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Introduction: In an intensive pharmacokinetic study of adalimumab (ADA) in Crohn's disease (CD), trough drug levels were significantly higher in syringe compared with pen users. Further data addressing the impact of delivery device on ADA drug level are lacking. Aim(s): Our aim was to compare drug levels associated with the use of pen and syringe delivery in patients undergoing maintenance ADA therapy for CD. Method(s): This was a retrospective observational study of adult patients with CD receiving 40 mg ADA fortnightly (for >14 weeks) across five centers. Therapeutic drug monitoring (TDM) was performed with ELISA as per manufacturer's instructions. Data on the first recorded drug level (independent of indication); markers of disease activity, including Harvey Bradshaw Index (HBI), C-reactive protein (CRP), and fecal calprotectin (FCP); and patient and disease characteristics were collected. Drug levels >4.9 mug/mL were considered therapeutic, and active disease was defined as CRP >5 mg/L or FCP >150 mug/g. Result(s): A total of 218 patients were included; 52% were male, the mean age was 39 years, and 60% received concomitant immunomodulation. Mean FCP level was 283 mug/g, and CRP level was 10.2 mg/L at TDM. Pens were used by 64% of the cohort. Syringe users had a higher albumin level (40 vs 38 g/L; P = 0.016), lower HBI (2.2 vs 3.4; P = 0.017), and higher rates of concomitant immunomodulation (71% vs 54%; P = 0.014) than pen users. No significant differences in disease activity (CRP or FCP), duration, or patient demographics between delivery device were observed. Considering all patients, there was no difference in drug levels in pen versus syringe (5.3 vs 5.2 mug/mL; P = 0.442; Fig. 1a). Fur-thermore, drug levels did not differ between pen and syringe users when controlling for disease activity (CRP or FCP). On subgroup analyses by center, syringe users at Alfred Health had significantly higher drug levels than pen users (6.1 vs 4.5 mug/mL; P = 0.039; Fig. 1b), a

Introduction: In an intensive pharmacokinetic study of adalimumab (ADA) in Crohn's disease (CD), trough drug levels were significantly higher in syringe compared with pen users. Further data addressing the impact of delivery device on ADA drug level are lacking. Aim(s): Our aim was to compare drug levels associated with the use of pen and syringe delivery in patients undergoing maintenance ADA therapy for CD. Method(s): This was a retrospective observational study of adult patients with CD receiving 40 mg ADA fortnightly (for >14 weeks) across five centers. Therapeutic drug monitoring (TDM) was performed with ELISA as per manufacturer's instructions. Data on the first recorded drug level (independent of indication); markers of disease activity, including Harvey Bradshaw Index (HBI), C-reactive protein (CRP), and fecal calprotectin (FCP); and patient and disease characteristics were collected. Drug levels >4.9 mug/mL were considered therapeutic, and active disease was defined as CRP >5 mg/L or FCP >150 mug/g. Result(s): A total of 218 patients were included; 52% were male, the mean age was 39 years, and 60% received concomitant immunomodulation. Mean FCP level was 283 mug/g, and CRP level was 10.2 mg/L at TDM. Pens were used by 64% of the cohort. Syringe users had a higher albumin level (40 vs 38 g/L; P = 0.016), lower HBI (2.2 vs 3.4; P = 0.017), and higher rates of concomitant immunomodulation (71% vs 54%; P = 0.014) than pen users. No significant differences in disease activity (CRP or FCP), duration, or patient demographics between delivery device were observed. Considering all patients, there was no difference in drug levels in pen versus syringe (5.3 vs 5.2 mug/mL; P = 0.442; Fig. 1a). Fur-thermore, drug levels did not differ between pen and syringe users when controlling for disease activity (CRP or FCP). On subgroup analyses by center, syringe users at Alfred Health had significantly higher drug levels than pen users (6.1 vs 4.5 mug/mL; P = 0.039; Fig. 1b), a