Plain language summary: Headache and migraine experiences in people with primary immunodeficiency receiving GAMMAPLEX® 5% or 10% intravenous immunoglobulin therapy

Plain Language SummaryWhat is this summary about?This research is about people with primary immunodeficiency (PI for short) who received a type of intravenous immunoglobulin (IVIG for short) treatment called GAMMAPLEX® 5% or 10%. Intravenous medicines are given by a needle into a vein. Headache and migraine are known side effects of IVIG infusions. The researchers wanted to understand more about headache and migraine related to this IVIG treatment. They also wanted to understand whether shortening the infusion time during treatment (known as the infusion rate) impacts these side effects.What were the results?Increasing the infusion rate every 15 minutes does not make it more likely that people with PI will experience headache and migraine related to GAMMAPLEX 5% or 10% treatment.What do the results mean?GAMMAPLEX 5% or 10% treatment where the infusion rate is increased every 15 minutes is a reasonable option for most people with PI. Shortening the time needed for an IVIG infusion may reduce the healthcare resources used and improve quality of life for people with PI who receive IVIG treatment.Clinical trial number: NCT03052608(Phase 3 CROWN study)Clinical trial number: NCT00278954 from January 18, 2006Clinical trial number: NCT01289847 from January 27, 2011Clinical trial number: NCT01963143 from September 13, 2013