Incidence of Venous Thromboembolic Events Among Amyotrophic Lateral Sclerosis Patients in a US Health Insurance Claims Database (P4.6-003)

Objective: Estimate the incidence of venous thromboembolism (VTE) in amyotrophic lateral sclerosis (ALS) patients compared to non-ALS controls. Background: Reduced mobility in ALS patients is hypothesized to increase risk of VTE (consisting of deep vein thrombosis (DVT) and pulmonary embolism (PE)). Few small, single-center studies have investigated the risk of VTE in ALS patients. Given the high morbidity and mortality associated with VTE, further understanding of risk in ALS may inform clinical care. Design/Methods: Patients were identified from a US health insurance claims database, Truven Health MarketScan®, between 2012 and 2018. ALS was defined as patients age ≥18 years with ≥2 ALS claims ≥27 days apart with ≥1 claim(s) from a neurologist visit or ≥1 ALS claim(s) and a prescription for Riluzole or Edaravone. Each ALS case was matched to 5 controls without ALS on age and gender. VTE was defined as ≥1 claim(s) for VTE and ≥1 anticoagulant prescription(s) or VTE related procedure(s) within 7 days of VTE claim date. Incidence rates were reported per 1,000 person-years (PYs). Hazard ratios (HR) and 95% confidence intervals (95% CIs) were estimated using Cox’s proportional hazards model. Results: Among 3,078 ALS subjects and 15,390 controls, incident VTE occurred in 70 ALS subjects (2.3%) and 47 controls (0.3%). Incidence rates of VTE were 18.2 per 1,000 PYs in ALS cases versus 2.5 in controls with a HR of 7.1 (95% CI: 4.9, 10.2). Median time from initial ALS claim to first VTE was 7 months (range: 0.4, 58 months). Conclusions: Consistent with previous studies, a higher incidence of VTE was observed in a large sample of ALS patients from across the US compared to matched controls. The markedly increased risk underscores the importance of preventive efforts and careful monitoring for DVT and PE in ALS patients. Disclosure: Dr. Kupelian has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen. Dr. Viscidi has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen. Dr. Hall has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen. Dr. Li has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen. Dr. Eaton has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen. Dr. Eaton holds stock and/or stock options in Biogen which sponsored research in which Dr. Eaton was involved as an investigator. Dr. Eaton holds stock and/or stock options in Biogen. Dr. Dilley has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen. Dr. Currier has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen. Dr. Ferguson has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen. Dr. Fanning has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen.