Proven Safety Profile
DMARDs=disease-modifying antirheumatic drugs; ALT=alanine aminotransferase; ANC=absolute neutrophil count; GI=gastrointestinal.
Studied in ≈3000 MTX-IR and TNF-IR patients with more than 8100 patient-years of exposure1-3
Mean duration of treatment in the safety population (N=2887) was 2.8 years (max 7.3 years), representing 8188 cumulative PY of exposure
Incidence rate of AEs was generally stable over time, with no indication of increased incidence rate in serious AEs and serious infections.2,3
Safety observations in the open-label extension population were consistent with those in the placebo-controlled trials.2,3
MTX-IR=methotrexate inadequate response; TNF-IR=tumor necrosis factor inhibitor inadequate response or intolerant; PY=patient-years; AE=adverse event; IR=incidence rate; MTX=methotrexate; DMARDs=disease-modifying antirheumatic drugs; q2w=every 2 weeks; TEAE=treatment emergent adverse event; ALT=alanine aminotransferase; AESI=event of special interest; DVT=deep vein thrombosis; PE=pulmonary embolism.
Overall, KEVZARA monotherapy long-term safety was studied in 471 patients, with ≈800 patient-years of exposure, and data were consistent with MONARCH studies2
Mean exposure in the long-term safety population was 1.7 years (max 3.5 years)
The incidence rate of AEs was generally stable over time, with no indication of increased incidence rate3,4
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 adalimumab4
Safety observations in the long-term population were generally consistent with those in the randomized, controlled population.5