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. 2017 Dec 22;3(2):e000567. doi: 10.1136/rmdopen-2017-000567

Table 3.

Safety overview after 24 weeks according to concomitant cDMARD or MTX use at baseline, subdivided by treatment

Concomitant treatment cDMARD MTX None (cDMARD-naïve or past use at baseline)
PBO, n=69 IXEQ4W, n=68 IXEQ2W, n=63 PBO, n=59 IXEQ4W, n=57 IXEQ2W, n=53 PBO, n=37 IXEQ4W, n=39 IXEQ2W, n=39
Treatment-emergent AE, n (%) 30 (43.5) 42 (61.8)* 40 (63.5)* 27 (45.8) 36 (63.2) 34 (64.2) 20 (54.1) 29 (74.4) 27 (69.2)
  Mild 15 (21.7) 28 (41.2)* 23 (36.5) 13 (22.0) 25 (43.9)* 18 (34.0) 12 (32.4) 15 (38.5) 18 (46.2)
  Moderate 13 (18.8) 13 (19.1) 14 (22.2) 12 (20.3) 10 (17.5) 13 (24.5) 8 (21.6) 11 (28.2) 7 (17.9)
  Severe 2 (2.9) 1 (1.5) 3 (4.8) 2 (3.4) 1 (1.8) 3 (5.7) 0 3 (7.7) 2 (5.1)
Serious AE, n (%) 2 (2.9) 3 (4.4) 4 (6.3) 1 (1.7) 2 (3.5) 0 0 3 (7.7) 3 (7.7)
AE leading to discontinuation, n (%) 2 (2.9) 1 (1.5) 4 (7.5) 2 (3.4) 1 (1.8) 4 (7.5) 0 1 (2.6) 0

The study was not designed to test equivalence or non-inferiority of treatment with ixekizumab alone versus treatment with ixekizumab combined with cDMARDs.

*P<0.05 versus PBO.

AE, adverse events; cDMARD, conventional disease-modifying antirheumatic drugs; IXEQ2W, 80 mg ixekizumab once every 2 weeks; IXEQ4W, 80 mg ixekizumab once every 4 weeks; MTX, methotrexate; n, number of patients; PBO, placebo.