Disease activity and functional status 4 months prior to GP1111 switch, at the time of switch and 4 months after switch, stratified by indication and by originator treatment history
| Originator-experienced switchers | Originator-naïve switchers | |||||||||
| 4 months preswitch | Switch (baseline) | 4 months postswitch | Preswitch (delta values)* | Postswitch (delta values)* | 4 months preswitch | Switch (baseline) | 4 months postswitch | Preswitch (delta values)* | Postswitch (delta values)* | |
| Rheumatoid arthritis n=203 | Rheumatoid arthritis n=482 | |||||||||
| DAS28 | 1.9 (1.5 to 2.4) | 1.9 (1.4 to 2.5) | 1.9 (1.5 to 2.5) | –0.04 (–0.3 to 0.5) | 0.02 (–0.2 to 0.3) | 2.4 (1.7 to 3.3) | 2.4 (1.8 to 3.3) | 2.2 (1.7 to 3.1) | 0.02 (–0.7 to 0.7) | –0.2 (–0.8 to 0.3) |
| HAQ (0–3) | 0.5 (0.1 to 1.0) | 0.5 (0.1 to 1.1) | 0.6 (0.1 to 1.3) | 0.0 (0.0 to 0.1) | 0.0 (0.0 to 0.1) | 0.6 (0.2 to 1.1) | 0.6 (0.1 to 1.1) | 0.6 (0.1 to 1.1) | 0.0 (–0.1 to 0.1) | 0.0 (–0.1 to 0.1) |
| CRP, mg/L | 2.0 (1.0 to 4.2) | 2.0 (0.9 to 3.6) | 2.1 (1.0 to –5.0) | 0.0 (–1.0 to 1.8) | 0.1 (–0.3 to 1.0) | 3.0 (1.1 to 7.0) | 3.0 (1.1 to 6.9) | 3.0 (1.7 to 6.1) | 0.0 (–1.2 to 2.0) | 0.0 (–2.5 to 1.4) |
| CDAI | 3.5 (1.8 to 6.3) | 2.9 (1.4 to 5.9) | 3.2 (1.4 to 6.9) | 0.2 (–0.8 to 1.0) | –0.3 (–1.1 to 0.6) | 5.7 (2.3 to 10.8) | 5.9 (2.4 to 10.4) | 5.0 (2.0 to 9.5) | –0.6 (–3.6 to 3.4) | –0.4 (–3.9 to 1.7) |
| VAS patient global, mm | 21 (11 to 51) | 21 (8 to 49) | 23 (8 to 51) | –1 (–6 to 3) | 0 (–4 to 5) | 34 (13 to 63) | 37 (13 to 60) | 32 (13 to 65) | 0 (–11 to 9) | –1 (–13 to 8) |
| VAS pain, mm | 20 (9 to 36) | 19 (7 to 41) | 23 (7 to 45) | –1 (–6 to 2) | 1 (–4 to 6) | 30 (12 to 54) | 28 (12 to 55) | 29 (11 to 56) | –1 (–9 to 7) | –1 (–11 to 6) |
| VAS fatigue, mm | 28 (13 to 62) | 28 (13 to 57) | 32 (12 to 61) | 0 (–4 to 5) | 0 (–6 to 7) | 46 (21 to 67) | 44 (21 to 68) | 46 (22 to 72) | 0 (–9 to 9) | –1 (–12 to 9) |
| Psoriatic arthritis n=70 | Psoriatic arthritis n=244 | |||||||||
| DAS28 | 1.9 (1.6 to 2.5) | 2.1 (1.6 to 2.4) | 1.9 (1.5 to 2.5) | 0.11 (–0.1 to 0.3) | –0.06 (–0.3 to 0.2) | 2.1 (1.7 to 2.8) | 2.1 (1.7 to 2.9) | 2.3 (1.7 to 3.0) | –0.0 (–0.4 to 0.5) | 0.01 (–0.4 to 0.3) |
| HAQ (0–3) | 0.5 (0.0 to 0.9) | 0.4 (0.0 to –1.0) | 0.4 (0.0 to 0.9) | 0.0 (0.0 to 0.0) | 0.0 (0.0 to 0.1) | 0.8 (0.3 to 1.0) | 0.8 (0.1 to 1.1) | 0.8 (0.1 to 1.3) | 0.0 (–0.1 to 0.1) | 0.0 (–0.1 to 0.1) |
| CRP, mg/L | 2.5 (0.9 to 4.2) | 2.5 (1.0 to 3.6) | 2.8 (1.0 to 4.2) | 0.0 (–0.9 to 2.1) | 0.0 (–1.3 to 0.0) | 2.0 (1.0 to 4.1) | 2.0 (1.0 to 4.0) | 3.0 (1.0 to 4.0) | 0.2 (–0.6 to 1.6) | 0 (–1 to 2) |
| CDAI | 2.9 (1.3 to 6.7) | 3.8 (1.9 to 8.4) | 3.3 (0.5 to 6.2) | 0.1 (–0.6 to 2.1) | –0.3 (–1.1 to 1.3) | 5.3 (2.3 to 8.9) | 5.3 (2.0 to 10.0) | 5.4 (2.5 to 10.0) | –0.3 (–2.0 to 2.3) | 0.0 (–2.3 to 2.3) |
| VAS patient global, mm | 21 (10 to 49) | 22 (10 to 42) | 21 (3 to 55) | 0 (–4 to 5) | 0 (–4 to 4) | 37 (15 to 67) | 38 (17 to 69) | 38 (18 to 73) | –1 (–7 to 14) | 1 (–9 to 9) |
| VAS pain, mm | 17 (5 to 45) | 25 (5 to 38) | 14 (3 to 46) | 0 (–4 to 4) | 0 (–4 to 5) | 29 (14 to 60) | 32 (9 to 60) | 32 (14 to 63) | 0 (–8 to 9) | 1 (–9 to 9) |
| VAS fatigue, mm | 34 (8 to 65) | 31 (12 to 57) | 36 (9 to 59) | –3 (–9 to 1) | 4 (–0.3 to 11) | 53 (24 to 75) | 53 (17 to 76) | 57 (29 to 80) | –1 (–9 to 10) | 3 (–4 to 13) |
| Axial spondyloarthritis n=161 | Axial spondyloarthritis n=445 | |||||||||
| BASDAI, mm | 21 (6 to 33) | 21 (7 to 36) | 24 (9 to 39) | –0 (–6 to 5) | 0.0 (–5 to 4) | 29 (14 to 48) | 28 (12 to 53) | 27 (11 to 52) | 0 (–6 to 7) | –1 (–9 to 6) |
| ASDAS | 1.5 (0.9 to 2.2) | 1.5 (0.9 to 2.3) | 1.6 (1.1 to 2.4) | –0.1 (–0.4 to 0.3) | 0.1 (–0.2 to 0.3) | 1.8 (1.0 to 2.7) | 1.8 (1.1 to 2.8) | 1.7 (1.1 to 2.8) | 0.0 (–0.3 to 0.5) | –0.02 (–0.4 to 0.4) |
| CRP, mg/L | 2.0 (1.0 to 4.0) | 2.0 (1.0 to 4.0) | 2.5 (1.0 to 4.8) | 0.0 (–0.8 to 0.4) | 0.1 (0.0 to 1.3) | 2.0 (1.0 to 4.0) | 2.7 (1.0 to 4.0) | 3.0 (1.0 to 4.0) | 0.0 (–0.5 to 2.0) | 0.0 (–0.9 to 1.0) |
| VAS patient global, mm | 20 (7 to 42) | 22 (10 to 40) | 22 (8 to 59) | –1 (–8 to 3) | 0 (–4 to 8) | 31 (12 to 58) | 27 (10 to 54) | 29 (9 to 59) | 0 (–11 to 8) | 0 (–9 to 8) |
| VAS pain, mm | 20 (5 to 37) | 19 (7 to 33) | 21 (4 to 41) | –1 (–9 to 3) | 0 (–3 to 6) | 26 (9 to 50) | 23 (8 to 50) | 23 (8 to 49) | –1 (–9 to 8) | –1 (–10 to 7) |
| VAS fatigue, mm | 27 (11 to 58) | 27 (11 to 47) | 29 (13 to 58) | –2 (–6 to 4) | –1 (–4 to 7) | 45 (19 to 71) | 43 (18 to 70) | 43 (16 to 68) | 0 (–11 to 11) | –1 (–12 to 6) |
Numbers are medians (IQRs) unless otherwise stated.
Time windows preswitch: 4 months’ window: –180 days to –91 days before start of GP1111, time windows switch: –90 days to +6 days after start of GP1111, time window postswitch: 4 months’ window: +7 days to +180 days after start of GP1111. In case of several visits within a given time window, the visit closest to the given time point was selected If a patient had no registrations, data will be registered as missing for that visit. For patients who withdrew <6 months postswitch, data from latest registered visit after baseline was carried forward. Patient pain (VAS 0-100), fatigue (VAS 0–100), patient global assessment (VAS 0–100).
*Delta values are changes in disease activity at time of switch minus 4 months before switch (preswitch), and 4 months after switch minus at the time of switch (postswitch) in individual patients. Paired t-tests were performed to compare changes in disease activity (delta values) preswitch and postswitch and showed no statistically significant differences (all p values>0.05).
ASDAS, Ankylosing Spondylitis Disease Activity Score; AxSpA, axial spondyloarthritis; BASDAI, Bath Ankylosing Spondylitis (BAS) Disease Activity Index; BASFI, BAS Functional Index; CDAI, Clinical Disease Activity Index; CRP, C-reactive protein; DAS, Disease Activity Score; HAQ, Health assessment Questionnaire; VAS, Visual Analogue Scale .