Intravenous immunoglobulin (IVIG) infusion-related headache and migraine affects a minority of patients with primary immunodeficiency undergoing the accelerated 15-minute protocol, according to study results published in Frontiers in Immunology.
Investigators from the University of California, San Diego pooled data for this analysis from 3 open-label pivotal trials, GMX01 (ClinicalTrials.gov Identifier: NCT00278954), GMX 04 (ClinicalTrials.gov Identifier: NCT01289847), and GMX07 (ClinicalTrials.gov Identifier: NCT01963143), which evaluated 5% or 10% Gammaplex IVIG infusion protocols and were conducted between 2006 and 2013. The patients (N=123) received 15-minute infusion protocols administered every 21 or 28 days starting at 0.01 mL/kg/min for 5% IVIG and 0.005 mL/kg/min for 10% IVIG and advancing to a maximum of 0.08 mL/kg/min if tolerated. The primary outcomes for this analysis were the rates of IVIG infusion-related headache and migraine.
The patients were aged median 30.0 (range, 3-78) years, 52.8% were men or boys, 93.5% were White, 85.4% had common variable immunodeficiency, and 83.3% received the 5% IVIG formulation.
Overall, the maximum infusion rate was achieved in 94.6% of infusions (n=1482). Stratified by characteristics, the maximum rate was reached by more adults than children (97.9% vs 87.4%; P <.0001), men or boys than women or girls (96.3% vs 92.5%; P =.0011), and during infusions on the 28-day schedule than the 21-day schedule (95.9% vs 93.4%; P =.0290), respectively.
The overall rates of IVIG infusion-related headache (6.1%) and migraine (0.5%) were low. Reported headaches were more common among adults than children (7.1% vs 3.9%; P =.0140), women or girls than men or boys (10.6% vs 2.4%; P <.0001), and at infusions on the 21-day cycle than the 28-day cycle (7.8% vs 4.3%; P =.0044), respectively. Significant group differences in migraine were only observed with gender, in which more women or girls reported migraine (0.9%) than men or boys (0.1%; P =.0498). No difference in headache (P =.7711) or migraine (P =.0963) were associated with 5% or 10% formulations.
Among patients, 28.5% reported an IVIG infusion-related headache event and 4.1% a migraine event. Patient-level reports of headache (P =.0693) did not depend on 5% or 10% formulations.
Most of the headache events (77%) and all of the migraine events (100%) occurred within 72 hours of infusion.
The limitations of this analysis included the open-label study designs, the pooling of data from independent trials, patients received differing formulations of IVIG, and the limited diversity among the study cohorts.
This study found that a 15-minute accelerated infusion protocol for IVIG was associated with low rates of headache and migraine, leading the authors to conclude, “Either formulation of this IVIG product can be administered using a 15-minute rate escalation protocol without excessive rates of headache or migraine.”
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Geng B, Clark K, Evangelista M, Wolford E. Low rates of headache and migraine associated with intravenous immunoglobulin infusion using a 15-minute rate escalation protocol in 123 patients with primary immunodeficiency. Front Immunol. 2023;13:1075527. doi10.3389/fimmu.2022.1075527