Universität zu Köln

Behrens, Frank, Tak, Paul P., Ostergaard, Mikkel, Stoilov, Rumen, Wiland, Piotr, Huizinga, Thomas W., Berenfus, Vadym Y., Vladeva, Stoyanka ORCID: 0000-0001-6457-5178, Rech, Juergen, Rubbert-Roth, Andrea, Korkosz, Mariusz, Rekalov, Dmitriy, Zupanets, Igor A., Ejbjerg, Bo J., Geiseler, Jens, Fresenius, Julia, Korolkiewicz, Roman P., Schottelius, Arndt J. and Burkhardt, Harald (2015). 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. Ann. Rheum. Dis., 74 (6). S. 1058 - 1065. LONDON: BMJ PUBLISHING GROUP. ISSN 1468-2060

Full text not available from this repository.

Abstract

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 1.5mg/kg) once a week for 4weeks, with follow-up to 16weeks. 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 1.5mg/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 0.3mg/kg subject. Both patients recovered fully. In exploratory efficacy analyses, subjects in the MOR103 1.0 and 1.5mg/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 1.0mg/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. Trial registration number NCT01023256

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Behrens, Frank UNSPECIFIED UNSPECIFIED UNSPECIFIED Tak, Paul P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ostergaard, Mikkel UNSPECIFIED UNSPECIFIED UNSPECIFIED Stoilov, Rumen UNSPECIFIED UNSPECIFIED UNSPECIFIED Wiland, Piotr UNSPECIFIED UNSPECIFIED UNSPECIFIED Huizinga, Thomas W. UNSPECIFIED UNSPECIFIED UNSPECIFIED Berenfus, Vadym Y. UNSPECIFIED UNSPECIFIED UNSPECIFIED Vladeva, Stoyanka UNSPECIFIED orcid.org/0000-0001-6457-5178 UNSPECIFIED Rech, Juergen UNSPECIFIED UNSPECIFIED UNSPECIFIED Rubbert-Roth, Andrea UNSPECIFIED UNSPECIFIED UNSPECIFIED Korkosz, Mariusz UNSPECIFIED UNSPECIFIED UNSPECIFIED Rekalov, Dmitriy UNSPECIFIED UNSPECIFIED UNSPECIFIED Zupanets, Igor A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ejbjerg, Bo J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Geiseler, Jens UNSPECIFIED UNSPECIFIED UNSPECIFIED Fresenius, Julia UNSPECIFIED UNSPECIFIED UNSPECIFIED Korolkiewicz, Roman P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schottelius, Arndt J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Burkhardt, Harald UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-402975
DOI:	10.1136/annrheumdis-2013-204816
Journal or Publication Title:	Ann. Rheum. Dis.
Volume:	74
Number:	6
Page Range:	S. 1058 - 1065
Date:	2015
Publisher:	BMJ PUBLISHING GROUP
Place of Publication:	LONDON
ISSN:	1468-2060
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language PULMONARY ALVEOLAR PROTEINOSIS; COLLEGE-OF-RHEUMATOLOGY; NECROSIS-FACTOR-ALPHA; GM-CSF; INFLAMMATORY ARTHRITIS; FLARE-UP; DISEASE; VALIDATION; AUTOIMMUNITY; MAVRILIMUMAB Multiple languages Rheumatology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/40297