Safety

Adverse events during the induction phase (12 weeks) of the AMAGINE-2 and AMAGINE-3 trials1,2

Summary table of adverse events during the induction phase

Adapted from Lebwohl M, et al. 2015. Table 4.
And supplement to: Lebwohl M, et al. 2015.1,2 Table S10.

One fatal event reported (cerebral infarction 20 days after last dose).1 Please consult the SmPC for full details.

Kyntheum® was generally well tolerated across phase III trials2

Summary of exposure-adjusted event rate of treatment-emergent adverse events through week 52 of the AMAGINE-2 and AMAGINE-3 trials2

Summary table of adverse events through week 52

Table adapted from supplement to Lebwohl M, et al. 2015.2 Table S11 and Table S12.

Patient-yr = Total patient years of exposure through week 52 excluding periods of placebo exposure in the induction phase. n, number of adverse events; r, exposure-adjusted event rate per 100 patient-years (n/Patient-yr100);**Three events of suicide attempt occurred in one individual; the first event occurred during the 12 week induction period; †Fatal events in AMAGINE-2 were cardiac arrest (constant 210 mg), cardiac arrest (ustekinumab), pancreatic carcinoma (ustekinumab); one additional fatal event occurred after the exposure period: completed suicide (placebo/210 mg; 27 days after last dose). Fatal events in AMAGINE-3 were cardiac arrest (140 mg/210 mg), accidental death motor vehicle (210 mg/140 mg Q2W); two additional fatal events occurred after the exposure period: histiocytosis haematophagic syndrome (140 mg/140 mg Q4W/210 mg rescue; 41 days after the last dose) and cardiomyopathy (210 mg /140 mg Q4W/210 mg rescue; 87 days after the last dose).

In the brodalumab clinical trials programme, there were 6 suicide attempts, and 4 completed suicides of which 3 were in the brodalumab group (N=4,464). The majority of patients with suicidal behaviour had a history of depression and/or suicidal ideation or behaviour (SIB) and available evidence does not support a causal association between brodalumab and SIB.3

Please consult the SmPC for full details.

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Q2W=every 2 weeks; Q4W=every 4 weeks

  1. Lebwohl M, et al. N Engl J Med 2015;373:1318–28.
  2. Supplement to: Lebwohl M, et al. N Engl J Med 2015;373:1318–28.
  3. Lebwohl M, et al. J Am Acad Dermatol 2018;78(1):81-89.
MAT-42358 Jan 2021