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.
This article originally appeared on Clinical Pain Advisor
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