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1. Real-World Effectiveness and Safety of SDZ ETN, an Etanercept Biosimilar, in Patients with Rheumatic Diseases: Final Results from Multi-Country COMPACT Study

Author

Schmalzing, Marc, Kellner, Herbert, Askari, Ayman, De Toro Santos, Javier, Vazquez Perez-Coleman, Julio Cesar, Foti, Rosario, Jeka, Sławomir, Haraoui, Boulos, Allanore, Yannick, Peichl, Peter, Oehri, Martin, Rahman, Masiur, Furlan, Fabricio, Romero, Elisa, Hachaichi, Sohaib, Both, Charlotte, Brueckmann, Ines, and Sheeran, Tom

Published
2024
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4. Methotrexate plus ustekinumab versus ustekinumab monotherapy in patients with active psoriatic arthritis (MUST): a randomised, multicentre, placebo-controlled, phase 3b, non-inferiority trial

Author

Alten, Rieke H.E., Benesova, Karolina, Bergner, Raoul, Braun, Jürgen, Demary, Winfried, Finzel, Stephanie, Kästner, Peter, Kleye, Arnd, Krüger, Klaus, Lorenz, Gabriele, Max, Regina, Poddubnyy, Denis, Rubbert-Roth, Andrea, Schwenke, Holger, Sieburg, Maren, Thaci, Diamant, Thiele, Astrid, Voll, Reinhard E., von Hinüber, Ulrich, Walter, Jochen, Wassenberg, Siegfried, Koehm, Michaela, Rossmanith, Tanja, Foldenauer, Ann C, Herrmann, Eva, Brandt-Jürgens, Jan, Burmester, Gerd R, Kellner, Herbert, Kiltz, Uta, Kofler, David M, Rech, Jürgen, Mojtahed-Poor, Sorwe, Jonetzko, Christin, Burkhardt, Harald, and Behrens, Frank

Published
2023
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5. Real-World Effectiveness and Safety of SDZ ETN, an Etanercept Biosimilar, in Patients with Rheumatic Diseases: Final Results from Multi-Country COMPACT Study

Author

Schmalzing, Marc, primary, Kellner, Herbert, additional, Askari, Ayman, additional, De Toro Santos, Javier, additional, Vazquez Perez-Coleman, Julio Cesar, additional, Foti, Rosario, additional, Jeka, Sławomir, additional, Haraoui, Boulos, additional, Allanore, Yannick, additional, Peichl, Peter, additional, Oehri, Martin, additional, Rahman, Masiur, additional, Furlan, Fabricio, additional, Romero, Elisa, additional, Hachaichi, Sohaib, additional, Both, Charlotte, additional, Brueckmann, Ines, additional, and Sheeran, Tom, additional

Published
2023
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10. Real-world effectiveness of golimumab in the treatment of patients with active rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis who failed initial TNF-α inhibitor therapy: a pooled analysis of European prospective observational studie

Author

Govoni, Marinella, primary, Batalov, Anastas, additional, Boumpas, Dimitrios T., additional, D’Angelo, Salvatore, additional, De Keyser, Filip, additional, Flipo, Rene-Marc, additional, Kellner, Herbert, additional, Leroi, Hermine, additional, and Khalifa, Ahmed, additional

Published
2023
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11. Real-world effectiveness and safety of SDZ ETN, an etanercept biosimilar, in patients with rheumatic diseases: final results from multi-country COMPACT study

Author

Schmalzing, Marc, Kellner, Herbert, Askari, Ayman, De-Toro, Javier, Vázquez Pérez-Coleman, Julio César, Foti, Rosario, Jeka, Slawomir, Haraoui, Boulos, Allanore, Yannick, Peichl, Peter, Oehri, Martin, Rahman, Masiur, Furlan, Fabricio, Romero, Elisa, Hachaichi, Sohaib, Both, Charlotte, Brueckmann, Ines, Sheeran, Tom, Schmalzing, Marc, Kellner, Herbert, Askari, Ayman, De-Toro, Javier, Vázquez Pérez-Coleman, Julio César, Foti, Rosario, Jeka, Slawomir, Haraoui, Boulos, Allanore, Yannick, Peichl, Peter, Oehri, Martin, Rahman, Masiur, Furlan, Fabricio, Romero, Elisa, Hachaichi, Sohaib, Both, Charlotte, Brueckmann, Ines, and Sheeran, Tom

Abstract

[Abstract] Introduction: COMPACT, a non-interventional study, evaluated the persistence, effectiveness, safety and patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA), axial-spondyloarthritis (axSpA) or psoriatic arthritis (PsA) treated with SDZ ETN (etanercept [ETN] biosimilar) in Europe and Canada. Methods: Patients (aged ≥ 18 years) who have been treated with SDZ ETN were categorised on the basis of prior treatment status (groups A-D): patients in clinical remission or with low disease activity under treatment with reference ETN or biosimilar ETN and switched to SDZ ETN; patients who received non-ETN targeted therapies and switched to SDZ ETN; biologic-naïve patients who started SDZ ETN after conventional therapy failure; or disease-modifying anti-rheumatic drug (DMARD)-naïve patients with RA considered suitable for treatment initiation with a biologic and started on treatment with SDZ ETN. The primary endpoint was drug persistence, defined as time from study enrolment until discontinuation of SDZ ETN treatment. Results: Of the 1466 patients recruited, 844 (57.6%) had RA, 334 (22.8%) had axSpA and 288 (19.6%) had PsA. Patients had an ongoing SDZ ETN treatment at the time of enrolment for an observed average of 138 days (range 1-841); 22.7% of patients discontinued SDZ ETN through 12 months of study observation. Overall, all the patients receiving SDZ ETN showed good treatment persistence at 12 months with discontinuation rates of 15.2%, 25.7% and 27.8% in groups A, B and C, respectively. Across all patient groups, no major differences were observed in the disease activity and PRO scores between baseline and month 12. Injection-site reactions were low across the treatment groups. Conclusion: These results support the effectiveness and safety of SDZ ETN treatment in patients with RA, axSpA or PsA in real-life conditions. The treatment persistence rates observed were consistent with previously published reports of patients treated with refere

Published
2023

12. Methotrexate plus ustekinumab versus ustekinumab monotherapy in patients with active psoriatic arthritis (MUST): a randomised, multicentre, placebo-controlled, phase 3b, non-inferiority trial

Author

Koehm, Michaela, primary, Rossmanith, Tanja, additional, Foldenauer, Ann C, additional, Herrmann, Eva, additional, Brandt-Jürgens, Jan, additional, Burmester, Gerd R, additional, Kellner, Herbert, additional, Kiltz, Uta, additional, Kofler, David M, additional, Rech, Jürgen, additional, Mojtahed-Poor, Sorwe, additional, Jonetzko, Christin, additional, Burkhardt, Harald, additional, Behrens, Frank, additional, Alten, Rieke H.E., additional, Benesova, Karolina, additional, Bergner, Raoul, additional, Braun, Jürgen, additional, Demary, Winfried, additional, Finzel, Stephanie, additional, Kästner, Peter, additional, Kleye, Arnd, additional, Krüger, Klaus, additional, Lorenz, Gabriele, additional, Max, Regina, additional, Poddubnyy, Denis, additional, Rubbert-Roth, Andrea, additional, Schwenke, Holger, additional, Sieburg, Maren, additional, Thaci, Diamant, additional, Thiele, Astrid, additional, Voll, Reinhard E., additional, von Hinüber, Ulrich, additional, Walter, Jochen, additional, and Wassenberg, Siegfried, additional

Published
2023
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13. Effectiveness of Different Rituximab Doses Combined with Leflunomide in the Treatment or Retreatment of Rheumatoid Arthritis: Part 2 of a Randomized, Placebo-Controlled, Investigator-Initiated Clinical Trial (AMARA)

Author

Koehm, Michaela, primary, Foldenauer, Ann C., additional, Rossmanith, Tanja, additional, Alten, Rieke, additional, Aringer, Martin, additional, Backhaus, Marina, additional, Burmester, Gerd R., additional, Feist, Eugen, additional, Kellner, Herbert, additional, Krueger, Klaus, additional, Müller-Ladner, Ulf, additional, Rubbert-Roth, Andrea, additional, Tony, Hans-Peter, additional, Wassenberg, Siegfried, additional, Burkhardt, Harald, additional, and Behrens, Frank, additional

Published
2022
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15. Evaluation of patient’s characteristics associated with severity of morning stiffness in patients with ankylosing spondylitis: Results from the German cohort of the real world evidence study 'INVISIBLE'

Author

Brandt-Jürgens, Jan, Baerlecken, Niklas, Kill, Angela, and Kellner, Herbert

Subjects
Medicine and health
Abstract

Introduction: Morning stiffness is found in appr. 75% of patients with Ankylosing Spondylitis (AS) and has a major impact on patient’s quality of life [ref:1], [ref:2]. There are limited data on patient’s characteristics associated with morning stiffness in AS [for full text, please go to the a.m. URL]

Published
2022
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16. Add-on or withdrawal of methotrexate do not impact efficacy of IL12/23 inhibition in active PsA: Data from the multicenter investigator-initiated randomized placebo-controlled MUST trial

Author

Köhm, Michaela, Rossmanith, Tanja, Foldenauer, Ann Christina, Kellner, Herbert, Kiltz, Uta, Rech, Jürgen, Burmester, Gerd-Rüdiger, Kofler, David, Brandt-Jürgens, Jan, Braun, Jürgen, Finzel, Stephanie, Bergner, Raoul, Sieburg, Maren, Kästner, Peter, Jonetzko, Christin, Burkhardt, Harald, and Behrens, Frank

Subjects
Medicine and health
Abstract

Introduction: Methotrexate (MTX) is used as first-line DMARD-therapy in active psoriatic arthritis (PsA) according to local guidelines, but its value for a combination therapy with bDMARDs has remained unclear to date. Here we report the results of an investigator-initiated, randomized, placebo-controlled [for full text, please go to the a.m. URL]

Published
2022
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20. Characterisation of depressive symptoms in rheumatoid arthritis patients treated with tocilizumab during routine daily care

Author

Behrens, Frank, primary, Burmester, Gerd-Rüdiger, additional, Feuchtenberger, Martin, additional, Kellner, Herbert, additional, Kuehne, Cornelia, additional, Liebhaber, Anke, additional, Wassenberg, Siegfried, additional, Gerlach, Johannes, additional, Zortel, Max, additional, Hofmann, Michael W., additional, and Amberger, Christopher, additional

Published
2022
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21. Muscle Ultrasound

Author

Reimers, Carl D., Kellner, Herbert, Fleckenstein, James L., editor, Crues, John V., III, editor, and Reimers, Carl D., editor

Published
1996
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22. German guidelines for the sequential medical treatment of rheumatoid arthritis with traditional and biologic disease-modifying antirheumatic drugs

Author

Albrecht, Katinka, Krüger, Klaus, Wollenhaupt, Jürgen, Alten, Rieke, Backhaus, Marina, Baerwald, Christoph, Bolten, Wolfgang, Braun, Jürgen, Burkhardt, Harald, Burmester, Gerd R., Gaubitz, Markus, Gause, Angela, Gromnica-Ihle, Erika, Kellner, Herbert, Kuipers, Jens, Krause, Andreas, Lorenz, Hans-Martin, Manger, Bernhard, Nüßlein, Hubert, Pott, Hans-Georg, Rubbert-Roth, Andrea, Schneider, Matthias, Specker, Christof, Schulze-Koops, Hendrik, Tony, Hans-Peter, Wassenberg, Siegfried, and Müller-Ladner, Ulf

Published
2014
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33. The Sensitivity to Change of the ASAS Health Index in an Observational Real-Life Cohort Study

Author

Regierer, Anne C., Weiß, Anja, Kiltz, Uta, Sieper, Joachim, Schwarze, Ilka, Bohl-Bu¨hler, Martin, Kellner, Herbert, Poddubnyy, Denis, Zink, Angela, Braun, Ju¨rgen, Listing, Joachim, and Strangfeld, Anja

Abstract

ObjectiveThe Assessment of Spondyloarthritis international Society Health Index (ASAS HI) measures global functioning and health in patients with axial spondyloarthritis (axSpA) covering domains of physical, emotional, and social functioning. The main aim of this study was to investigate the sensitivity to change of ASAS HI in comparison with established variables of disease activity, function, and mental health.MethodsPatients with axSpA from the disease register RABBIT-SpA with follow-up time of at least 12 months and available ASAS HI questionnaires were included. Patients received questionnaires addressing disease activity (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI], Ankylosing Spondylitis Disease Activity Score [ASDAS]), physical function (Bath Ankylosing Spondylitis Functional Index [BASFI]), mental health (5-item World Health Organization Well-Being Index [WHO-5]), and global functioning (ASAS HI). Standardized response means (SRMs) were calculated to compare the sensitivity to change of different variables.ResultsSix hundred and sixty-seven patients were included, 552 treated with biologic disease-modifying antirheumatic drugs (bDMARDs) and 115 with conventional synthetic DMARDs and/or nonsteroidal antiinflammatory drugs (control group). Between baseline and month 12, the mean ASAS HI declined from 6.9 to 5.1 in the bDMARD group and from 5.9 to 5.6 in the conventionally treated group. In the bDMARD group, the SRM of ASAS HI was 0.52, compared to 0.59 for BASFI, 0.65 for WHO-5, 0.73 for BASDAI, and 0.90 for ASDAS. The following ASAS HI domains were most frequently affected: pain (78% agreed), maintaining body position (75%), and energy/drive (73%). In the patients receiving bDMARDs, there was an improvement in all items. In the control group, the largest improvement was seen in pain.ConclusionAs expected, ASDAS and BASDAI as disease activity scores showed high sensitivity to change, whereas changes in physical function (BASFI), mental health (WHO-5), and the broader concept of functioning and health (ASAS HI) were moderate.

Published
2023
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34. ICHIBAN, a non-interventional study evaluating tocilizumab long-term effectiveness and safety in patients with active rheumatoid arthritis

Author

Specker, Christof, primary, Alberding, Annette, additional, Aringer, Martin, additional, Burmester, Gerd-Rüdiger, additional, Flacke, Jan-Paul, additional, Hofmann, Michael W., additional, Kästner, Peter, additional, Kellner, Herbert, additional, Moosig, Frank, additional, Sieburg, Maren, additional, Tony, Hans-Peter, additional, and Fliedner, Gerhard, additional

Published
2021
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36. Rituximab plus leflunomide in rheumatoid arthritis: a randomized, placebo-controlled, investigator-initiated clinical trial (AMARA study)

Author

Behrens, Frank, primary, Koehm, Michaela, additional, Rossmanith, Tanja, additional, Alten, Rieke, additional, Aringer, Martin, additional, Backhaus, Marina, additional, Burmester, Gerd R, additional, Feist, Eugen, additional, Herrmann, Eva, additional, Kellner, Herbert, additional, Krueger, Klaus, additional, Lehn, Annette, additional, Müller-Ladner, Ulf, additional, Rubbert-Roth, Andrea, additional, Tony, Hans-Peter, additional, Wassenberg, Siegfried, additional, and Burkhardt, Harald, additional

Published
2021
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37. Use of a self-injection assessment questionnaire to assess patient satisfaction with a self-injection device in rheumatoid arthritis patients receiving SDZ-ETN (GP2015) in Germany: An interim analysis of the real-world COMPACT study

Author

Schmalzing, Marc, Zinke, Silke, Schnorfeil, Michael, Hachaichi, Sohaib, Gerencser, Vivien, and Kellner, Herbert

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Introduction: The interim analysis of the COMPACT study assessed patient usage behaviour and feelings of self-administered injection with a self-injection device (SD) using the validated Self-Injection Assessment Questionnaire1 (SIAQ) in patients with rheumatoid arthritis (RA) receiving the approved[for full text, please go to the a.m. URL], Deutscher Rheumatologiekongress 2020, 48. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh), 34. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh)

Published
2020

46. Spontanes Auftreten von ventrikulären Tachykardien bei Spondylitis ankylosans

Author

Kellner, Herbert

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Vorgeschichte: Der 60-jährige Patient stellte sich erstmals 2008 zur rheumatologischen Weiterbetreuung vor. Seit 1982 war eine Spondylitis ankylosans bekannt. Zu diesem Zeitpunkt erfolgten nur Therapien mit NSAR (zuletzt Indometacin). Von 8/2008 - 5/2017 wurde der Patient mit verschiedenen[zum vollständigen Text gelangen Sie über die oben angegebene URL], 47. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh), 33. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh), 29. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Published
2019
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47. Ungeklärte Belastungsdyspnoe bei einem sportlich aktiven Bechterew-Patienten

Author

Kellner, Herbert

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Vorgeschichte: Bei dem 42-jährigen, HLA-B27 positiven Patienten wurde 2002 eine Spondylitis ankylosans diagnostiziert und zunächst mit NSAR und Coxiben behandelt. Ab 2004 erfolgten verschiedene TNF-Ak Therapien (Infliximab, Adalimumab). Seit 8/2017 wurde der Patient auf Biosimilar Etanercept[zum vollständigen Text gelangen Sie über die oben angegebene URL], 47. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh), 33. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh), 29. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Published
2019

48. In the real world clinical setting Etanercept Biosimilar SB4 (Benepali) demonstrates equivalent safety and effectiveness in biologic naive as well as with Enbrel, pretreated patients with RA, SpA or PsA

Author

Kellner, Herbert

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Background: Biosimilar TNFα inhibitors have only become available in the last few years. Etanercept biosimilar (SB4-Benepali®) has been laucheed in March 2016 in Germany. Although controlled studies have shown equivalent efficacy and safety compared to the originator, so far only limited [for full text, please go to the a.m. URL], 47. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh), 33. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh), 29. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Published
2019

49. Einfluss der Kombinationstherapie von Rituximab und Lefluonmid auf Patient-Reported Outcomes und Funktion in Patienten mit Rheumatoider Arthritis: Ergebnisse einer multizentrischen, randomisierten, Placebo-kontrollierten Investigator initiierten Studie (AMARA-Study)

Author

Köhm, Michaela, Rossmanith, Tanja, Dauth, Stephanie, Alten, Rieke H.-E., Aringer, Martin, Backhaus, Marina, Burmester, Gerd-Rüdiger, Feist, Eugen, Kellner, Herbert, Krüger, Klaus, Müller-Ladner, Ulf, Rubbert-Roth, Andrea, Tony, Hans-Peter, Wassenberg, Siegfried, Burkhardt, Harald Louis, and Behrens, Frank

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Einleitung: Biologikatherapien wie Rituximab (RTX) stellen eine wirksame Therapieoption in der Behandlung der Rheumatoiden Arthritis (RA) dar. Zumeist sind hier ausschließlich Kombinationstherapien mit Methotrexat (MTX) zugelassen, obwohl bei Kontraindikationen oder Unverträglichkeiten andere[zum vollständigen Text gelangen Sie über die oben angegebene URL], 46. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh), 32. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh), Wissenschaftliche Herbsttagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Published
2019

50. Retrospektiver Vergleich der Wirksamkeit und Verträglichkeit von Remicade mit dem Biosimilar Infliximab Inflectra über ein Beobachtungsintervall von 30 Monaten

Author

Vogel, Lukas and Kellner, Herbert

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Einleitung: Seit Februar 2015 stehen Biosimilar zur Behandlung chronisch- entzündlicher Erkrankungen zur Verfügung. Ziel der Untersuchung war es, das Referenzprodukt Remicade mit dem Biosimilar Inflectra hinsichtlich seiner Wirksamkeit und Verträglichkeit in einer retrospektiven Unterschung[zum vollständigen Text gelangen Sie über die oben angegebene URL], 46. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh), 32. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh), Wissenschaftliche Herbsttagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

Published
2019

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