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Table 3 Mean pharmacokinetic parameter estimate of brodalumab following multiple subcutaneous and intravenous doses given to rheumatoid arthritis patients a

From: A phase Ib multiple ascending dose study evaluating safety, pharmacokinetics, and early clinical response of brodalumab, a human anti-IL-17R antibody, in methotrexate-resistant rheumatoid arthritis

  Predicted human exposure after multiple SC (n = 6) or IV (n = 2) doses Exposure margin based on exposure in monkeys after 3-month weekly SC doses or 1-month weekly IV dosesb
Dose (mg) AUC0-tc(μg/h/ml) Cmax(μg/ml) AUC (μg/h/ml) Cmax(μg/ml)
50 (SC) 71.3 0.947 4,458 1,246
140 (SC) 2170 9.05 146 130
210 (SC) 6610 23.2 48 51
420 (IV) 24,800 113 126 89
700 (IV) 48,600 198 64 51
  1. aAUC, area under the curve; AUC0-t, area under the serum concentration time curve; Cmax, maximum serum concentration; IV, intravenous; SC, subcutaneous. bNo adverse effect level for monkeys is 90 mg/kg SC or 350 mg/kg IV. AUC0-168 hours and Cmax after the 12th dose of 90 mg/kg weekly SC were 159,000 μg/h/ml and 1,180 μg/ml, respectively. AUC0-168 hours and Cmax after fourth dose of 350 mg/kg weekly IV were 782 000 μg/h/ml and 10,100 μg/ml, respectively. cAUC0-t = AUC0-336 hours for SC cohorts and AUC0-672 hours for IV cohorts.