A systematic literature review and indirect comparison of iron isomaltoside and ferric carboxymaltose in iron deficiency anemia after failure or intolerance of oral iron treatment

ABSTRACT

Objectives: The efficacy of oral iron in treating iron deficiency anemia (IDA) can be limited by poor gastrointestinal (GI) absorption and adverse GI symptoms; intravenous (IV) iron is a well-established alternative. The present study compared the efficacy of two IV iron formulations in patients with IDA: iron isomaltoside (IIM) and ferric carboxymaltose (FCM).

Methods: A systematic literature review (SLR) was conducted to identify randomized controlled trials (RCTs) of IIM and FCM in patients with IDA. An adjusted indirect treatment comparison (ITC) of IIM and FCM was then conducted to evaluate differences in change from baseline hemoglobin and the proportion of patients achieving a clinically-relevant response.

Results: The SLR identified no completed RCTs of IIM versus FCM, 5 RCTs of IIM (4 versus oral iron and 1 versus iron sucrose), and 14 RCTs of FCM (11 versus oral iron and 3 versus iron sucrose). In an ITC via iron sucrose, IIM resulted in a significantly larger increase from baseline hemoglobin with a mean difference of +0.249 g/dL with IIM relative to FCM, but there was no significant difference in the proportion of patients with a clinically-relevant response.

Conclusions: IIM resulted in a larger increase from baseline hemoglobin than FCM in patients with IDA, but with no difference in the proportion of patients responding. Studies comparing IIM and FCM directly would be needed to confirm these findings.

KEYWORDS:

• Iron deficiency anemia
• iron
• administration
• intravenous
• indirect treatment comparison

Declaration of interest

RF Pollock is a shareholder and director of Covalence Research Ltd, which received consultancy fees from Pharmacosmos A/S for the present study. G Muduma is a full-time employee of Pharmacosmos A/S, the marketing authorization holder for iron isomaltoside (Monofer). The study and medical writing activities were funded wholly by Pharmacosmos A/S. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

One of the reviewers on this manuscript has disclosed that they have received industry-supplied funding for consultancies, lectures and/or travel from Vifor Pharma (Spain & Switzerland), Wellspect HealthCare (Sweden), Pharmacosmos A/S (Denmark), Ferrer Pharma (Spain), CSL Behring (Germany), PharmaNutra (Italy) and Zambon (Spain), and are a member of the editorial board of Revista Española de Anestesiología y Reanimación, Medicina Intensiva and Blood Transfusion. Peer reviewers on this manuscript have no other relevant financial or relationships or otherwise to disclose.

Supplementary material

Supplemental data for this article can be accessed here.

Additional information

Funding

This manuscript was funded by Pharmacosmos A/S.

Notes on contributors

Gorden Muduma

G Muduma conceived of the study; G Muduma and RF Pollock were involved in the design, analysis, and interpretation of data; RF Pollock drafted the paper; and G Muduma revised it critically for intellectual content. G Muduma and RF Pollock approve of the final version to be published and both authors agree to be accountable for all aspects of the work.