), Month 6, 12, 18, and 24
Population: Analysis population included all enrolled participants treated with Inflectra. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows. Analysis for this outcome measure was planned for participants with indication RA, and not for participants with SpA, PA, CD, UC.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease (CD) | Absolute Variation in Mean Health Assessment Questionnaire (HAQ) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 6 | -0.3 Units on a scale | Standard Deviation 0.1 |
| Crohn's Disease (CD) | Absolute Variation in Mean Health Assessment Questionnaire (HAQ) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 12 | 0.0 Units on a scale | Standard Deviation 0.4 |
| Crohn's Disease (CD) | Absolute Variation in Mean Health Assessment Questionnaire (HAQ) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 18 | -0.2 Units on a scale | Standard Deviation 0.5 |
| Crohn's Disease (CD) | Absolute Variation in Mean Health Assessment Questionnaire (HAQ) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 24 | 0.4 Units on a scale | Standard Deviation 0.6 |
Secondary
Absolute Variation in Mean Mayo Score Compared With Baseline at Month 6, 12, 18, and 24
Mayo score was evaluated in participants with UC. Mayo score consists of 4 items (stool frequency, rectal bleeding, findings of endoscopy, physician global assessment), each graded from 0 (no severity) to 3 (maximum severity), with higher scores indicating more severe disease. Total score was sum of 4 items resulting in a score range of 0 (no severity) to 12 (maximum severity), where higher score indicated increased severity. Score \<=2 indicated UC inactive, score between \>=3 and \<=5 indicated mild UC, score between \>=6 and \<=10 indicated moderate UC, and score \>11 indicated severe UC. Absolute variation = mean result of laboratory test during period in question - result of laboratory test at baseline.
Time frame: Baseline (Inclusion Visit), Month 6, 12, 18, and 24
Population: Analysis population included all enrolled participants treated with Inflectra. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows. Analysis for this outcome measure was planned for participants with indications UC and not for participants with RA, PA, SpA and CD.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease (CD) | Absolute Variation in Mean Mayo Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 6 | -0.7 Units on a scale | Standard Deviation 2.3 |
| Crohn's Disease (CD) | Absolute Variation in Mean Mayo Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 12 | -1.3 Units on a scale | Standard Deviation 2.6 |
| Crohn's Disease (CD) | Absolute Variation in Mean Mayo Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 18 | -1.2 Units on a scale | Standard Deviation 3.3 |
| Crohn's Disease (CD) | Absolute Variation in Mean Mayo Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 24 | -1.4 Units on a scale | Standard Deviation 2.9 |
Secondary
Absolute Variation in Mean Pediatric Ulcerative Colitis Activity Index (PUCAI) Score Compared With Baseline at Month 6, 12, 18, and 24
PUCAI score was intended for pediatric participants with UC. PUCAI had 6 items with scores as: abdominal pain (no pain =0, pain can be ignored =5, pain cannot be ignored =10); rectal bleeding (none =0, small amount only \[in less than 50% of stools\] =10, small amount with most stools =20, large amount \[\>50% of the stool content\] =30); stool consistency of most stools (formed =0, partially formed =5, completely unformed =10); number of stools per 24 hours (0-2 =0, 3-5 =5, 6-8 =10, \>8 =15); nocturnal stools (no =0, yes =10); activity level (no limitation of activity =0, occasional limitation of activity =5, severely restricted activity =10). PUCAI score = sum of scores of 6 items; score range of 0= no severity to 85= extreme severity. PUCAI score \<10: UC in remission, score between \>=10 and \<35: mild UC, score between \>=35 and \<65: moderate UC, and score \>=65: severe UC. Absolute variation = mean result of laboratory test during period in question - result of laboratory test at baseline.
Time frame: Baseline (Inclusion Visit), Month 6, 12, 18, and 24
Population: Analysis population included all enrolled participants treated with Inflectra. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows. Analysis for this outcome measure was planned for pediatric participants with indications UC and not for participants with RA, PA, SpA and CD.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease (CD) | Absolute Variation in Mean Pediatric Ulcerative Colitis Activity Index (PUCAI) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 6 | -5.3 Units on a scale | Standard Deviation 22.6 |
| Crohn's Disease (CD) | Absolute Variation in Mean Pediatric Ulcerative Colitis Activity Index (PUCAI) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 12 | 2.2 Units on a scale | Standard Deviation 6.8 |
| Crohn's Disease (CD) | Absolute Variation in Mean Pediatric Ulcerative Colitis Activity Index (PUCAI) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 18 | 1.8 Units on a scale | Standard Deviation 5.4 |
| Crohn's Disease (CD) | Absolute Variation in Mean Pediatric Ulcerative Colitis Activity Index (PUCAI) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 24 | 2.2 Units on a scale | Standard Deviation 6 |
Secondary
Absolute Variation in Mean Simple Disease Activity Index (SDAI) Score Compared With Baseline at Month 6, 12, 18, and 24
SDAI was evaluated in participants with indication RA. SDAI is the numerical sum of 5 parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0 (very well) -10 cm (worst) VAS; higher scores = greater affection due to disease activity, and C-reactive protein (CRP) (mg/dL). SDAI total score =0 (no disease) to 86 (extreme severity of disease), where higher scores indicated higher disease activity. SDAI score \<=3.3 indicated achievement of remission state, score \>3.3 and/or \<=11 indicated mildly active state, score \>11 and/or \<=26 indicated moderately active state, and score \>26 indicated very active state. Absolute variation = mean result of laboratory test during period in question - result of laboratory test at baseline.
Time frame: Baseline (Inclusion Visit), Month 6, 12, 18, and 24
Population: Analysis population included all enrolled participants treated with Inflectra. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows. Analysis for this outcome measure was planned for participants with indication RA, and not for participants with SpA, PA, CD, UC.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease (CD) | Absolute Variation in Mean Simple Disease Activity Index (SDAI) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 6 | -1.6 Units on a scale | Standard Deviation 10.7 |
| Crohn's Disease (CD) | Absolute Variation in Mean Simple Disease Activity Index (SDAI) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 12 | -1.5 Units on a scale | Standard Deviation 11.4 |
| Crohn's Disease (CD) | Absolute Variation in Mean Simple Disease Activity Index (SDAI) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 18 | -4.0 Units on a scale | Standard Deviation 14 |
| Crohn's Disease (CD) | Absolute Variation in Mean Simple Disease Activity Index (SDAI) Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 24 | -3.1 Units on a scale | Standard Deviation 11.9 |
Secondary
Absolute Variation of Mean Fatigue Score Compared With Baseline at Month 6, 12, 18, and 24
Fatigue score was evaluated among participants with RA, SpA, and PA. Participants' fatigue severity was measured on a VAS with a score range of 0 (no fatigue) to 10 (highest level of fatigue). Higher score signifies more severity. Absolute variation = mean result of laboratory test during period in question - result of laboratory test at baseline.
Time frame: Baseline (Inclusion Visit), Month 6, 12, 18, and 24
Population: Analysis population included all enrolled participants treated with Inflectra. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows. Analysis for this outcome measure was planned for participants with indications RA, SpA, PA and not for participants with CD, UC.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease (CD) | Absolute Variation of Mean Fatigue Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 6 | -0.6 Units on a scale | Standard Deviation 1.8 |
| Crohn's Disease (CD) | Absolute Variation of Mean Fatigue Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 12 | 0.1 Units on a scale | Standard Deviation 2.7 |
| Crohn's Disease (CD) | Absolute Variation of Mean Fatigue Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 18 | -0.3 Units on a scale | Standard Deviation 2.2 |
| Crohn's Disease (CD) | Absolute Variation of Mean Fatigue Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 24 | 0.0 Units on a scale | Standard Deviation 2.2 |
| Ulcerative Colitis (UC) | Absolute Variation of Mean Fatigue Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 24 | -0.1 Units on a scale | Standard Deviation 2.6 |
| Ulcerative Colitis (UC) | Absolute Variation of Mean Fatigue Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 6 | 0.0 Units on a scale | Standard Deviation 2.2 |
| Ulcerative Colitis (UC) | Absolute Variation of Mean Fatigue Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 18 | -0.1 Units on a scale | Standard Deviation 2.3 |
| Ulcerative Colitis (UC) | Absolute Variation of Mean Fatigue Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 12 | 0.1 Units on a scale | Standard Deviation 2.3 |
| Rheumatoid Arthritis (RA) | Absolute Variation of Mean Fatigue Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 24 | 0.4 Units on a scale | Standard Deviation 2.5 |
| Rheumatoid Arthritis (RA) | Absolute Variation of Mean Fatigue Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 12 | -0.3 Units on a scale | Standard Deviation 2.2 |
| Rheumatoid Arthritis (RA) | Absolute Variation of Mean Fatigue Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 18 | 0.1 Units on a scale | Standard Deviation 2.6 |
| Rheumatoid Arthritis (RA) | Absolute Variation of Mean Fatigue Score Compared With Baseline at Month 6, 12, 18, and 24 | Month 6 | -0.4 Units on a scale | Standard Deviation 2.1 |
Secondary
Absolute Variation of Mean Global Disease Assessment Compared With Baseline at Month 6, 12, 18, and 24
The global disease assessment by the physician for participants with RA, SpA and PA was evaluated on a 0 to 10 cm VAS, with 0 cm = no disease activity and 10 cm = worst disease activity. Higher scores indicated worse condition. Absolute variation = mean result of laboratory test during period in question - result of laboratory test at baseline.
Time frame: Baseline (Inclusion Visit), Month 6, 12, 18, and 24
Population: Analysis population included all enrolled participants treated with Inflectra. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows. Analysis for this outcome measure was planned for participants with indications RA, SpA, PA and not for participants with CD, UC.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease (CD) | Absolute Variation of Mean Global Disease Assessment Compared With Baseline at Month 6, 12, 18, and 24 | Month 6 | -0.3 Units on a scale | Standard Deviation 2.3 |
| Crohn's Disease (CD) | Absolute Variation of Mean Global Disease Assessment Compared With Baseline at Month 6, 12, 18, and 24 | Month 12 | -0.4 Units on a scale | Standard Deviation 2.5 |
| Crohn's Disease (CD) | Absolute Variation of Mean Global Disease Assessment Compared With Baseline at Month 6, 12, 18, and 24 | Month 18 | -0.5 Units on a scale | Standard Deviation 2.5 |
| Crohn's Disease (CD) | Absolute Variation of Mean Global Disease Assessment Compared With Baseline at Month 6, 12, 18, and 24 | Month 24 | 0.1 Units on a scale | Standard Deviation 3.1 |
| Ulcerative Colitis (UC) | Absolute Variation of Mean Global Disease Assessment Compared With Baseline at Month 6, 12, 18, and 24 | Month 24 | -0.1 Units on a scale | Standard Deviation 2.4 |
| Ulcerative Colitis (UC) | Absolute Variation of Mean Global Disease Assessment Compared With Baseline at Month 6, 12, 18, and 24 | Month 6 | -0.0 Units on a scale | Standard Deviation 2.2 |
| Ulcerative Colitis (UC) | Absolute Variation of Mean Global Disease Assessment Compared With Baseline at Month 6, 12, 18, and 24 | Month 18 | -0.1 Units on a scale | Standard Deviation 2.2 |
| Ulcerative Colitis (UC) | Absolute Variation of Mean Global Disease Assessment Compared With Baseline at Month 6, 12, 18, and 24 | Month 12 | -0.2 Units on a scale | Standard Deviation 2.3 |
| Rheumatoid Arthritis (RA) | Absolute Variation of Mean Global Disease Assessment Compared With Baseline at Month 6, 12, 18, and 24 | Month 24 | -0.5 Units on a scale | Standard Deviation 2.6 |
| Rheumatoid Arthritis (RA) | Absolute Variation of Mean Global Disease Assessment Compared With Baseline at Month 6, 12, 18, and 24 | Month 12 | -0.4 Units on a scale | Standard Deviation 2.3 |
| Rheumatoid Arthritis (RA) | Absolute Variation of Mean Global Disease Assessment Compared With Baseline at Month 6, 12, 18, and 24 | Month 18 | -0.3 Units on a scale | Standard Deviation 2.4 |
| Rheumatoid Arthritis (RA) | Absolute Variation of Mean Global Disease Assessment Compared With Baseline at Month 6, 12, 18, and 24 | Month 6 | -0.5 Units on a scale | Standard Deviation 2.2 |
Secondary
Cook and Medley Score at Baseline
Cook-Medley questionnaire, also called cynical distrust scale, contained 8 items, scoring from 0 (trust) to 4 (no trust). The total score of the questionnaire was calculated by adding together the scores for the 8 items. Total possible score range was from 0 (trust) to 32 (no trust), higher score signifies greater cynical distrust. This outcome measure was evaluated in participants who were informed of a switch from infliximab reference to Inflectra.
Time frame: Baseline (data recorded at inclusion visit)
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crohn's Disease (CD) | Cook and Medley Score at Baseline | 19.0 Units on a scale | Standard Deviation 4.9 |
| Ulcerative Colitis (UC) | Cook and Medley Score at Baseline | 17.1 Units on a scale | Standard Deviation 5.7 |
| Rheumatoid Arthritis (RA) | Cook and Medley Score at Baseline | 18.7 Units on a scale | Standard Deviation 4.1 |
| Ankylosing Spondylitis (SpA) | Cook and Medley Score at Baseline | 18.1 Units on a scale | Standard Deviation 5.1 |
| Psoriatic Arthritis (PA) | Cook and Medley Score at Baseline | 20.0 Units on a scale | Standard Deviation 6.1 |
Secondary
Cumulative Dose
Cumulative dose is the sum of doses administered during inclusion visit to month 6, 12, 18, and 24.
Time frame: 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
Population: Analysis population included all enrolled participants treated with Inflectra. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease (CD) | Cumulative Dose | Inclusion to Month 18 | 1445.2 mg | Standard Deviation 1116 |
| Crohn's Disease (CD) | Cumulative Dose | Inclusion to Month 24 | 1718.0 mg | Standard Deviation 1305.8 |
| Crohn's Disease (CD) | Cumulative Dose | Inclusion to Month 12 | 1353.9 mg | Standard Deviation 1057.4 |
| Crohn's Disease (CD) | Cumulative Dose | Inclusion to Month 6 | 1028.9 mg | Standard Deviation 782.1 |
| Ulcerative Colitis (UC) | Cumulative Dose | Inclusion to Month 18 | 1433.6 mg | Standard Deviation 1090.3 |
| Ulcerative Colitis (UC) | Cumulative Dose | Inclusion to Month 24 | 1616.9 mg | Standard Deviation 1229.6 |
| Ulcerative Colitis (UC) | Cumulative Dose | Inclusion to Month 6 | 1071.6 mg | Standard Deviation 810 |
| Ulcerative Colitis (UC) | Cumulative Dose | Inclusion to Month 12 | 1437.6 mg | Standard Deviation 1118.1 |
| Rheumatoid Arthritis (RA) | Cumulative Dose | Inclusion to Month 6 | 630.7 mg | Standard Deviation 449 |
| Rheumatoid Arthritis (RA) | Cumulative Dose | Inclusion to Month 24 | 929.6 mg | Standard Deviation 668.2 |
| Rheumatoid Arthritis (RA) | Cumulative Dose | Inclusion to Month 18 | 762.8 mg | Standard Deviation 592.4 |
| Rheumatoid Arthritis (RA) | Cumulative Dose | Inclusion to Month 12 | 804.5 mg | Standard Deviation 603.3 |
| Ankylosing Spondylitis (SpA) | Cumulative Dose | Inclusion to Month 24 | 1405.8 mg | Standard Deviation 892.1 |
| Ankylosing Spondylitis (SpA) | Cumulative Dose | Inclusion to Month 6 | 986.1 mg | Standard Deviation 589.4 |
| Ankylosing Spondylitis (SpA) | Cumulative Dose | Inclusion to Month 12 | 1202.0 mg | Standard Deviation 755 |
| Ankylosing Spondylitis (SpA) | Cumulative Dose | Inclusion to Month 18 | 1159.5 mg | Standard Deviation 726.7 |
| Psoriatic Arthritis (PA) | Cumulative Dose | Inclusion to Month 18 | 1258.2 mg | Standard Deviation 965.2 |
| Psoriatic Arthritis (PA) | Cumulative Dose | Inclusion to Month 24 | 1502.0 mg | Standard Deviation 1213.7 |
| Psoriatic Arthritis (PA) | Cumulative Dose | Inclusion to Month 6 | 1015.4 mg | Standard Deviation 832.1 |
| Psoriatic Arthritis (PA) | Cumulative Dose | Inclusion to Month 12 | 1251.4 mg | Standard Deviation 914.9 |
Secondary
General Anxiety Disorder (GAD7) Score
GAD7: questionnaire of anxiety with 7 items, scoring from 0 (no anxiety) to 3 (extreme anxiety). The total GAD7 score was calculated by adding together the scores for the 7 items, ranged from 0 (no anxiety) to 21 (extreme anxiety), higher scores indicated severe anxiety. This outcome measure was evaluated in participants who were informed of a switch from infliximab reference to Inflectra.
Time frame: Baseline (inclusion visit) through post each infusion (during 2 years)
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crohn's Disease (CD) | General Anxiety Disorder (GAD7) Score | 5.5 Units on a scale | Standard Deviation 3.7 |
| Ulcerative Colitis (UC) | General Anxiety Disorder (GAD7) Score | 3.4 Units on a scale | Standard Deviation 3.2 |
| Rheumatoid Arthritis (RA) | General Anxiety Disorder (GAD7) Score | 3.8 Units on a scale | Standard Deviation 5.1 |
| Ankylosing Spondylitis (SpA) | General Anxiety Disorder (GAD7) Score | 4.8 Units on a scale | Standard Deviation 5.1 |
| Psoriatic Arthritis (PA) | General Anxiety Disorder (GAD7) Score | 7.8 Units on a scale | Standard Deviation 6.3 |
Secondary
Infliximab Trough Level (IFX-TL) at Inclusion Visit
Trough level was plasma concentration of drug before infusion.
Time frame: Before infusion at baseline (data recorded at inclusion visit)
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crohn's Disease (CD) | Infliximab Trough Level (IFX-TL) at Inclusion Visit | 6.69 micrograms per milliliter | Standard Deviation 5.58 |
| Ulcerative Colitis (UC) | Infliximab Trough Level (IFX-TL) at Inclusion Visit | 7.66 micrograms per milliliter | Standard Deviation 5.94 |
| Rheumatoid Arthritis (RA) | Infliximab Trough Level (IFX-TL) at Inclusion Visit | 6.06 micrograms per milliliter | Standard Deviation 6.83 |
| Ankylosing Spondylitis (SpA) | Infliximab Trough Level (IFX-TL) at Inclusion Visit | 7.32 micrograms per milliliter | Standard Deviation 6.14 |
| Psoriatic Arthritis (PA) | Infliximab Trough Level (IFX-TL) at Inclusion Visit | 7.40 micrograms per milliliter | Standard Deviation 2.82 |
Secondary
Mean Administered Dose of Inflectra (in mg)
Mean dose (in milligrams \[mg\]) administered was sum of dose of all infusions administered divided by total number of doses administered.
Time frame: 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
Population: Analysis population included all enrolled participants treated with Inflectra. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease (CD) | Mean Administered Dose of Inflectra (in mg) | Inclusion to Month 6 | 451.0 mg | Standard Deviation 184.5 |
| Crohn's Disease (CD) | Mean Administered Dose of Inflectra (in mg) | Month 6 to Month 12 | 473.4 mg | Standard Deviation 195.6 |
| Crohn's Disease (CD) | Mean Administered Dose of Inflectra (in mg) | Month 12 to Month 18 | 503.1 mg | Standard Deviation 211.7 |
| Crohn's Disease (CD) | Mean Administered Dose of Inflectra (in mg) | Month 18 to Month 24 | 515.6 mg | Standard Deviation 223.6 |
| Ulcerative Colitis (UC) | Mean Administered Dose of Inflectra (in mg) | Inclusion to Month 6 | 493.9 mg | Standard Deviation 202.1 |
| Ulcerative Colitis (UC) | Mean Administered Dose of Inflectra (in mg) | Month 18 to Month 24 | 533.6 mg | Standard Deviation 218.5 |
| Ulcerative Colitis (UC) | Mean Administered Dose of Inflectra (in mg) | Month 6 to Month 12 | 534.0 mg | Standard Deviation 213.2 |
| Ulcerative Colitis (UC) | Mean Administered Dose of Inflectra (in mg) | Month 12 to Month 18 | 520.8 mg | Standard Deviation 212.7 |
| Rheumatoid Arthritis (RA) | Mean Administered Dose of Inflectra (in mg) | Month 18 to Month 24 | 317.5 mg | Standard Deviation 109.2 |
| Rheumatoid Arthritis (RA) | Mean Administered Dose of Inflectra (in mg) | Month 6 to Month 12 | 313.4 mg | Standard Deviation 127.3 |
| Rheumatoid Arthritis (RA) | Mean Administered Dose of Inflectra (in mg) | Month 12 to Month 18 | 313.1 mg | Standard Deviation 121.7 |
| Rheumatoid Arthritis (RA) | Mean Administered Dose of Inflectra (in mg) | Inclusion to Month 6 | 313.7 mg | Standard Deviation 125.4 |
| Ankylosing Spondylitis (SpA) | Mean Administered Dose of Inflectra (in mg) | Inclusion to Month 6 | 406.9 mg | Standard Deviation 113.4 |
| Ankylosing Spondylitis (SpA) | Mean Administered Dose of Inflectra (in mg) | Month 6 to Month 12 | 411.3 mg | Standard Deviation 123 |
| Ankylosing Spondylitis (SpA) | Mean Administered Dose of Inflectra (in mg) | Month 18 to Month 24 | 417.3 mg | Standard Deviation 127 |
| Ankylosing Spondylitis (SpA) | Mean Administered Dose of Inflectra (in mg) | Month 12 to Month 18 | 414.8 mg | Standard Deviation 120.6 |
| Psoriatic Arthritis (PA) | Mean Administered Dose of Inflectra (in mg) | Month 18 to Month 24 | 433.7 mg | Standard Deviation 155.6 |
| Psoriatic Arthritis (PA) | Mean Administered Dose of Inflectra (in mg) | Month 12 to Month 18 | 437.7 mg | Standard Deviation 155.1 |
| Psoriatic Arthritis (PA) | Mean Administered Dose of Inflectra (in mg) | Month 6 to Month 12 | 441.2 mg | Standard Deviation 152.2 |
| Psoriatic Arthritis (PA) | Mean Administered Dose of Inflectra (in mg) | Inclusion to Month 6 | 440.8 mg | Standard Deviation 142.5 |
Secondary
Mean Administered Posology of Inflectra (in mg/kg)
Mean posology administered was sum of posology of all infusions administered divided by total number of infusions administered. Posology = dose (mg) / weight (kg).
Time frame: 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
Population: Analysis population included all enrolled participants treated with Inflectra. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease (CD) | Mean Administered Posology of Inflectra (in mg/kg) | Inclusion to Month 6 | 6.6 mg/kg | Standard Deviation 2.2 |
| Crohn's Disease (CD) | Mean Administered Posology of Inflectra (in mg/kg) | Month 6 to Month 12 | 6.8 mg/kg | Standard Deviation 2.2 |
| Crohn's Disease (CD) | Mean Administered Posology of Inflectra (in mg/kg) | Month 12 to Month 18 | 7.1 mg/kg | Standard Deviation 2.3 |
| Crohn's Disease (CD) | Mean Administered Posology of Inflectra (in mg/kg) | Month 18 to Month 24 | 7.3 mg/kg | Standard Deviation 2.3 |
| Ulcerative Colitis (UC) | Mean Administered Posology of Inflectra (in mg/kg) | Inclusion to Month 6 | 7.0 mg/kg | Standard Deviation 2.2 |
| Ulcerative Colitis (UC) | Mean Administered Posology of Inflectra (in mg/kg) | Month 18 to Month 24 | 7.4 mg/kg | Standard Deviation 2.4 |
| Ulcerative Colitis (UC) | Mean Administered Posology of Inflectra (in mg/kg) | Month 6 to Month 12 | 7.3 mg/kg | Standard Deviation 2.3 |
| Ulcerative Colitis (UC) | Mean Administered Posology of Inflectra (in mg/kg) | Month 12 to Month 18 | 7.2 mg/kg | Standard Deviation 2.4 |
| Rheumatoid Arthritis (RA) | Mean Administered Posology of Inflectra (in mg/kg) | Month 18 to Month 24 | 4.5 mg/kg | Standard Deviation 1.3 |
| Rheumatoid Arthritis (RA) | Mean Administered Posology of Inflectra (in mg/kg) | Month 6 to Month 12 | 4.4 mg/kg | Standard Deviation 1.4 |
| Rheumatoid Arthritis (RA) | Mean Administered Posology of Inflectra (in mg/kg) | Month 12 to Month 18 | 4.4 mg/kg | Standard Deviation 1.4 |
| Rheumatoid Arthritis (RA) | Mean Administered Posology of Inflectra (in mg/kg) | Inclusion to Month 6 | 4.3 mg/kg | Standard Deviation 1.4 |
| Ankylosing Spondylitis (SpA) | Mean Administered Posology of Inflectra (in mg/kg) | Inclusion to Month 6 | 5.3 mg/kg | Standard Deviation 1.1 |
| Ankylosing Spondylitis (SpA) | Mean Administered Posology of Inflectra (in mg/kg) | Month 6 to Month 12 | 5.4 mg/kg | Standard Deviation 1.3 |
| Ankylosing Spondylitis (SpA) | Mean Administered Posology of Inflectra (in mg/kg) | Month 18 to Month 24 | 5.5 mg/kg | Standard Deviation 1.3 |
| Ankylosing Spondylitis (SpA) | Mean Administered Posology of Inflectra (in mg/kg) | Month 12 to Month 18 | 5.5 mg/kg | Standard Deviation 1.3 |
| Psoriatic Arthritis (PA) | Mean Administered Posology of Inflectra (in mg/kg) | Month 18 to Month 24 | 5.4 mg/kg | Standard Deviation 1.3 |
| Psoriatic Arthritis (PA) | Mean Administered Posology of Inflectra (in mg/kg) | Month 12 to Month 18 | 5.4 mg/kg | Standard Deviation 1.3 |
| Psoriatic Arthritis (PA) | Mean Administered Posology of Inflectra (in mg/kg) | Month 6 to Month 12 | 5.5 mg/kg | Standard Deviation 1.3 |
| Psoriatic Arthritis (PA) | Mean Administered Posology of Inflectra (in mg/kg) | Inclusion to Month 6 | 5.4 mg/kg | Standard Deviation 1.1 |
Secondary
Mean Duration of Post-infusion Monitoring at the Hospital
Mean post-infusion monitoring at hospital was sum of duration of all monitoring at hospital divided by total number monitoring times.
Time frame: 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
Population: Analysis population included all enrolled participants treated with Inflectra. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease (CD) | Mean Duration of Post-infusion Monitoring at the Hospital | Inclusion to Month 6 | 53.9 Minutes | Standard Deviation 31.2 |
| Crohn's Disease (CD) | Mean Duration of Post-infusion Monitoring at the Hospital | Month 6 to Month 12 | 48.2 Minutes | Standard Deviation 27.9 |
| Crohn's Disease (CD) | Mean Duration of Post-infusion Monitoring at the Hospital | Month 12 to Month 18 | 45.9 Minutes | Standard Deviation 23 |
| Crohn's Disease (CD) | Mean Duration of Post-infusion Monitoring at the Hospital | Month 18 to Month 24 | 48.4 Minutes | Standard Deviation 25.5 |
| Ulcerative Colitis (UC) | Mean Duration of Post-infusion Monitoring at the Hospital | Inclusion to Month 6 | 55.0 Minutes | Standard Deviation 33.5 |
| Ulcerative Colitis (UC) | Mean Duration of Post-infusion Monitoring at the Hospital | Month 18 to Month 24 | 48.0 Minutes | Standard Deviation 29.6 |
| Ulcerative Colitis (UC) | Mean Duration of Post-infusion Monitoring at the Hospital | Month 6 to Month 12 | 47.3 Minutes | Standard Deviation 26.8 |
| Ulcerative Colitis (UC) | Mean Duration of Post-infusion Monitoring at the Hospital | Month 12 to Month 18 | 45.5 Minutes | Standard Deviation 23.3 |
| Rheumatoid Arthritis (RA) | Mean Duration of Post-infusion Monitoring at the Hospital | Month 18 to Month 24 | 53.8 Minutes | Standard Deviation 31.8 |
| Rheumatoid Arthritis (RA) | Mean Duration of Post-infusion Monitoring at the Hospital | Month 6 to Month 12 | 55.7 Minutes | Standard Deviation 27.1 |
| Rheumatoid Arthritis (RA) | Mean Duration of Post-infusion Monitoring at the Hospital | Month 12 to Month 18 | 53.6 Minutes | Standard Deviation 28.8 |
| Rheumatoid Arthritis (RA) | Mean Duration of Post-infusion Monitoring at the Hospital | Inclusion to Month 6 | 63.6 Minutes | Standard Deviation 30.4 |
| Ankylosing Spondylitis (SpA) | Mean Duration of Post-infusion Monitoring at the Hospital | Inclusion to Month 6 | 66.6 Minutes | Standard Deviation 34.6 |
| Ankylosing Spondylitis (SpA) | Mean Duration of Post-infusion Monitoring at the Hospital | Month 6 to Month 12 | 60.0 Minutes | Standard Deviation 29.1 |
| Ankylosing Spondylitis (SpA) | Mean Duration of Post-infusion Monitoring at the Hospital | Month 18 to Month 24 | 58.6 Minutes | Standard Deviation 31.5 |
| Ankylosing Spondylitis (SpA) | Mean Duration of Post-infusion Monitoring at the Hospital | Month 12 to Month 18 | 59.1 Minutes | Standard Deviation 30.5 |
| Psoriatic Arthritis (PA) | Mean Duration of Post-infusion Monitoring at the Hospital | Month 18 to Month 24 | 57.1 Minutes | Standard Deviation 33.3 |
| Psoriatic Arthritis (PA) | Mean Duration of Post-infusion Monitoring at the Hospital | Month 12 to Month 18 | 54.6 Minutes | Standard Deviation 30.8 |
| Psoriatic Arthritis (PA) | Mean Duration of Post-infusion Monitoring at the Hospital | Month 6 to Month 12 | 58.7 Minutes | Standard Deviation 37.6 |
| Psoriatic Arthritis (PA) | Mean Duration of Post-infusion Monitoring at the Hospital | Inclusion to Month 6 | 66.3 Minutes | Standard Deviation 47.1 |
Secondary
Mean Inflectra Trough Level (IFX-TL) (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit)
Trough level was plasma concentration of drug before infusion. In this outcome measure mean of all IFX-TLs for all infusions occurring during specified duration is reported.
Time frame: Before every infusion occurred during: inclusion visit up to 6-Month visit; 6-Month visit up to 12-Month visit; 12-Month visit up to 18-Month visit, and 18-Month visit up to 24-Month visit
Population: Analysis population included all enrolled participants treated with Inflectra. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease (CD) | Mean Inflectra Trough Level (IFX-TL) (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Inclusion to Month 6 | 8.4 micrograms per milliliter | Standard Deviation 13.1 |
| Crohn's Disease (CD) | Mean Inflectra Trough Level (IFX-TL) (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 6 to Month 12 | 7.3 micrograms per milliliter | Standard Deviation 7.9 |
| Crohn's Disease (CD) | Mean Inflectra Trough Level (IFX-TL) (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 12 to Month 18 | 7.7 micrograms per milliliter | Standard Deviation 5.9 |
| Crohn's Disease (CD) | Mean Inflectra Trough Level (IFX-TL) (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 18 to Month 24 | 7.7 micrograms per milliliter | Standard Deviation 5.5 |
| Ulcerative Colitis (UC) | Mean Inflectra Trough Level (IFX-TL) (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Inclusion to Month 6 | 6.5 micrograms per milliliter | Standard Deviation 5.4 |
| Ulcerative Colitis (UC) | Mean Inflectra Trough Level (IFX-TL) (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 18 to Month 24 | 6.8 micrograms per milliliter | Standard Deviation 4.5 |
| Ulcerative Colitis (UC) | Mean Inflectra Trough Level (IFX-TL) (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 6 to Month 12 | 7.0 micrograms per milliliter | Standard Deviation 5.1 |
| Ulcerative Colitis (UC) | Mean Inflectra Trough Level (IFX-TL) (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 12 to Month 18 | 5.3 micrograms per milliliter | Standard Deviation 4.2 |
| Rheumatoid Arthritis (RA) | Mean Inflectra Trough Level (IFX-TL) (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 18 to Month 24 | 2.1 micrograms per milliliter | Standard Deviation 2.5 |
| Rheumatoid Arthritis (RA) | Mean Inflectra Trough Level (IFX-TL) (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 6 to Month 12 | 3.5 micrograms per milliliter | Standard Deviation 5.3 |
| Rheumatoid Arthritis (RA) | Mean Inflectra Trough Level (IFX-TL) (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 12 to Month 18 | 2.3 micrograms per milliliter | Standard Deviation 3.3 |
| Rheumatoid Arthritis (RA) | Mean Inflectra Trough Level (IFX-TL) (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Inclusion to Month 6 | 4.2 micrograms per milliliter | Standard Deviation 3.9 |
| Ankylosing Spondylitis (SpA) | Mean Inflectra Trough Level (IFX-TL) (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Inclusion to Month 6 | 6.9 micrograms per milliliter | Standard Deviation 5.9 |
| Ankylosing Spondylitis (SpA) | Mean Inflectra Trough Level (IFX-TL) (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 6 to Month 12 | 8.9 micrograms per milliliter | Standard Deviation 6.1 |
| Ankylosing Spondylitis (SpA) | Mean Inflectra Trough Level (IFX-TL) (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 18 to Month 24 | 7.8 micrograms per milliliter | Standard Deviation 6.4 |
| Ankylosing Spondylitis (SpA) | Mean Inflectra Trough Level (IFX-TL) (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 12 to Month 18 | 7.2 micrograms per milliliter | Standard Deviation 5.2 |
| Psoriatic Arthritis (PA) | Mean Inflectra Trough Level (IFX-TL) (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 18 to Month 24 | 8.5 micrograms per milliliter | Standard Deviation 6.5 |
| Psoriatic Arthritis (PA) | Mean Inflectra Trough Level (IFX-TL) (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 12 to Month 18 | 6.8 micrograms per milliliter | Standard Deviation 6 |
| Psoriatic Arthritis (PA) | Mean Inflectra Trough Level (IFX-TL) (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 6 to Month 12 | 7.4 micrograms per milliliter | Standard Deviation 6.7 |
| Psoriatic Arthritis (PA) | Mean Inflectra Trough Level (IFX-TL) (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Inclusion to Month 6 | 9.2 micrograms per milliliter | Standard Deviation 6.2 |
Secondary
Mean Infusion Time
Mean infusion time was sum of duration of all infusions administered divided by total number of infusion times administered.
Time frame: 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
Population: Analysis population included all enrolled participants treated with Inflectra. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease (CD) | Mean Infusion Time | Inclusion to Month 6 | 75.3 Minutes | Standard Deviation 25.2 |
| Crohn's Disease (CD) | Mean Infusion Time | Month 6 to Month 12 | 73.2 Minutes | Standard Deviation 25.1 |
| Crohn's Disease (CD) | Mean Infusion Time | Month 12 to Month 18 | 72.7 Minutes | Standard Deviation 25.6 |
| Crohn's Disease (CD) | Mean Infusion Time | Month 18 to Month 24 | 71.9 Minutes | Standard Deviation 24.7 |
| Ulcerative Colitis (UC) | Mean Infusion Time | Inclusion to Month 6 | 79.7 Minutes | Standard Deviation 28 |
| Ulcerative Colitis (UC) | Mean Infusion Time | Month 18 to Month 24 | 69.9 Minutes | Standard Deviation 25 |
| Ulcerative Colitis (UC) | Mean Infusion Time | Month 6 to Month 12 | 73.9 Minutes | Standard Deviation 29.4 |
| Ulcerative Colitis (UC) | Mean Infusion Time | Month 12 to Month 18 | 70.5 Minutes | Standard Deviation 26.4 |
| Rheumatoid Arthritis (RA) | Mean Infusion Time | Month 18 to Month 24 | 86.9 Minutes | Standard Deviation 26.2 |
| Rheumatoid Arthritis (RA) | Mean Infusion Time | Month 6 to Month 12 | 88.4 Minutes | Standard Deviation 28.1 |
| Rheumatoid Arthritis (RA) | Mean Infusion Time | Month 12 to Month 18 | 86.1 Minutes | Standard Deviation 26.3 |
| Rheumatoid Arthritis (RA) | Mean Infusion Time | Inclusion to Month 6 | 94.8 Minutes | Standard Deviation 30.3 |
| Ankylosing Spondylitis (SpA) | Mean Infusion Time | Inclusion to Month 6 | 92.7 Minutes | Standard Deviation 27.4 |
| Ankylosing Spondylitis (SpA) | Mean Infusion Time | Month 6 to Month 12 | 89.3 Minutes | Standard Deviation 25.9 |
| Ankylosing Spondylitis (SpA) | Mean Infusion Time | Month 18 to Month 24 | 87.4 Minutes | Standard Deviation 24.9 |
| Ankylosing Spondylitis (SpA) | Mean Infusion Time | Month 12 to Month 18 | 87.6 Minutes | Standard Deviation 25.7 |
| Psoriatic Arthritis (PA) | Mean Infusion Time | Month 18 to Month 24 | 95.1 Minutes | Standard Deviation 24.1 |
| Psoriatic Arthritis (PA) | Mean Infusion Time | Month 12 to Month 18 | 94.9 Minutes | Standard Deviation 30.9 |
| Psoriatic Arthritis (PA) | Mean Infusion Time | Month 6 to Month 12 | 96.8 Minutes | Standard Deviation 29.3 |
| Psoriatic Arthritis (PA) | Mean Infusion Time | Inclusion to Month 6 | 100.1 Minutes | Standard Deviation 26.4 |
Secondary
Mean of Number of Immunogenicity Assays Done (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit)
Time frame: Inclusion visit up to 6-Month visit, 6-Month visit up to 12-Month visit, 12-Month visit up to 18-Month visit, and 18-Month visit up to 24-Month visit
Population: Analysis population included all enrolled participants treated with Inflectra. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease (CD) | Mean of Number of Immunogenicity Assays Done (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Inclusion up to Month 6 | 0.3 Assays | Standard Deviation 0.8 |
| Crohn's Disease (CD) | Mean of Number of Immunogenicity Assays Done (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 6 to Month 12 | 0.5 Assays | Standard Deviation 1 |
| Crohn's Disease (CD) | Mean of Number of Immunogenicity Assays Done (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 12 to Month 18 | 0.5 Assays | Standard Deviation 1 |
| Crohn's Disease (CD) | Mean of Number of Immunogenicity Assays Done (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 18 to Month 24 | 0.5 Assays | Standard Deviation 1.2 |
| Ulcerative Colitis (UC) | Mean of Number of Immunogenicity Assays Done (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Inclusion up to Month 6 | 0.4 Assays | Standard Deviation 0.8 |
| Ulcerative Colitis (UC) | Mean of Number of Immunogenicity Assays Done (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 18 to Month 24 | 0.6 Assays | Standard Deviation 1.2 |
| Ulcerative Colitis (UC) | Mean of Number of Immunogenicity Assays Done (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 6 to Month 12 | 0.4 Assays | Standard Deviation 1 |
| Ulcerative Colitis (UC) | Mean of Number of Immunogenicity Assays Done (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 12 to Month 18 | 0.6 Assays | Standard Deviation 1.1 |
| Rheumatoid Arthritis (RA) | Mean of Number of Immunogenicity Assays Done (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 18 to Month 24 | 0.2 Assays | Standard Deviation 0.4 |
| Rheumatoid Arthritis (RA) | Mean of Number of Immunogenicity Assays Done (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 6 to Month 12 | 0.1 Assays | Standard Deviation 0.3 |
| Rheumatoid Arthritis (RA) | Mean of Number of Immunogenicity Assays Done (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 12 to Month 18 | 0.1 Assays | Standard Deviation 0.4 |
| Rheumatoid Arthritis (RA) | Mean of Number of Immunogenicity Assays Done (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Inclusion up to Month 6 | 0.1 Assays | Standard Deviation 0.3 |
| Ankylosing Spondylitis (SpA) | Mean of Number of Immunogenicity Assays Done (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Inclusion up to Month 6 | 0.1 Assays | Standard Deviation 0.3 |
| Ankylosing Spondylitis (SpA) | Mean of Number of Immunogenicity Assays Done (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 6 to Month 12 | 0.1 Assays | Standard Deviation 0.4 |
| Ankylosing Spondylitis (SpA) | Mean of Number of Immunogenicity Assays Done (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 18 to Month 24 | 0.1 Assays | Standard Deviation 0.3 |
| Ankylosing Spondylitis (SpA) | Mean of Number of Immunogenicity Assays Done (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 12 to Month 18 | 0.1 Assays | Standard Deviation 0.4 |
| Psoriatic Arthritis (PA) | Mean of Number of Immunogenicity Assays Done (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 18 to Month 24 | 0.1 Assays | Standard Deviation 0.4 |
| Psoriatic Arthritis (PA) | Mean of Number of Immunogenicity Assays Done (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 12 to Month 18 | 0.2 Assays | Standard Deviation 0.4 |
| Psoriatic Arthritis (PA) | Mean of Number of Immunogenicity Assays Done (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 6 to Month 12 | 0.1 Assays | Standard Deviation 0.3 |
| Psoriatic Arthritis (PA) | Mean of Number of Immunogenicity Assays Done (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Inclusion up to Month 6 | 0.1 Assays | Standard Deviation 0.3 |
Secondary
Mean Time Between Infusions
Time frame: 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
Population: Analysis population included all enrolled participants treated with Inflectra. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crohn's Disease (CD) | Mean Time Between Infusions | Inclusion to Month 6 | 7.5 Weeks | Standard Deviation 3.5 |
| Crohn's Disease (CD) | Mean Time Between Infusions | Month 18 to Month 24 | 8.7 Weeks | Standard Deviation 6.2 |
| Crohn's Disease (CD) | Mean Time Between Infusions | Month 12 to Month 18 | 12.8 Weeks | Standard Deviation 9 |
| Crohn's Disease (CD) | Mean Time Between Infusions | Month 6 to Month 12 | 11.9 Weeks | Standard Deviation 8 |
| Ulcerative Colitis (UC) | Mean Time Between Infusions | Month 6 to Month 12 | 13.3 Weeks | Standard Deviation 10.3 |
| Ulcerative Colitis (UC) | Mean Time Between Infusions | Inclusion to Month 6 | 7.7 Weeks | Standard Deviation 3.5 |
| Ulcerative Colitis (UC) | Mean Time Between Infusions | Month 18 to Month 24 | 14.4 Weeks | Standard Deviation 11.6 |
| Ulcerative Colitis (UC) | Mean Time Between Infusions | Month 12 to Month 18 | 13.8 Weeks | Standard Deviation 9.8 |
| Rheumatoid Arthritis (RA) | Mean Time Between Infusions | Inclusion to Month 6 | 7.5 Weeks | Standard Deviation 2 |
| Rheumatoid Arthritis (RA) | Mean Time Between Infusions | Month 18 to Month 24 | 15.4 Weeks | Standard Deviation 9.9 |
| Rheumatoid Arthritis (RA) | Mean Time Between Infusions | Month 12 to Month 18 | 13.7 Weeks | Standard Deviation 8.6 |
| Rheumatoid Arthritis (RA) | Mean Time Between Infusions | Month 6 to Month 12 | 12.7 Weeks | Standard Deviation 7.3 |
| Ankylosing Spondylitis (SpA) | Mean Time Between Infusions | Inclusion to Month 6 | 7.0 Weeks | Standard Deviation 1.7 |
| Ankylosing Spondylitis (SpA) | Mean Time Between Infusions | Month 6 to Month 12 | 10.7 Weeks | Standard Deviation 6.9 |
| Ankylosing Spondylitis (SpA) | Mean Time Between Infusions | Month 18 to Month 24 | 13.8 Weeks | Standard Deviation 10.4 |
| Ankylosing Spondylitis (SpA) | Mean Time Between Infusions | Month 12 to Month 18 | 12.7 Weeks | Standard Deviation 8.9 |
| Psoriatic Arthritis (PA) | Mean Time Between Infusions | Month 12 to Month 18 | 13.0 Weeks | Standard Deviation 8.7 |
| Psoriatic Arthritis (PA) | Mean Time Between Infusions | Inclusion to Month 6 | 7.2 Weeks | Standard Deviation 1.6 |
| Psoriatic Arthritis (PA) | Mean Time Between Infusions | Month 18 to Month 24 | 13.3 Weeks | Standard Deviation 8.9 |
| Psoriatic Arthritis (PA) | Mean Time Between Infusions | Month 6 to Month 12 | 11.7 Weeks | Standard Deviation 7.8 |
Secondary
Number of Participants With Anti-Infliximab Antibody Assay Assessment at Inclusion Visit
Time frame: Baseline (data recorded at inclusion visit)
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Crohn's Disease (CD) | Number of Participants With Anti-Infliximab Antibody Assay Assessment at Inclusion Visit | 79 Participants |
| Ulcerative Colitis (UC) | Number of Participants With Anti-Infliximab Antibody Assay Assessment at Inclusion Visit | 37 Participants |
| Rheumatoid Arthritis (RA) | Number of Participants With Anti-Infliximab Antibody Assay Assessment at Inclusion Visit | 9 Participants |
| Ankylosing Spondylitis (SpA) | Number of Participants With Anti-Infliximab Antibody Assay Assessment at Inclusion Visit | 24 Participants |
| Psoriatic Arthritis (PA) | Number of Participants With Anti-Infliximab Antibody Assay Assessment at Inclusion Visit | 5 Participants |
Secondary
Number of Participants With Immunogenicity Assay at Inclusion Visit
Time frame: Baseline (data recorded at inclusion visit)
Population: Analysis population included all enrolled participants treated with Inflectra.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Crohn's Disease (CD) | Number of Participants With Immunogenicity Assay at Inclusion Visit | 87 Participants |
| Ulcerative Colitis (UC) | Number of Participants With Immunogenicity Assay at Inclusion Visit | 44 Participants |
| Rheumatoid Arthritis (RA) | Number of Participants With Immunogenicity Assay at Inclusion Visit | 13 Participants |
| Ankylosing Spondylitis (SpA) | Number of Participants With Immunogenicity Assay at Inclusion Visit | 24 Participants |
| Psoriatic Arthritis (PA) | Number of Participants With Immunogenicity Assay at Inclusion Visit | 5 Participants |
Secondary
Number of Participants With Infliximab Trough Level (IFX-TL) Assay at Inclusion Visit
Trough level was plasma concentration of drug before infusion.
Time frame: Baseline (data recorded at inclusion visit)
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Crohn's Disease (CD) | Number of Participants With Infliximab Trough Level (IFX-TL) Assay at Inclusion Visit | 82 Participants |
| Ulcerative Colitis (UC) | Number of Participants With Infliximab Trough Level (IFX-TL) Assay at Inclusion Visit | 40 Participants |
| Rheumatoid Arthritis (RA) | Number of Participants With Infliximab Trough Level (IFX-TL) Assay at Inclusion Visit | 8 Participants |
| Ankylosing Spondylitis (SpA) | Number of Participants With Infliximab Trough Level (IFX-TL) Assay at Inclusion Visit | 21 Participants |
| Psoriatic Arthritis (PA) | Number of Participants With Infliximab Trough Level (IFX-TL) Assay at Inclusion Visit | 5 Participants |
Secondary
Number of Participants With Presence of Anti-infliximab Antibodies at Inclusion Visit
Time frame: Baseline (data recorded at inclusion visit)
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Crohn's Disease (CD) | Number of Participants With Presence of Anti-infliximab Antibodies at Inclusion Visit | 9 Participants |
| Ulcerative Colitis (UC) | Number of Participants With Presence of Anti-infliximab Antibodies at Inclusion Visit | 6 Participants |
| Rheumatoid Arthritis (RA) | Number of Participants With Presence of Anti-infliximab Antibodies at Inclusion Visit | 1 Participants |
| Ankylosing Spondylitis (SpA) | Number of Participants With Presence of Anti-infliximab Antibodies at Inclusion Visit | 8 Participants |
| Psoriatic Arthritis (PA) | Number of Participants With Presence of Anti-infliximab Antibodies at Inclusion Visit | 3 Participants |
Secondary
Number of Participants With Presence of At-least 1 Anti-Infliximab Antibodies (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit)
Time frame: Inclusion visit up to 6-Month visit, 6-Month visit up to 12-Month visit, 12-Month visit up to 18-Month visit, and 18-Month visit up to 24-Month visit
Population: Analysis population included all enrolled participants treated with Inflectra. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Crohn's Disease (CD) | Number of Participants With Presence of At-least 1 Anti-Infliximab Antibodies (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Inclusion to Month 6 | 7 Participants |
| Crohn's Disease (CD) | Number of Participants With Presence of At-least 1 Anti-Infliximab Antibodies (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 6 to Month 12 | 5 Participants |
| Crohn's Disease (CD) | Number of Participants With Presence of At-least 1 Anti-Infliximab Antibodies (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 12 to Month 18 | 5 Participants |
| Crohn's Disease (CD) | Number of Participants With Presence of At-least 1 Anti-Infliximab Antibodies (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 18 to Month 24 | 9 Participants |
| Ulcerative Colitis (UC) | Number of Participants With Presence of At-least 1 Anti-Infliximab Antibodies (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Inclusion to Month 6 | 3 Participants |
| Ulcerative Colitis (UC) | Number of Participants With Presence of At-least 1 Anti-Infliximab Antibodies (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 18 to Month 24 | 2 Participants |
| Ulcerative Colitis (UC) | Number of Participants With Presence of At-least 1 Anti-Infliximab Antibodies (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 6 to Month 12 | 2 Participants |
| Ulcerative Colitis (UC) | Number of Participants With Presence of At-least 1 Anti-Infliximab Antibodies (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 12 to Month 18 | 5 Participants |
| Rheumatoid Arthritis (RA) | Number of Participants With Presence of At-least 1 Anti-Infliximab Antibodies (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 18 to Month 24 | 7 Participants |
| Rheumatoid Arthritis (RA) | Number of Participants With Presence of At-least 1 Anti-Infliximab Antibodies (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 6 to Month 12 | 7 Participants |
| Rheumatoid Arthritis (RA) | Number of Participants With Presence of At-least 1 Anti-Infliximab Antibodies (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 12 to Month 18 | 7 Participants |
| Rheumatoid Arthritis (RA) | Number of Participants With Presence of At-least 1 Anti-Infliximab Antibodies (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Inclusion to Month 6 | 4 Participants |
| Ankylosing Spondylitis (SpA) | Number of Participants With Presence of At-least 1 Anti-Infliximab Antibodies (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Inclusion to Month 6 | 7 Participants |
| Ankylosing Spondylitis (SpA) | Number of Participants With Presence of At-least 1 Anti-Infliximab Antibodies (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 6 to Month 12 | 9 Participants |
| Ankylosing Spondylitis (SpA) | Number of Participants With Presence of At-least 1 Anti-Infliximab Antibodies (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 18 to Month 24 | 8 Participants |
| Ankylosing Spondylitis (SpA) | Number of Participants With Presence of At-least 1 Anti-Infliximab Antibodies (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 12 to Month 18 | 9 Participants |
| Psoriatic Arthritis (PA) | Number of Participants With Presence of At-least 1 Anti-Infliximab Antibodies (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 18 to Month 24 | 4 Participants |
| Psoriatic Arthritis (PA) | Number of Participants With Presence of At-least 1 Anti-Infliximab Antibodies (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 12 to Month 18 | 5 Participants |
| Psoriatic Arthritis (PA) | Number of Participants With Presence of At-least 1 Anti-Infliximab Antibodies (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Month 6 to Month 12 | 5 Participants |
| Psoriatic Arthritis (PA) | Number of Participants With Presence of At-least 1 Anti-Infliximab Antibodies (Inclusion Visit up to 6-Month Visit, 6-Month Visit up to 12-Month Visit, 12-Month Visit up to 18-Month Visit, and 18-Month Visit up to 24-Month Visit) | Inclusion to Month 6 | 2 Participants |
Secondary
Physician Global Assessment (PGA) of Disease for RA, SpA and PA
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crohn's Disease (CD) | Physician Global Assessment (PGA) of Disease for RA, SpA and PA | 3.5 cm | Standard Deviation 2.6 |
| Ulcerative Colitis (UC) | Physician Global Assessment (PGA) of Disease for RA, SpA and PA | 3.2 cm | Standard Deviation 2.4 |
| Rheumatoid Arthritis (RA) | Physician Global Assessment (PGA) of Disease for RA, SpA and PA | 3.2 cm | Standard Deviation 2.3 |
Secondary
Stress Score
The questionnaire on stress after the switch to the biosimilar contained 3 items (emotional reactivity, repetition syndrome and tendency to avoid), each scored from 0 (no stress) to 4 (extreme stress). The overall score of stress was calculated by adding together the scores for the 3 items, ranged from 0 (no stress) to 12 (highest level of stress), higher scores indicated greater levels of stress. This outcome measure was evaluated in participants who were informed of a switch from infliximab reference to Inflectra.
Time frame: Baseline (inclusion visit) up to Month 12
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Crohn's Disease (CD) | Stress Score | 2.3 Units on a scale | Standard Deviation 1.7 |
| Ulcerative Colitis (UC) | Stress Score | 2.0 Units on a scale | Standard Deviation 2.6 |
| Rheumatoid Arthritis (RA) | Stress Score | 1.3 Units on a scale | Standard Deviation 1.6 |
| Ankylosing Spondylitis (SpA) | Stress Score | 1.9 Units on a scale | Standard Deviation 2.1 |
| Psoriatic Arthritis (PA) | Stress Score | 3.4 Units on a scale | Standard Deviation 2.7 |