Hematology Month in Review: August 2024

In this hematology month in review for August 2024, the US Preventive Services Task Force (USPSTF) released a new recommendation statement indicating the current evidence is insufficient to determine the benefit-risk of iron deficiency screening and supplementation during pregnancy. The US Food and Drug Administration (FDA) approved a new treatment for chronic graft-versus-host disease (cGVHD), for those who failed previous therapy.

Phase 2 results demonstrated the efficacy of nipocalimab therapy for pregnancies at an elevated risk for recurrent early-onset severe hemolytic disease of the fetus and newborn (HDFN). Cases of iron deficiency were found to persist over a 3-year period in a statewide health system and anemia was linked to adverse outcomes after percutaneous coronary intervention (PCI).

Finally, moderate-to-severe anemia was linked to an elevated risk of cardiac outcomes, compared with normal hemoglobin (Hb) levels, in patients with acute COVID-19 infection admitted to the ICU.

USPSTF: Iron Deficiency Screening, Supplementation in Pregnancy Lacks Evidence

New USPSTF recommendations determined the current evidence is insufficient to evaluate the benefits and harms of screening and routine iron supplementation for iron deficiency and anemia during pregnancy to prevent adverse maternal and infant health outcomes.

These Grade 1 recommendations apply to asymptomatic pregnant adolescents and adults but do not apply to those who are severely malnourished, have symptoms of iron deficiency or anemia, or have specific hematologic conditions or nutritional deficiencies that may increase the need for iron intake.

FDA Approves Axatilimab for Chronic Graft-Versus-Host Disease

On August 14, the FDA approved axatilimab-csfr (Niktimvo) for the treatment of chronic graft-versus-host disease (cGVHD), after failure of prior systemic therapy in adult and pediatric patients weighing >40 kg.

Approval was awarded based on positive findings from the randomized, open-label, multicenter Phase 2 AGAVE-201 trial, investigating 3 dosages of the colony-stimulating factor-1 receptor-blocking antibody.

UNITY: Nipocalimab Improves Survival in Early-Onset Severe HDFN

Results from the Phase 2 UNITY trial supported the efficacy of nipocalimab for pregnancies at an elevated risk for recurrent early-onset severe HDFN. Nipocalimab in pregnancies at risk for HDFN led to a notably higher percentage of live births at or after 32 weeks gestation, and delayed fetal anemia or intrauterine transfusions, as compared with the historical benchmark.

“For mothers with severe HDFN, the outcome not only of the condition but of the treatment can be devastating,” said Mark Kilby, DSc, MD, University of Birmingham. “This is why the search for therapies to reduce the consequences of the maternal immune response has been focused on this cohort of women.”

Iron Deficiency Cases Persist Over 3 Years in Statewide Health System

A retrospective study of EMR data revealed more than half of people with iron deficiency still experienced low iron levels within 3 years of diagnosis. Younger patients, females, and Black individuals were more likely to remain iron deficient.

Among those whose iron levels were restored to normal in the same period, it took a median time to iron deficiency resolution of 1.9 years, suggesting notable insufficiencies in treatment delivery.

“Two years is too long and well beyond the timeframe within which iron deficiency should be able to be sufficiently treated and resolved,” said lead author Jacob Cogan, MD, University of Minnesota. “The numbers are pretty striking and suggest a need to put systems in place to better identify patients and treat them more efficiently.”

Anemia Linked to Adverse Outcomes After Percutaneous Coronary Intervention

Anemia is frequently identified in patients undergoing Impella-supported high-risk PCI (HRPCI) and is correlated with major adverse cardiovascular and cerebrovascular events (MACCE), bleeding events, and death. These results were obtained from a recent post hoc analysis of the PROTECT III study.

“Current clinical guidelines lack recommendations for the concurrent management of anemia in patients undergoing PCI or large-bore procedures such as Impella-supported HRPCI, other than advising measures to minimize bleeding risks and utilizing risk scores to guide dual antiplatelet therapy,” investigators wrote.

Anemia Increases Cardiac Arrest, Stroke Risk in COVID-19 Admissions

Moderate-to-severe anemia was associated with a raised risk of cardiac arrest or stroke, compared with normal Hb levels, in an international registry of patients with acute COVID-19 infection admitted to the ICU.

These data were determined by Cox proportional hazards regression analysis assessing the time to stroke or cardiac arrest by anemia status using death as a competing risk.

“Anemia status persisted as an independent risk factor for the composite cardiac arrest and stroke outcome after adjusting for both the pre-selected and expanded set of covariates observed to increase with anemia severity,” investigators wrote.