Table 1.
Baseline characteristics of patients, stratified by histological classification and investigational medicinal product
|
Overall |
B-cell poor |
B-cell rich |
|||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| All patients (n=161) | Rituximab (n=82) | Tocilizumab (n=79) | p value | All patients (n=79) | Rituximab (n=38) | Tocilizumab (n=41) | p value | All patients (n=64) | Rituximab (n=33) | Tocilizumab (n=31) | p value | ||
| Sex | |||||||||||||
| Female | 128 (80%) | 62 (76%) | 66 (84%) | 0·21 | 69 (87%) | 32 (84%) | 37 (90%) | 0·42 | 50 (78%) | 23 (70%) | 27 (87%) | 0·092 | |
| Male | 33 (20%) | 20 (24%) | 13 (16%) | 0·21 | 10 (13%) | 6 (16%) | 4 (10%) | 0·42 | 14 (22%) | 10 (30%) | 4 (13%) | 0·092 | |
| Age, years | 55·5 (47·4–65·3) | 55·7 (47·7–65·5) | 55·5 (47·3–65·1) | 0·81 | 56·3 (47·2–65·9) | 57·9 (47·0–68·9) | 54·7 (47·3–64·3) | 0·54 | 55·3 (48·1–64·6) | 54·1 (47·1–63·1) | 57·4 (51·3–67·4) | 0·22 | |
| Median disease duration, years | 9·0 (4·0–19·0) | 9·50 (4·0–20·7) | 9·00 (4·0–18·0) | 0·71 | 11·0 (6·0–22·5) | 11·0 (6·0–24·7) | 12·0 (5·0–21·0) | 0·72 | 7·0 (4·0–15·2) | 6·0 (4·0–16·0) | 7·0 (4·5–13·5) | 0·76 | |
| Clinical disease activity index | 29·8 (21·7–40·6) | 30·6 (22·8–40·6) | 29·4 (21·5–40·3) | 0·67 | 30·4 (22·3–39·8) | 30·8 (23·5–38·4) | 30·4 (22·3–44·2) | 0·64 | 29·0 (21·1–40·9) | 28·9 (20·7–40·7) | 31·4 (21·6–41·1) | 0·72 | |
| ESR (mm/h) | 31·0 (17·0–48·0) | 34·5 (17·0–48·0) | 28·0 (18·5–46·5) | 0·57 | 29·0 (17·0–44·0) | 30·5 (16·0–44·5) | 28·0 (19·0–42·0) | 0·91 | 34·5 (19·0–54·0) | 41·0 (19·0–54·0) | 32·0 (19·0–55·5) | 0·71 | |
| CRP (mg/L) | 11·0 (5·0–27·0) | 10·0 (5·0–23·0) | 15·0 (5·0–32·0) | 0·29 | 9·0 (2·5–18·0) | 7·5 (1·0–15·7) | 13·0 (6·0–23·0) | 0·098 | 16·5 (7·7–33·7) | 14·0 (8·0–32·0) | 18·0 (6·0–44·0) | 0·83 | |
| RF or ACPA positive | 140 (87%) | 73 (89%) | 67 (85%) | 0·42 | 67 (85%) | 34 (89%) | 33 (80%) | 0·26 | 55 (86%) | 28 (85%) | 27 (87%) | 0·79 | |
| RF positive | 119 (74%) | 64 (78%) | 55 (70%) | 0·22 | 55 (70%) | 29 (76%) | 26 (63%) | 0·21 | 49 (77%) | 26 (79%) | 23 (74%) | 0·66 | |
| ACPA positive | 128 (80%) | 67 (82%) | 61 (77%) | 0·48 | 61 (77%) | 30 (79%) | 31 (76%) | 0·72 | 50 (78%) | 26 (79%) | 24 (77%) | 0·89 | |
| Haemoglobin (g/L) | 123·0 (110·5–131·5) | 121·0 (109·0–131·0) | 123·0 (111·5–131·7) | 0·58 | 123·0 (110·5–129·0) | 123·0 (109·5–129·0) | 123·0 (111·0–129·0) | 0·99 | 120·0 (109·2–131·5) | 120·0 (108·5–132·0) | 119·5 (110·2–130·0) | 0·855 | |
| Number of tender joints (0–28) | 11·0 (6·0–18·0) | 10·5 (6·2–18·7) | 11·0 (6·0–16·0) | 0·63 | 11·0 (7·0–18·0) | 11·0 (7·0–17·7) | 12·0 (7·0–18·0) | 0·85 | 10·0 (6·0–17·2) | 10·0 (6·0–19·0) | 12·0 (6·0–15·5) | 0·824 | |
| Number of swollen joints (0-28) | 6·0 (3·0–10·0) | 6·00 (4·0–9·0) | 6·0 (3·0–10·5) | 0·76 | 6·0 (4·0–10·5) | 5·0 (3·2–8·7) | 7·0 (4·0–12·0) | 0·17 | 6·0 (3·7–9·3) | 6·0 (4·0–9·0) | 6·0 (3·5–10·0) | 0·984 | |
| DAS28-ESR | 5·81 (1·25) | 5·84 (1·19) | 5·78 (1·31) | 0·74 | 5·88 (1·10) | 5·80 (1·04) | 5·95 (1·17) | 0·56 | 5·85 (1·32) | 5·76 (1·41) | 5·94 (1·23) | 0·581 | |
| DAS28-CRP | 5·31 (1·20) | 5·30 (1·15) | 5·33 (1·26) | 0·90 | 5·28 (1·13) | 5·13 (1·02) | 5·41 (1·23) | 0·27 | 5·40 (1·27) | 5·33 (1·30) | 5·48 (1·24) | 0·639 | |
| Ultrasound 12-max score (Power Doppler) | 4·0 (1·0–9·0) | 4·0 (0·2–8·0) | 6·0 (1·5–10·0) | 0·44 | 4·0 (0·0–8·0) | 4·0 (3·0–7·0) | 2·0 (0·0–8·0) | 0·39 | 6·0 (2·0–10·5) | 6·0 (1·5–9·0) | 7·0 (4·0–12·2) | 0·289 | |
| Ultrasound 12-max score (synovial thickening) | 15·0 (11·5–22·0) | 16·0 (13·0–22·0) | 15·0 (10·0–20·2) | 0·41 | 14·0 (9·0–18·0) | 14·0 (9·5–17·5) | 13·5 (7·2–19·2) | 0·59 | 19·0 (14·5–24·5) | 19·0 (15·0–22·0) | 19·0 (14·0–25·0) | 0·934 | |
| SHSS, total | 8·5 (2·5–39·6) | 8·5 (2·5–39·6) | 9·3 (2·5–36·9) | 0·89 | 6·0 (1·0–39·6) | 6·0 (1·0–37·0) | 6·0 (1·0–50·0) | 0·64 | 10·8 (3·5–51·0) | 12·5 (2·9–64·5) | 10·5 (5·3–24·3) | 0·666 | |
| SHSS, joint space narrowing | 6·8 (1·1–29·6) | 6·3 (1·3–29·6) | 7·0 (1·4–29·0) | 0·82 | 3·0 (0·3–28·5) | 2·5 (0·0–23·0) | 5·00 (1·0–30·5) | 0·41 | 8·8 (2·3–34·5) | 8·0 (2·8–43·1) | 9·8 (2·9–20·1) | 0·756 | |
| SHSS, erosion | 1·5 (0·0–8·9) | 3·3 (0·1–8·9) | 0·8 (0·0–8·4) | 0·35 | 1·8 (0·0–10·5) | 3·5 (0·0–9·0) | 1·5 (0·0–11·0) | 0·80 | 1·5 (0·0–6·9) | 2·5 (0·4–16·8) | 0·8 (0·0–5·4) | 0·401 | |
| Previous methotrexate use | 161 (100%) | 82 (100%) | 79 (100%) | NA | 79 (100%) | 38 (100%) | 41 (100%) | NA | 64 (100%) | 33 (100%) | 31 (100%) | NA | |
| Previous prednisolone use | 90 (56%) | 44 (54%) | 46 (58%) | 0·56 | 42 (53%) | 23 (61%) | 19 (46%) | 0·21 | 40 (62%) | 18 (55%) | 22 (71%) | 0·175 | |
| Number of previous biological drugs used, (%; anti-TNF vs other*)† | .. | .. | .. | 0·19 | .. | .. | .. | 0·15 | .. | .. | .. | 0·711 | |
| One | 116 (72%; 116 vs 0) | 62 (76%; 62 vs 0) | 54 (68%; 54 vs 0) | NA | 52 (66%; 52 vs 0) | 25 (66%; 25 vs 0) | 27 (66%; 27 vs 0) | NA | 50 (78%; 50 vs 0) | 27 (82%; 27 vs 0) | 23 (74%; 23 vs 0) | NA | |
| Two | 36 (22%; 32 vs 4] | 14 (17%; 11 vs 3) | 22 (28%; 21 vs 1) | NA | 21 (27%; 19 vs 2) | 8 (21%;6 vs 2) | 13 (32%; 13 vs 0) | NA | 11 (17%; 9 vs 2) | 5 (15%;4 vs 1) | 6 (19%; 5 vs 1) | NA | |
| Three or more | 9 (6%;5 vs 4) | 6 (7%;3 vs 3) | 3 (4%;2 vs 1) | NA | 6 (8%;3 vs 3) | 5 (13%;2 vs 3) | 1 (2%;1 vs 0) | NA | 3 (5%;2 vs 1) | 1 (3%;1 vs 0) | 2 (6%;1 vs 1) | NA | |
Data are n (%), median [IQR], or mean (SD). ACPA=anti-citrullinated protein antibody. CRP=C-reactive protein. DAS28=28 joint count Disease Activity Score. ESR=erythrocyte sedimentation rate. RF=rheumatoid factor. NA=not applicable. SHSS=Sharp van der Heijde score. TNF=tumour necrosis factor.
*
Eight patients in total used non-TNF inhibitor biological drugs (seven received abatacept and one received vaccine RA TNF-K-006 for a clinical study).
†
p values refer to the χ2 comparing the number of biological drugs used in rituximab and tocilizumab groups.