ETA-SB4-ETA back-switchers (n=120). Characteristics at the start of SB4, reasons for SB4 withdrawal and changes in disease activity among withdrawals due to LOE
| RA | PsA | AxSpA | |
| Patient number, n | 80 | 20 | 20 |
| Characteristics at the start of SB4 | |||
| Female, n (%) | 58 (73) | 11 (55) | 7 (35) |
| Age, years | 59 (52 to 70) | 45 (36 to 56) | 43 (38 to 56) |
| Concomitant MTX, n (%) | 39 (49) | 7 (35) | 1 (5) |
| Patients with available data, n* | 64 | 17 | 18 |
| In remission, % | 61 | 82 | 19 |
| PGS, mm* | 27 (12 to 54) | 25 (13 to 63) | 23 (13 to 44) |
| DAS28 | 2.2 (1.6 to 3.2) | 1.8 (1.4 to 2.2) | – |
| CRP, mg/L | 3 (1 to 8) | 1 (1 to 5) | 3 (1 to 6) |
| Swollen joint count | 0 (0 to 1) | 0 (0 to 0) | – |
| ASDAS | – | – | 1.7 (1.4 to 2.4) |
| PASS yes, % | 81 | 82 | 88 |
| Reason for SB4 withdrawal, n (%) | |||
| AE | 34 (42) | 7 (35) | 6 (30) |
| LOE | 38 (48) | 11 (55) | 13 (65) |
| Other/several/not stated | 8 (10) | 2 (10) | 1 (5) |
| Characteristics at the restart of ETA in patients who stopped due to LOE and back-switched, n=62 | |||
| Patient number, n | 38 | 11 | 13 |
| Swollen joint count | 2 (0 to 5) | 0 (0 to 2) | – |
| CRP, mg/L | 3 (2 to 11) | 3 (2 to 7) | 4 (1 to 6) |
| PGS, mm | 64 (50 to 76) | 78 (18 to 90) | 42 (35 to 63) |
| Delta values† in patients who stopped due to LOE and back-switched | |||
| Patients with available data, n† | 31 | 8 | 11 |
| Delta-swollen joint count | 1 (0 to 4) | 0 (0 to 0) | – |
| Delta-CRP, mg/L | 0 (-1 to 5) | 1 (0 to 2) | 0 (0 to 4) |
| Delta-PGS, mm | 30 (12 to 52) | 15 (7 to 77) | 25 (19 to 35) |
Numbers are medians (interquartile ranges) unless otherwise stated.
Patients stopped due to adverse events, n=47: arthralgia 1 patient, bladder dysfunction 1,blurred vision 1, diarrhoea 4, dizziness 2, dyspnoea 2, erectile dysfunction 1, hair loss 1,headache/migraine 4, hyperhidrosis 2, hypertension 1, hypotension 1, infections 2, leg cramps 1, local injection problems 3, myalgia 1, nausea 2, neuropathies 1, psoriasis worsening or pustulosis 1, rash/itching 9, not stated 21 (total=62 events, this is a subgroup of the eventsshown in table 3).
*Available data varied according to variable, numbers are shown for PGS.
†Calculated as disease activity at time of restart ETA minus at the time of SB4 start for each patient.
AE, adverse event; ASDAS, the Ankylosing Spondylitis Disease Activity Score; AxSpA, axial spondyloarthritis; CRP, C reactive protein; DAS28, 28-joint Disease Activity Score (four variables, CRP-based); LOE, lack of effect; MTX, methotrexate; PASS, patient acceptable symptom state; PGS, patient’s global score; PsA, psoriatic arthritis; RA, rheumatoid arthritis; SB4, biosimilar etanercept.