Clinical response after 3 months for each induction therapy group, intention-to-treat analysis
| Clinical response | A. MTX+SASP+HCQ+IM GCs (n=85) | B. MTX+SASP+HCQ+oral GCs (n=89) | C. MTX+oral GCs (n=90) |
|---|---|---|---|
| DAS, mean (SD)† | 1.86 (0.96) | 1.82 (0.86) | 2.21 (1.04) |
| ΔDAS (T3–T0), mean (SD)‡ | −1.39 (1.00) | −1.54 (0.98) | −1.19 (1.02) |
| Disease state according to DAS, n (%) | |||
| Moderate to high disease activity (DAS≥2.4)§,* | 20 (24) | 19 (21) | 36 (40) |
| Low disease activity (1.6≥DAS<2.4) | 28 (33) | 32 (36) | 26 (29) |
| remission(DAS<1.6) | 37 (44) | 38 (43) | 28 (31) |
| EULAR response criteria, n (%) | |||
| Good | 45 (53) | 43 (48) | 39 (43) |
| Moderate | 23 (27) | 30 (34) | 23 (26) |
| None¶ | 17 (20) | 16 (18) | 28 (31) |
| TJC44, median (IQR)# | 1 (0–4) | 1 (0–5) | 3 (0–7) |
| SJC44, median (IQR) | 1 (0 - 3) | 1 (0–3) | 1 (0–4) |
| VAS global (0–100mm), median (IQR)** | 24 (13–36) | 26 (15–48) | 39.5 (21–54) |
| ESR in mm/h, median (IQR) | 14 (6–27) | 10 (5–21) | 12.5 (7–22.5) |
| CRP in mg/l, median (IQR)†† | 4.4 (1.2–8) | 3.2 (1–5.6) | 5 (2–9) |
| HAQ, mean (SD) | 0.53 (0.54) (n=73) | 0.52 (0.55) (n=83) | 0.69 (0.64) (n=79) |
| ΔHAQ (T3–T0), mean (SD) | −0.41 (0.50) (n=69) | −0.40 (0.53) (n=78) | −0.37 (0.57) (n=78) |
| RADAI (0–10), mean (SD)‡‡ | 1.99 (1.78) (n=71) | 1.93 (1.81) (n=79) | 2.57 (2.02) (n=76) |
| ΔRADAI (T3–T0), mean (SD) | −1.95 (1.73) (n=67) | −1.96 (1.92) (n=71) | −1.54 (1.75) (n=73) |
Not everyone filled in a (complete) questionnaire and therefore n is different for HAQ and RADAI.
CRP, C-reactive protein; DAS, Disease Activity Score; ESR, erythrocyte sedimentation rate; GCs, glucocorticosteroids; HAQ, Health Assessment Questionnaire; HCQ, hydroxychloroquine; MTX, methotrexate; RADAI, Rheumatoid Arthritis Disease Activity Index questionnaire; SASP, sulfasalazine; SJC44, swollen joint count (44 joints); TJC44, tender joint count (44 joints); VAS, visual analogue scale.
↵* Starting biological agent.
↵† p=0.021 and p=0.007 for respectively A vs C and B vs C.
↵‡ p=0.020 B vs C.
↵§ p=0.020 and p=0.007 for respectively A vs C and B vs C.
↵¶ p=0.04 B vs C.
↵** p=0.018 A vs C.
↵# p=0.0009 A vs C.
↵†† p=0.035 B vs C.
↵‡‡ p=0.038 B vs C.