Disease activity 3 months prior to versus 3 months after the switch from INX to CT-P13 stratified by diagnosis
Disease activity | Changes over time | p* | ||||
3 Months preswitch | Switch | 3 Months postswitch | ∆Preswitch | ∆Postswitch | ||
RA, n=403 | ||||||
Patients with available data, n‡ | 319 | 310 | 309 | 276 | 265 | – |
DAS28 | 2.2 (1.7–2.9) | 2.2 (1.8–3.0) | 2.2 (1.8–3.2) | 0.1 (−0.2 to 0.5) | 0.0 (−0.4 to 0.4) | 0.8 |
HAQ (0–3) | 0.6 (0.1–1.0) | 0.6 (0.1–1.0) | 0.6 (0.2–1.1) | 0.0 (0.0–0.1) | 0.1 (−0.1 to 0.1) | 0.3 |
CRP, mg/L (<10 mg/L) | 4 (2–7) | 4.5 (2–8) | 5 (2–8) | 0 (−1 to 2) | 0 (−2 to 3) | 0.4 |
Patient’s global score, mm | 26 (12–51) | 25 (11–51) | 26 (12–56) | 0.0 (−7 to 8) | 0.0 (−7 to 9) | 0.5 |
PsA, n=120 | ||||||
Patients with available data, n‡ | 94 | 92 | 94 | 78 | 81 | – |
DAS28 | 2.5 (1.7–3.1) | 2.3 (1.7–3.1) | 2.4 (1.8–3.3) | 0.0 (−0.4 to 0.2) | 0.1 (−0.4 to 0.6) | 0.10 |
HAQ (0–3) | 0.5 (0.1–1.1) | 0.6 (0.1–1.1) | 0.5 (0.1–1.1) | 0.0 (−0.1 to 0.1) | 0.0 (0.0–0.1) | 0.5 |
CRP, mg/L (<10 mg/L) | 4 (1–6) | 4 (1–6) | 3 (2–7) | 0 (−1 to 1) | 0 (−1 to 2) | 0.046 |
Patient’s global score, mm | 32 (10–56) | 34 (10–67) | 35 (11–62) | −3 (−12 to 4) | 0 (−7 to 11) | 0.01 |
AxSpA, n=279 | ||||||
Patients with available data, n‡ | 202 | 199 | 204 | 160 | 169 | – |
BASDAI, mm | 23 (8–40) | 24 (10–40) | 25 (11–45) | 0 (−4 to 5) | 0 (−4 to 7) | 0.3 |
CRP, mg/L | 3 (1–6) | 4 (1–8) | 4 (1–8) | 0 (−1 to 1) | 0 (−1 to 2) | 0.2 |
Patient’s global score, mm | 26 (10–53) | 31 (14–56) | 27 (11–59) | 1 (−4 to 8) | −1 (−7 to 7) | 0.7 |
ASDAS | 1.8 (1.2–2.6) | 2.0 (1.4–2.6) | 2.0 (1.2–2.9) | 0.0 (−0.3 to 0.4) | 0.0 (−0.3 to 0.3) | 0.8 |
3 Months’ flare rates preswitch versus postswitch† | ||||||
RA and PsA (ΔDAS28 ≥0.6), % | 22 | 22 | ||||
RA and PsA (ΔDAS28 ≥1.2), % | 10 | 10 | ||||
AxSpA (ΔASDAS), % | 3 | 4 |
Numbers are medians (interquartile ranges) unless otherwise stated (%).
Including only patients with complete data gave virtually identical results, supporting that data were missing at random. Comparisons of before versus after the switch were done in the patients who had complete data for that variable.
Notes: Missing data at the 3 months' visit were imputed with the 6 months’ visit according to the following time windows:
Time windows preswitch: 3 months’ window: 0–25 weeks, 6 months’ window: 25–32 weeks before start of CT-P13.
Time window switch: 12 weeks before until 1 week after start of CT-P13.
Time window postswitch: 3 months’ window: 9–17 weeks, 6 months’ window: 17–32 weeks after start of CT-P13. Overlapping time windows at baseline were allowed to reduce missing data. Any visit was only used once, and the registration closest to the given time point was selected. If a patient had no registrations, data were registered as missing for that visit.
*Comparison of ∆preswitch versus ∆postswitch, Wilcoxon matched-pair signed-rank test.
†There was no overlap between the patients who had a flare preswitch versus postswitch.
‡The number of patients with available data varied slightly across measures of disease activity. Exact numbers are shown for DAS28 and ASDAS. Individual patients might not have complete data for all variables at a certain time point.
ASDAS, Ankylosing Spondylitis Disease Activity Score; AxSpA, axial spondyloarthritis; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; CRP, C reactive protein; DAS28, 28 Joint Disease Activity Score (four variables, CRP-based); HAQ, Health Assessment Questionnaire; RA, rheumatoid arthritis; PsA, psoriatic arthritis.