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Table 2 Change from baseline at week 24 in HbA1c in patients with RA and subgroups of patients with RA and diabetes from phase III studies of sarilumab + csDMARDs or sarilumab monotherapy

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 csDMARDs in TNFi-INT/IR patients Monotherapy in MTX-INT/IR patients
Change in HbA1c at week 24 Placebo + csDMARDs Sarilumab 150 mg q2w + csDMARDs Sarilumab 200 mg q2w + csDMARDs Adalimumab 40 mg q2w monotherapy Sarilumab 200 mg q2w monotherapy
Patients with a medical history of diabetes or baseline use of antidiabetic medication
 Number 15 16 15 14 6
 Baseline mean (SD) 7.20 (1.06) 6.94 (1.08) 6.96 (1.09) 6.77 (0.89) 6.65 (1.17)
 LS mean change (SE)a 0.23 (0.11) − 0.24 (0.11) − 0.44 (0.11) 0.15 (0.11) − 0.28 (0.16)
 LS mean difference, 95% CIa   − 0.47 (− 0.77, − 0.17) − 0.67 (− 0.98, − 0.37)   − 0.43 (− 0.80, − 0.05)
p value vs. placebo/adalimumaba   0.0021 < 0.0001   0.0257
Baseline HbA1c ≥ 7.0%
 Number 11 10 9 6 4
 Baseline mean (SD) 7.80 (0.58) 7.77 (0.59) 7.88 (0.61) 7.57 (0.49) 7.78 (0.54)
 LS mean change (SE)a − 0.08 (0.13) − 0.56 (0.13) − 0.77 (0.14) 0.29 (0.16) − 0.67 (0.20)
 LS mean diff, 95% CIa   − 0.48 (− 0.84, − 0.12) − 0.69 (− 1.06, − 0.32)   − 0.96 (− 1.46, − 0.46)
p value vs. placebo/adalimumaba   0.0097 0.0003   0.0002
  1. All assessments are set to missing from the time a patient prematurely discontinues study medication
  2. CI confidence interval, csDMARD conventional synthetic disease-modifying antirheumatic drug, HbA1c glycosylated haemoglobin, INT intolerant, IR inadequate response, LS least squares, MMRM mixed-effect model repeat measurement, MTX methotrexate, Number number of patients with assessment at both baseline and week 24, q2w every 2 weeks, SD standard deviation, SE standard error, TNFi tumour necrosis factor-α inhibitor
  3. aMMRM assuming an unstructured covariance structure. Model = subgroup, treatment, region, visit, treatment-by-visit interaction, treatment-by-subgroup interaction and treatment-by-visit-by-subgroup interaction. Nominal p values for differences between sarilumab and comparator