Table 1.
Pharmacodynamic properties | |
Mechanism of action | Fully human monoclonal antibody of IgG1/κ isotype; binds selectively to IL-17A and inhibits its interaction with the IL-17 receptor; inhibits the release of proinflammatory cytokines and chemokines |
In pts with AS (proof-of-concept study) | ↓ Levels of CRP, S100A8 and S100A9 (inflammatory biomarkers) |
↓ Signs and symptoms of AS (assessed by ASAS20) at week 6, sustained at week 28 and through 2 years | |
↓ Inflammation (assessed by MRI) | |
Significant correlation between clinical response (assessed by ASAS40) and genetic polymorphisms in rs30187 (a non-synonymous single-nucleotide polymorphism of ERAP1) | |
Pharmacokinetic properties | |
Pharmacokinetic properties of SEC in pts with AS are similar to those in pts with plaque psoriasis | |
First-order absorption and linear pharmacokinetics; Cmax attained ≈ 6 days after dosing; estimated bioavailability 79%; low total volume of distribution | |
Most elimination via intracellular catabolism (following endocytosis); clearance 0.16 L/day; estimated terminal half-life 25.7 days; unlikely to be excreted in urine or secreted into bile | |
Special populationsa | Hepatic or renal impairment is not expected to influence SEC metabolism or secretion |
Age, sex and race do not affect SEC clearance | |
No dosage adjustment required in pts aged ≥ 65 years | |
Drug interactionsa | No drug interaction studies have been performed |
The formation of CYP enzymes can be altered by ↑ levels of certain cytokines during chronic inflammation | |
No interaction when SEC is coadministered with methotrexate ± corticosteroids in pts with AS or PsA |
↓ decreased, ↑ increased, AS ankylosing spondylitis, ASAS20/40 improvement of ≥ 20/≥ 40% in Assessment of SpondyloArthritis international Society score, Cmax maximum plasma concentration, CRP C-reactive protein, Ig immunoglobulin, IL interleukin, PsA psoriatic arthritis, pts patients, SEC secukinumab
aConsult local prescribing information for detailed recommendations