{"doi":"10.2217/imt-2022-0097","title":"Systemic IgG Exposure and Safety in Patients with Primary Immunodeficiency: A Randomized Crossover Study Comparing a Novel Investigational Wearable Infusor Versus the Crono Pump","abstract":"Aim: A novel, Investigational Wearable Infusor (IWI) was evaluated in a randomized, controlled, crossover, open-label study to determine if its delivery of subcutaneous immunoglobulin (IgPro20) achieved a comparable area under the concentration-time curve (AUC) for immunoglobulin G (IgG) versus the Crono S-PID-50 infusion pump (CP). EudraCT: 2016-003798-16. Materials & methods: Patients with primary immunodeficiency (PID) were randomized to receive IgPro20 in Sequence 1 (CP/IWI) or 2 (IWI/CP). The primary end point was AUC for IgG during the final week of each 4-week period. Results: 23 patients were enrolled. Evaluation of area under the concentration-time curve from time 0 (pre-infusion) to 7 days after infusion (AUC0–7 days) (IWI: 1806 h*g/l; CP: 1829 h*g/l) and geometric mean ratio indicated comparable AUCs for IgG for both devices. Conclusion: Similar IgG exposure, indicated by AUC values, can be achieved with IgPro20 using the IWI or CP in PID.","journal":"Immunotherapy","year":2022,"id":257876,"datarank":0.8690493563489711,"base_score":2.9444389791664403,"endowment":2.9444389791664403,"self_citation_contribution":0.44166584687496613,"citation_network_contribution":0.42738350947400494,"self_endowment_contribution":0.44166584687496613,"citer_contribution":0.42738350947400494,"corpus_percentile":null,"corpus_rank":null,"citation_count":18,"citer_count":18,"citers_with_citation_signal":13,"citers_with_endowment":13,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9641,"is_data_producer":true,"deposit_databanks":{"EudraCT":["2016-003798-16"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2022-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":104929,"name":"Charlotte Cunningham‐Rundles","orcid":"0000-0003-0725-0320","position":1,"is_corresponding":false},{"id":254997,"name":"John Anderson","orcid":"0000-0003-3578-8064","position":2,"is_corresponding":false},{"id":395710,"name":"Patricia Lugar","orcid":"0000-0002-7725-7424","position":3,"is_corresponding":false},{"id":610986,"name":"Michael Palumbo","orcid":"0000-0001-7483-0849","position":4,"is_corresponding":false},{"id":846628,"name":"Niraj Patel","orcid":"0000-0002-3657-145X","position":5,"is_corresponding":false},{"id":908803,"name":"Jutta Hofmann","orcid":null,"position":6,"is_corresponding":false},{"id":381689,"name":"Fiona Glassman","orcid":"0000-0002-1292-6332","position":7,"is_corresponding":false},{"id":908804,"name":"Eileen Rogers","orcid":null,"position":8,"is_corresponding":false},{"id":908805,"name":"Michaela Praus","orcid":null,"position":9,"is_corresponding":false},{"id":908419,"name":"Mikhail Rojavin","orcid":"0000-0002-9010-2865","position":10,"is_corresponding":false},{"id":908418,"name":"Richard L. Wasserman","orcid":"0000-0002-3447-4859","position":0,"is_corresponding":true}],"reference_count":23,"raw_metadata":null,"created_at":"2026-07-19T00:25:34.440699Z","pmid":"36128795","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}