Hypophosphatemia after high-dose iron repletion with ferric carboxymaltose and ferric derisomaltose-the randomized controlled HOMe aFers study.

BACKGROUND: In patients with iron deficiency anemia, ferric carboxymaltose (FCM) and ferric derisomaltose (FDI) allow high-dose iron repletion. While FCM is reported to induce hypophosphatemia, the frequency of hypophosphatemia after an equivalent dosage of FDI had not been assessed prospectively. METHODS: In the prospective, single-center, double-blind HOMe aFers study, 26 women with iron deficiency anemia (hemoglobin < 12 g/dL plus either plasma ferritin ≤ 100 ng/mL or a plasma ferritin ≤ 300 ng/mL and transferrin saturation (TSAT) ≤ 30%) were randomized to a single intravenous infusion of 20 mg/kg body weight (up to a maximum of 1000 mg) FCM or FDI. The primary endpoint was the incidence of hypophosphatemia (plasma phosphorus levels < 2.0 mg/dL at day 1, day 7 ± 2, and/or day 35 ± 2 after the infusion). In order to investigate potential skeletal and cardiovascular implications, we assessed changes in other components of mineral and bone metabolism, left ventricular function, and arrhythmias. RESULTS: Hypophosphatemia occurred more frequently in women treated with FCM (9 out of 12 [75%]) than in those treated with FDI (1 out of 13 [8%]; p = 0.001). Within 24 h after iron supplementation, women in the FCM group had significant higher plasma intact FGF23 (p < 0.001) and lower plasma 1.25-dihydroxyvitamin D (p < 0.001). As an indicator of urinary phosphorus losses, urinary fractional phosphorus excretion was higher in the FCM group (p = 0.021 at day 7 ± 2 after iron supplementation). We did not observe differences in skeletal and cardiovascular markers, potentially because of the limited number of participants. CONCLUSIONS: While both FCM and FDI provide efficient iron repletion in participants with iron deficiency anemia, FCM induced hypophosphatemia more often than FDI. TRIAL REGISTRATION: Clinical Trials.gov NCT02905539. Registered on 8 September 2016. 2015-004808-36 (EudraCT Number) U1111-1176-4563 (WHO Universal Trial Number) DRKS00010766 (Deutsches Register Klinischer Studien).

Vaccination during concurrent subcutaneous immunotherapy: safety of simultaneous application.

BACKGROUND: During subcutaneous immunotherapy (SCIT), injections should be separated from vaccinations against infectious diseases by at least 1 week, because it is assumed that adverse reactions can result from the additional activation of the immune system. METARIAL AND METHODS: Data of a total of 875 individuals receiving SCIT and/or vaccination in one ENT-practice were included and analyzed retrospectively. 444 individuals had received vaccination against infectious diseases, 336 allergic patients received only SCIT. Moreover, 79 allergic patients had received vaccination and SCIT injections simultaneously on one day in different locations, while 16 patients inadvertently received SCIT injections within up to 4 days after vaccination. Some of the patients were observed for consecutive years receiving several vaccinations parallel to SCIT. Systemic reactions (SRs) during SCIT were classified according to the WAO (World Allergy Organization) grading. RESULTS: Patients exclusively receiving vaccinations did not report any drug-related SR. One SR third grade and two SRs second grade occurred in 3 asthmatic patients exclusively receiving SCIT. The patients simultaneously receiving vaccination and SCIT did not have any SR. This was also the case for the subjects consecutively receiving parallel SCIT and vaccination for up to 5 years. CONCLUSION: The international guidelines for allergen-specific immunotherapy (SIT) recommend an intermission of at least one week between SCIT and the administration of vaccines. However, these findings demonstrate the possibility to shorten or abolish this interval without increasing the risk of SRs.