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Table 3 Overview of TEAEs during the double-blind treatment phases of phase III trials

From: Interleukin-6 receptor blockade or TNFα inhibition for reducing glycaemia in patients with RA and diabetes: post hoc analyses of three randomised, controlled trials

  Combination therapy with MTX in MTX-IR patients Combination therapy with csDMARDs in TNFi-INT/IR patients Monotherapy in MTX-INT/IR patients  
52 weeks 24 weeks 24 weeks
  Placebo Sarilumab 150 mg q2w Sarilumab 200 mg q2w Placebo Sarilumab 150 mg q2w Sarilumab 200 mg q2w Adalimumab 40 mg q2w Sarilumab 200 mg q2w Total
TEAE, n/N (%)
 With diabetes 20/27 (74.1) 21/27 (77.8) 36/37 (97.3) 17/23 (73.9) 18/23 (78.3) 13/21 (61.9) 11/16 (68.8) 7/10 (70.0) 143/184 (77.7)
 Without diabetes 226/370 (61.1) 279/374 (74.6) 276/359 (76.9) 73/158 (46.2) 101/158 (63.9) 107/163 (65.6) 106/168 (63.1) 111/174 (63.8) 1279/1924 (66.5)
Treatment-emergent SAE, n/N (%)
 With diabetes 4/27 (14.8) 3/27 (11.1) 5/37 (13.5) 1/23 (4.3) 2/23 (8.7) 2/21 (9.5) 1/16 (6.3) 0/10 18/184 (9.8)
 Without diabetes 17/370 (4.6) 34/374 (9.1) 40/359 (11.1) 5/158 (3.2) 4/158 (2.5) 8/163 (4.9) 11/168 (6.5) 9/174 (5.2) 128/1924 (6.7)
TEAE leading to death, n/N (%)
 With diabetes 1/27 (3.7) 0/27 0/37 0/23 0/23 0/21 0/16 0/10 1/184 (0.5)
 Without diabetes 1/370 (0.3) 2/374 (0.5) 1/359 (0.3) 1/158 (0.6) 0/158 0/163 0/168 1/174 (0.6) 6/1924 (0.3)
TEAE leading to treatment discontinuation, n/N (%)
 With diabetes 2/27 (7.4) 1/27 (3.7) 5/37 (13.5) 1/23 (4.3) 3/23 (13.0) 2/21 (9.5) 2/16 (12.5) 1/10 (10.0) 17/184 (9.2)
 Without diabetes 18/370 (4.9) 50/374 (13.4) 49/359 (13.6) 7/158 (4.4) 11/158 (7.0) 15/163 (9.2) 11/168 (6.5) 10/174 (5.7) 171/1924 (8.9)
  1. csDMARD conventional synthetic disease-modifying antirheumatic drug, INT intolerant, IR inadequate response, MTX methotrexate, q2w every 2 weeks, SAE serious TEAE, TEAE treatment-emergent adverse event, TNFi tumour necrosis factor-α inhibitor