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Ann Rheum Dis. 2015 Jun;74(6):1058-64. doi: 10.1136/annrheumdis-2013-204816. Epub 2014 Feb 17.

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.

Author information

1
CIRI/Division of Rheumatology, Johann Wolfgang Goethe-University, Frankfurt am Main, Germany Department of Translational Medicine and Pharmacology, Fraunhofer Institute IME, Frankfurt am Main, Germany.
2
Academic Medical Center/University of Amsterdam, Amsterdam, The Netherlands GlaxoSmithKline, Stevenage, UK University of Cambridge, Cambridge, UK.
3
Copenhagen Center for Arthritis Research, Center for Rheumatology and Spinal Diseases, Copenhagen University Hospital Glostrup, Glostrup, Denmark.
4
University Hospital (MHAT) St Ivan Rilski, Sofia, Bulgaria.
5
Department of Rheumatology and Internal Medicine, Wroclaw Medical University, Wroclaw, Poland.
6
Department of Rheumatology, Leiden University Medic al Center, Leiden, The Netherlands.
7
Regional Clinical Hospital, Donetsk, Ukraine.
8
Second Internal Clinic UMHAT Stara Zagora, Stara Zagora, Bulgaria.
9
University of Erlangen-Nuremberg, Erlangen, Germany.
10
Med Clinic I, University of Cologne, Cologne, Germany.
11
Malopolskie Centrum Medyczne, Krakow, Poland.
12
Zaporizhzhia Regional Hospital, Zaporozhe, Ukraine.
13
National University of Pharmacy, Kharkiv, Ukraine.
14
Department of Rheumatology, Hospital at Slagelse, Slagelse, Denmark.
15
Asklepios Clinic Munich-Gauting, Gauting, Germany.
16
MorphoSys AG, Martinsried/Planegg, Germany.

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 1.5 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.

KEYWORDS:

DAS28; DMARDs (biologic); Rheumatoid Arthritis; Treatment

PMID:
24534756
PMCID:
PMC4431325
DOI:
10.1136/annrheumdis-2013-204816
[Indexed for MEDLINE]
Free PMC Article
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