D0361 - A Pooled Analysis of Early and Sustained Response in Patients With IBD With Iron Deficiency Anemia Who Were Treated With Ferric Maltol

Carsten Schmidt, PD, MA, FEBGH¹, Michael Cody, MD², Jose Menoyo, MD³, Jackie Mitchell, PhD, MA⁴, Ann Yellowlees, PhD, MA^5
1Universitätsmedizin Marburg-Campus Fulda, Fulda, Hessen, Germany; ²Shield Therapeutics PLC, Dallas, TX; ³Shield Therapeutics PLC, Boston, MA; ⁴Shield Therapeutics PLC, Newcastle, England, United Kingdom; ⁵Quantics Biostatistics, Edinburgh, Scotland, United Kingdom

Introduction: Iron deficiency (ID) accounts for around half of the estimated 2.2 billion cases of anemia globally.¹ In western countries about 3.4% of the general population are anemic, and up to 30% of patients with inflammatory bowel disease (IBD) are reported to have ID anemia (IDA).²

Patients with inflammatory bowel disease (IBD) experience ID associated with chronic gastrointestinal (GI) blood loss, impaired absorption across damaged bowel mucosa, and inflammation-associated downregulation of absorption.¹

Ferric maltol (FM) optimizes iron absorption while reducing the GI adverse events compared with traditional oral iron replacement options.¹ Here, we present a novel pooled efficacy assessment of FM in the treatment of IDA at Week 4, to evaluate early response, and at Week 12.

Methods: Data were pooled from the combined phase 3 AEGIS 1 and 2 (301/2) studies, and a phase 3b study (304), which included adults with a diagnosis of Crohn’s disease (CD) or ulcerative colitis (UC) and IDA defined as Hb ≥9.5–< 12.0 g/dL for females and ≥9.5–< 13.0 g/dL for males in 301/2 and as Hb ≥8.0–≤11.0 g/dL for women and ≥8.0–≤12.0 g/dL for men in 304.

Change in Hb concentration from baseline (BL) was pooled at Week 4 and at Week 12.

Results: Results:

In 301/2, the mean age was 39.3 years and 65% were female; 55% had CD and 45% had UC. In 304 the mean age was 40.2 years and 58% were female; 62% had CD and 37% had UC.

At Week 4, the 301/2 population (n=59) had a mean improvement in Hb from BL of 1.08 g/dL (95% confidence interval [CI], 0.91–1.25) and the 304 population (n=125) had a mean increase of 1.27 g/dL (95% CI, 1.10–1.44).

At Week12, those in 301/2 (n=58) had a mean gain in Hb from BL of 2.26 g/dL (95% CI, 1.96–2.56) and patients in 304 (n=125) had a mean increase of 2.45 g/dL (95% CI, 2.20–2.70).

The pooled analysis showed mean increase in Hb from BL of 1.18 g/dL (95% CI, 1.05–1.30) at Week 4 (n=184), and of 2.37 g/dL (95% CI, 2.18–2.57) at Week 12 (n=183).

Discussion: Patients with IBD and IDA who received FM had a clinically meaningful >1.0 g/dL Hb improvement at Week 4, and a >2.0 g/dL increase at Week 12 in a pooled analysis of three pivotal randomized controlled trials.

These findings support physicians in making treatment decisions for patients with IBD and ID.



References

< !1. Schmidt et al. J Clin Med. 2021;10:4448.

< !2. Voegtlin et al. J Crohns Colitis. 2010;4:642–8.






Disclosures:


Carsten Schmidt, PD, MA, FEBGH¹, Michael Cody, MD², Jose Menoyo, MD³, Jackie Mitchell, PhD, MA⁴, Ann Yellowlees, PhD, MA⁵. D0361 - A Pooled Analysis of Early and Sustained Response in Patients With IBD With Iron Deficiency Anemia Who Were Treated With Ferric Maltol, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.