DMARDs=disease-modifying antirheumatic drugs; ALT=alanine aminotransferase; ANC=absolute neutrophil count; GI=gastrointestinal.

Studied in ≈3000 MTX-IR and TNF-IR patients with over 8100 patient-years of exposure^1-3

Mean duration of treatment in the safety population (N=2887) was 2.8 years (max 7.3 years), representing 8188 cumulative PY of exposure

• 773 patients (27%) were treated for ≥240 weeks (4.6 years)
• 36 patients (1.2%) were treated for >360 weeks (7 years)

Incidence rate of AEs was generally stable over time, with no indication of increased incidence rate in serious AEs and serious infections.^2,3

MOBILITY (MTX-IR), TARGET (TNF-IR), LONG-TERM SAFETY POPULATIONS^2,3

In the long-term safety population, the rate of thromboembolic events (MedDRA high-level group term “embolism and thrombosis”) was 0.8 per 100 PY (as reported and evaluated post hoc; not a prespecified AESI)²

• Rate of DVT was 0.2 per 100 PY; rate of PE was 0.2 per 100 PY

Safety observations in the open-label extension population were consistent with those in the placebo-controlled trials.^2,3

*Incidence rate per 100 PY at risk of first event.

^†TEAE period from day of first treatment dose to 60 days after the last treatment dose.²

^‡Injection site reactions (including erythema and pruritus) were mild in severity for the majority of patients and necessitated drug discontinuation in 3 (<0.5%) patients receiving KEVZARA.³

MTX-IR=methotrexate inadequate response; TNF-IR=tumor necrosis factor inhibitor inadequate response or intolerant; PY=patient-years; IR=incidence rate; MTX=methotrexate; 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.

MONARCH: NO UNEXPECTED SAFETY SIGNALS WITH KEVZARA

Overall, KEVZARA monotherapy long-term safety was studied in 471 patients, with ≈800 patient-years of exposure, and data were consistent with MONARCH studies¹

Mean exposure in the long-term safety population was 1.7 years (max 3.5 years)

• 320 patients (87%) were treated for ≥72 weeks

Incidence rate of AEs was generally stable over time, with no indication of increased incidence rate^2,3

MONARCH (MTX-IR) AND MONARCH LONG-TERM SAFETY POPULATIONS^2,3*^†

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 adalimumab³

Safety observations in the long-term population were generally consistent with those in the randomized, controlled population.⁴

*Adverse events reported for the long-term safety population were selected based on occurrence in ≥3% of patients in the randomized, controlled population in any treatment group; ^†Patients from the KEVZARA ONE study population were included in these long-term monotherapy safety data; ^‡One patient was randomized, but not treated, in the adalimumab group and was not included in the safety population; ^§Patient years per group are as follows: 80.5 (adalimumab 40 mg), 80.1 (KEVZARA 200 mg), and 348.1 (long-term safety population for KEVZARA 200 mg). ^||In the randomized trial, 1 patient in the KEVZARA group died of acute cardiac failure secondary to aortic dissection and papillary muscle rupture on day 36; ^¶In the randomized trial, 1 patient receiving KEVZARA was diagnosed with infective bursitis and another patient was diagnosed with mastitis, and 1 patient receiving adalimumab was diagnosed with bacterial arthritis and another patient was diagnosed with a respiratory tract infection; ^#Protocol defined as ≥2 doses within 11 calendar days or within 6 days for adalimumab-treated patients who switched to weekly dosing; Dyslipidemia was defined by standardized MedDRA query.^2,3

MTX-IR=methotrexate inadequate response; q2w=once every 2 weeks; PY=patient-years; IR=incidence rate; TEAE=treatment emergent adverse event; ALT=alanine aminotransferase.

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