P0689 High-dose IV iron safely and effectively treats IBD-associated anaemia regardless of inflammatory activity – real-life evidence from Germany

Abstract Background Iron deficiency anaemia (IDA) is a common complication of inflammatory bowel disease (IBD), with relevant impact on quality of life and disease outcomes. While guidelines recommend intravenous (IV) iron for moderate-to-severe IDA, concerns remain regarding its use in patients with high inflammatory activity, as oral iron may aggravate mucosal inflammation. We combined real-world data from two large German multicenter studies to assess the efficacy and safety of high-dose IV iron in patients with IBD, with special emphasis on inflammation. Methods A total of 421 patients with Crohn’s disease or ulcerative colitis received IV iron substitution: 197 were treated with iron isomaltoside and 224 with ferric carboxymaltose. Mean cumulative dose was ∼1,200 mg over 12–16 weeks. Haematologic response (≥ 2 g/dL haemoglobin increase), iron parameters, C-reactive protein (CRP), clinical disease indices (CDAI/CAI), and patient-reported IBD-related symptoms (fatigue, impaired concentration, headache, pallor, hair loss, exertional dyspnoea, sleep disorders, restless legs syndrome) were evaluated. Patients were additionally stratified by baseline CRP (< 5 mg/L; 5–10 mg/L; > 10 mg/L). Results Haemoglobin rose significantly from 10.7 g/dL to 13.1 g/dL, with ≥ 2 g/dL improvement in 57% of patients. Ferritin increased by ∼96 µg/L, and transferrin saturation from 8.1% to 24%. IV iron efficacy was independent of baseline CRP levels. Importantly, CRP decreased significantly during treatment (from 6.4 mg/L to 3.5 mg/L on average), with the strongest reductions in patients with elevated baseline CRP (> 5 mg/L). Clinical disease activity (CDAI/CAI) and IBD-related symptoms improved consistently, irrespective of disease type, inflammatory activity or concomitant immunosuppressive/biologic therapy. No evidence for worsening of disease activity was observed. Conclusion High-dose IV iron therapy is effective, safe, and well tolerated in IBD patients, even in the presence of active inflammation. Not only does it correct IDA, but it is inflammation-neutral and associated with significant improvements in CRP, disease activity indices and patient-reported symptoms, underscoring its value as standard care in IBD-associated anaemia. Conflict of interest: Dr. Aksan, Aysegül: Aysegül Aksan is an employee of Fresenius Kabi Deutschland GmbH Siayor-Pietrzak, Karolina: Karolina Siayor has no conflicts of interest. Dignass, Axel: Personal Fees: AbbVie, Alfasigma, CED Service GmbH, Celltrion, Dr. Falk Pharma, Falk Foundation, Ferring, Fresenius Kabi, Gilead, High5MD, J & J, Lilly, Materia Prima, MSD, Pfizer, Pharmacosmos, Sandoz, Stada, Streamed-Up, Takeda, Tillotts, Vifor Pharma Grant Abbvie, J & J, Takeda Non-financial support Abbvie, J & J, Takeda Other: Abivax, AbbVie, Alfasigma, Dr Falk Pharma, Fewrring, J & J, Pfizer Stein, Jürgen Michael: Jürgen Stein has received honoraria from AbbVie, CSL Vifor, Schär, Falk, Ferring, Fresenius Kabi, Immundiagnostik, Janssen, Medice, Pfizer, Pharmacosmos, Shield, Shire, Takeda, and Thermo Fisher and has board memberships with AbbVie, CSL Vifor Schär, Ferring, Fresenius Kabi, Immundiagnostik, Janssen, NPS Pharmaceuticals, Pharmacosmos, Shield, and Takeda.