<> <http://www.w3.org/2000/01/rdf-schema#comment> "The repository administrator has not yet configured an RDF license."^^<http://www.w3.org/2001/XMLSchema#string> .
<> <http://xmlns.com/foaf/0.1/primaryTopic> <https://discovery.ucl.ac.uk/id/eprint/10204836> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://www.w3.org/1999/02/22-rdf-syntax-ns#type> <http://purl.org/ontology/bibo/AcademicArticle> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://www.w3.org/1999/02/22-rdf-syntax-ns#type> <http://purl.org/ontology/bibo/Article> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/dc/terms/title> "A Phase 2 randomised trial of safety and pharmacokinetics of IgPro20 and IgPro10 in patients with diffuse cutaneous systemic sclerosis"^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/ontology/bibo/abstract> "OBJECTIVES: The primary objective was the safety of subcutaneous immunoglobulin, IgPro20 (Hizentra, CSL Behring) in adults with diffuse cutaneous systemic sclerosis (dcSSc). Secondary objectives included pharmacokinetics and relative bioavailability of IgPro20, and safety and pharmacokinetics of intravenous immunoglobulin, IgPro10 (Privigen, CSL Behring). METHODS: In this prospective, multicentre, randomised, open-label, crossover Phase 2 study (NCT04137224), patients (aged ≥18 years) with dcSSc were assigned to 16 weeks of IgPro20 (0.5 g/kg/week) followed by 16 weeks of IgPro10 (2 g/kg/4 weeks over 2–5 sessions), or vice-versa. Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), infusion site reactions (ISRs), clinical tests, pharmacokinetic and bioavailability were assessed. RESULTS: Twenty-seven patients were randomised from 9 October 2019–31 August 2021. In total, 22 patients (81.5%) experienced 107 TEAEs (IgPro20, 49; IgPro10, 58); most were mild/moderate. Six patients (22.2%) experienced ten SAEs (IgPro20, 6; IgPro10, 4); no treatment-related SAEs and no deaths were reported. IgPro20 ISR rate was low (2 per 100 infusions). Maximum immunoglobulin G concentration (mean [standard deviation]) was numerically lower following IgPro20 (23.7 [1.2] g/l) vs IgPro10 (46.1 [1.2] g/l), as was the geometric mean dose-normalised, baseline-corrected area under the concentration-time curve from time point 0 to tau (IgPro20, 44.8 [1.4] h*g/l; IgPro10, 60.2 [1.4] h*g/l). The bioavailability of IgPro20 relative to IgPro10 was 76.1%. CONCLUSION: This study shows that in patients with dcSSc, safety, pharmacokinetic and bioavailability profiles of IgPro20, and safety and pharmacokinetics of IgPro10, are similar to those observed in other approved indications."^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/dc/terms/date> "2025-02-05" .
<https://discovery.ucl.ac.uk/id/document/1828762> <http://www.w3.org/1999/02/22-rdf-syntax-ns#type> <http://purl.org/ontology/bibo/Document> .
<https://discovery.ucl.ac.uk/id/org/ext-daeb92daf570917684167066877da0ed> <http://www.w3.org/1999/02/22-rdf-syntax-ns#type> <http://xmlns.com/foaf/0.1/Organization> .
<https://discovery.ucl.ac.uk/id/org/ext-daeb92daf570917684167066877da0ed> <http://xmlns.com/foaf/0.1/name> "Oxford University Press (OUP)"^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/dc/terms/publisher> <https://discovery.ucl.ac.uk/id/org/ext-daeb92daf570917684167066877da0ed> .
<https://discovery.ucl.ac.uk/id/publication/ext-17e996020859af3dd68791c432d12c96> <http://www.w3.org/1999/02/22-rdf-syntax-ns#type> <http://purl.org/ontology/bibo/Collection> .
<https://discovery.ucl.ac.uk/id/publication/ext-17e996020859af3dd68791c432d12c96> <http://xmlns.com/foaf/0.1/name> "Rheumatology"^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/dc/terms/isPartOf> <https://discovery.ucl.ac.uk/id/publication/ext-17e996020859af3dd68791c432d12c96> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/ontology/bibo/status> <http://purl.org/ontology/bibo/status/forthcoming> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/dc/terms/creator> <https://discovery.ucl.ac.uk/id/person/ext-d5bb7445a34d48a2d508c55e26dabc9a> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/ontology/bibo/authorList> <https://discovery.ucl.ac.uk/id/eprint/10204836#authors> .
<https://discovery.ucl.ac.uk/id/eprint/10204836#authors> <http://www.w3.org/1999/02/22-rdf-syntax-ns#_1> <https://discovery.ucl.ac.uk/id/person/ext-d5bb7445a34d48a2d508c55e26dabc9a> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/dc/terms/creator> <https://discovery.ucl.ac.uk/id/person/ext-ed595569fd6941a6ea2a8bd6da8a08ac> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/ontology/bibo/authorList> <https://discovery.ucl.ac.uk/id/eprint/10204836#authors> .
<https://discovery.ucl.ac.uk/id/eprint/10204836#authors> <http://www.w3.org/1999/02/22-rdf-syntax-ns#_2> <https://discovery.ucl.ac.uk/id/person/ext-ed595569fd6941a6ea2a8bd6da8a08ac> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/dc/terms/creator> <https://discovery.ucl.ac.uk/id/person/ext-e5f0ef18ff8c1c6ec1239175cea641d5> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/ontology/bibo/authorList> <https://discovery.ucl.ac.uk/id/eprint/10204836#authors> .
<https://discovery.ucl.ac.uk/id/eprint/10204836#authors> <http://www.w3.org/1999/02/22-rdf-syntax-ns#_3> <https://discovery.ucl.ac.uk/id/person/ext-e5f0ef18ff8c1c6ec1239175cea641d5> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/dc/terms/creator> <https://discovery.ucl.ac.uk/id/person/ext-4a72798082c99e321b19664c8127ca16> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/ontology/bibo/authorList> <https://discovery.ucl.ac.uk/id/eprint/10204836#authors> .
<https://discovery.ucl.ac.uk/id/eprint/10204836#authors> <http://www.w3.org/1999/02/22-rdf-syntax-ns#_4> <https://discovery.ucl.ac.uk/id/person/ext-4a72798082c99e321b19664c8127ca16> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/dc/terms/creator> <https://discovery.ucl.ac.uk/id/person/ext-1b76949c673e43aa25ff41be7f5c3abc> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/ontology/bibo/authorList> <https://discovery.ucl.ac.uk/id/eprint/10204836#authors> .
<https://discovery.ucl.ac.uk/id/eprint/10204836#authors> <http://www.w3.org/1999/02/22-rdf-syntax-ns#_5> <https://discovery.ucl.ac.uk/id/person/ext-1b76949c673e43aa25ff41be7f5c3abc> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/dc/terms/creator> <https://discovery.ucl.ac.uk/id/person/ext-c72568f35e672f6ddefa76021d4fabf0> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/ontology/bibo/authorList> <https://discovery.ucl.ac.uk/id/eprint/10204836#authors> .
<https://discovery.ucl.ac.uk/id/eprint/10204836#authors> <http://www.w3.org/1999/02/22-rdf-syntax-ns#_6> <https://discovery.ucl.ac.uk/id/person/ext-c72568f35e672f6ddefa76021d4fabf0> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/dc/terms/creator> <https://discovery.ucl.ac.uk/id/person/ext-ee7a7d44046554301a08df6f7d600e01> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/ontology/bibo/authorList> <https://discovery.ucl.ac.uk/id/eprint/10204836#authors> .
<https://discovery.ucl.ac.uk/id/eprint/10204836#authors> <http://www.w3.org/1999/02/22-rdf-syntax-ns#_7> <https://discovery.ucl.ac.uk/id/person/ext-ee7a7d44046554301a08df6f7d600e01> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/dc/terms/creator> <https://discovery.ucl.ac.uk/id/person/ext-0bf5882037b11ba73b8f26bb593962c5> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/ontology/bibo/authorList> <https://discovery.ucl.ac.uk/id/eprint/10204836#authors> .
<https://discovery.ucl.ac.uk/id/eprint/10204836#authors> <http://www.w3.org/1999/02/22-rdf-syntax-ns#_8> <https://discovery.ucl.ac.uk/id/person/ext-0bf5882037b11ba73b8f26bb593962c5> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/dc/terms/creator> <https://discovery.ucl.ac.uk/id/person/ext-f0b853b91280ec418fcfea9797078c2d> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/ontology/bibo/authorList> <https://discovery.ucl.ac.uk/id/eprint/10204836#authors> .
<https://discovery.ucl.ac.uk/id/eprint/10204836#authors> <http://www.w3.org/1999/02/22-rdf-syntax-ns#_9> <https://discovery.ucl.ac.uk/id/person/ext-f0b853b91280ec418fcfea9797078c2d> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/dc/terms/creator> <https://discovery.ucl.ac.uk/id/person/ext-65749dc59099ba2331cbf982af786481> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/ontology/bibo/authorList> <https://discovery.ucl.ac.uk/id/eprint/10204836#authors> .
<https://discovery.ucl.ac.uk/id/eprint/10204836#authors> <http://www.w3.org/1999/02/22-rdf-syntax-ns#_10> <https://discovery.ucl.ac.uk/id/person/ext-65749dc59099ba2331cbf982af786481> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/dc/terms/creator> <https://discovery.ucl.ac.uk/id/person/ext-81006b96af7872bb3f4fdf97cbe5d030> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/ontology/bibo/authorList> <https://discovery.ucl.ac.uk/id/eprint/10204836#authors> .
<https://discovery.ucl.ac.uk/id/eprint/10204836#authors> <http://www.w3.org/1999/02/22-rdf-syntax-ns#_11> <https://discovery.ucl.ac.uk/id/person/ext-81006b96af7872bb3f4fdf97cbe5d030> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/dc/terms/creator> <https://discovery.ucl.ac.uk/id/person/ext-4b6378676d58e54659b1decabba7c8e9> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/ontology/bibo/authorList> <https://discovery.ucl.ac.uk/id/eprint/10204836#authors> .
<https://discovery.ucl.ac.uk/id/eprint/10204836#authors> <http://www.w3.org/1999/02/22-rdf-syntax-ns#_12> <https://discovery.ucl.ac.uk/id/person/ext-4b6378676d58e54659b1decabba7c8e9> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/dc/terms/creator> <https://discovery.ucl.ac.uk/id/person/ext-8f354c43d840448e5c6b8918b7576b4f> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/ontology/bibo/authorList> <https://discovery.ucl.ac.uk/id/eprint/10204836#authors> .
<https://discovery.ucl.ac.uk/id/eprint/10204836#authors> <http://www.w3.org/1999/02/22-rdf-syntax-ns#_13> <https://discovery.ucl.ac.uk/id/person/ext-8f354c43d840448e5c6b8918b7576b4f> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/dc/terms/creator> <https://discovery.ucl.ac.uk/id/person/ext-bc16a74e88af34240e475e4f8b07cede> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/ontology/bibo/authorList> <https://discovery.ucl.ac.uk/id/eprint/10204836#authors> .
<https://discovery.ucl.ac.uk/id/eprint/10204836#authors> <http://www.w3.org/1999/02/22-rdf-syntax-ns#_14> <https://discovery.ucl.ac.uk/id/person/ext-bc16a74e88af34240e475e4f8b07cede> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/dc/terms/creator> <https://discovery.ucl.ac.uk/id/person/ext-bdb5ddbf9069b6eaa52cbf2dafbe148e> .
<https://discovery.ucl.ac.uk/id/eprint/10204836> <http://purl.org/ontology/bibo/authorList> <https://discovery.ucl.ac.uk/id/eprint/10204836#authors> .
<https://discovery.ucl.ac.uk/id/eprint/10204836#authors> <http://www.w3.org/1999/02/22-rdf-syntax-ns#_15> <https://discovery.ucl.ac.uk/id/person/ext-bdb5ddbf9069b6eaa52cbf2dafbe148e> .
<https://discovery.ucl.ac.uk/id/person/ext-65749dc59099ba2331cbf982af786481> <http://www.w3.org/1999/02/22-rdf-syntax-ns#type> <http://xmlns.com/foaf/0.1/Person> .
<https://discovery.ucl.ac.uk/id/person/ext-65749dc59099ba2331cbf982af786481> <http://xmlns.com/foaf/0.1/givenName> "Adrian"^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/person/ext-65749dc59099ba2331cbf982af786481> <http://xmlns.com/foaf/0.1/familyName> "Panaite"^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/person/ext-65749dc59099ba2331cbf982af786481> <http://xmlns.com/foaf/0.1/name> "Adrian Panaite"^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/person/ext-f0b853b91280ec418fcfea9797078c2d> <http://www.w3.org/1999/02/22-rdf-syntax-ns#type> <http://xmlns.com/foaf/0.1/Person> .
<https://discovery.ucl.ac.uk/id/person/ext-f0b853b91280ec418fcfea9797078c2d> <http://xmlns.com/foaf/0.1/givenName> "Jeanine"^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/person/ext-f0b853b91280ec418fcfea9797078c2d> <http://xmlns.com/foaf/0.1/familyName> "Jochems"^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/person/ext-f0b853b91280ec418fcfea9797078c2d> <http://xmlns.com/foaf/0.1/name> "Jeanine Jochems"^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/person/ext-8f354c43d840448e5c6b8918b7576b4f> <http://www.w3.org/1999/02/22-rdf-syntax-ns#type> <http://xmlns.com/foaf/0.1/Person> .
<https://discovery.ucl.ac.uk/id/person/ext-8f354c43d840448e5c6b8918b7576b4f> <http://xmlns.com/foaf/0.1/givenName> "Yannick"^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/person/ext-8f354c43d840448e5c6b8918b7576b4f> <http://xmlns.com/foaf/0.1/familyName> "Allanore"^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/person/ext-8f354c43d840448e5c6b8918b7576b4f> <http://xmlns.com/foaf/0.1/name> "Yannick Allanore"^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/person/ext-0bf5882037b11ba73b8f26bb593962c5> <http://www.w3.org/1999/02/22-rdf-syntax-ns#type> <http://xmlns.com/foaf/0.1/Person> .
<https://discovery.ucl.ac.uk/id/person/ext-0bf5882037b11ba73b8f26bb593962c5> <http://xmlns.com/foaf/0.1/givenName> "Jana"^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/person/ext-0bf5882037b11ba73b8f26bb593962c5> <http://xmlns.com/foaf/0.1/familyName> "Radewonuk"^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/person/ext-0bf5882037b11ba73b8f26bb593962c5> <http://xmlns.com/foaf/0.1/name> "Jana Radewonuk"^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/person/ext-e5f0ef18ff8c1c6ec1239175cea641d5> <http://www.w3.org/1999/02/22-rdf-syntax-ns#type> <http://xmlns.com/foaf/0.1/Person> .
<https://discovery.ucl.ac.uk/id/person/ext-e5f0ef18ff8c1c6ec1239175cea641d5> <http://xmlns.com/foaf/0.1/givenName> "Susanna M"^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/person/ext-e5f0ef18ff8c1c6ec1239175cea641d5> <http://xmlns.com/foaf/0.1/familyName> "Proudman"^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/person/ext-e5f0ef18ff8c1c6ec1239175cea641d5> <http://xmlns.com/foaf/0.1/name> "Susanna M Proudman"^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/person/ext-ed595569fd6941a6ea2a8bd6da8a08ac> <http://www.w3.org/1999/02/22-rdf-syntax-ns#type> <http://xmlns.com/foaf/0.1/Person> .
<https://discovery.ucl.ac.uk/id/person/ext-ed595569fd6941a6ea2a8bd6da8a08ac> <http://xmlns.com/foaf/0.1/givenName> "Otylia"^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/person/ext-ed595569fd6941a6ea2a8bd6da8a08ac> <http://xmlns.com/foaf/0.1/familyName> "Kowal-Bielecka"^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/person/ext-ed595569fd6941a6ea2a8bd6da8a08ac> <http://xmlns.com/foaf/0.1/name> "Otylia Kowal-Bielecka"^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/person/ext-81006b96af7872bb3f4fdf97cbe5d030> <http://www.w3.org/1999/02/22-rdf-syntax-ns#type> <http://xmlns.com/foaf/0.1/Person> .
<https://discovery.ucl.ac.uk/id/person/ext-81006b96af7872bb3f4fdf97cbe5d030> <http://xmlns.com/foaf/0.1/givenName> "Amgad"^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/person/ext-81006b96af7872bb3f4fdf97cbe5d030> <http://xmlns.com/foaf/0.1/familyName> "Shebl"^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/person/ext-81006b96af7872bb3f4fdf97cbe5d030> <http://xmlns.com/foaf/0.1/name> "Amgad Shebl"^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/person/ext-1b76949c673e43aa25ff41be7f5c3abc> <http://www.w3.org/1999/02/22-rdf-syntax-ns#type> <http://xmlns.com/foaf/0.1/Person> .
<https://discovery.ucl.ac.uk/id/person/ext-1b76949c673e43aa25ff41be7f5c3abc> <http://xmlns.com/foaf/0.1/givenName> "Margitta"^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/person/ext-1b76949c673e43aa25ff41be7f5c3abc> <http://xmlns.com/foaf/0.1/familyName> "Worm"^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/person/ext-1b76949c673e43aa25ff41be7f5c3abc> <http://xmlns.com/foaf/0.1/name> "Margitta Worm"^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/person/ext-4a72798082c99e321b19664c8127ca16> <http://www.w3.org/1999/02/22-rdf-syntax-ns#type> <http://xmlns.com/foaf/0.1/Person> .
<https://discovery.ucl.ac.uk/id/person/ext-4a72798082c99e321b19664c8127ca16> <http://xmlns.com/foaf/0.1/givenName> "Marzena"^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/person/ext-4a72798082c99e321b19664c8127ca16> <http://xmlns.com/foaf/0.1/familyName> "Olesińska"^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/person/ext-4a72798082c99e321b19664c8127ca16> <http://xmlns.com/foaf/0.1/name> "Marzena Olesińska"^^<http://www.w3.org/2001/XMLSchema#string> .
<https://discovery.ucl.ac.uk/id/person/ext-ee7a7d44046554301a08df6f7d600e01> <http://www.w3.org/1999/02/22-rdf-syntax-ns#type> <http://xmlns.com/foaf/0.1/Person> .
<https://discovery.ucl.ac.uk/id/person/ext-ee7a7d44046554301a08df6f7d600e01> <http://xmlns.com/foaf/0.1/givenName> "Marco"^^<http://www.w3.org/2001/XMLSchema#string> .
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