Table 3

Summary of safety: adverse events up to week 16 (safety population, pooled analysis)

AEs, n (%)*PBO (N=320)BRO 140 mg Q2W (N=318)BRO 210 mg Q2W (N=321)
Any AE174 (54.4)164 (51.6)175 (54.5)
AEs causally related to treatment†62 (19.4)52 (16.4)48 (15.0)
SAE9 (2.8)6 (1.9)11 (3.4)
Death000
AEs leading to treatment discontinuation7 (2.2)3 (0.9)4 (1.2)
AEs leading to treatment interruption41 (12.8)30 (9.4)38 (11.8)
Selected AEs of interest‡
 Infections and infestations91 (28.4)75 (23.6)96 (29.9)
 Crohn’s disease000
 Neutropenia03 (0.9)3 (0.9)
 Suicidal ideation and behaviour01 (0.3)§0
 MACE2 (0.6)00
 Hypersensitivity¶2 (0.6)1 (0.3)7 (2.2)
 Malignancy01 (0.3)1 (0.3)
  • *Subjects with multiple events in the same category are counted only once in that category. Subjects with events in more than one category are counted once in each of those categories.

  • †Causally related to treatment as assessed by investigator.

  • ‡Adverse events of interest are important identified risks (eg, infections, neutropenia, worsening of Crohn’s disease), important potential risks (eg, hypersensitivity, suicidal behaviour (including attempted/completed suicide attempt), suicidal ideation, MACE, malignancy) and other events of interest (injection site reactions) in response to the emerging safety profile of brodalumab.

  • §Patient (35-year-old female, history of suicidal ideation) diagnosed following the first completed electronic Columbia Suicide Severity Rating Scale assessment, 8 days after first dose; resolved on same day.

  • ¶Adverse events occurring within 1 day of an injection and corresponding to the broad scope for the hypersensitivity SMQ have been included.

  • AE, adverse event; BRO, brodalumab; MACE, major adverse cardiovascular events; MedDRA, Medical Dictionary for Regulatory activities; PBO, placebo; Q2W, every 2 weeks; SAE, serious adverse event; SMQ, standardised MedDRA query.