MOR103, a human monoclonal antibody to granulocyte–macrophage colony-stimulating factor, in the treatment of patients with moderate rheumatoid arthritis: results of a phase Ib/IIa randomised, double-blind, placebo-controlled, dose-escalation trial

doi:10.1136/annrheumdis-2013-204816

MOR103, a human monoclonal antibody to granulocyte–macrophage colony-stimulating factor, in the treatment of patients with moderate rheumatoid arthritis: results of a phase Ib/IIa randomised, double-blind, placebo-controlled, dose-escalation trial

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MOR103, a human monoclonal antibody to granulocyte–macrophage colony-stimulating factor, in the treatment of patients with moderate rheumatoid arthritis: results of a phase Ib/IIa randomised, double-blind, placebo-controlled, dose-escalation trial

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dc.contributor.author	Behrens, Frank	pl
dc.contributor.author	Tak, Paul P	pl
dc.contributor.author	Østergaard, Mikkel	pl
dc.contributor.author	Stoilov, Rumen	pl
dc.contributor.author	Wiland, Piotr	pl
dc.contributor.author	Huizinga, Thomas W	pl
dc.contributor.author	Berenfus, Vadym Y	pl
dc.contributor.author	Vladeva, Stoyanka	pl
dc.contributor.author	Rech, Juergen	pl
dc.contributor.author	Rubbert-Roth, Andrea	pl
dc.contributor.author	Korkosz, Mariusz [SAP20001201]	pl
dc.contributor.author	Rekalov, Dmitriy	pl
dc.contributor.author	Zupanets, Igor A	pl
dc.contributor.author	Ejbjerg, Bo J	pl
dc.contributor.author	Geiseler, Jens	pl
dc.contributor.author	Fresenius, Julia	pl
dc.contributor.author	Korolkiewicz, Roman P	pl
dc.contributor.author	Schottelius, Arndt J	pl
dc.contributor.author	Burkhardt, Harald	pl
dc.date.accessioned	2020-04-03T12:05:07Z
dc.date.available	2020-04-03T12:05:07Z
dc.date.issued	2015	pl
dc.identifier.issn	0003-4967	pl
dc.identifier.uri	https://ruj.uj.edu.pl/xmlui/handle/item/153155
dc.language	eng	pl
dc.rights	Udzielam licencji. Uznanie autorstwa - Użycie niekomercyjne 3.0 Polska	*
dc.rights.uri	http://creativecommons.org/licenses/by-nc/3.0/pl/legalcode	*
dc.title	MOR103, a human monoclonal antibody to granulocyte–macrophage colony-stimulating factor, in the treatment of patients with moderate rheumatoid arthritis: results of a phase Ib/IIa randomised, double-blind, placebo-controlled, dose-escalation trial	pl
dc.type	JournalArticle	pl
dc.description.physical	1058-1064	pl
dc.description.additional	Bibliogr. s. 1064	pl
dc.abstract.en	Objectives To determine the safety, tolerability and signs of efficacy of MOR103, a human monoclonal antibody to granulocyte–macrophage colony-stimulating factor (GM-CSF), in patients with rheumatoid arthritis (RA). Methods Patients with active, moderate RA were enrolled in a randomised, multicentre, double-blind, placebo-controlled, dose-escalation trial of intravenous MOR103 (0.3, 1.0 or 1.5 mg/kg) once a week for 4 weeks, with follow-up to 16 weeks. The primary outcome was safety. Results Of the 96 randomised and treated subjects, 85 completed the trial (n=27, 24, 22 and 23 for pooled placebo and MOR103 0.3, 1.0 and 1.5 mg/kg, respectively). Treatment emergent adverse events (AEs) in the MOR103 groups were mild or moderate in intensity and generally reported at frequencies similar to those in the placebo group. The most common AE was nasopharyngitis. In two cases, AEs were classified as serious because of hospitalisation: paronychia in a placebo subject and pleurisy in a MOR103 0.3 mg/kg subject. Both patients recovered fully. In exploratory efficacy analyses, subjects in the MOR103 1.0 and 1.5 mg/kg groups showed significant improvements in Disease Activity Score-28 scores and joint counts and significantly higher European League Against Rheumatism response rates than subjects receiving placebo. MOR103 1.0 mg/kg was associated with the largest reductions in disease activity parameters. Conclusions MOR103 was well tolerated and showed preliminary evidence of efficacy in patients with active RA. The data support further investigation of this monoclonal antibody to GM-CSF in RA patients and potentially in those with other immune-mediated inflammatory diseases.	pl
dc.description.volume	74	pl
dc.description.number	6	pl
dc.description.publication	1,05	pl
dc.identifier.doi	10.1136/annrheumdis-2013-204816	pl
dc.identifier.eissn	1468-2060	pl
dc.title.journal	Annals of the Rheumatic Diseases	pl
dc.language.container	eng	pl
dc.subtype	Article	pl
dc.rights.original	CC-BY-NC; otwarte czasopismo; ostateczna wersja wydawcy; w momencie opublikowania; 0	pl
dc.identifier.project	ROD UJ / OP	pl
.pointsMNiSW	[2015 A]: 45