Table 2.
Overall comparison of outcomes by treatment group
| TNFi initiators | Non-TNFi initiators | TNFi versus non-TNFi* | ||
| All patients | 2372 | 593 | – | – |
| Binary outcomes | Response rate n/N (%) | Response rate n/N (%) | Adjusted OR (95% CI) | P value† |
| Achievement of low disease activity (CDAI score of ≤10)‡ | 597/1498 (39.9) | 154/370 (41.6) | 1.00 (0.94 to 1.05) | 0.87 |
| Achievement of remission based on CDAI (≤2.8)§ | 363/2066 (17.6) | 82/504 (16.3) | 1.02 (0.98 to 1.06) | 0.26 |
| Achievement of MID in CDAI¶ | 940/2066 (45.5) | 227/504 (45.0) | 1.01 (0.97 to 1.07) | 0.55 |
| Achievement of remission based on mDAS28 | 449/1835 (24.5) | 118/447 (26.4) | 0.99 (0.95 to 1.04) | 0.65 |
| Patient-reported problem with sleep** | 451/1937 (23.3) | 114/496 (23.0) | 1.00 (0.96 to 1.05) | 0.84 |
| Patient-reported anxiety** | 239/1937 (12.3) | 62/496 (12.5) | 1.00 (0.97 to 1.03) | 0.92 |
| Patient-reported problem with sleep†† | 588/2363 (24.9) | 136/591 (23.0) | 1.02 (0.98 to 1.06) | 0.35 |
| Patient-reported anxiety†† | 308/2363 (13.0%) | 73/591 (12.4%) | 1.01 (0.98 to 1.04) | 0.70 |
| Count outcomes | Incidence rate (per 100 person-years) | Incidence rate (per 100 person-years) | Adjusted IRR (95% CI) | P value |
| Anaemia | 19.04 | 24.01 | 0.79 (0.64 to 0.98) | 0.03 |
| Continuous outcomes | N, mean±SD | N, mean±SD | Adjusted β coefficient (95% CI)‡‡ | P value |
| Change in CDAI | 2065, –6.8±14.0 | 504, –6.5±13.8 | –0.78 (–1.87 to 0.31) | 0.16 |
| Change in HAQ | 1732, –0.1±0.6 | 373, –0.1±0.5 | –0.05 (–0.11 to 0.00) | 0.07 |
| Change in EQ-5D | 1097, 0.0±0.2 | 357, 0.0±0.2 | –0.01 (–0.03 to 0.01) | 0.48 |
| Change in patient-reported morning stiffness (hours per day) | 1599, –0.3±2.5 | 396, –0.2±2.9 | –0.15 (–0.41 to 0.12) | 0.29 |
| Change in patient-reported fatigue | 1119, –4.7±30.1 | 363, –6.3±26.2 | 1.27 (–1.84 to 4.38) | 0.42 |
*Estimates from multivariable models.
†The reported p values are associated with the adjusted ORs.
‡Among those with moderate or high disease activity at baseline.
§Among those with low, moderate or high disease activity at baseline.
¶Defined as ≥2 if baseline CDAI score=2.8–10; ≥6 if baseline CDAI score=10.1–22; ≥11 if baseline CDAI score>22.
**Imputed as missing if patients switched to another biologic before 1-month follow-up.
††Imputed with the last observation on drug.
‡‡Change in continuous outcomes is defined as the outcome value at 1-year follow-up minus the outcome value at baseline.
CDAI, Clinical Disease Activity Index; EQ-5D, EuroQol-5 Dimension; HAQ, Health Assessment Questionnaire; IRR, incidence rate ratio; mDAS28, 28-Joint Modified Disease Activity Score; MID, minimum important difference; TNFi, tumour necrosis factor inhibitor.