Table 2

Clinical response for each induction therapy group, according to intention-to-treat

Clinical responseA. MTX+SASP+HCQ+IM GCs (n=77)B. MTX+SASP+HCQ+oral GCs (n=84)C. MTX+oral GCs (n=87)
Disease activity
 AUC DAS, mean (SD)*22.32 (7.16) (n=91)23.24 (8.31) (n=93)25.63 (8.37) (n=97)
 DAS, mean (SD)1.40 (0.68)1.61 (0.87)1.68 (0.89)
 TJC44, median (IQR)0 (0–2)0 (0–4)1 (0–4)
 SJC44, median (IQR)†0 (0–2)0 (0–1)0 (0–2)
 General health, median (IQR)‡18 (8–32)22,5 (9.5–37.5)23 (10–40)
 ESR in mm/h, median (IQR)11 (5–18)10,5 (6.5–20.5)12 (6–21)
 CRP in mg/L, median (IQR)3 (1–5.2)4 (1–7)3 (1.9–5)
 ΔDAS (T12–T0), mean (SD)−1.83 (−1.03)−1.75 (−1.14)−1.69 (−1.27)
Disease state according to DAS, n (%)
 Moderate to high disease activity (DAS ≥2.4)8 (10)15 (18)19 (22)
 Low disease activity (1.6≥ DAS <2.4)22 (29)24 (29)24 (28)
 Remission (DAS <1.6)47 (61)45 (54)44 (51)
 Boolean remission criteria, n (%)§17 (22)13 (16)14 (16)
EULAR response criteria (T12–T0), n (%)¶
 Good54 (70)52 (62)57 (66)
 Moderate13 (17)19 (23)9 (10)
 None10 (13)13 (15)21 (24)
Radiographs (hand/foot)
 Total SHS (0–488), median (IQR)1 (0–3)1 (0–3)1 (0–3.5)
 Erosion score (0–280), median (IQR)0.5 (0–1.25)0.5 (0–1.5)0.5 (0–1.5)
 JSN score (0–168), median (IQR)0.5 (0–1.5)0 (0–1.5)0.5 (0–1.5)
 ΔTotal SHS (T12–T0), median (IQR)0.13 (0–1)0 (0–1)0 (0–1)
 Patients with progression >0.5, n (%)25 (33)24 (29)28 (33)
 Patients with progression >1.2, n (%)16 (21)20 (24)19 (23)
 Erosive disease, n (%)**8 (10)19 (23)15 (17)
Patient-reported outcomes††
 AUC HAQ, mean (SD)6.46 (4.96) (n=84)6.92 (5.43) (n=86)8.59 (5.90) (n=92)
 HAQ, mean (SD)0.38 (0.46) (n=69)0.51 (0.55) (n=78)0.63 (0.57) (n=82)
 ΔHAQ (T12–T0), mean (SD)−0.48 (−0.63) (n=65)−0.42 (−0.59) (n=74)−0.47 (−0.53) (n=80)
 RADAI (0–10), mean (SD)1.43 (1.24) (n=68)1.78 (1.52) (n=75)2.15 (1.81) (n=79)
 ΔRADAI (T12–T0), mean (SD)−2.22 (−1.68) (n=63)−2.06 (−1.87) (n=69)−2.11 (−1.91) (n=74)
  • *p=0.0497 for B versus C.

  • †p=0.022 for B versus C.

  • ‡General health is measured with a Visual Analogue Scale from 0 to 100 mm.

  • §Boolean remission criteria are defined as having a TJC44 ≤1, SJC44 ≤1, VAS global ≤10 mm and CRP ≤10 mg/L.

  • ¶EULAR response criteria are based on attained level and change in DAS.

  • **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.

  • AUC, area under the curve; 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; RADAI, Rheumatoid Arthritis Disease Activity Index questionnaire; SASP, sulfasalazine; SHS, modified Sharp–Van der Heijde score; SJC44, swollen joint count (44 joints); TJC44, tender joint count (44 joints); VAS, visual analogue scale.