Asklepios Clinic Munich Gauting

München, Germany

Asklepios Clinic Munich Gauting

München, Germany

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Behrens F.,Goethe University Frankfurt | Behrens F.,Fraunhofer Institute for Molecular Biology and Applied Ecology | Tak P.P.,University of Amsterdam | Tak P.P.,Glaxosmithkline | And 19 more authors.
Annals of the Rheumatic Diseases | Year: 2015

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. © 2015, BMJ Publishing Group. All rights reserved.


Behrens F.,Goethe University Frankfurt | Behrens F.,Fraunhofer Institute for Molecular Biology and Applied Ecology | Tak P.P.,Glaxosmithkline | Ostergaard M.,Copenhagen University | And 16 more authors.
Annals of the Rheumatic Diseases | Year: 2014

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. © 2014 BMJ Publishing Group Ltd & European League Against Rheumatism.


PubMed | National University of Pharmacy, Copenhagen University, Leiden University, MorphoSys and 12 more.
Type: Clinical Trial, Phase I | Journal: Annals of the rheumatic diseases | Year: 2015

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).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.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.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.NCT01023256.


Kuehnl A.,Ludwig Maximilians University of Munich | Kuehnl A.,TU Munich | Lindner M.,Asklepios Clinic Munich Gauting | Hornung H.-M.,Ludwig Maximilians University of Munich | And 4 more authors.
World Journal of Surgery | Year: 2010

Background: The purpose of this study was to examine our results of combined resection of the atrium and nonsmall- cell lung cancer using a concurrent and continuously updated database. Methods: A total of 35 patients underwent extended pulmonary resection with partial resection of the atrium. The main focus of the study was to define subgroups of patients who can potentially benefit from surgery. Results: Pneumonectomy was performed in 31 cases, and the other 4 patients underwent a lesser resection. Postoperative morbidity was 20%, and the mortality rate was 9%. The median intensive care unit stay was 2 days and the hospital stay 13 days. The survival rates were 80% at 1 year, 21% at 3 years, and 16% at 5 years. The median survival of patients with low-grade tumors (G1/2) was 27 months, contrasted by only 15 months' survival for patients with high-grade tumors (P = 0.026). Multivariate analysis indicated that completeness of resection had a significant impact on survival (P = 0.042). Conclusions: Combined resection of lung and atrium is a complex surgical procedure, but it can be performed with fair morbidity and mortality rates, even in patients with an increased number of preoperative risk factors. Patients suffering from low-grade tumors benefit significantly from radical surgery. Future studies must define whether a multimodal therapeutic approach that includes induction therapy can prolong patient survival. © Société Internationale de Chirurgie 2010.

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