Baseline characteristics and clinical response after 12 months for each induction therapy group, according to intention-to-treat
| Characteristics | A. MTX+SASP+HCQ+IM GCs (n=91) | B. MTX+SASP+HCQ+oral GCs (n=93) | C. MTX+oral GCs (n=97) |
|---|---|---|---|
| Demographic | |||
| Age (years), mean (SD) | 53 (15) | 54 (14) | 54 (14) |
| Sex, female, n (%) | 55 (60) | 67 (72) | 68 (70) |
| Disease characteristics | |||
| Symptom duration (days), mean (SD)* | 162 (98) | 184 (92) | 154 (83) |
| ACPA positive, n (%) | 74 (81) | 67 (72) | 75 (77) |
| RF positive, n (%) | 69 (76) | 65 (70) | 65 (67) |
| Fulfilment of RA criteria, n (%) | |||
| 1987† | 69 (76) | 57 (61) | 63 (65) |
| 2010 | 87 (96) | 88 (95) | 95 (98) |
| Disease activity | |||
| DAS, mean (SD) | 3.28 (0.82) | 3.40 (1.07) | 3.38 (0.97) |
| TJC44, median (IQR) | 8 (4–14) | 9 (5–15) | 10 (4–14) |
| SJC44, median (IQR) | 8 (5–12) | 7 (4–12) | 7 (4–12) |
| General health, median (IQR)‡ | 52 (34–70) | 55 (29–69) | 53 (38–70) |
| ESR in mm/h, median (IQR) | 27 (14–40) | 22 (13–40) | 24 (14–42) |
| CRP in mg/L, median (IQR) | 8 (3.5–23) | 6.5 (4.5–19) | 11 (5–26) |
| Radiographs (hand/foot) | |||
| Total SHS (0–488), median (IQR) | 0.5 (0–2) | 0.5 (0–2) | 1 (0–2.5) |
| Erosion score (0–280), median (IQR) | 0 (0–1) | 0 (0–1) | 0.5 (0–1) |
| JSN score (0–168), median (IQR) | 0 (0–1) | 0 (0–1) | 0 (0–1.5) |
| Erosive disease, n (%)§ | 10 (11) | 6 (6) | 8 (8) |
| Patient-reported outcomes¶ | |||
| HAQ, mean (SD) | 0.98 (0.67) (n=84) | 0.96 (0.64) (n=86) | 1.06 (0.68) (n=92) |
| RADAI (0–10), mean (SD) | 3.97 (1.83) (n=81) | 3.94 (1.61) (n=82) | 4.21 (1.82) (n=87) |
*p=0.018 for B versus C.
†p=0.034 for A versus B.
‡General health is measured with a Visual Analogue Scale from 0 to 100 mm.
§Erosive disease is defined as having an erosion score >1 in three separate joints.36
¶Not everyone filled in a (complete) questionnaire and therefore n is different for HAQ and RADAI.
ACPA, anti-citrullinated protein/peptide antibodies; CRP, C-reactive protein; DAS, Disease Activity Score; ESR, erythrocyte sedimentation rate; GCs, glucocorticoids; HAQ, Health Assessment Questionnaire; HCQ, hydroxychloroquine; IM, intramuscular; JSN, joint space narrowing; MTX, methotrexate; RA, rheumatoid arthritis; RADAI, RA Disease Activity Index questionnaire; RF, rheumatoid factor; SASP, sulfasalazine; SHS, modified Sharp–Van der Heijde score; SJC44, swollen joint count (44 joints); TJC44, tender joint count (44 joints).