Table 1.
Patient demographics, treatment characteristics, and clinical outcomes after four cycles of treatment in patients who switched from infliximab (reference product) to the biosimilar CT-P13 versus those who continued on reference product
| Switched to CT-P13 (n = 7) | Continued on RP (n = 6) | |
|---|---|---|
| Baseline characteristics | ||
| Indication | 2 RA, 2 PsA, 3 AS | 3 PsA, 3 AS |
| Age (years) | 49 (13) | 53 (15) |
| Gender (male:female) | 5:2 | 6:0 |
| Treatment prior to study | ||
| Infliximab RP dose (mg/kg) | 4.8 (0.7)a | 3.3 (0.5) |
| Infliximab RP dose interval (days) | 56 (4) | 56 (5) |
| Duration of infliximab RP treatment (cycles) | 76 (26) | 75 (18) |
| Treatment during study | ||
| Study drug | CT-P13 | Infliximab RP |
| Dose (mg/kg) | 5.0 (0.4)a | 3.3 (0.5) |
| Dose interval (days) | 56 (7) | 56 (5) |
| Concomitant DMARDs [n (%)] | 5 (71.4) | 5 (83.3) |
| Clinical statusb | ||
| At start of study | ||
| Remission [n (%)] | 2 (28.6) | 4 (66.7) |
| At end of study | ||
| Remission [n (%)] | 5 (71.4) | 5 (83.3) |
| Significant response [n (%)] | 1 (14.3) | 0 |
| Continued improvement [n (%)] | 1 (14.3) | 1 (16.7) |
| Safety results | ||
| Patients experiencing ≥1 AE [n (%)] | 4 (57.1)c | 3 (50.0) |
| Upper airway infection [n (severity)] | 3 (mild) | 2 (mild) |
| Gastrointestinal infection [n (severity)] | 1 (mild) | 1 (mild) |
| Cutaneous AE [n (severity)] | 1 (severe)d | 0 |
| Discontinuation due to AE [n (%)] | 1 (14.3)d | 0 |
Data are median (interquartile range) unless otherwise stated
AE adverse event, AS ankylosing spondylitis, BASDAI, Bath Ankylosing Spondylitis Disease Activity Index, DAS28 Disease Activity Score in 28 joints, DMARD disease-modifying antirheumatic drug, PsA psoriatic arthritis, RA rheumatoid arthritis, RP reference product
a P < 0.005 (Mann–Whitney U test)
bRemission defined as DAS28 <2.6 in RA/PsA patients or BASDAI <2.0 in AS patients. Significant response defined as a reduction in DAS28 of ≥1.2 points in RA/PsA patients or a reduction in BASDAI of ≥2.0 points in AS patients. Continued improvement defined as a reduction in DAS28 <1.2 points in RA/PsA patients or a reduction in BASDAI <2.0 points in AS patients. All responses were assessed in relation to the start of the study
cOne patient experienced two AEs
dDermatitis