{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T20:26:10Z","timestamp":1786998370373,"version":"build-2736575974"},"reference-count":35,"publisher":"Elsevier BV","issue":"2","license":[{"start":{"date-parts":[[2011,6,1]],"date-time":"2011-06-01T00:00:00Z","timestamp":1306886400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Molecular Genetics and Metabolism"],"published-print":{"date-parts":[[2011,6]]},"DOI":"10.1016\/j.ymgme.2011.02.018","type":"journal-article","created":{"date-parts":[[2011,3,5]],"date-time":"2011-03-05T09:22:31Z","timestamp":1299316951000},"page":"113-120","source":"Crossref","is-referenced-by-count":64,"title":["Incidence and timing of infusion-related reactions in patients with mucopolysaccharidosis type II (Hunter syndrome) on idursulfase therapy in the real-world setting: A perspective from the Hunter Outcome Survey (HOS)"],"prefix":"10.1016","volume":"103","author":[{"given":"Barbara K.","family":"Burton","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David A.H.","family":"Whiteman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.ymgme.2011.02.018_bb0005","doi-asserted-by":"crossref","first-page":"329","DOI":"10.1016\/j.ymgme.2006.09.001","article-title":"A phase I\/II clinical trial of enzyme replacement therapy in mucopolysaccharidosis II","volume":"90","author":"Muenzer","year":"2007","journal-title":"Mol. Genet. Metab."},{"key":"10.1016\/j.ymgme.2011.02.018_bb0010","doi-asserted-by":"crossref","first-page":"465","DOI":"10.1097\/01.gim.0000232477.37660.fb","article-title":"A phase II\/III clinical study of enzyme replacement therapy with idursulfase in mucopolysaccharidosis II","volume":"8","author":"Muenzer","year":"2006","journal-title":"Genet. Med."},{"key":"10.1016\/j.ymgme.2011.02.018_bb0015","doi-asserted-by":"crossref","first-page":"2743","DOI":"10.1001\/jama.285.21.2743","article-title":"Enzyme replacement therapy in Fabry disease: a randomized controlled trial","volume":"285","author":"Schiffmann","year":"2001","journal-title":"JAMA"},{"key":"10.1016\/j.ymgme.2011.02.018_bb0020","doi-asserted-by":"crossref","first-page":"9","DOI":"10.1056\/NEJM200107053450102","article-title":"Safety and efficacy of recombinant human alpha-galactosidase A-replacement therapy in Fabry's disease","volume":"345","author":"Eng","year":"2001","journal-title":"N. Engl. J. Med."},{"key":"10.1016\/j.ymgme.2011.02.018_bb0025","doi-asserted-by":"crossref","first-page":"1479","DOI":"10.1016\/S0140-6736(95)91038-7","article-title":"Replacement therapy with imiglucerase for type 1 Gaucher's disease","volume":"345","author":"Zimran","year":"1995","journal-title":"Lancet"},{"key":"10.1016\/j.ymgme.2011.02.018_bb0030","doi-asserted-by":"crossref","first-page":"99","DOI":"10.1212\/01.wnl.0000251268.41188.04","article-title":"Recombinant human acid alpha-glucosidase: major clinical benefits in infantile-onset Pompe disease","volume":"68","author":"Kishnani","year":"2007","journal-title":"Neurology"},{"key":"10.1016\/j.ymgme.2011.02.018_bb0035","doi-asserted-by":"crossref","first-page":"581","DOI":"10.1016\/j.jpeds.2004.01.046","article-title":"Enzyme replacement therapy for mucopolysaccharidosis I: a randomized, double-blinded, placebo-controlled, multinational study of recombinant human alpha-l-iduronidase","volume":"144","author":"Wraith","year":"2004","journal-title":"J. Pediatr."},{"key":"10.1016\/j.ymgme.2011.02.018_bb0040","doi-asserted-by":"crossref","first-page":"533","DOI":"10.1016\/j.jpeds.2005.12.014","volume":"148","author":"Harmatz","year":"2006","journal-title":"J. Pediatr."},{"key":"10.1016\/j.ymgme.2011.02.018_bb0045","first-page":"S100","article-title":"Management of infusion-related reactions to enzyme replacement therapy in a cohort of patients with mucopolysaccharidosis disorders","volume":"47","author":"Miebach","year":"2009","journal-title":"Int. J. Clin. Pharmacol. Ther."},{"key":"10.1016\/j.ymgme.2011.02.018_bb0050","doi-asserted-by":"crossref","first-page":"450","DOI":"10.1016\/j.molmed.2003.08.004","article-title":"Significance of immune response to enzyme-replacement therapy for patients with a lysosomal storage disorder","volume":"9","author":"Brooks","year":"2003","journal-title":"Trends Mol. Med."},{"key":"10.1016\/j.ymgme.2011.02.018_bb0055","doi-asserted-by":"crossref","first-page":"391","DOI":"10.1016\/j.jaci.2005.12.1303","article-title":"Second symposium on the definition and management of anaphylaxis: summary report\u2014Second National Institute of Allergy and Infectious Disease\/Food Allergy and Anaphylaxis Network symposium","volume":"117","author":"Sampson","year":"2006","journal-title":"J. Allergy Clin. Immunol."},{"key":"10.1016\/j.ymgme.2011.02.018_bb0060","doi-asserted-by":"crossref","first-page":"217","DOI":"10.1016\/S1081-1206(10)61217-3","article-title":"Biphasic anaphylactic reactions","volume":"95","author":"Lieberman","year":"2005","journal-title":"Ann. Allergy Asthma Immunol."},{"key":"10.1016\/j.ymgme.2011.02.018_bb0065","doi-asserted-by":"crossref","first-page":"241","DOI":"10.1016\/S1529-1049(02)00049-1","article-title":"Immunologic considerations for enzyme replacement therapy in the treatment of lysosomal storage disorders","volume":"2","author":"Richards","year":"2002","journal-title":"Clin. Appl. Immunol. Rev."},{"key":"10.1016\/j.ymgme.2011.02.018_bb0070","doi-asserted-by":"crossref","first-page":"1608","DOI":"10.1016\/S0140-6736(03)13311-9","article-title":"Immune tolerance after long-term enzyme-replacement therapy among patients who have mucopolysaccharidosis I","volume":"361","author":"Kakavanos","year":"2003","journal-title":"Lancet"},{"key":"10.1016\/j.ymgme.2011.02.018_bb0075","doi-asserted-by":"crossref","first-page":"2081","DOI":"10.1182\/blood.V93.6.2081.406k07_2081_2088","article-title":"Immunosurveillance of alglucerase enzyme therapy for Gaucher patients: induction of humoral tolerance in seroconverted patients after repeat administration","volume":"93","author":"Rosenberg","year":"1999","journal-title":"Blood"},{"key":"10.1016\/j.ymgme.2011.02.018_bb0080","doi-asserted-by":"crossref","first-page":"229","DOI":"10.1542\/peds.2007-3847","article-title":"Long-term efficacy and safety of laronidase in the treatment of mucopolysaccharidosis I","volume":"123","author":"Clarke","year":"2009","journal-title":"Pediatrics"},{"key":"10.1016\/j.ymgme.2011.02.018_bb0085","unstructured":"Myozyme\u00ae prescribing information 6829 (01\/09), Genzyme Corporation, Cambridge, MA, USA."},{"issue":"Suppl 1","key":"10.1016\/j.ymgme.2011.02.018_bb0090","first-page":"S86","article-title":"Perspectives from B cell immunology: fact and fancy","volume":"47","author":"Hunt","year":"2009","journal-title":"Int. J. Clin. Pharmacol. Ther."},{"key":"10.1016\/j.ymgme.2011.02.018_bb0095","series-title":"The Metabolic and Molecular Bases of Inherited Disease","first-page":"3421","article-title":"The mucopolysaccharidoses","author":"Neufeld","year":"2001"},{"key":"10.1016\/j.ymgme.2011.02.018_bb0100","doi-asserted-by":"crossref","first-page":"249","DOI":"10.1001\/jama.281.3.249","article-title":"Prevalence of lysosomal storage disorders","volume":"281","author":"Meikle","year":"1999","journal-title":"Jama"},{"key":"10.1016\/j.ymgme.2011.02.018_bb0105","doi-asserted-by":"crossref","first-page":"2134","DOI":"10.1073\/pnas.70.7.2134","article-title":"The defect in the Hunter syndrome: deficiency of sulfoiduronate sulfatase","volume":"70","author":"Bach","year":"1973","journal-title":"Proc. Natl Acad. Sci. USA"},{"key":"10.1016\/j.ymgme.2011.02.018_bb0110","doi-asserted-by":"crossref","first-page":"828","DOI":"10.1136\/adc.57.11.828","article-title":"Mild form of Hunter's syndrome: clinical delineation based on 31 cases","volume":"57","author":"Young","year":"1982","journal-title":"Arch. Dis. Child."},{"key":"10.1016\/j.ymgme.2011.02.018_bb0115","doi-asserted-by":"crossref","first-page":"481","DOI":"10.1111\/j.1469-8749.1983.tb13794.x","article-title":"The natural history of the severe form of Hunter's syndrome: a study based on 52 cases","volume":"25","author":"Young","year":"1983","journal-title":"Dev. Med. Child Neurol."},{"key":"10.1016\/j.ymgme.2011.02.018_bb0120","doi-asserted-by":"crossref","first-page":"534","DOI":"10.1007\/s10545-009-1119-7","article-title":"Mortality and cause of death in mucopolysaccharidosis type II\u2014a historical review based on data from the Hunter Outcome Survey","volume":"32","author":"Jones","year":"2009","journal-title":"J. Inherit. Metab. Dis."},{"key":"10.1016\/j.ymgme.2011.02.018_bb0125","doi-asserted-by":"crossref","first-page":"267","DOI":"10.1007\/s00431-007-0635-4","article-title":"Mucopolysaccharidosis type II (Hunter syndrome): a clinical review and recommendations for treatment in the era of enzyme replacement therapy","volume":"167","author":"Wraith","year":"2008","journal-title":"Eur. J. Pediatr."},{"key":"10.1016\/j.ymgme.2011.02.018_bb0130","unstructured":"Elaprase\u00ae prescribing information HU-700 (10\/07), Shire HGT Inc. Cambridge, MA, USA."},{"key":"10.1016\/j.ymgme.2011.02.018_bb0135","doi-asserted-by":"crossref","first-page":"733","DOI":"10.1007\/s10545-008-0980-0","article-title":"Home treatment with Elaprase and Naglazyme is safe in patients with mucopolysaccharidoses types II and VI, respectively","volume":"31","author":"Bagewadi","year":"2008","journal-title":"J. Inherit. Metab. Dis."},{"key":"10.1016\/j.ymgme.2011.02.018_bb0140","doi-asserted-by":"crossref","first-page":"234","DOI":"10.1016\/j.ymgme.2009.04.007","article-title":"Home infusion therapy is safe and enhances compliance in patients with mucopolysaccharidoses","volume":"97","author":"Burton","year":"2009","journal-title":"Mol. Genet. Metab."},{"key":"10.1016\/j.ymgme.2011.02.018_bb0145","doi-asserted-by":"crossref","first-page":"508","DOI":"10.1097\/GIM.0b013e31817701e6","article-title":"Initial report from the Hunter Outcome Survey","volume":"10","author":"Wraith","year":"2008","journal-title":"Genet. Med."},{"key":"10.1016\/j.ymgme.2011.02.018_bb0150","series-title":"Guidance for Industry: Bioanalytical Methods Validation","author":"US FDA Center for Drug Evaluation and Research","year":"2001"},{"key":"10.1016\/j.ymgme.2011.02.018_bb0155","series-title":"ICH, Q2(R1): \u201cValidation of Analytical Procedures: Text and Methodology\u201d","year":"2005"},{"key":"10.1016\/j.ymgme.2011.02.018_bb0160","series-title":"EMEA. \u201cICH Topic Q2B: Validation of Analytical Procedures: Methodology (CPMP\/ICH\/281\/95), ICH Topic Q2B, Step 4 Consensus Guideline\u201d","year":"1996"},{"key":"10.1016\/j.ymgme.2011.02.018_bb0165","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/j.jim.2004.06.002","article-title":"Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products","volume":"289","author":"Mire-Sluis","year":"2004","journal-title":"J. Immunol. Meth."},{"key":"10.1016\/j.ymgme.2011.02.018_bb0170","doi-asserted-by":"crossref","first-page":"123","DOI":"10.1016\/j.ymgme.2010.06.011","article-title":"Home treatment with intravenous enzyme replacement therapy with idursulfase for mucopolysaccharidosis type II \u2014 data from the Hunter Outcome Survey","volume":"101","author":"Burton","year":"2010","journal-title":"Mol. Genet. Metab."},{"key":"10.1016\/j.ymgme.2011.02.018_bb0175","doi-asserted-by":"crossref","first-page":"e1228","DOI":"10.1542\/peds.2008-0999","article-title":"Multidisciplinary management of Hunter syndrome","volume":"124","author":"Muenzer","year":"2009","journal-title":"Pediatrics"}],"container-title":["Molecular Genetics and Metabolism"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1096719211000618?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1096719211000618?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2020,6,16]],"date-time":"2020-06-16T22:38:34Z","timestamp":1592347114000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1096719211000618"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2011,6]]},"references-count":35,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2011,6]]}},"alternative-id":["S1096719211000618"],"URL":"https:\/\/doi.org\/10.1016\/j.ymgme.2011.02.018","relation":{},"ISSN":["1096-7192"],"issn-type":[{"value":"1096-7192","type":"print"}],"subject":[],"published":{"date-parts":[[2011,6]]}}}