Gastroenterology

Gastroenterology

Volume 141, Issue 3, September 2011, Pages 846-853.e2
Gastroenterology

Original Research
Clinical—Alimentary Tract
FERGIcor, a Randomized Controlled Trial on Ferric Carboxymaltose for Iron Deficiency Anemia in Inflammatory Bowel Disease

https://doi.org/10.1053/j.gastro.2011.06.005Get rights and content

Background & Aims

Iron deficiency anemia (IDA) is common in chronic diseases and intravenous iron is an effective and recommended treatment. However, dose calculations and inconvenient administration may affect compliance and efficacy. We compared the efficacy and safety of a novel fixed-dose ferric carboxymaltose regimen (FCM) with individually calculated iron sucrose (IS) doses in patients with inflammatory bowel disease (IBD) and IDA.

Methods

This randomized, controlled, open-label, multicenter study included 485 patients with IDA (ferritin <100 μg/L, hemoglobin [Hb] 7–12 g/dL [female] or 7–13 g/dL [male]) and mild-to-moderate or quiescent IBD at 88 hospitals and clinics in 14 countries. Patients received either FCM in a maximum of 3 infusions of 1000 or 500 mg iron, or Ganzoni-calculated IS dosages in up to 11 infusions of 200 mg iron. Primary end point was Hb response (Hb increase ≥2 g/dL); secondary end points included anemia resolution and iron status normalization by week 12.

Results

The results of 240 FCM-treated and 235 IS-treated patients were analyzed. More patients with FCM than IS achieved Hb response (150 [65.8%] vs 118 [53.6%]; 12.2% difference, P = .004) or Hb normalization (166 [72.8%] vs 136 [61.8%]; 11.0% difference, P = .015). Both treatments improved quality of life scores by week 12. Study drugs were well tolerated and drug-related adverse events were in line with drug-specific clinical experience. Deviations from scheduled total iron dosages were more frequent in the IS group.

Conclusions

The simpler FCM-based dosing regimen showed better efficacy and compliance, as well as a good safety profile, compared with the Ganzoni-calculated IS dose regimen.

Section snippets

Study Design and Patients

The study was designed as a randomized, controlled, multicenter, open-label trial testing a novel treatment regimen using FCM (Ferinject; Vifor Pharma, Glattbrugg, Switzerland) for noninferiority compared with the Ganzoni-calculated doses of IS (Venofer; Vifor Pharma, Glattbrugg, Switzerland) in patients with IBD and IDA. The study was conducted from October 2008 to December 2009 at 88 hospitals and clinics in 14 countries in accordance with the Declaration of Helsinki and Good Clinical

Patient Characteristics

A total of 880 patients were screened; 485 were randomized. Most common screening failures were not meeting the inclusion or exclusion criteria (361 patients, 91.4%). Two patients did not participate because of the projected number of IS injections. Details of patient disposition to treatment arms and populations analyzed are summarized in a CONSORT diagram (Figure 1). No differences were observed in patient demographics, type and history of IBD, and laboratory measures between the treatment

Discussion

This study is the largest study to date addressing IDA in IBD. It showed that patients with IDA secondary to IBD responded significantly better to FCM with its simplified dose regimen than to the Ganzoni-calculated IS dose regimen. The FCM regimen resulted in Hb normalization in 73% of patients, and almost twice as many FCM-treated patients responded with normalization of both Hb and ferritin than in the IS group (31% vs 17%). Disease-related (IBDQ) physical and mental quality of life (SF-36)

Acknowledgments

The authors thank all investigators at all study sites (see Appendix), the support in funding and conducting the study (Barbara von Eisenhart Rothe, responsible Medical Director; Janne Harjunpää, statistical analysis; Vifor Pharma, Switzerland), and medical writing support (Walter Fürst; SFL Regulatory Affairs & Scientific Communication, Switzerland).

The corresponding author had full access to all of the data and takes full responsibility for the veracity of the data and statistical analysis.

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    Conflicts of interest The authors disclose the following: Philippe Marteau: Speakers honoraria from Vifor International. Tariq Iqbal: Speakers honoraria from Vifor International. Jürgen Stein: Consultancy and speakers honoraria from Vifor International. Florian S. Gutzwiller: Research funding from Vifor International. Lise Riopel: Employee Vifor Pharma, Switzerland. Christoph Gasche: received grant and consultancy honoraria from Vifor International, Pharmacosmos A/S, Fresenius Medical Care, Renapharma Sweden.

    The remaining authors disclose no conflicts.

    Funding Supported by Vifor Pharma, Switzerland, which sponsored this study and supported the development of the study design and preparation of the manuscript; and by Parexel International, Germany, an independent clinical research organization that conducted the trial and performed the statistical analysis.

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