Publikationen

Hier finden Sie Publikationen von GKM Mitarbeitern und zu Projekten, die die GKM durchgeführt oder unterstützt hat.

2019

→ Frank Behrens, Michaela Koehm, Eva C. Schwaneck, Marc Schmalzing, Holger Gnann, Gerd Greger, Hans-Peter Tony, Harald Burkhardt

Use of a “critical difference” statistical criterion improves the predictive utility of the Health Assessment Questionnaire-Disability Index score in patients with rheumatoid arthritis
BMC Part of Springer nature,
https://bmcrheumatol.biomedcentral.com/articles/10.1186/s41927-019-0095-2
Published Online December 10, 2019; DOI: 10.1186/s41927-019-0095-2

→ Traussnigg S., Schattenberg J.M., Demir M., Wiegand J., Geier A., Teuber G., Hofmann W.P., Kremer A.E., Spreda F, Kluwe J., Petersen J., Boettler T., Rainer F., Halilbasic E., Greinwald R., Pröls M., Manns MP., Fickert P., Trauner M., on behalf of the Austrian/German NAFLD-norUDCA study group

Norursodeoxycholic acid versus placebo in the treatment of non-alcoholic fatty liver disease: a double-blind,
randomised, placebo-controlled, phase 2 dose-finding trial
Lancet Gastroenterol Hepatol 2019
Published Online July 22, 2019; DOI: 10.1016/S2468-1253(19)30184-0

→ F. Behrens, M. Koehm, EC. Schwaneck, M. Schmalzing, BM. Wittig, H. Gnann, G. Greger, H-P. Tony & H Burkhardt (2019)

Addition or removal of concomitant methotrexate alters adalimumab effectiveness in rheumatoid arthritis but not psoriatic arthritis, Scandinavian Journal of Rheumatology,
first published online July 16.2019, DOI: 10.1080/03009742.2019.1600717

→ Augsburger M., Sarra G-M., Imesch P.

Treat and extend versus pro re nata regimens of ranibizumab and aflibercept in neovascular age-related macular degeneration: a comparative study
Graefe’s Archive for Clinical and Experimental Ophthalmology
First Online: 29 June 2019

→ Zanos P., Keyworth H., Georgiou P., Hambsch B., Otte D. M., Kitchen I., Zimmer A., Bailey A.

Chronic nicotine administration restores brain region specific upregulation of oxytocin receptor binding levels in a G72 mouse model of schizophrenia
European Journal of Neuroscience , January 2019

2018

Ancuța C., Petrariu L. A., Opriș Belinski D.
Activitatea fizică la pacienţii cu poliartrită reumatoidă trataţi cu adalimumab în practica clinică: Studiul PACE – rezultate locale România
ePoster Congresul Naţional de Reumatologie a XXV-a editie 12 Octombrie 2018 Poiana Brasov, Romania

Codreanu C , Ancuța C., Bojincă M., Opriș Belinski D.
Impactul tratamentului cu adalimumab: rezultate clinice, utilizarea resurselor de asistenţă medicală (inclusiv concedii medicale) la pacienții cu spondilita anchilozantă în practica clinică: studiul IDEA -rezultate locale România
e-Poster /prezentare Congresul Național De Reumatologie Ediția a XXV-a editie 12 Octombrie 2018 Poiana Brasov, Romania

Miehlke S., Aust D., Mihaly E., ArmerdingP., Böhm G., Bonderup O., Fernández-Bañares F., Kupcinskas J., Munck L., RehbehnK.-U., Nacak T., Greinwald R., and Münch A., on behalf of the BUG-1/LMC Study Group
Efficacy and Safety of Budesonide, vs Mesalazine or Placebo, as Induction Therapy for Lymphocytic Colitis.
Gastroenterology 2018 (available online 7 September 2018)

Dignass A., Schnabel R., Romatowski J., Pavlenko V., Dorofeyev A., Derova J., Jonaitis L., Dilger K., Nacak T. and Greinwald R.; the International SAT-25 Study Group
Efficacy and safety of a novel high-dose mesalazine tablet in mild to moderate active ulcerative colitis: a double-blind, multicentre, randomised trial
United European Gastroenterol J. 2018 Feb; 6(1):138-147

Behrens F., Koehm M., Schwaneck E. C., Schmalzing M., Gnann H., Greger G., Tony H.-P., Burkhardt H.
Minimal disease activity is a stable measure of therapeutic response in psoriatic arthritis patients receiving treatment with adalimumab. Rheumatology July 2018

2017

Berges R., Schremmer D., Limberg R. Avanafil for the treatment of erectile dysfunction in practice. Non-interventional study AVANTI. MMW Fortschr Med. 2017 Jun;159(Suppl 5):16-21. doi: 10.1007/s15006-017-9804-1, 2017

Patchev A., Lux H. SAE Reporting im Zeitalter der Digitalisierung. CRpro, Ausgabe 2, Mai 2017

Röthler A. Vigilanzsystem Experteninhalt, InnovationsLOTSE, www.medizintechnologie.de, 2017

Khobzey K., Liskova I., Szegedi A., Pavlovsky L., Lunder T., Kingo K., Miljković J., Péč J., Bohinc M., Hojnik M. Effectiveness of adalimumab in the treatment of scalp and nail affection in patients with moderate to severe plaque psoriasis in routine clinical practice. Acta Dermatovenerol Alp Pannonica Adriat. 26(1):11-14, 2017

Laux G., Barthel B., Hajak G., Lemke M., Volz H.-P. Pooled Analysis of Four Non-Interventional Studies: Effectiveness and Tolerability of the Antidepressant Agomelatine in Daily Practice. Adv Ther. 2017 Feb 18. doi: 10.1007/s12325-017-0485-z. [Epub ahead of print], 2017

Röthler A. Post Market Surveillance (PMS) Experteninhalt, InnovationsLOTSE, www.medizintechnologie.de, 2017

Röthler A. Post Market Clinical Follow-up (PMCF) Experteninhalt, InnovationsLOTSE, www.medizintechnologie.de, 2017

2016

Michetti P., Weinman J., Mrowietz U., Smolen J., Peyrin-Biroulet L., Louis E., Schremmer D., Tundia N., Nurwakagari P., Selenko-Gebauer N. Impact of Treatment-Related Beliefs on Medication Adherence in Immune-Mediated Inflammatory Diseases: Results of the Global ALIGN Study. Advances in Therapy, first published online: November 16, 2016, doi: 10.1007/s12325-016-0441-3, 2016

Scharbatke E. C., Behrens F., Schmalzing M., Koehm M., Greger G., Gnann H., Burkhardt H., Tony H.-P. Association of Improvement in Pain With Therapeutic Response as Determined by Individual Improvement Criteria in Patients With Rheumatoid Arthritis. Arthritis Care Res (Hoboken); 68(11):1607-1615, 2016

Losch F.-P., Holtkamp M., McMurray R., Lendemans D., Kockelmann E. Antikonvulsive Zusatztherapie mit Eslicarbazepinacetat – Ergebnisse der EPOS-Studie bei Erwachsenen in Deutschland. Nervenarzt (2016), doi:10.1007/s00115-016-0199-5, 2016

Patchev A., Röthler A., Schremmer D., Patchev S. Der „NIS-Lotse“: Antworten auf häufige Fragen bei der Planung einer nicht-interventionellen Studie. Pharmazeutische Medizin 02/16, 2016

Behrens F., Koehm M., Thac D., Gnann H., Greger G., Wittig B.M., Burkhardt H. Anti-citrullinated protein antibodies are linked to erosive disease in an observational study of patients with psoriatic arthritis. Rheumatology, first published online: June 21, 2016, doi: 10.1093/rheumatology/kew229, 2016

Ottiger C., Gygli N., Huber A.R., Fernandez-Tresguerres B., Pardo S., Petruschke T. Performance of a Blood Glucose Monitoring System in a Point-of-Care Setting. Journal of Diabetes Science and Technology. 2016 Mar 16. pii: 1932296816638854, 2016

Holtkamp M., McMurray R., Bagul M., Sousa R., Kockelmann E. Real-world data on eslicarbazepine acetate as add-on to antiepileptic monotherapy. Acta Neurol Scand; Article first published online: 24 FEB 2016, DOI: 10.1111/ane.12574, 2016

2015

Scholtz A.W., Ilgner J., Loader B., Pritschow B.W., Weisshaar G. Cinnarizine and dimenhydrinate in the treatment of vertigo in medical practice. Wien Klin Wochenschr; 2015 Dec 11. [Epub ahead of print], 2015

Volz H.-P., Escafit-Schülke M.-L. Effekte von Agomelatin bei depressiven Patienten im Praxisalltag – Ergebnisse der nicht interventionellen Studie VIVRE. Nervenheilkunde; 34: 809-817, 2015

Eisenhardt A., Schneider T., Scheithe K., Colling C., Heidenreich A., TRIPTOSIX-Studiengruppe. Lebensqualität von Patienten mit Prostatakarzinom unter Androgendeprivation mit GnRH-Analoga – Ergebnisse der nicht-interventionellen Studie TRIPTOSIX. Der Urologe; First online: 01 November 2015, doi:10.1007/s00120-015-3989-7, 2015

Patchev A., Otto A., Engler C., Obermeier M. AMNOG: Was bei der Endpunktwahl für Zulassungsstudien zu berücksichtigen ist. Pharmazeutische Medizin; 17(3): 134-139, 2015

Bedini J.L., Wallace J.F., Petruschke T., Pardo S. A Multicenter Performance Evaluation of a Blood Glucose Monitoring System in 21 Leading Hospitals in Spain. J Diabetes Sci Technol; pii: 1932296815598777 [Epub ahead of print] PubMed PMID: 26253142, 2015

Bedini J.L., Wallace J.F., Pardo S., Petruschke T. Performance Evaluation of Three Blood Glucose Monitoring Systems Using ISO 15197: 2013 Accuracy Criteria, Consensus and Surveillance Error Grid Analyses, and Insulin Dosing Error Modeling in a Hospital Setting. J Diabetes Sci Technol; pii: 1932296815609368 [Epub ahead of print] PubMed PMID: 26445813, 2015

Rothermel J., Scheithe K., Nazari N., Hauffa BP., Reniehr T. Adherence to Growth Hormone Treatment: Impact of Height, Age and Puberty. Poster presentation, European Society for Paediatric Endocrinology (ESPE) Congress 2015; Poster P3-936 Abstract 530; Barcelona, 1-3 October, 2015

Laux G., Barthel B., Hajak G., Lemke M., Volz H.P. Wirk- und Verträglichkeitsprofil des Antidepressivums Agomelatin in der täglichen Praxis. Gepoolte Analyse von vier nicht-interventionellen Studien. Psychopharmakotherapie; 22:136-47, 2015

Engler C., Michelson G. Talkingeyes® – an ISO certified telemedical eye examination network as an effective tool for data collection in clinical research. Poster presentation, European Society of Ophthalmology (SOE) Congress 2015, Vienna, 6-9 June 2015.

Feuchtenberger M., Kleinert S., Scharbatke E.C., Gnann H., Behrens F., Wittig B.M., Greger G., Tony H.P. The impact of prior biologic therapy on adalimumab response in patients with rheumatoid arthritis. Clin Exp Rheumatol; 33(3):321-9, 2015.

Merseburger A.S., Scheithe K., Colling C. How patients prefer to learn that they have cancer: Results of a survey on patients’ preference for communication in prostate cancer using the MPP-d (German version of the Measure of Patients’ Preferences). J Clin Oncol 33 (suppl; abstr e20591), 2015.

Thaci D., Behrens F., Greger G., Burkhardt H., Gnann H., Schopf R., Wittig B.M. Association between Skin and Joint Involvement in Patients with Psoriatic Arthritis Treated with Adalimumab: Analysis of Data from a German Non-Interventional Study. Dermatology. 2015;230(3):213-21.

Ziegler R., Eichholz R., Schulz B. Use of a Combined Blood-Glucose- and beta-Ketone-Measuring Device Improves Glycemic Control in Insulin-Treated Patients with Diabetes: The Gold Plus Study. Journal of Diabetes Science and Technology; 1-5, 2015.

2014

Miehlke S., Madisch A., Kupcinskas L., Petrauskas D., Bohm G., Marks H.J., Neumeyer M., Nathan T., Fernández-Banares F., Greinwald R., Mohrbacher R., Vieth M., Bonerdup O.K., and the BUC-60/COC Study Group. Budesonide Is More Effective Than Mesalazine or Placebo in Short-term Treatment of Collagenous Colitis. Gastroentreology; 146(5):1222-1230, 2014.

Patchev A., Rost M., Engler C., Obermeier M., Hautmann C. The impact of German benefit assessment on endpoint selection in clinical research and drug development in Germany – lessons (to be) learned. Poster presentation, 16. Jahreskongress für klinische Pharmakologie, Cologne, October 9 – 10, 2014.

Rost M. An introduction to value dossiers for early benefit assessment in Germany – Part 1: Processes and players. Regulatory Rapporteur; Volume 11, Issue 11: 25-27, 2014.

Rost M. An introduction to value dossiers for early benefit assessment in Germany – Part 2: Demonstration of additional benefit. Regulatory Rapporteur; Volume 11, Issue 12: 29-32, 2014.

Witt C., Jehn M.L., Omid N., Hanisch M., Liebers U., Ehrlich R., Krohn I., Schremmer D. Multicenter study on COPD out-patient healthcare in Germany (ORCAS). Poster presentation, European Respiratory Society Annual Congress Munich, German, September 6–10, 2014.

2013

Hefter H., Benecke R., Erbguth F., Jost W., Reichel G., Wissel J. An open-label cohort study of the improvement of quality of life and pain in de novo cervical dystonia patients after injections with 500 U botulinum toxin A (Dysport). BMJ Open; 3:e001853, doi:10.1136/bmjopen-2012-001853, 2013.

Laux G., Huttner N. Agomelatin in der Depressionsbehandlung über 12 Monate. Follow-up der VIVALDI-Studie. Psychopharmakotherapie; 20: 119-127, 2013.

Braun A., Gnann H., Saracbasi E., Grifka J., Kiltz U., Letschert K., Braun J. Optimizing the identification of patients with axial spondyloarthritis in primary care–the case for a two-step strategy combining the most relevant clinical items with HLA B27. Rheumatology (Oxford) 4;52(8):1418-24, 2013

Behrens F., Tony H.-P., Alten R., Kleinert S., Scharbatke E. C., Köhm M., Gnann H., Tams J., Greger G., Burkhardt H. Development and Validation of a New Disease Activity Score in 28 Joints–Based Treatment Response Criterion for Rheumatoid Arthritis. Arthritis Care & Research Volume 65, Issue 10, pages 1608-1616, 2013

2012

Beer A.M., Fey S., Zimmer M., Teske W., Schremmer D., Wiebelitz K.R. Wirksamkeit und Sicherheit eines homöopathischen Komplexpräparates bei chronischen Rückenschmerzen. Doppelblinde, randomisierte, placebokontrollierte, klinische Studie. MMW (154. Jg): 48-57, 2012.

Nemes L., Pollmann H., Becker T. Interim data on long-term efficacy, safety and tolerability of a plasma-derived factor VIII concentrate in 109 patients with severe haemophilia A. Haemophilia; 1-7, 2012.

Rieckmann P., Heidenreich F., Sailer M., Zettl U.K., Zessack N., Hartung H.P., Gold R. Treatment de-escalation after mitoxantrone therapy: results of a phase IV, multicentre, open-label, randomized study of subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis. Ther Adv Neurol Disord; 5(1):3-12, 2012.

Rost M. Design und Auswertung einer Medizinproduktstudie – nur die Variation einer Arzneimittelstudie? DZKF 3/4 – 2012.

2011

Bidlingmaier C., Kurnik K., Escuriola-Ettingshausen C., Jager R., Klamroth R., Male C., Marosi A., Nemes L., von Stackelberg A., Kreuz W. Immune tolerance induction with a factor VIII concentrate containing con Willebrand factor (Haemoctin SDH®) in 14 patients with severe haemophilia A. Haemophilia; 1-4, 2011.

Eisenbraun J., Scheer R., Kroz M, Schad F., Huber R. Quality of life in breast cancer patients during chemotherapy and concurrenct therapy with a mistletoe extract. Phytomedicine; 18:151-157, 2011.

Espinola-Klein C., Weisser G., Jagodzinski A., Savvidis S., Warnholtz A., Ostad M-A., Gori T., Munzel T. b-Blockers in Patients With Intermittent Claudication and Arterial Hypertension: Results From the Nebivolol or Metoprolol in Arterial Occlusive Disease Trial. Hypertension; 58:148-154, 2011.

Hahn A., Novotny M., Shotekov P.M., Cirek Z., Bognar-Steinberg I., Baumann W. Comparison of Cinnarazine/Dimenhydrinate Fixed Combination with the Respective Monotherapies for Vertigo of Various Origins. Clin Drug Investig; 31 (6): 371-383, 2011.

Hefter H., Kupsch A., Mungersdorf M., Paus S., Stenner A., Jost W., on behalf of the Dysport Cervical Dystonia Study Group. A botulinum toxin A treatment algorithm for de novo mangement of torticollis and laterocollis. BMJ Open; 1:e000196, doi:10.1136/bmjopen-2011-000196, 2011.

Herzog T., Lemmers H.P., Arlt G., Raakow R., Weimann A., Pascher A., Knoefel W. T., Hesse U., Scheithe K., Groll S., Uhl W. Treatment of postoperative ileus with choline citrate-results of a prospective, randomised, placebo-controlled, double-blind multicentre trial. Int J Colorectal Dis; 26:645-652, 2011.

Kleinert S., Tony H.P., Krause A., Feuchtenberger M., Wassenberg S., Richter C., Rother E., Spieler W., Gnann H., Wittig B.M. Impact of patient and disease characteristics on therapuetic success during adalimumab treatment of patients with rheumatoid arthritis: data from a German noninterventional observational study. Rheuma