Proven Safety Profile
ANC=absolute neutrophil count; GI=gastrointestinal.
Mean duration of treatment in the safety population (N=2887) was 2.8 years (max 7.3 years), representing 8188 cumulative PY of observation
Incidence rate of AEs was generally stable over time, with no indication of increased incidence rate in serious AEs and serious infections.4
In the long-term safety population, the rate of thromboembolic events (MedDRA high-level group term "embolism and thrombosis") were 0.8 per 100 PY (as reported and evaluated post hoc; not a prespecified AESI)3
Safety observations in the open-label extension population were consistent with those in the placebo-controlled trials.5,6
MTX-IR=methotrexate inadequate response; TNF-IR=tumor necrosis factor inhibitor inadequate response or intolerant; PY=patient-years; AE=adverse event; IR=incidence rate; DMARDs=disease-modifying antirheumatic drugs; q2w=every 2 weeks; TEAE=treatment-emergent adverse event; ALT=alanine aminotransferase; AESI=adverse event of special interest; DVT=deep vein thrombosis; PE=pulmonary embolism.
KEVZARA monotherapy safety was studied in 471 patients, with more than 798 patient-years of exposure3
Mean exposure in the long-term safety population was 1.7 years (max 3.5 years)
Incidence rate of AEs was generally stable over time, with no indication for increased incidence rate3,6
In MONARCH, the safety profiles of KEVZARA and adalimumab were generally comparable, except for neutropenia and injection site erythema for KEVZARA and headache and RA for adalimumab7
Safety observations in the long-term population were generally consistent with those in the randomized, controlled population.6