Table 1

Baseline characteristics of patients with rheumatoid arthritis according to MTX interruption (MTX-hold) or MTX maintenance (MTX-maintain)

Patients for safety analysesPatients for immunogenicity analyses
MTX-hold (n=60)MTX-maintain (n=69)P valueMTX-hold (n=37)MTX-maintain (n=55)P value
Current age, years61 (52–70.5)58 (49–68)0.39559 (45–68)59 (51.5–68)0.828
Female sex51 (85.0)63 (91.3)0.26534 (91.9)50 (90.9)>0.999
Caucasian race28 (46.7)29 (42)0.59719 (51.4)25 (45.5)0.579
Disease parameters
 Disease duration17 (10–30.5)17 (10–24)0.80119 (10–28)17 (10–25)0.616
 RF positivity48 (80)53/68* (77.9)0.77631 (83.8)44 (80)0.647
 Anti-CCP positivity27/37* (73)35/47* (74.5)0.87717/22* (77.3)26/36* (72.2)0.670
 CRP, mg/dL4.4 (1.1–9.3)3.7 (1.6–7.0)0.6555.6 (1.0–9.6)4.0 (2.5–7.5)0.847
 CDAI7.0 (4.0–9.0)6.0 (3.0–8.0)0.4856.0 (2.0–8.0)6.0 (3.0–8.0)0.548
 SDAI7.1 (4.1–10.1)6.3 (3.9–9.3)0.3806.8 (3.1–9.4)6 (3.8–8.3)0.618
 DAS28-CRP2.72 (2.10–3.15)2.33 (1.96–2.82)0.1782.43 (1.80–3.15)2.34 (2.02–2.87)0.927
 CDAI ≤2.811 (18.3)10 (14.5)0.55610 (27)8 (14.5)0.139
 SDAI ≤3.312 (20)14 (20.3)0.96712 (32.4)11 (20)0.177
 DAS28-CRP ≤2.630 (50)46 (66.6)0.05521 (56.8)36 (65.5)0.400
 Boolean criteria9 (15)14 (20.3)0.4349 (24.3)12 (21.8)0.779
Current therapy
 Prednisone33 (55)24 (34.8)0.02119 (51.4)18 (32.9)0.074
 Prednisone dose, mg/dL5 (4.38–5)5 (5–5)0.4955 (2.5–5)5 (5–5)0.336
 MTX dose20 (17.5–25)20 (15–25)0.39720 (15–25)20 (15–25)0.314
 MTX 10–15 mg/week16 (26.7)23 (33.3)0.41111 (29.7)20 (36.4)0.509
 MTX 17.5–25 mg/week44 (73.3)46 (66.7)26 (70.3)35 (63.6)
 MTX monotherapy13 (21.7)18 (26.1)0.5589 (24.3)16 (29.1)0.614
 MTX in combination47 (78.3)51 (73.9)28 (75.7)39 (70.9)
 Leflunomide8 (13.3)17 (24.6)0.1056 (16.2)13 (23.6)0.389
 Other sDMARD10 (16.7)19 (27.5)0.1406 (16.2)16 (29.1)0.156
 Abatacept7 (11.7)9 (13.0)0.8136 (16.2)7 (12.7)0.638
 Other bDMARD18 (30.0)14 (20.3)0.20311 (29.7)9 (16.4)0.128
  • Results are expressed in median (IQR) and n (%).

  • Continuous data are compared using Mann-Whitney U test and categorical variables with χ2 or Fisher’s exact test, as appropriate, as two-sided analyses.

  • For safety analyses, all patients who adhered to the protocol were included. For immunogenicity analyses, patients with baseline positive S1/S2 IgG were excluded from both groups and patients with CDAI >10 at day 28 who withdrew MTX only once were excluded only from the MTX-hold group.

  • *Percentages calculated according to available data.

  • Anti-CCP, anticyclic citrullinated peptides; bDMARD, biologic disease-modifying antirheumatic drugs; CDAI, Clinical Disease Activity Index; CRP, C reactive protein; DAS28-CRP, disease activity score with 28 joints and C reactive protein; MTX, methotrexate; RF, rheumatoid factor; SDAI, Simplified Disease Activity Index; sDMARD, synthetic disease-modifying antirheumatic drugs.