Abstracts tagged "Adalimumab"

Abstract Number: 3009 • 2016 ACR/ARHP Annual Meeting
Safety and Effectiveness of Adalimumab±Methotrexate for the Treatment of Polyarticular Juvenile Idiopathic Arthritis
Daniel J Lovell¹, Nicola Ruperto², Carol Wallace¹, Mary Toth¹, Ivan Foeldvari², John Bohnsack¹, Diana Milojevic¹, C. Egla Rabinovich¹, Daniel Kingsbury¹, Katherine Marzan¹, Pierre Quartier³, Kirsten Minden², Elizabeth Chalom¹, Gerd Horneff², Rolf M. Kuester², Jason Dare¹, Miriam Heinrich⁴, Hartmut Kupper⁴, Jasmina Kalabic⁴, Hermine I. Brunner¹, Alberto Martini² and on behalf of PRINTO and PRCSG, ¹PRCSG, Cincinnati, OH, ²PRINTO-IRCCS, Genova, Italy, ³Hopital Necker-Enfants Malades, Paris, France, ⁴AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany
Background/Purpose: Juvenile Idiopathic Arthritis (JIA) is the most common chronic inflammatory rheumatic diseases of childhood. Due to their long-term safety and efficacy, biologic disease modifying…
Abstract Number: 605 • 2016 ACR/ARHP Annual Meeting
Assessment of Comparative Immunogenicity in Biosimilar Development: Immunogenicity and Pharmacokinetics Following a Single Dose of M923, a Proposed Biosimilar for Reference Adalimumab (HUMIRA®), Compared with US- and EU-Sourced Reference Adalimumab in Healthy Subjects
Jan Hillson¹, Tim Mant², Tanmoy Ganguly³, William Avery³, Molly Rosano³, Carolyn Huntenburg³, Donna Palmer⁴, Siddesh Darne⁴, Borislava Pavlova⁴, Jennifer Doralt⁴, Russell Reeve⁵, Niti Goel⁵, Doris Weilert⁵, Paul Rhyne⁶, John Caminis⁴ and James Roach³, ¹Clinical Research, Momenta Pharmaceuticals, Inc., Cambridge, MA, ²Quintiles Drug Research Unit at Guy's Hospital, London, London, United Kingdom, ³Momenta Pharmaceuticals, Inc., Cambridge, MA, ⁴Shire, Cambridge, MA, ⁵Quintiles, Inc., Durham, NC, ⁶Q2 Solutions, Marietta, GA
Background/Purpose: 324 healthy volunteers were randomized 1:1:1 to receive a single 40 mg dose of M923, US-sourced reference adalimumab, or EU-sourced reference adalimumab by subcutaneous…
Abstract Number: 1735 • 2016 ACR/ARHP Annual Meeting
Canadian Humira Post-Marketing Observational Epidemiological Study Assessing Effectiveness in Psoriatic Arthritis (Complete-PsA): Interim Analysis
Majed Khraishi¹, Boulos Haraoui², Louis Bessette^3,4, Yatish Setty⁵, William G. Bensen⁶ and Valencia P. Remple^7,8, ¹Department of Medicine, Memorial University of Newfoundland, St. John's, NF, Canada, ²Centre hospitalier de l'Université de Montréal, Montreal, QC, Canada, ³Faculty of Medicine, Laval University, Quebec, QC, Canada, ⁴Centre Hospitalier de l'Université Laval, Quebec, QC, Canada, ⁵Grey Bruce Health Services, Owen Sound, ON, Canada, ⁶Department of Medicine, Division of Rheumatology, McMaster University, Hamilton, ON, Canada, ⁷AbbVie Corporation, Montreal, QC, Canada, ⁸School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada
Background/Purpose: COMPLETE-PsA is an ongoing observational study planning to enroll 670 psoriatic arthritis (PsA) patients (pts) from ~40 sites across Canada. Main objectives are to…
Abstract Number: 3011 • 2016 ACR/ARHP Annual Meeting
Long-Term Outcomes after Disease Activity Guided Tapering of Tumor Necrosis Factor Inhibition in Rheumatoid Arthritis: 3 Year Data of a Randomised Controlled Pragmatic Non Inferiority Strategy Study
Alfons A. den Broeder¹, Chantal A.M. Bouman¹, Frank H.J. van den Hoogen^1,2, Jaap Fransen², Ronald F. van Vollenhoven³, Johannes W.J. Bijlsma⁴, Aatke van der Maas¹ and Noortje van Herwaarden¹, ¹Rheumatology, Sint Maartenskliniek, Nijmegen, Netherlands, ²Rheumatology, Radboud University Medical Center, Nijmegen, Netherlands, ³Amsterdam Rheumatology and Immunology Center ARC, Amsterdam, Netherlands, ⁴Department of Rheumatology and Clinical Immunology, University Medical Center Utrecht, Utrecht, Netherlands
Long-term Outcomes After Disease Activity Guided Tapering of TNF Inhibitors in Rheumatoid Arthritis: 3 Year Data of a Randomized Controlled Pragmatic Non Inferiority Strategy Study…
Abstract Number: 2L • 2015 ACR/ARHP Annual Meeting
Baricitinib Versus Placebo or Adalimumab in Patients with Active Rheumatoid Arthritis (RA) and an Inadequate Response to Background Methotrexate Therapy: Results of a Phase 3 Study
Peter C. Taylor¹, Edward C. Keystone^2,3, D. van der Heijde⁴, Yoshiya Tanaka⁵, Taeko Ishii⁶, Kahaku Emoto⁶, Lili Yang⁶, Vipin Arora⁶, Carol L. Gaich⁶, Terence Rooney⁶, Douglas E. Schlichting⁶, William Macias⁶, Stephanie de Bono⁶ and Michael E. Weinblatt⁷, ¹Nuffield Dept. of Orthopaedics, Rheumatology and Musculoskeletal, Sciences, Kennedy Institute of Rheumatology, University of Oxford,, Oxford, United Kingdom, ²University of Toronto, Toronto, ON, Canada, ³Rebecca MacDonald Centre, Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada, ⁴Leiden University Medical Center, Leiden, Netherlands, ⁵The First Dept. of Internal Medicine, University of Occupational & Environmental Health, Kitakyusyu, Japan, ⁶Eli Lilly and Company, Indianapolis, IN, ⁷Brigham and Women’s Hospital, Boston, MA
Background/Purpose: In phase 3 studies, baricitinib (bari) improved disease activity in patients (pts) with active RA and an inadequate response (IR) to conventional synthetic DMARDs1…
Abstract Number: 3L • 2015 ACR/ARHP Annual Meeting
A Randomised Controlled Trial of the Clinical Effectiveness, Safety and Cost-Effectiveness of Adalimumab in Combination with Methotrexate for the Treatment of Juvenile Idiopathic Arthritis Associated Uveitis
Athimalaipet V Ramanan¹, Andrew D. Dick², Andrew McKay³, Ashley Jones⁴, Paula Williamson⁴, Sandrine Compeyrot-Lacassagne⁵, Ben Hardwick⁴, Helen Hickey⁴, Dyfrig Hughes⁶, Patricia Woo⁵, Diana Benton¹, Clive Edelsten⁵ and Michael W. Beresford⁷, ¹University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom, ²University of Bristol, Bristol Eye Hospital, Bristol, United Kingdom, ³Biostatistics, Clinical Trials Research Centre, University of Liverpool, Liverpool, United Kingdom, ⁴Clinical Trials Research Centre, University of Liverpool, Liverpool, United Kingdom, ⁵Great Ormond Street Hospital, London, United Kingdom, ⁶Bangor University, Bangor, United Kingdom, ⁷University of Liverpool, Liverpool, United Kingdom
Background/Purpose: Uveitis associated with Juvenile Idiopathic Arthritis (JIA) is a major cause of morbidity with potentially sight-threatening complications. Despite current screening and (pre-biologic) therapeutic options,…
Abstract Number: 552 • 2015 ACR/ARHP Annual Meeting
The Relationship Between Efficacy and Toxicity in Patients with Rheumatoid Arthritis Receiving Methotrexate in Combination with Adalimumab
Gerd Burmester¹, Gurjit S. Kaeley², Arthur Kavanaugh³, Cem Gabay⁴, Daryl MacCarter⁵, Peter Nash⁶, Tsutomu Takeuchi⁷, Anabela Cardoso⁸, Shufang Liu⁹, Hartmut Kupper¹⁰ and Jasmina Kalabic¹¹, ¹Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany, ²University of Florida, Jacksonville, FL, ³University of California, San Diego School of Medicine, LaJolla, CA, ⁴Rheumatology, Geneva University Hospital, Geneva, Switzerland, ⁵Coeur d'Alene Arthritis Clinic, Coeur d'Alene, ID, ⁶Department of Medicine, University of Queensland, Brisbane, Australia, ⁷Keio University School of Medicine, Tokyo, Japan, ⁸Torre Oriente, AbbVie, Lisboa, Portugal, ⁹Immunology Development, AbbVie, North Chicago, IL, ¹⁰AbbVie Deutschland GmBH & Co. KG, Ludwigshafen, Germany, ¹¹AbbVie, North Chicago, IL
Background/Purpose: Combination treatment of rheumatoid arthritis (RA) with methotrexate (MTX)+adalimumab (ADA) has been shown to be more effective than ADA monotherapy. However, MTX is associated…
Abstract Number: 2868 • 2015 ACR/ARHP Annual Meeting
Relative Efficacy of Adalimumab Versus Secukinumab in Active Psoriatic Arthritis: A Matching-Adjusted Indirect Comparison
Keith A. Betts¹, Manish Mittal², Avani Joshi², Jinlin Song¹ and Yanjun Bao², ¹Analysis Group, Inc., Boston, MA, ²AbbVie Inc., North Chicago, IL
Background/Purpose: The phase 3 FUTURE 1 and FUTURE 2 trials demonstrated efficacy of secukinumab (SEC) for active psoriatic arthritis (PsA). However, there is limited data…
Abstract Number: 589 • 2015 ACR/ARHP Annual Meeting
Adalimumab Concentration at 16 Weeks of Treatment Is Associated with Treatment Discontinuation within One Year
Mieke F. Pouw^1,2, Denis Mulleman³, Mike T. Nurmohamed^1,4, Theo Rispens⁵, Gilles Paintaud³, Gertjan Wolbink^1,2 and David Ternant³, ¹Rheumatology, Jan van Breemen Research Institute | Reade, Amsterdam, Netherlands, ²Immunopathology, Sanquin Research, Amsterdam, Netherlands, ³Université François-Rabelais de Tours, CNRS 7292, Tours, France, Tours, France, ⁴Rheumatology, VU University Medical Center, Amsterdam, Netherlands, ⁵Sanquin Research, Amsterdam, Netherlands
Background/Purpose: Anti-drug antibodies (ADAb) in patients treated with adalimumab have been associated with decreased adalimumab concentrations and loss of clinical response, and therefore treatment discontinuation.…
Abstract Number: 3112 • 2015 ACR/ARHP Annual Meeting
Incidence of Anti-Drug Antibodies in Rheumatoid Arthritis Patients Treated with Adalimumab, Etanercept, or Infliximab in a Real-World Setting
RJ Moots¹, Ricardo Xavier², Chi Chiu Mok³, Mahboob U Rahman⁴, Wen-Chan Tsai⁵, Mustafa Al Maini⁶, Karel Pavelka⁷, Ehab Mahgoub⁸, Sameer Kotak⁹, Joan Korth-Bradley¹⁰, Ronald Pedersen¹¹, Linda Mele⁸, Qi Shen⁸ and Bonnie Vlahos⁸, ¹Department of Musculoskeletal Biology, University of Liverpool, Liverpool, United Kingdom, ²Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil, ³Medicine, Tuen Mun Hospital, Hong Kong, Hong Kong, ⁴Perelman School of Medicine, University of Pennsylvania, Philadephia, PA, ⁵Kaohsiung Medical University, Kaohsiung, Taiwan, ⁶Rheumatology, Allergy and Clinical Immunology Division, Mafraq Hospital, Abu Dhabi, United Arab Emirates, ⁷Charles University, Prague, Czech Republic, ⁸GIPB - Clinical Sciences, Pfizer, Collegeville, PA, ⁹Global Health and Value, Pfizer, New York, NY, ¹⁰GIPB- Clinical Sciences, Pfizer, Collegeville, PA, ¹¹Department of Biostatistics, Pfizer, Collegeville, PA
Background/Purpose: Treatment with biologics can elicit unwanted immune responses such as antidrug antibodies (ADA), which may decrease their clinical efficacy and increase adverse events. However,…
Abstract Number: 595 • 2015 ACR/ARHP Annual Meeting
Discovery of Serum Protein Biomarkers of Response to Adalimumab in Rheumatoid Arthritis and Their Relationship to Biomarkers of Response to Infliximab
Ignacio Ortea¹, Bernd Roschitzki², Eva Tomero³, Juan G. Ovalles-Bonilla⁴, Javier Lopez-Longo⁵, Inmaculada de la Torre⁵, Isidoro Gonzalez-Alvaro⁶, Juan J Gomez-Reino⁷ and Antonio Gonzalez⁸, ¹Maimónides Health Research Institute (IMIBIC), Cordoba, Spain, ²Functional Genomics Center Zurich, University and ETH Zurich, Zurich, Switzerland, ³Rheumatology, Hospital Universitario de La Princesa. IIS La Princesa, Madrid, Spain, ⁴Rheumatology, Hospital General Universitario Gregorio Marañón, Madrid, Spain, ⁵Gregorio Marañon Hospital, Madrid, Spain, ⁶Hospital Univ. de La Princesa, IIS Princesa, Madrid, Spain, ⁷Instituto Investigacion Sanitaria- Hospital Clinico Universitario de Santiago, Santiago de Compostela, Spain, ⁸Laboratorio Investigacion 10 and Rheumatology Unit, Instituto Investigacion Sanitaria- Hospital Clinico Universitario de Santiago, Santiago de Compostela, Spain
Background/Purpose: Biomarkers of response to treatment in rheumatoid arthritis (RA) are sorely needed given the large inter-individual variability in efficacy of the available drugs. However,…
Abstract Number: 598 • 2015 ACR/ARHP Annual Meeting
Economic Impact of Decreasing Adalimumab and Etanercept Doses and Drug Monitoring in Patients with Rheumatoid Arthritis in Clinical Remission: Preliminary Study from a Local Biologics Unit
José Rosas¹, Francisca Llinares-Tello², José Miguel Senabre¹, Gregorio Santos-Soler¹, Esteban Salas-Heredia¹, Xabier Barber³, Ana Pons⁴, Catalina Cano⁴, Marisa Lorente⁵ and Juan Molina⁶, ¹Rheumatology, Hospital Marina Baixa, Villajoyosa, Spain, ²Clinical Analysis, Hospital Marina Baixa, Clinical Analysis, Villajoyosa, Spain, ³Centro de Investigación Operativa, Miguel Hernández University, Elche, Spain, ⁴Hospital Marina Baixa, Nursing, Villajoyosa, Spain, ⁵Marina Baixa Hospital, Nursing, Villajoyosa, Spain, ⁶Hospital Marina Baixa, Clinical Analysis, Villajoyosa, Spain
Background/Purpose: To evaluate the economic impact of adalimumab (ADL) and etanercept (ETN) dose reduction (by decreasing treatment frequency) and drug monitoring in patients with rheumatoid…
Abstract Number: 612 • 2015 ACR/ARHP Annual Meeting
Thromboembolic Events Are Not Associated with Anti-Adalimumab Antibodies
Gerd Burmester¹, Cem Gabay², Dilek Arikan³, Anabela Cardoso⁴, Jasmina Kalabic³, Nathan Pfeifer³, Nupun A. Varothai³, Stefan Florentinus⁵ and Josef S. Smolen⁶, ¹Department of Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany, ²Rheumatology, Geneva University Hospital, Geneva, Switzerland, ³AbbVie, North Chicago, IL, ⁴Torre Oriente, AbbVie, Lisboa, Portugal, ⁵AbbVie Inc., North Chicago, IL, ⁶Department of Medicine 3, Division of Rheumatology, Medical University Vienna, Vienna, Austria
Background/Purpose: Treatment of rheumatoid arthritis (RA) with anti-Tumor Necrosis Factor (TNF) such as adalimumab may result in some patients (pts) developing anti-adalimumab antibodies (AAA). Findings…
Abstract Number: 651 • 2015 ACR/ARHP Annual Meeting
The Prediction of Long-Term Minimal Disease Activity and Its Benefits in Patients with Psoriatic Arthritis
Philip J. Mease¹, Arthur Kavanaugh², Laura C Coates³, Iain McInnes⁴, Maja Hojnik⁵, Ying Zhang⁶, Jaclyn K. Anderson⁶, Alex Dorr⁶ and Dafna Gladman⁷, ¹Rheumatology Research, Swedish Medical Center, Seattle, WA, ²University of California San Diego, La Jolla, CA, ³Leeds Teaching Hospitals Trust, Leeds, United Kingdom, ⁴University of Glasgow, Institute of Infection Immunity and Inflammation, Glasgow, United Kingdom, ⁵AbbVie, Ljubljana, Slovenia, ⁶AbbVie, North Chicago, IL, ⁷Rheumatology, University of Toronto, Toronto Western Hospital, Toronto, ON, Canada
Background/Purpose: Minimal disease activity (MDA)1 is a clinically meaningful and comprehensive treatment target for psoriatic arthritis (PsA). The purpose was to determine if baseline (BL)…
Abstract Number: 2036 • 2015 ACR/ARHP Annual Meeting
Infliximab Versus Adalimumab in Severe Uveitis: Multicenter Study from the French Uveitis Network
Hélène Vallet¹, Pascal Sève², Lucie Biard³, Elodie Feurer⁴, Sophie Rivière⁵, Philip Bielfeld⁶, Laurent Perard⁷, Boris Bienvenu⁸, Sébastien Abad⁹, Aude Rigolet¹⁰, Alban Deroux¹¹, Antoinette Perlat¹², Damien Sène¹³, Isabelle Marie¹⁴, Emmanuel Heron¹⁵, Eric Hachulla¹⁶, Olivier Fain¹⁷, Gaëlle Clavel¹⁸, Jean Sibilia¹⁹, Nathalie Tieulié²⁰, Yoland Schoindre²¹, Jean Baptiste Fraison²², Guillaume Moulis²³, Thomas Papo²⁴, Gilles Blaison²⁵, Julie Gueudry²⁶, Olivier Lidove²⁷, Phuc LE Hoang²⁸, Catherine Chapelon²⁹, Mathieu Resche Regon³⁰, Patrice Cacoub¹³, Bahram Bodaghi²⁸ and David Saadoun³¹, ¹Internal medicine, DHU 2iB Internal Medicine Referal Center for Autoimmune diseases Pitie Hospital, Paris, France, ²Internal medicine, CHU Lyon, Lyon, France, ³Biostatistics, Saint-Louis Hospital, Paris, France, ⁴Internal Medicine, Hôpital de la Croix Rousse, Lyon, France, ⁵service de médecine interne A,, CHU de Montpellier, Montpellier Cedex 5, France, ⁶CHU de Dijon, Dijon, France, ⁷Hôpital Edouard Herriot, Lyon, France, ⁸Internal Medicine, Hospital Caen, Caen, France, ⁹Hôpital Avicenne, Bobigny, France, ¹⁰Médecine Interne 1, Hôpital Pitié-Salpêtrière, Paris, France, ¹¹Internal Medicine, CHU Grenoble, Grenoble, France, ¹²Internal medicine, CHU de Rennes, Rennes, France, ¹³Department of Internal Medicine, Pitié-Salpêtrière Hospital, Paris, France, ¹⁴Service de médecine interne, CHU de Rouen, Rouen, France., Rouen, France, ¹⁵Internal medicine, Hôpital des XV-XX, Paris, France, ¹⁶CHU Lille, Lille, France, ¹⁷Internal Medicine, Hospital J. Verdier, Bondy, France, ¹⁸Rheumatology, Fondation Rothschild, Paris, France, ¹⁹Rheumatology, Hôpital de Hautepierre, Strasbourg, France, ²⁰CHU Nice, Nice, France, ²¹Department de Internal Medicine and Clinical Immunology, Hôpital Pitié-Salpêtrière, AP-PH, UPMC, Paris, France, ²²Hôpital Jean Verdier, Bondy, France, ²³CHU Purpan, Toulouse, France, ²⁴CHU Bichat, Paris, France, ²⁵Internal Medicine, Hopital de Colmar, Colmar, France, ²⁶Ophtalmology, CHU de Rouen, Rouen, France, ²⁷Internal Medicine, Bichat-Claude Bernard Hospital, University Paris-7, Paris, France, ²⁸Ophtalmology, Assistance Publique-Hôpitaux de Paris, Hôpital Pitié Salpétrière, Paris, France, ²⁹Department of Internal Medicine 2. Referal center for SLE/APS, CHU Pitié-Salpêtrière, Paris, France, ³⁰biostatistics Saint Louis Hospital, paris, France, ³¹Department of Internal Medicine and clinical Immunology. French National Reference Center for Autoimmune Diseases. DHU I2B (Inflammation, Immunotherapy and Biotherapy), UPMC, Paris VI, Hôpital Pitié Salpétrière, AP-HP, UPMC, Univ Paris 06, Paris, France
Background/Purpose: Anti-tumour necrosis factor (TNF) molecules have become a valuable addition to the therapeutic armamentarium for patients with severe uveitis. However, direct comparison of safety…

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