Abstracts tagged "Adalimumab"

Abstract Number: 1352 • 2017 ACR/ARHP Annual Meeting
The Relevance of Elevated CRP As an Inclusion Criterion in Clinical Trials in Patients with Rheumatoid Arthritis
Craig Scoville¹, Jessica L. Suboticki², Sheng Zhong³ and Edward C. Keystone⁴, ¹Idaho Falls Arthritis Clinic, Idaho Falls, ID, ²AbbVie Inc., Mettawa, IL, ³AbbVie Inc., North Chicago, IL, ⁴Mount Sinai Hospital, University of Toronto, Toronto, ON, Canada
Background/Purpose: Elevated C-reactive protein (CRP) is often used as an entry criterion in clinical trials (CT) with rheumatoid arthritis (RA) patients (pts), resulting in the…
Abstract Number: 2440 • 2017 ACR/ARHP Annual Meeting
Long-Term Efficacy, Safety and Immunogenicity Results from a Randomized, Double-Blind, Phase III Confirmatory Efficacy and Safety Study Comparing GP2017, a Proposed Biosimilar, with Reference Adalimumab
Andrew Blauvelt¹, Jean-Phillipe Lacour², Joseph Fowler³, Ellen Schuck⁴, Julia Jauch-Lembach⁴, Alison Balfour⁴ and Craig Leonardi⁵, ¹Oregon Medical Research Center, Portland, OR, ²University of Nice Sophia Antipolis, Nice, France, ³Dermatology Specialists, Louisville, KY, ⁴Hexal AG, Holzkirchen, Germany, ⁵Central Dermatology, St. Louis, MO
Background/Purpose: Based on the evaluation of physicochemical, biological, preclinical, and clinical data, a biosimilar may be approved for use in the same indications for which…
Abstract Number: 1418 • 2017 ACR/ARHP Annual Meeting
The Value of Adalimumab Trough Levels and Clinical Assessments in Predicting Clinical Response in Patients with Established Rheumatoid Arthritis and an Inadequate Response to Methotrexate
Josef S. Smolen¹, Nael Mostafa², Xin Huang², Peter Noertersheuser³, Ben Klünder³, Kun Chen², Jasmina Kalabic³, Iain Sainsbury², Ruud Oerlemans⁴, Stefan Florentinus⁴ and Gerd R. Burmester⁵, ¹Medical University Vienna, Division of Rheumatology, Department of Internal Medicine III, Vienna, Austria, ²AbbVie Inc., North Chicago, IL, ³AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, ⁴AbbVie, Nederland, Hoofddorp, Netherlands, ⁵Rheumatology and Clinical Immunology, Charité - University Medicine Berlin, Free University and Humboldt University Berlin, Berlin, Germany
Background/Purpose: Low trough levels of the tumor necrosis factor inhibitor, adalimumab (ADL), and anti-ADL antibodies (AAA) were reported to be correlated with lack of response…
Abstract Number: 2442 • 2017 ACR/ARHP Annual Meeting
Biosimilar Candidate BI 695501 and Adalimumab Reference Product Have Similar Efficacy and Safety in Patients with Moderately-to-Severely Active Rheumatoid Arthritis (RA): 1-Year Results from a Phase III Study
Stanley B Cohen¹, Alberto Alonso-Ruiz², Piotr A. Klimiuk³, Eric Lee⁴, Nuala Peter⁵, Niklas Czeloth⁵ and Girish Jayadeva⁵, ¹Metroplex Clinical Research Center, Dallas, TX, ²Hospital de Cruces, Barakaldo, Spain, ³Medical University of Bialystok and Gabinet Internistyczno-Reumatologiczny, Bialystok, Poland, ⁴Inland Rheumatology, Upland, CA, ⁵Boehringer Ingelheim, Ingelheim a.R., Germany
Background/Purpose: Clinical equivalence has been shown for BI 695501 and the adalimumab reference product (RP) through similar ACR20 response at Weeks (wks) 12 and 24…
Abstract Number: 1419 • 2017 ACR/ARHP Annual Meeting
Characteristics of Patients with Early Rheumatoid Arthritis Who Have a Delayed Response to Treatment with Methotrexate in Monotherapy or in Combination with Adalimumab
Josef S. Smolen¹, Xianwei Bu², Xin Wang², Jessica L. Suboticki³ and Arthur Kavanaugh⁴, ¹Medical University Vienna, Division of Rheumatology, Department of Internal Medicine III, Vienna, Austria, ²AbbVie Inc., North Chicago, IL, ³AbbVie Inc., Mettawa, IL, ⁴Medicine, University of California, San Diego, La Jolla, CA
Background/Purpose: In patients (pts) with rheumatoid arthritis (RA), treat-to-target recommendations call for adjustment of treatment if a target is not met within 3-6 months (mths)…
Abstract Number: 2443 • 2017 ACR/ARHP Annual Meeting
Randomized, Double-Blind, Single-Dose, Three-Arm Parallel Trial to Determine the Pharmacokinetics and Safety of GP2017, EU- and US-Adalimumab in Healthy Male Subjects
Julia Jauch-Lembach¹, Andrej Skerjanec¹, Halimuniyazi Haliduola¹, Nicole Hass¹, Oliver von Richter¹, Rainard Fuhr² and Thomas Koernicke², ¹Hexal AG, Holzkirchen, Germany, ²PAREXEL International GmbH, Berlin, Germany
Background/Purpose: GP2017 is a proposed adalimumab biosimilar that has been shown to be similar to reference adalimumab at an analytical and preclinical level. The aim…
Abstract Number: 1420 • 2017 ACR/ARHP Annual Meeting
The Ability of Patients with Early Rheumatoid Arthritis to Taper Low-Dose Glucocorticoids on Methotrexate Monotherapy and in Combination with Adalimumab
Josef S. Smolen¹, Prashanth Sunkureddi², Jaclyn K. Anderson³, Jenny Griffith³, Dingfeng Jiang³, Kun Chen³, Jessica L. Suboticki⁴ and Arthur Kavanaugh⁵, ¹Division of Rheumatology, Medical University of Vienna and Hietzing Hospital, Vienna, Austria, ²Clear Lake Rheumatology, Nassau Bay, TX, ³AbbVie Inc., North Chicago, IL, ⁴AbbVie Inc., Mettawa, IL, ⁵Medicine, University of California, San Diego, La Jolla, CA
Background/Purpose: Low dose glucocorticoids (GCs) are recommended in combination with ≥1 synthetic DMARDs as part of the initial treatment strategy in rheumatoid arthritis (RA), with…
Abstract Number: 2453 • 2017 ACR/ARHP Annual Meeting
Methotrexate Discontinuation from Combination Therapy with Adalimumab Is Not Associated with Inferior Outcomes at 6 Months
Dimitrios A. Pappas¹, Chitra Karki¹, Ying Shan¹, Jessica L. Suboticki², Jenny Griffith³ and Joel Kremer⁴, ¹Corrona, LLC, Southborough, MA, ²AbbVie Inc., Mettawa, IL, ³AbbVie Inc., North Chicago, IL, ⁴Albany Medical College and The Center for Rheumatology, Albany, NY
Background/Purpose: Methotrexate is frequently administered in combination with biologics for the therapy of Rheumatoid Arthritis (RA) as it leads to superior outcomes compared to biologic…
Abstract Number: 1422 • 2017 ACR/ARHP Annual Meeting
Impact of Adalimumab on Prednisone Use in Patients with Rheumatoid Arthritis in a Real World Setting – Results from the Corrona Registry
Dimitrios A. Pappas¹, Chitra Karki¹, Heather J. Litman¹, Taylor Blachley¹, Jessica L. Suboticki², Jenny Griffith³ and Joel Kremer⁴, ¹Corrona, LLC, Southborough, MA, ²AbbVie Inc., Mettawa, IL, ³AbbVie Inc., North Chicago, IL, ⁴Albany Medical College and The Center for Rheumatology, Albany, NY
Background/Purpose: Steroids are used to reduce inflammation and pain among rheumatoid arthritis (RA) patients, but they can cause harmful side effects, and in some patients,…
Abstract Number: 2495 • 2017 ACR/ARHP Annual Meeting
Biosimilarity between Humira® and the Biosimilar Candidate SB5 in Product Quality
Nayoung Lee, Minlee Kim, JongAh Joanne Lee, Soohwan Kim and Hahymn Yang, Samsung Bioepis, Incheon, Korea, Republic of (South)
Background/Purpose: A biosimilar is a biopharmaceutical product that is highly similar to an already licensed one in terms of quality, safety, and efficacy. We (Samsung…
Abstract Number: 1424 • 2017 ACR/ARHP Annual Meeting
Impact of Glucocorticoid Therapy on the Efficacy of SC Abatacept or Adalimumab in RA Patients with Inadequate Response to MTX: A Post Hoc Analysis of Data from a Head-to-Head Trial
Yannick Degboé^1,2, Michael Schiff³, Michael Weinblatt⁴, Roy Fleischmann⁵, HA Ahmad⁶ and Arnaud Constantin^2,7, ¹Toulouse University Hospital, Toulouse, France, ²Université Paul Sabatier, Toulouse, France, ³University of Colorado, Denver, CO, ⁴Brigham and Women’s Hospital, Boston, MA, ⁵University of Texas Southwestern Medical Center, Dallas, TX, ⁶Bristol-Myers Squibb, Princeton, NJ, ⁷Purpan University Hospital, Toulouse, France
Background/Purpose: In patients with RA, low-dose glucocorticoids (GCs) have been shown to increase clinical, functional and radiographic efficacy when combined with conventional synthetic DMARDs;1 however,…
Abstract Number: 2799 • 2017 ACR/ARHP Annual Meeting
Efficacy, Safety and Immunogenicity in Randomized, Double-Blind (DB) and Open-Label Extension (OLE) Studies Comparing FKB327, an Adalimumab Biosimilar, with the Adalimumab Reference Product (Humira®; RP) in Patients (pts) with Active Rheumatoid Arthritis (RA)
Mark C. Genovese¹, Josephine Glover², Nobuhito Matsunaga³, Diane Chisholm⁴ and Rieke Alten⁵, ¹Stanford University Medical Center, Palo Alto, CA, ²Coephycient Pharmaceutical Consultancy, Guildford, United Kingdom, ³Fujifilm Kyowa Kirin Biologics, Chiyoda-ku, Tokyo, Japan, ⁴Fujifilm Kyowa Kirin Biologics, Galashiels, United Kingdom, ⁵University Medicine Berlin, Berlin, Germany
Background/Purpose: FKB327 is a proposed biosimilar of the adalimumab RP. A randomized, DB, Phase 3 study (NCT02260791) compared the efficacy, safety, pharmacokinetics (PK) and immunogenicity…
Abstract Number: 1471 • 2017 ACR/ARHP Annual Meeting
Flare Incidence and Predictive Factors in a Population of Patients with Rheumatoid Arthritis Under Optimised Treatment with Adalimumab and Infliximab
Amara Pieren¹, Dora Pascual-Salcedo², Pilar Aguado³, Gema Bonilla⁴, Eugenio De Miguel⁵, Irene Monjo⁶, Laura Nuño³, Diana Peiteado³, Alejandro Villalba³, Enrique Moral Coro⁴, C. Tornero⁷, Patricia Bogas⁴, Alejandro Balsa³ and Chamaida Plasencia-Rodriguez⁴, ¹Rheumatologyº, Hospital La Paz, Madrid, Spain, ²Immuno-Rheumatology Research group, La Paz University Hospital, Madrid, Spain, ³Rheumatology, La Paz University Hospital, Madrid, Spain, ⁴Hospital Universitario La Paz, Madrid, Spain, ⁵Rheumatology, University Hospital La Paz, IdiPaz, Madrid, Spain, ⁶Internal Medicine, Hospital Universitario La Paz, MADRID, Spain, ⁷Rheumatology, Rheumatology. La Paz University Hospital, Spain., Madrid, Spain
Background/Purpose:Anti-TNF has drastically changed the prognostic of the RA,carrying an important healthcare expense.This is why,optimisation seems a successful strategy that should not be linked to…
Abstract Number: 2868 • 2017 ACR/ARHP Annual Meeting
Pharmacodynamic Analysis of Whole Blood Gene Expression over 2 Years in a Phase IIIb Head-to-Head Trial of Abatacept and Adalimumab in Patients with RA
O Jabado¹, MA Maldonado¹, Michael Schiff², Michael Weinblatt³, Roy Fleischmann⁴, William H. Robinson⁵, A Greenfield¹ and SE Connolly¹, ¹Bristol-Myers Squibb, Princeton, NJ, ²University of Colorado, Denver, CO, ³Brigham and Women’s Hospital, Boston, MA, ⁴Metroplex Clinical Research Center Dallas, Dallas, TX, ⁵Stanford University, Palo Alto, CA
Background/Purpose: The head-to-head AMPLE study compared the safety and efficacy of abatacept (co-stimulatory modulator) versus adalimumab (TNFα inhibitor) for treatment of RA over 2 years.…
Abstract Number: 1521 • 2017 ACR/ARHP Annual Meeting
Impact of Time Since Diagnosis, Age, and Number of Prior Non-Steroidal Anti-Inflammatory Drugs on 52-Week Clinical Response to Adalimumab in Patients with Ankylosing Spondylitis
Joachim Sieper¹, Atul A. Deodhar², Maja Hojnik³, Ying Zhang⁴ and Maxime Dougados⁵, ¹Charité Universitätsmedizin Berlin, Berlin, Germany, ²Oregon Health & Science University, Portland, OR, ³AbbVie, Ljubljana, Slovenia, ⁴AbbVie Inc., North Chicago, IL, ⁵René Descartes University and Hôpital Cochin, Paris, France
Background/Purpose : Ankylosing spondylitis (AS) patients (pts) were found to respond better to TNF inhibitors (TNFi) if treated early in the disease course.1 The actual…

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