N/A
Completed N=1,426
National Observational Study On The Use Of Inflectra™ An Infliximab Biosimilar In Real Life
Source: ClinicalTrials.gov NCT02925338 ↗Enrolled (actual)
1,426
Serious AEs
12.5%
Results posted
Jan 2023
Primary outcomePrimary: Percentage of Participants Without Treatment Failure During 2-Years of Observation — 59.2; 53.5; 53.5; 61.1 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Without Treatment Failure During 2-Years of Observation |
59.2; 53.5; 53.5; 61.1; 64.6; 19.2 | — |
| PRIMARY Number of Participants With Pre-treatment Assessment Prior to Initiation of Inflectra Treatment (Anti-Tumor Necrosis Factor [TNF] Aplha) Therapy |
458; 177; 118; 355; 86; 5 | — |
| PRIMARY Time Between Diagnosis and Inclusion in Study |
10.05; 8.77; 15.18; 13.58; 11.50 | — |
| PRIMARY Time Between Diagnosis and the First Inflectra Infusion |
9.37; 8.22; 14.39; 12.80; 10.78 | — |
| PRIMARY Number of Participants Who Received Biotherapy Other Than Inflectra Before Inclusion in the Study |
347; 146; 116; 344; 81; 4 | — |
| PRIMARY Number of Participants With Reasons for Discontinuation of Previous Biotherapy |
13; 5; 5; 29; 6; 80 | — |
| PRIMARY Duration of Previous Biotherapies |
51.3; 33.2; 81.0; 73.1; 70.4 | — |
| PRIMARY Mean of Number of Doses Administered in Previous Biotherapy |
38.2; 26.5; 33.5; 39.2; 24.3 | — |
| PRIMARY Last Dosage Administered of a Previous Biotherapy |
104.4; 86.8; 204.8; 216.7; 238.4 | — |
| PRIMARY Number of Participants Who Received Concomitant Treatments Prior to Initiation of Inflectra |
5; 1; 0; 0; 0; 440 | — |
| SECONDARY Physician Global Assessment (PGA) of Disease for RA, SpA and PA |
3.5; 3.2; 3.2 | — |
| SECONDARY Mean Administered Dose of Inflectra (in mg) |
451.0; 493.9; 313.7; 406.9; 440.8; 473.4 | — |
| SECONDARY Mean Administered Posology of Inflectra (in mg/kg) |
6.6; 7.0; 4.3; 5.3; 5.4; 6.8 | — |
| SECONDARY Cumulative Dose |
1028.9; 1071.6; 630.7; 986.1; 1015.4; 1353.9 | — |
| SECONDARY Mean Infusion Time |
75.3; 79.7; 94.8; 92.7; 100.1; 73.2 | — |
| SECONDARY Mean Time Between Infusions |
7.5; 7.7; 7.5; 7.0; 7.2; 11.9 | — |
| SECONDARY Mean Duration of Post-infusion Monitoring at the Hospital |
53.9; 55.0; 63.6; 66.6; 66.3; 48.2 | — |
| SECONDARY Absolute Variation in Mean Disease Activity Score (DAS) 28 Compared With Baseline at Month 6, 12, 18, and 24 |
-0.1; -0.2; -0.2; -0.3; -0.2; -0.2 | — |
| SECONDARY Absolute Variation in Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score Compared With Baseline at Month 6, 12, 18, and 24 |
-0.1; -0.2; -0.2; -0.3 | — |
| SECONDARY Absolute Variation in Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Score Compared With Baseline at Month 6, 12, 18, and 24 |
-0.1; -0.2; -0.0; 0.1 | — |
| SECONDARY Absolute Variation in Mean Mayo Score Compared With Baseline at Month 6, 12, 18, and 24 |
-0.7; -1.3; -1.2; -1.4 | — |
| SECONDARY Absolute Variation in Mean Pediatric Ulcerative Colitis Activity Index (PUCAI) Score Compared With Baseline at Month 6, 12, 18, and 24 |
-5.3; 2.2; 1.8; 2.2 | — |
| SECONDARY Absolute Variation in Mean Colitis Endoscopic Index of Severity (UCEIS) Score Compared With Baseline at Month 6, 12, 18, and 24 |
0.25; -0.80; 0.00; -2.50 | — |
| SECONDARY Absolute Variation in Mean Harvey-Bradshaw Score Compared With Baseline at Month 6, 12, 18, and 24 |
-0.1; -0.2; -0.4; -0.6 | — |
| SECONDARY Absolute Variation in Mean Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Compared With Baseline at Month 6, 12, 18, and 24 |
-2.35; -5.98; -1.37 | — |
| SECONDARY Absolute Variation of Mean Global Disease Assessment Compared With Baseline at Month 6, 12, 18, and 24 |
-0.3; -0.0; -0.5; -0.4; -0.2; -0.4 | — |
| SECONDARY Absolute Variation of Mean Fatigue Score Compared With Baseline at Month 6, 12, 18, and 24 |
-0.6; 0.0; -0.4; 0.1; 0.1; -0.3 | — |
| SECONDARY Absolute Variation in Mean Simple Disease Activity Index (SDAI) Score Compared With Baseline at Month 6, 12, 18, and 24 |
-1.6; -1.5; -4.0; -3.1 | — |
| SECONDARY Absolute Variation in Mean Health Assessment Questionnaire (HAQ) Score Compared With Baseline at Month 6, 12, 18, and 24 |
-0.3; 0.0; -0.2; 0.4 | — |
| SECONDARY Absolute Variation in Mean Ankylosing Spondylitis Disease Activity Score (ASDAS) Score Compared With Baseline at Month 6, 12, 18, and 24 |
-0.1; -0.1; -0.2; -0.2 | — |
| SECONDARY Cook and Medley Score at Baseline |
19.0; 17.1; 18.7; 18.1; 20.0 | — |
| SECONDARY Stress Score |
2.3; 2.0; 1.3; 1.9; 3.4 | — |
| SECONDARY General Anxiety Disorder (GAD7) Score |
5.5; 3.4; 3.8; 4.8; 7.8 | — |
| SECONDARY Number of Participants With Immunogenicity Assay at Inclusion Visit |
87; 44; 13; 24; 5 | — |
| SECONDARY Number of Participants With Anti-Infliximab Antibody Assay Assessment at Inclusion Visit |
79; 37; 9; 24; 5 | — |
| SECONDARY Number of Participants With Presence of Anti-infliximab Antibodies at Inclusion Visit |
9; 6; 1; 8; 3 | — |
| SECONDARY Number of Participants With Infliximab Trough Level (IFX-TL) Assay at Inclusion Visit |
82; 40; 8; 21; 5 | — |
| SECONDARY Infliximab Trough Level (IFX-TL) at Inclusion Visit |
6.69; 7.66; 6.06; 7.32; 7.40 | — |
| 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) |
0.3; 0.4; 0.1; 0.1; 0.1; 0.5 | — |
| 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) |
7; 3; 4; 7; 2; 5 | — |
| 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) |
8.4; 6.5; 4.2; 6.9; 9.2; 7.3 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02925338). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.