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Table 5 Adverse events in the safety population

From: Efficacy and safety of the human anti-IL-1beta monoclonal antibody canakinumab in rheumatoid arthritis: results of a 12-week, phase II, dose-finding study

Parameter

Canakinumab 150 mg SC q4wk, n = 69

Canakinumab 300 mg SC q4wk, n = 64

Canakinumab 300 mg SC q2wk + 600 mg IV loading dose, n = 71

Placebo, n = 70

Patients with at least 1 AE, n (%)

32 (46.4)

35 (54.7)

40 (56.3)

37 (52.9)

Patients with serious AEs, n (%)*

1 (1.4)

4 (6.3)

3 (4.2)

5 (7.1)

Discontinuations due to AEs, n (%)

1 (1.4)

3 (4.7)

5 (7.0)

2 (2.9)

Most frequent AEs (in ≥ 5% of patients)

Bronchitis, n (%)

-

4 (6.3)

-

-

Nasopharyngitis, n (%)

4 (5.8)

4 (6.3)

4 (5.6)

4 (5.7)

Upper respiratory tract infection, n (%)

-

-

4 (5.6)

-

  1. *Serious AEs: canakinumab 150 mg SC q4wk--thoracic vertebral fracture (n = 1); canakinumab 300 mg SC q2wk--cellulitis, abscess limb (n = 1), diverticulitis (n = 1), soft tissue infection (n = 1); canakinumab 600 mg IV plus 300 mg SC q2wk, gastritis (n = 1), urosepsis (n = 1); placebo--abdominal hernia, obstructive (n = 1), atrial fibrillation (n = 1), gastric ulcer hemorrhage (n = 1), RA flare (n = 2)
  2. Abbreviations: AE, adverse event; IV, intravenous; q2wk, every 2 weeks; q4wk, every 4 weeks; RA, rheumatoid arthritis; SC, subcutaneous
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BMC Musculoskeletal Disorders

ISSN: 1471-2474

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