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Table 4 Safety of abatacept administered in combination with MTX or pooled data for other non-MTX csDMARDs in the ATTAIN, ASSURE, and ARRIVE studies

From: Abatacept used in combination with non-methotrexate disease-modifying antirheumatic drugs: a descriptive analysis of data from interventional trials and the real-world setting

  ATTAIN ASSURE ARRIVE
ABA + MTX (n = 175) ABA + all non-MTX csDMARDs (n = 42) ABA + MTX (n = 535) ABA + all non-MTX csDMARDs (n = 143) ABA + MTX (n = 490) ABA + all non-MTX csDMARDs (n = 176)
Deaths 0 1 (2.4) 3 (0.6) 1 (0.7) 1 (0.2) 0
SAEs 16 (9.1) 5 (11.9) 54 (10.1) 24 (16.8) 45 (9.2) 13 (7.4)
Related SAEs 4 (2.3) 1 (2.4) 9 (1.7) 6 (4.2) 14 (2.9) 1 (0.6)
Discontinuations due to SAEs 3 (1.7) 4 (9.5) 12 (2.2) 4 (2.8) 7 (1.4) 1 (0.6)
AEs 139 (79.4) 30 (71.4) 480 (89.7) 127 (88.8) 383 (78.2) 131 (74.4)
Related AEs 73 (41.7) 15 (35.7) 299 (55.9) 83 (58.0) 217 (44.3) 67 (38.1)
Discontinuations due to AEs 5 (2.9) 4 (9.5) 28 (5.2) 8 (5.6) 20 (4.1) 7 (4.0)
AEs of interest (system organ class)
 Infections and infestations 67 (38.3) 17 (40.5) 292 (54.6) 90 (62.9) 203 (41.4) 63 (35.8)
 Skin and subcutaneous tissue disorders 27 (15.4) 7 (16.7) 133 (24.9) 37 (25.9) 61 (12.4) 24 (13.6)
 Eye disorders 8 (4.6) 2 (4.8) 45 (8.4) 22 (15.4) 24 (4.9) 6 (3.4)
 Cardiac disorders 7 (4.0) 5 (11.9) 28 (5.2) 11 (7.7) 16 (3.3) 5 (2.8)
 Blood and lymphatic system disorders 2 (1.1) 3 (7.1) 28 (5.2) 10 (7.0) 10 (2.0) 3 (1.7)
 Immune system disorders 2 (1.1) 1 (2.4) 13 (2.4) 5 (3.5) 7 (1.4) 4 (2.3)
 Neoplasms (benign, malignant and unspecified) 3 (1.7) 2 (4.8) 20 (3.7) 3 (2.1) 6 (1.2) 2 (1.1)
  1. All data are n (%)
  2. Non-MTX csDMARDs include azathioprine, hydroxychloroquine, leflunomide, and sulfasalazine
  3. ABA abatacept, AE adverse event, csDMARD conventional synthetic disease-modifying antirheumatic drug, MTX methotrexate, SAE serious adverse event