RT Journal Article
SR Electronic
T1 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
JF Annals of the Rheumatic Diseases
JO Ann Rheum Dis
FD BMJ Publishing Group Ltd and European League Against Rheumatism
SP 1058
OP 1064
DO 10.1136/annrheumdis-2013-204816
VO 74
IS 6
A1 Frank Behrens
A1 Paul P Tak
A1 Mikkel Østergaard
A1 Rumen Stoilov
A1 Piotr Wiland
A1 Thomas W Huizinga
A1 Vadym Y Berenfus
A1 Stoyanka Vladeva
A1 Juergen Rech
A1 Andrea Rubbert-Roth
A1 Mariusz Korkosz
A1 Dmitriy Rekalov
A1 Igor A Zupanets
A1 Bo J Ejbjerg
A1 Jens Geiseler
A1 Julia Fresenius
A1 Roman P Korolkiewicz
A1 Arndt J Schottelius
A1 Harald Burkhardt
YR 2015
UL http://ard.bmj.com/content/74/6/1058.abstract
AB 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.Trial registration number NCT01023256