PT  - JOURNAL ARTICLE
AU  - Frank Behrens
AU  - Paul P Tak
AU  - Mikkel Østergaard
AU  - Rumen Stoilov
AU  - Piotr Wiland
AU  - Thomas W Huizinga
AU  - Vadym Y Berenfus
AU  - Stoyanka Vladeva
AU  - Juergen Rech
AU  - Andrea Rubbert-Roth
AU  - Mariusz Korkosz
AU  - Dmitriy Rekalov
AU  - Igor A Zupanets
AU  - Bo J Ejbjerg
AU  - Jens Geiseler
AU  - Julia Fresenius
AU  - Roman P Korolkiewicz
AU  - Arndt J Schottelius
AU  - Harald Burkhardt
TI  - 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
AID  - 10.1136/annrheumdis-2013-204816
DP  - 2015 Jun 01
TA  - Annals of the Rheumatic Diseases
PG  - 1058--1064
VI  - 74
IP  - 6
4099  - http://ard.bmj.com/content/74/6/1058.short
4100  - http://ard.bmj.com/content/74/6/1058.full
SO  - Ann Rheum Dis2015 Jun 01; 74
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