Severe Hypophosphatemia Following Ferric Carboxymaltose in a Patient With Inflammatory Bowel Disease

Abstract Background Iron-deficiency anemia is common in inflammatory bowel disease, requiring oral or intravenous iron replacement therapy. Treatment with standard oral irons is limited by poor absorption and gastrointestinal toxicity. Ferric maltol is an oral iron designed for improved absorption and tolerability. Methods In this open-label, phase 3b trial (EudraCT 2015-002496-26 and NCT02680756), adults with nonseverely active inflammatory bowel disease and iron-deficiency anemia (hemoglobin, 8.0-11.0/12.0 g/dL [women/men]; ferritin, <30 ng/mL/<100 ng/mL with transferrin saturation <20%) were randomized to oral ferric maltol 30 mg twice daily or intravenous ferric carboxymaltose given according to each center’s standard practice. The primary endpoint was a hemoglobin responder rate (≥2 g/dL increase or normalization) at week 12, with a 20% noninferiority limit in the intent-to-treat and per-protocol populations. Results For the intent-to-treat (ferric maltol, n = 125/ferric carboxymaltose, n = 125) and per-protocol (n = 78/88) analyses, week 12 responder rates were 67% and 68%, respectively, for ferric maltol vs 84% and 85%, respectively, for ferric carboxymaltose. As the confidence intervals crossed the noninferiority margin, the primary endpoint was not met. Mean hemoglobin increases at weeks 12, 24, and 52 were 2.5 vs 3.0 g/dL, 2.9 vs 2.8 g/dL, and 2.7 vs 2.8 g/dL with ferric maltol vs ferric carboxymaltose. Treatment-emergent adverse events occurred in 59% and 36% of patients, respectively, and resulted in treatment discontinuation in 10% and 3% of patients, respectively. Conclusions Ferric maltol achieved clinically relevant increases in hemoglobin but did not show noninferiority vs ferric carboxymaltose at week 12. Both treatments had comparable long-term effectiveness for hemoglobin and ferritin over 52 weeks and were well tolerated.

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P255 Efficacy and safety of a restrictive ferric carboxymaltose infusion strategy for iron deficiency anemia in inflammatory bowel disease patients

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab076.381 ◽

2021 ◽

Vol 15 (Supplement_1) ◽

pp. S292-S292

Author(s):

F Crispino ◽

M Grova ◽

M Maida ◽

S Renna ◽

A Casà ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Iron Deficiency ◽

Iron Deficiency Anemia ◽

Bowel Disease ◽

Univariate Analysis ◽

Deficiency Anemia ◽

Ferric Carboxymaltose ◽

Good Tolerability ◽

Inflammatory Bowel ◽

Rate Of Response

Abstract Background Iron deficiency anemia (IDA) is a common condition in patients with inflammatory bowel disease (IBD) and ferric carboxymaltose (FCM) has shown fast correction of hemoglobin (Hb) levels and good tolerability. We evaluated the response to FCM in IBD patients with IDA. The primary outcome was the assessment of the rate of response to single or multiple FCM infusions after 12 months from the first infusion. Secondary outcomes were the response to a single FCM infusion after 3 months and the assessment of FCM safety. Methods We retrospectively included 185 consecutive patients from IBD Unit of “Villa Sofia-V. Cervello” Hospital who received at least a dose of 500 mg FCM infusion between 2015 and 2018. Complete response (CR) was defined as Hb ≥13 g/dL (men) or ≥12 g/dL (women) or Hb increase ≥2 g/dL; partial response (PR) was defined as Hb increase ≥1 and <2 g/dl, without anemia correction; response was considered either CR or PR. Failure was defined as Hb increase <1 g/dl. A univariate analysis was performed among complete responders, partial responders and failures at 3 and 12 months. Results After 12 months the mean number of FCM infusions was 1.7 ± 1.1 and the rate of response was 139/185 (75.1%; CR: 48.6%; PR: 26.4%). Concerning our secondary endpoint, 169/185 patients received a single infusion of FCM within 3 months, and 134/169 patients (79.2%) achieved response (CR: 56.8%; PR: 22.4%). At univariate analysis low ferritin was the only variable associated with failure at 12 months (p < 0.003). No adverse events were reported. Conclusion A restrictive FCM infusion strategy is effective in most IBD patients with IDA. Interestingly, no association was found with Hb and weight at baseline, so further studies are needed to assess their effective role in deciding dosage of FCM.

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VP151 Endovenous Iron Deficiency Anemia Treatment In Inflammatory Bowel Disease: Hospital-based Health Technology Assessment

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462317003944 ◽

2017 ◽

Vol 33 (S1) ◽

pp. 219-220

Author(s):

Jovana Stojanovic ◽

Flavia Kheiraoui ◽

Enrica Maria Proli ◽

Franco Scaldaferri ◽

Massimo Volpe ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Iron Deficiency ◽

Technology Assessment ◽

Bowel Disease ◽

Health Technology ◽

Deficiency Anemia ◽

Ferric Carboxymaltose ◽

Efficacy And Safety ◽

Iv Iron ◽

Inflammatory Bowel

INTRODUCTION:Iron Deficiency Anemia (IDA), a common cause of anemia in the world, is a frequently neglected disease that represents the main extraintestinal manifestation affecting patients with inflammatory bowel disease (IBD) (1). The release of new intravenous (IV) iron compounds represents a great opportunity for both physicians and patients, but the higher costs might hold back their optimal diffusion. A Health Technology Assessment (HTA) approach was used to provide insights on the sustainability of the IV iron formulations in a hospital setting, with a special focus on ferric carboxymaltose.METHODS:Epidemiology of IBD, as well as IDA associated with these conditions, was assessed with a systematic appraisal of the published literature. Data on efficacy and safety of IV iron formulations currently used in Italy were retrieved from the available medical electronic databases. A hospital based cost-analysis of the outpatient delivery of IV iron treatments was performed. Organizational and ethical implications were discussed.RESULTS:The reported prevalence of anemia in patients with IBD varies markedly from 10 to 73 percent for Crohn's Disease and from 9 to 67 percent for Ulcerative Colitis. Although there are no studies on direct comparison of different IV iron preparations, the literature indicates good efficacy and safety profiles of these formulations. However, ferric carboxymaltose seemed to provide a better and faster correction of hemoglobin and serum ferritin levels in iron-deficient patients (2,3). Our analyses indicated that ferric carboxymaltose, in spite of a greater price, would have positive benefits for the hospital, in terms of reduced costs related to individual patient management, and for the patients themselves, by reducing the number of infusions and accesses to health facilities.CONCLUSIONS:This hospital-based HTA reports an overall positive organizational, economic and ethical evaluation for the sustainable introduction of ferric carboxymaltose in the Italian outpatient setting.

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