SAT0605 BODY MASS INDEX AND SYSTEMIC CORTICOSTEROID USE AS INDICATORS OF DISEASE BURDEN AND THEIR INFLUENCE ON THE SAFETY PROFILE OF CERTOLIZUMAB PEGOL ACROSS INDICATIONS

Abstract

Background: Certolizumab pegol (CZP) is an anti-TNF drug approved for rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), psoriasis (PSO) and Crohn’s disease (CD). Older age, comorbidity burden and corticosteroid (CS) use have been linked to increased risk of serious infectious events (SIEs) in CZP-treated patients (pts) with RA.1 However, the impact of overall disease burden on the risk of serious adverse events (SAEs) has not been fully examined for other CZP indications. High body mass index (BMI) has been associated with systemic inflammation and greater comorbidity risk.2,3 Greater disease burden in these pts may lead to increased CS use – a known risk factor for SAEs.1 Objectives: To examine the contribution of BMI and CS use to the risk of SIEs, malignancies and major adverse cardiovascular events (MACE) in CZP-treated pts across indications. Methods: Safety data were pooled across 49 CZP clinical trials (27 RA, 1 axSpA, 1 PsA, 5 PSO, 15 CD). SAEs of potential concern were medically reviewed by an external expert committee using predefined case rules. Incidence rates (IR) were calculated per 100 pt–years (PY). Multivariate Cox modeling was used to estimate relative risk (hazard ratio [HR]) of time to first SIE, malignancy or MACE by baseline BMI ( Results: Across indications, 11,317 pts received CZP (21,695 PY total exposure; max: 7.8 years [yrs]; exposure for RA: 13,542 PY; axSpA: 978 PY; PsA: 1,316 PY; PSO: 1,481 PY; CD: 4,378 PY). Mean BMI was 27.8 kg/m2 in RA, 27.6 kg/m2 in axSpA, 29.8 kg/m2 in PsA, 30.1 kg/m2 in PSO, and 24.0 kg/m2 in CD. Overall, 4,132 pts (37%) took CS at baseline, more so in RA (46%) and axSpA (51%). Across indications, IRs were 0.82/100 PY for all malignancies (IR for malignancies excluding non-melanoma skin cancer [NMSC] was 0.66/100 PY), 0.47/100 PY for MACE, and 3.62/100 PY for SIEs. According to the Cox model, age ≥45 yrs, disease duration Conclusion: In CZP-treated pts across indications, malignancy risk was not influenced by BMI or CS use. As expected, obesity and CS use increased the risk of MACE. The SIE risk associated with CS use was compounded in obese pts, which may reflect the contribution of comorbidities, disease activity or other factors not examined here.