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Table 3 Summary of treatment-emergent AEs in the safety population and most common treatment-emergent AEs

From: Sarilumab plus methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate: results of a randomized, placebo-controlled phase III trial in Japan

  Placebo-controlled period
Sarilumab
Non-placebo-controlled period
Sarilumab
Placebo + MTX
(n = 81)
150 mg q2w + MTX
(n = 81)
200 mg q2w + MTX
(n = 80)
Placebo + MTX to sarilumab 150 mg q2w + MTX
(n = 14)a
Placebo + MTX to sarilumab 200 mg q2w + MTX
(n = 15)a
150 mg q2w + MTX
(n = 81)
200 mg q2w + MTX
(n = 80)
AEs 49 (60.5) 65 (80.2) 60 (75.0) 12 (85.7) 13 (86.7) 76 (93.8) 71 (88.8)
Serious AEs 6 (7.4) 4 (4.9) 4 (5.0) 0 2 (13.3) 8 (9.9) 5 (6.3)
AEs leading to permanent treatment discontinuation 3 (3.7) 6 (7.4) 7 (8.8) 1 (7.1) 2 (13.3) 11 (13.6) 8 (10.0)
AEs leading to death 0 0 0 0 0 0 0
Most common AEs by system organ class
 Infections and infestations 23 (28.4) 36 (44.4) 24 (30.0) 9 (64.3) 8 (53.3) 55 (67.9) 42 (52.5)
  Nasopharyngitis 12 (14.8) 16 (19.8) 12 (15.0) 5 (35.7) 4 (26.7) 27 (33.3) 23 (28.8)
  Upper respiratory tract infection 4 (4.9) 6 (7.4) 4 (5.0) 0 0 8 (9.9) 7 (8.8)
  Gastroenteritis 1 (1.2) 1 (1.2) 3 (3.8) 0 0 2 (2.5) 6 (7.5)
  Cystitis 1 (1.2) 3 (3.7) 1 (1.3) 0 0 5 (6.2) 1 (1.3)
 Blood and lymphatic system disorders 0 11 (13.6) 12 (15.0) 2 (14.3) 3 (20.0) 15 (18.5) 13 (16.3)
  Neutropenia 0 7 (8.6) 9 (11.3) 2 (14.3) 1 (6.7) 10 (12.3) 9 (11.3)
 Vascular disorders 0 3 (3.7) 4 (5.0) 0 1 (6.7) 5 (6.2) 5 (6.3)
  Hypertension 0 2 (2.5) 4 (5.0) 0 0 4 (4.9) 5 (6.3)
 Gastrointestinal disorders 11 (13.6) 10 (12.3) 20 (25.0) 4 (28.6) 4 (26.7) 19 (23.5) 25 (31.3)
  Stomatitis 3 (3.7) 5 (6.2) 8 (10.0) 2 (14.3) 1 (6.7) 6 (7.4) 8 (10.0)
 Hepatobiliary disorders 4 (4.9) 9 (11.1) 11 (13.8) 1 (7.1) 2 (13.3) 11 (13.6) 10 (12.5)
  Hepatic function abnormal 4 (4.9) 6 (7.4) 8 (10.0) 0 0 8 (9.9) 7 (8.8)
 Skin and subcutaneous tissue disorders 8 (9.9) 15 (18.5) 12 (15.0) 1 (7.1) 2 (13.3) 25 (30.9) 19 (23.8)
  Eczema 1 (1.2) 4 (4.9) 3 (3.8) 1 (7.1) 0 7 (8.6) 4 (5.0)
 General disorders and administration site conditions 3 (3.7) 11 (13.6) 12 (15.0) 1 (7.1) 0 16 (19.8) 15 (18.8)
  Injection site erythema 0 7 (8.6) 7 (8.8) 1 (7.1) 0 8 (9.9) 7 (8.8)
  Injection site pruritus 0 4 (4.9) 4 (5.0) 1 (7.1) 0 5 (6.2) 4 (5.0)
 Investigations 6 (7.4) 11 (13.6) 12 (15.0) 4 (28.6) 0 14 (17.3) 14 (17.5)
  ALT increased 4 (4.9) 5 (6.2) 3 (3.8) 3 (21.4) 0 7 (8.6) 4 (5.0)
  1. Values are the number (%) of patients with AEs overall or by system organ class and preferred term (≥ 5 patients by preferred term in any treatment group)
  2. aTreatment-emergent AEs during active dose only
  3. AE adverse event, ALT alanine aminotransferase, MTX methotrexate, q2w every 2 weeks