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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