The annual meeting of the American Society of Hematology was held from Dec. 10 to 13 in New Orleans and attracted participants from around the world, including hematology specialists as well as clinical practitioners and other health care professionals. The conference featured presentations focusing on the diagnosis, treatment, and prevention of disorders affecting blood, bone marrow, and the immunologic, hemostatic, and vascular systems.

In a multicenter, randomized, noninferiority, phase III study, Federico Stella, M.D., of the University of Milan in Italy, and colleagues found that adhering to a low-microbial protective diet (PD) during the hematopoietic stem cell transplantation (HSCT) period puts an unnecessary burden on patients and affects quality of life.

The authors compared a nonrestrictive diet (NRD) to PD in terms of infection rate, feeding outcomes, and acute graft-versus-host disease (aGVHD) incidence in autologous and allogeneic HSCT recipients. Two hundred twenty-four patients were randomly assigned to receive PD (112 patients) or NRD (112 patients) from the start of chemotherapy for the entire duration of neutropenia, with follow-up of 100 days for allogeneic recipients and 30 days for other patients. The researchers observed no difference in cumulative incidence of infections, fever, feeding outcomes, or any grade of aGVHD between the groups.

“These results, together with data published in settings other than posttransplantation, demonstrate that the use of restrictive diet is an unnecessary burden for patients’ quality of life,” Stella said. “Undoubtedly, our data are more mature in the setting of autologous HSCT, where the use of a restrictive diet should be no longer recommended. Subgroup analysis on allogeneic HSCT recipients is not powered to draw practice-changing conclusions; thus, the use of nonrestrictive diet in this setting needs to be confirmed in future trials.”

Several authors disclosed financial ties to the pharmaceutical and biotechnology industries.

Abstract No. 169

In the ALIFE2 study, a multicenter, international, investigator-initiated, randomized controlled trial, Saskia Middeldorp, M.D., of the Radboud University Medical Center in Nijmegen, Netherlands, and colleagues found that low-molecular-weight heparin (LMWH) should not be prescribed to women with recurrent miscarriage and inherited thrombophilia, as it does not increase the chance of live birth and is associated with side effects.

The authors screened more than 10,000 women with recurrent (two or more) miscarriages for the presence of inherited thrombophilia. Ultimately, 326 pregnant women with confirmed inherited thrombophilia (i.e., factor V Leiden, prothrombin gene mutation, antithrombin, protein C, or protein S deficiency) were randomly assigned to either self-administered daily injections with LMWH or standard pregnancy care alone. Randomization was done prior to seven weeks of gestation. Women with a history of venous thromboembolism and those with antiphospholipid syndrome were excluded.

The researchers observed no difference in live birth rate between treatment arms. Live birth rate was 71.6 percent in the LMWH group and 70.9 percent in the standard care arm. In the LMWH group, 43.9 percent of women reported adverse events compared with 26.5 percent of women receiving standard care (absolute difference, 17.4 percent). Adverse event differences included easy bruising, skin reactions at the injection site, and minor bleeding.

“Testing women with recurrent miscarriage for inherited thrombophilia should not be performed,” Middeldorp said. “This will lower burden and costs of unnecessary treatment and avoid costs associated with thrombophilia testing.”

Several authors disclosed financial ties to the pharmaceutical and biotechnology industries.

Abstract No. LBA-5

In ADVANCE, a phase III, multicenter, randomized, double-blinded, placebo-controlled trial in adults with persistent or chronic immune thrombocytopenia (ITP), Catherine Broome, M.D., of Georgetown University in Washington, D.C., and colleagues found that blocking the neonatal Fc receptor with efgartigimod reduces total and pathogenic immunoglobulin G levels, resulting in rapid improvements of platelet counts.

In a 2:1 ratio, the authors randomly assigned participants with an average of two platelet counts of <30×10⁹/L during screening to receive either 10 mg/kg efgartigimod or placebo for 24 weeks. The researchers found that efgartigimod resulted in a 51.7 percent response rate by international working group criteria in patients with chronic ITP who had failed at least two regimens. Most of the patients in the trial had failed three regimens or more.

“We are optimistic that this will offer an additional therapeutic option for patients with ITP who have not responded well to currently available therapy,” Broome said.

Several authors disclosed financial ties to pharmaceutical companies, including argenx, which manufactures efgartigimod and funded the study.

Abstract No. 3

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