Table 2.
Baseline clinical characteristics in monotherapy and combination therapy initiators by therapy class
| Characteristicsa | Monotherapy initiators | Combination therapy initiators | ||||
|---|---|---|---|---|---|---|
| TNFi | IL-6Ri | P-value | TNFi | IL-6Ri | P-valueb | |
| Total, N | 737 | 286 | 1315 | 401 | ||
| CDAI | 24.9 (12.3) | 26.9 (12.4) | 0.02 | 24.8 (12.2) | 26.7 (12.2) | 0.007 |
| Tender joint count | 9.0 (7.1) | 9.6 (7.2) | 0.23 | 9.0 (7.0) | 10.0 (7.4) | 0.01 |
| Swollen joint count | 6.0 (5.3) | 6.9 (5.3) | 0.02 | 6.6 (5.3) | 6.7 (5.4) | 0.60 |
| Physician-reported global assessment | 42.8 (21.6) | 45.5 (20.6) | 0.06 | 40.8 (20.5) | 44.3 (20.0) | 0.003 |
| Patient-reported global assessment | 56.5 (23.4) | 58.4 (24.2) | 0.26 | 52.2 (24.7) | 55.5 (23.5) | 0.02 |
| HAQ-DIc | 1.1 (0.7) | 1.3 (0.7) | < 0.001 | 1.1 (0.7) | 1.2 (0.7) | 0.08 |
| EQ-5Dc | 0.7 (0.2) | 0.6 (0.2) | 0.20 | 0.7 (0.2) | 0.7 (0.2) | 0.15 |
| Patient reported pain | 59.8 (25.0) | 62.2 (25.1) | 0.18 | 54.3 (25.9) | 57.3 (24.1) | 0.04 |
| Patient reported fatiguec | 58.2 (27.3) | 58.5 (27.7) | 0.85 | 53.9 (27.7) | 57.3 (26.9) | 0.03 |
| Morning stiffness, n (%) | 678 (92.4) | 274 (96.1) | 0.03 | 1208 (92.4) | 376 (94.5) | 0.15 |
| Morning stiffness duration, hc,d | 2.3 (3.8) | 2.4 (3.7) | 0.64 | 2.2 (3.9) | 2.3 (4.2) | 0.66 |
| DP1, n (%)e | 165 (22.4) | 65 (22.7) | 0.91 | 260 (19.8) | 87 (21.7) | 0.40 |
| DP2, n (%)c,e | 228 (33.1) | 82 (30.4) | 0.41 | 356 (28.5) | 119 (31.3) | 0.28 |
| Prior use of csDMARDs, n (%) | 0.65 | 0.03 | ||||
| 0 | 90 (12.2) | 29 (10.1) | - | - | ||
| 1 | 275 (37.3) | 109 (38.1) | 642 (48.8) | 221 (55.1) | ||
| 2 + | 372 (50.5) | 148 (51.7) | 673 (51.2) | 180 (44.9) | ||
| Prior use of TNFi, n (%) | < 0.001 | < 0.001 | ||||
| 0 | 69 (9.4) | 32 (11.2) | 104 (7.9) | 34 (8.5) | ||
| 1 | 540 (73.3) | 177 (61.9) | 984 (74.8) | 254 (63.3) | ||
| 2 | 128 (17.4) | 77 (26.9) | 227 (17.3) | 113 (28.2) | ||
| Prior use of any non-TNFi, n (%) | 123 (16.7) | 99 (34.6) | < 0.001 | 202 (15.4) | 130 (32.4) | < 0.001 |
| Prednisone use, n (%) | 0.01 | 0.18 | ||||
| No use | 517 (70.1) | 190 (66.4) | 928 (70.6) | 261 (65.1) | ||
| Current use, missing dose | 6 (0.8) | 1 | 21 (1.6) | 6 (1.5) | ||
| Current use, dose < 10 mg | 147 (19.9) | 49 (17.1) | 259 (19.7) | 92 (22.9) | ||
| Current use, dose ≥ 10 mg | 67 (9.1) | 46 (16.1) | 107 (8.1) | 42 (10.5) | ||
| b/tsDMARD line of therapy, n (%) | < 0.001 | < 0.001 | ||||
| Second | 509 (69.1) | 123 (43.0) | 937 (71.3) | 175 (43.6) | ||
| Third | 228 (30.9) | 163 (57.0) | 378 (28.7) | 226 (56.4) | ||
aValues are mean (standard deviation) unless indicated otherwise
bP-values from unadjusted comparison tests of characteristic distributions between therapy groups
cVariables (for monotherapy initiators) with more than 5% of missing data
dOnly calculated for those reporting morning stiffness
eDP1: tender joint count (TJC, 28) – swollen joint count (SJC, 28) ≥ 7; DP2: SJC (28)/TJC (28) < 0.5
b/tsDMARD, biologic/targeted synthetic disease modifying anti-rheumatic drug; CDAI, clinical disease activity index; csDMARDs, conventional synthetic disease modifying anti-rheumatic drugs; DP, disproportionate pain; HAQ-DI, Health Assessment Questionnaire-Disability Index; IL-6Ri, interleukin-6 receptor inhibitor; n/N, number of patients; SJC, swollen joint counts; TJC, tender joint count; TNFi, tumor necrosis factor inhibitor