Frequency of remission and good radiographic outcome in the included studies
| Trial (year) | n* | Remission at 6 OR 12 months, n (%) | Good radiographic outcome from 12 to 24 months†, n (%) | Good functional outcome from 12 to 24 months, n (%) | ||||||
| 4V-remission | 4V-near-remission | Non-remission | ΔmTSS ≤0 | ΔmTSS ≤0.5 | ΔmTSS ≤5 | n total | ΔHAQ-DI ≤0‡ | ΔHAQ-DI ≤0 HAQ-DI ≤0.5 | ||
| DE019 (2004) | 425 | 68 (16.0) | 45 (10.6) | 312 (73.4) | 245 (57.6) | 297 (69.9) | 397 (93.4) | 398 | 281 (70.6) | 114 (28.6) |
| TEMPO (2004) | 442 | 113 (25.6) | 91 (20.6) | 238 (53.8) | 282 (63.8) | 330 (74.7) | 423 (95.7) | 421 | 300 (71.3) | 152 (36.1) |
| COMET (2008) | 344 | 102 (29.7) | 107 (31.1) | 135 (39.2) | 250 (72.7) | 289 (84.0) | 329 (95.6) | 324 | 237 (73.1) | 138 (42.6) |
| RAPID 1 (2008) | 650 | 177 (27.2) | 143 (22.0) | 330 (50.8) | 424 (65.2) | 508 (78.2) | 636 (97.7) | 642 | 420 (65.4) | 135 (21.0) |
| RAPID 2 (2009) | 417 | 51 (12.2) | 81 (19.4) | 285 (68.4) | 286 (68.6) | 324 (77.7) | 398 (95.4) | 435 | 290 (66.7) | 79 (18.2) |
| GO-FORWARD (2010) | 352 | 86 (24.4) | 74 (21.0) | 192 (54.6) | 200 (56.8) | 228 (64.8) | 304 (86.4) | 358 | na | 105 (29.3) |
| GO-BEFORE (2011) | 499 | 117 (23.5) | 80 (16.0) | 302 (60.5) | 403 (80.8) | 446 (89.4) | 493 (98.8) | 507 | na | 187 (36.9) |
| LITHE (2011) | 796 | 146 (18.3) | 174 (21.9) | 476 (59.8) | 558 (70.1) | 640 (80.4) | 790 (99.2) | 550 | 369 (67.1) | 123 (22.4) |
| DE013 (2013) | 540 | 156 (28.9) | 50 (9.3) | 334 (61.8) | 286 (53.0) | 351 (65.0) | 483 (89.4) | 518 | 383 (73.9) | 249 (48.1) |
| GO-FURTHER (2014) | 483 | 54 (11.2) | 89 (18.4) | 340 (70.4) | 151 (31.3) | 191 (39.5) | 405 (83.9) | 493 | na | 94 (19.1) |
| FUNCTION (2016) | 844 | 308 (36.5) | 151 (17.9) | 385 (45.6) | 713 (84.5) | 766 (90.8) | 840 (99.5) | 616 | 470 (76.3) | 250 (40.6) |
| Total n | 5792 | 1378 | 1085 | 3329 | 3798 | 4370 | 5498 | 5262‡ | 2750 | 1626 |
| Meta-analytic % | 23.0 | 18.9 | 58.1 | 64.1 | 74.1 | 94.6 | 70.6 | 31.1 | ||
| (95% CI) | (18.0 to 28.0) | (15.4 to 22.1) | (52.0 to 64.1) | (54.9 to 73.2) | (66.2 to 82.0) | (92.9 to 96.4) | (67.7 to 73.5) | (24.9 to 37.2) | ||
4V-remission=SJC28, TJC28, CRP (mg/dL) and PGA (0–10), all ≤1; 4V-near-remission=SJC28, TJC28, CRP (mg/dL) ≤1 and PGA (0–10) >1; non-remission=SJC28 >1 or TJC28 >1 or CRP (mg/dL) >1 at 6 or 12 months of follow-up in all cases.
*Number of patients with information both on remission status and on radiographic outcome.
†All trials used van der Heijde mTSS (0 to 448) except the LITHE trial, in which the Genant mTSS (0 to 202) was used instead.
‡Not possible to be determined in the three golimumab trials due to changes that occurred in the research environment and statistical software available since the initial data analyses (thus, n=3904).
CRP, C reactive protein; HAQ-DI, Health Assessment Questionnaire–Disability Index; ∆mTSS, change in the modified total Sharp score during the second year of follow-up; PGA, patient global assessment; SJC28, swollen 28-joint count; TJC28, tender 28-joint count.