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Table 4 Selected treatment-emergent adverse events

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
52 weeks
Combination therapy with csDMARDs in TNFi-INT/IR patients
24 weeks
Monotherapy in MTX-INT/IR patients
24 weeks
Total
Placebo + MTX 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
 
Patients with ≥ 1 infection, n/N (%)  
 With diabetes 12/27 (44.4) 12/27 (44.4) 20/37 (54.1) 8/23 (34.8) 10/23 (43.5) 4/21 (19.0) 9/16 (56.3) 3/10 (30.0) 78/184 (42.4)
 Without diabetes 115/370 (31.1) 156/374 (41.7) 139/359 (38.7) 40/158 (25.3) 30/158 (19.0) 52/163 (31.9) 42/168 (25.0) 50/174 (28.7) 624/1924 (32.4)
Patients with ≥ 1 serious infection, n/N (%)  
 With diabetes 4/27 (14.8) 1/27 (3.7) 1/37 (2.7) 0/23 1/23 (4.3) 0/21 0/16 0/10 7/184 (3.8)
 Without diabetes 6/370 (1.6) 10/374 (2.7) 14/359 (3.9) 2/158 (1.3) 0/158 2/163 (1.2) 2/168 (1.2) 2/174 (1.1) 38/1924 (2.0)
Patients with infection leading to treatment discontinuation, n/N (%)  
 With diabetes 1/27 (3.7) 0/27 0/37 0/23 3/23 (13.0) 0/21 0/16 0/10 4/184 (2.2)
 Without diabetes 5/370 (1.4) 13/374 (3.5) 11/359 (3.1) 1/158 (0.6) 2/158 (1.3) 5/163 (3.1) 2/168 (1.2) 1/174 (0.6) 40/1924 (2.1)
Patients with opportunistic infections (including tuberculosis), n/N (%)  
 With diabetes 0/27 0/27 1/37 (2.7) 0/23 0/23 0/21 0/16 0/10 1/184 (0.5)
 Without diabetes 2/370 (0.5) 2/374 (0.5) 3/359 (0.8) 1/158 (0.6) 0/158 2/163 (1.2) 1/168 (0.6) 1/174 (0.6) 12/1924 (0.6)
Patients with tuberculosis, n/N (%)  
 With diabetes 0/27 0/27 0/37 0/23 0/23 0/21 0/16 0/10 0/184
 Without diabetes 0/370 0/374 0/359 0/158 0/158 0/163 1/168 (0.6) 0/174 1/1924 (0.1)
Patients with ≥ 1 hypersensitivity, n/N (%)  
 With diabetes 1/27 (3.7) 1/27 (3.7) 3/37 (8.1) 2/23 (8.7) 3/23 (13.0) 4/21 (19.0) 0/16 2/10 (20.0) 16/184 (8.7)
 Without diabetes 17/370 (4.6) 25/374 (6.7) 26/359 (7.2) 5/158 (3.2) 7/158 (4.4) 7/163 (4.3) 10/168 (6.0) 8/174 (4.6) 105/1924 (5.5)
Patients with ≥ 1 serious hypersensitivity, n/N (%)  
 With diabetes 0/27 0/27 0/37 0/23 0/23 0/21 0/16 0/10 0/184
 Without diabetes 0/370 0/374 1/359 (0.3) 0/158 0/158 0/163 1/168 (0.6) 0/174 2/1924 (0.1)
Patients with ≥ 1 hypersensitivity leading to treatment discontinuation, n/N (%)  
 With diabetes 0/27 0/27 1/37 (2.7) 0/23 0/23 0/21 0/16 1/10 (10.0) 2/184 (1.1)
 Without diabetes 1/370 (0.3) 3/374 (0.8) 1/359 (0.3) 0/158 0/158 1/163 (0.6) 1/168 (0.6) 0/174 7/1924 (0.4)
ANC < 1.5 G/L (non-black patients) or < 1.0 G/L (black patients), n/N (%)  
 With diabetes 1/27 (3.7) 1/27 (3.7) 5/37 (13.5) 0/23 1/23 (4.3) 5/21 (23.8) 1/16 (6.3) 3/10 (30.0) 17/184 (9.2)
 Without diabetes 5/370 (1.4) 72/374 (19.3) 88/359 (24.5) 2/158 (1.3) 30/158 (19.0) 37/162 (22.8) 39/167 (23.4) 59/174 (33.9) 332/1922 (17.3)
Platelets < 50 G/L, n/N (%)  
 With diabetes 0/27 0/27 0/37 0/23 0/23 0/21 0/16 0/10 0/184
 Without diabetes 0/370 0/374 2/358 (0.6) 0/158 0/158 1/162 (0.6) 0/0 1/174 (0.6) 4/1921 (0.2)
Total cholesterol baseline normal/missing to post baseline ≥ 6.2 mmol/L, n/N (%)  
 With diabetes 6/25 (24.0) 2/23 (8.7) 12/30 (40.0) 6/19 (31.6) 9/23 (39.1) 7/20 (35.0) 2/15 (13.3) 2/7 (28.6) 46/162 (28.4)
 Without diabetes 62/325 (19.1) 128/327 (39.1) 140/315 (44.4) 18/140 (12.9) 51/130 (39.2) 52/141 (36.9) 35/131 (26.7) 53/140 (37.9) 539/1649 (32.7)
Total LDL-C baseline normal/missing to post-baseline LDL-C ≥ 4.1 mmol/L, n/N (%)  
 With diabetes 2/25 (8.0) 3/25 (12.0) 11/32 (34.4) 4/21 (19.0) 7/22 (31.8) 5/20 (25.0) 1/15 (6.7) 2/9 (22.2) 35/169 (20.7)
 Without diabetes 41/344 (11.9) 82/342 (24.0) 101/334 (30.2) 10/148 (6.8) 39/146 (26.7) 38/151 (25.2) 28/142 (19.7) 40/153 (26.1) 379/1760 (21.5)
Total triglycerides baseline normal/missing to post-baseline ≥ 4.6 mmol/L, n/N (%)  
 With diabetes 2/27 (7.4) 0/0 3/36 (8.3) 0/23 1/23 (4.3) 0/21 1/16 (6.3) 1/10 (10.0) 8/181 (4.4)
 Without diabetes 1/368 (0.3) 11/372 (3.0) 13/358 (3.6) 1/157 (0.6) 5/153 (3.3) 6/161 (3.7) 4/164 (2.4) 3/173 (1.7) 44/1906 (2.3)
ALT > 3 to ≤ 5 ULN, n/N (%)  
 With diabetes 0/27 0/27 6/37 (16.2) 0/23 0/23 0/21 2/16 (12.5) 0/10 8/184 (4.3)
 Without diabetes 9/370 (2.4) 33/374 (8.8) 25/359 (7.0) 2/158 (1.3) 4/157 (2.5) 7/161 (4.3) 10/167 (6.0) 11/174 (6.3) 101/1920 (5.3)
ALT > 5 to ≤ 10 ULN, n/N (%)  
 With diabetes 0/27 0/27 2/37 (5.4) 0/23 0/23 0/21 1/16 (6.3) 0/10 3/184 (1.6)
 Without diabetes 1/370 (0.3) 11/374 (2.9) 8/359 (2.2) 0/158 0/158 0/161 2/167 (1.2) 3/174 (1.7) 25/1920 (1.3)
  1. ALT alanine aminotransferase, ANC absolute neutrophil count, csDMARD conventional synthetic disease-modifying antirheumatic drug, INT intolerant, IR inadequate response, LDL-C low-density lipoprotein cholesterol, MTX methotrexate, q2w every 2 weeks, TNFi tumour necrosis factor α inhibitor, ULN upper limit of normal