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Cynthia Nourisson, Martin Soubrier, Aurélien Mulliez, Athan Baillet, Thomas Bardin, Alain Cantagrel, Bernard Combe, Maxime Dougados, René-Marc Flipo, Thierry Schaeverbeke, Jean Sibilia, Olivier Vittecoq, Philippe Ravaud, Jacques-Eric Gottenberg, Xavier Mariette, Anne Tournadre
Objective: The impact of gender on the response and tolerance to abatacept was assessed in a large prospective cohort during 2 years of follow-up. Methods: From the 1017 patients included in the Orencia and Rheumatoid Arthritis registry, disease activity was assessed at baseline, 6, 12 and 24 months. The relationship between the European League Against Rheumatism (EULAR) response, Disease Activity Score 28 (DAS28) remission, rate of adverse events and gender was explored in multivariate analysis...
2017: RMD Open
Jean-Hugues Salmon, Jeanne-Marie Perotin, Jacques Morel, Moustapha Dramé, Alain Cantagrel, Liana Euller Ziegler, Philippe Ravaud, Jean Sibilia, Isabelle Pane, Xavier Mariette, Jacques-Eric Gottenberg
Objective: The aim was to evaluate the incidence of serious infusion-related reactions (SIRRs) in RA treated by non-TNF-targeted biologics. Methods: We analysed data from three independent prospective registers, namely autoimmunity and rituximab, Orencia (abatacept) and RA (ORA) and Registry RoAcTEmra (tocilizumab), promoted by the French Society of Rheumatology and including patients with RA. SIRRs were defined by an occurrence during or within 24 h of an infusion and requiring discontinuation of treatment...
January 1, 2018: Rheumatology
Xavier Mariette
Professor Xavier Mariette, MD, PhD, has served as the Head of the Rheumatology Department of Bicêtre Hospital, Paris-Sud University since 1999, a role he took following 10 years of practice of clinical immunology. Professor Mariette has initiated a number of clinical research studies on biotherapies in autoimmune diseases. He is the head of the French RATIO (Research Axed on Tolerance of Biotherapy) observatory, collecting specific rare serious adverse events in patients treated with anti-TNF. He initiated the French AIR (Autoimmunity and Rituximab) and ORA (Orencia and Rheumatoid arthritis) registries of patients with autoimmune diseases treated with rituximab and abatacept...
September 2017: Immunotherapy
Hannah A Blair, Emma D Deeks
The biological DMARD (bDMARD) abatacept (Orencia® ), a recombinant fusion protein, selectively modulates a co-stimulatory signal necessary for T-cell activation. In the EU, abatacept is approved for use in patients with highly active and progressive rheumatoid arthritis (RA) not previously treated with methotrexate. Abatacept is also approved for the treatment of moderate to severe active RA in patients with an inadequate response to previous therapy with at least one conventional DMARD (cDMARD), including methotrexate or a TNF inhibitor...
July 2017: Drugs
Themis Alissafi, Aggelos Banos, Louis Boon, Tim Sparwasser, Alessandra Ghigo, Kajsa Wing, Dimitrios Vassilopoulos, Dimitrios Boumpas, Triantafyllos Chavakis, Ken Cadwell, Panayotis Verginis
Design of efficacious Treg-based therapies and establishment of clinical tolerance in autoimmune diseases have proven to be challenging. The clinical implementation of Treg immunotherapy has been hampered by various impediments related to the stability and isolation procedures of Tregs as well as the specific in vivo targets of Treg modalities. Herein, we have demonstrated that Foxp3+ Tregs potently suppress autoimmune responses in vivo through inhibition of the autophagic machinery in DCs in a cytotoxic T-lymphocyte-associated protein 4-dependent (CTLA4-dependent) manner...
June 30, 2017: Journal of Clinical Investigation
Augustin Latourte, Jacques-Eric Gottenberg, Cécile Luxembourger, Isabelle Pane, Pascal Claudepierre, Pascal Richette, Pierre Lafforgue, Bernard Combe, Alain Cantagrel, Jean Sibilia, René-Marc Flipo, Philippe Gaudin, Olivier Vittecoq, Thierry Schaeverbeke, Maxime Dougados, Jeremie Sellam, Philippe Ravaud, Xavier Mariette, Raphaèle Seror
Objective: To investigate the frequency and risk factors of postoperative complications in RA patients treated with abatacept (ABA). Methods: The Orencia RA registry recruited 1012 patients receiving ABA for RA in routine care. Data from patients treated with ABA who underwent surgery were reviewed to describe the frequency of postoperative complications. Characteristics of patients and surgeries with and without complications were compared to identify factors associated with complications...
April 1, 2017: Rheumatology
Fahd Adeeb, Shakeel Anjum, Philip Hodnett, Ahmad Kashif, Mary Brady, Siobhan Morrissey, Joseph Devlin, Alexander Duncan Fraser
OBJECTIVES: This case series explores the potential efficacy of Abatacept in patients presenting with morphea subtypes and deep tissue involvement. METHODS: Three patients with established morphea subtypes and deep tissue involvement and with no contraindication to Abatacept were included in this prospective open-label study. The index patient was exceptionally severely affected with a mean Modified Rodnan Skin Score (MRSS) of 38/51. At baseline, whole-body MRI and skin biopsy were performed which confirmed classical deposition of dense fibrous tissue in the appropriate layer of the skin...
June 2017: Seminars in Arthritis and Rheumatism
Cynthia Bean, Shauna-Kay Spencer, Teylor Bowles, Patrick B Kyle, Jan M Williams, Jacob Gibbens, Kedra Wallace
PROBLEM: Angiogenic imbalance during pregnancy is associated with immune activation, hypertension, increased T cell infiltration, and neurological insults. METHOD OF STUDY: On gestational day (GD) 12, timed-pregnant rats were infused with anti-angiogenic factors sFlt-1 and sEndoglin (4.7 and 7 μg/kg) to create HELLP syndrome via mini-osmotic pumps for 8 days, with a subset of these rats having Orencia (2 mg/kg) infused on GD13. On GD19, blood-brain barrier (BBB) permeability was evaluated via Evan's Blue infusion, blood was collected for T-cell measurements, inflammatory cytokine secretion...
October 2016: American Journal of Reproductive Immunology: AJRI
Hiroto Tsuboi, Isao Matsumoto, Shinya Hagiwara, Tomoya Hirota, Hiroyuki Takahashi, Hiroshi Ebe, Masahiro Yokosawa, Mizuki Yagishita, Hidenori Takahashi, Izumi Kurata, Ayako Ohyama, Fumika Honda, Hiromitsu Asashima, Haruka Miki, Naoto Umeda, Yuya Kondo, Shintaro Hirata, Kazuyoshi Saito, Yoshiya Tanaka, Yoshiro Horai, Hideki Nakamura, Atsushi Kawakami, Takayuki Sumida
OBJECTIVE: To clarify the efficacy and safety of abatacept for secondary Sjögren's syndrome (SS) associated with rheumatoid arthritis (RA). METHODS: The primary endpoint of this open-labeled, prospective, observational multicenter study for secondary SS with RA was the remission rate of Simplified Disease Activity Index (SDAI) at 52 weeks after initiation of abatacept. The secondary endpoints included Saxon's test and Schirmer's test. Adverse events and adherence rate during the study period were also analyzed...
November 2016: Modern Rheumatology
Jonathan Shepherd, Keith Cooper, Petra Harris, Joanna Picot, Micah Rose
BACKGROUND: Juvenile idiopathic arthritis (JIA) is characterised by joint pain, swelling and a limitation of movement caused by inflammation. Subsequent joint damage can lead to disability and growth restriction. Treatment commonly includes disease-modifying antirheumatic drugs (DMARDs), such as methotrexate. Clinical practice now favours newer drugs termed biologic DMARDs where indicated. OBJECTIVE: To assess the clinical effectiveness and cost-effectiveness of four biologic DMARDs [etanercept (Enbrel(®), Pfizer), abatacept (Orencia(®), Bristol-Myers Squibb), adalimumab (Humira(®), AbbVie) and tocilizumab (RoActemra(®), Roche) - with or without methotrexate where indicated] for the treatment of JIA (systemic or oligoarticular JIA are excluded)...
April 2016: Health Technology Assessment: HTA
Clément Lahaye, Martin Soubrier, Aurélien Mulliez, Thomas Bardin, Alain Cantagrel, Bernard Combe, Maxime Dougados, René-Marc Flipo, Xavier Le Loët, Thierry Shaeverbeke, Philippe Ravaud, Xavier Mariette, Jacques-Eric Gottenberg
OBJECTIVE: To study the effect of age on the risk-benefit balance of abatacept in RA. METHODS: Data from the French orencia and RA registry, including a 2-year follow-up, were used to compare the effectiveness and safety of abatacept according to age. RESULTS: Among the 1017 patients, 103 were very elderly (⩾75 years), 215 elderly (65-74), 406 intermediate aged (50-64) and 293 very young (<50). At baseline, elderly and very elderly patients had longer disease duration, higher CRP levels and higher disease activity...
May 2016: Rheumatology
E J Feng, A J Orencia, J P Whisnant
To investigate whether stroke pathogenesis and sequelae are conditional on place of initial stroke occurrence, 2,238 incident stroke cases among Rochester, Minnesota, residents in the period from 1950 to 1984 were evaluated. Virtually compete case ascertainment of first strokes in Rochester nursing homes (153 strokes), hospitals (194), and homes (1,891) was possible through a medical record linkage system. Stroke cases were reviewed by a neurologist applying uniform criteria. Although most patients had the first stroke at home (84%), there was an increasing trend over the study period of first strokes occurring while patients were hospitalized...
1993: Journal of Stroke and Cerebrovascular Diseases: the Official Journal of National Stroke Association
A J Orencia, E J Feng, J P Whisnant
To investigate the risk and prognostic factors for in-hospital incident stroke and stroke mortality, surveillance was conducted on Rochester, MN, residents free of stroke when admitted to the hospital in the years 1950 through 1984. The in-hospital first stroke attack rates remained stable for the calendar years 1970,1976, and 1980. Of the first strokes that occurred in the hospital, 42% were adventitious. In approximately 60% of patients with adventitious strokes, the strokes developed within 2 days after a hospital procedure...
1992: Journal of Stroke and Cerebrovascular Diseases: the Official Journal of National Stroke Association
J H Salmon, J E Gottenberg, P Ravaud, A Cantagrel, B Combe, R M Flipo, T Schaeverbeke, E Houvenagel, P Gaudin, D Loeuille, S Rist, M Dougados, J Sibilia, X Le Loët, O Meyer, E Solau-Gervais, C Marcelli, T Bardin, I Pane, G Baron, E Perrodeau, X Mariette
OBJECTIVES: Little data are available regarding the rate and predicting factors of serious infections in patients with rheumatoid arthritis (RA) treated with abatacept (ABA) in daily practice. We therefore addressed this issue using real-life data from the Orencia and Rheumatoid Arthritis (ORA) registry. METHODS: ORA is an independent 5-year prospective registry promoted by the French Society of Rheumatology that includes patients with RA treated with ABA. At baseline, 3 months, 6 months and every 6 months or at disease relapse, during 5 years, standardised information is prospectively collected by trained clinical nurses...
June 2016: Annals of the Rheumatic Diseases
Janet E Pope, Emmanouil Rampakakis, John Sampalis
OBJECTIVES: Assessment of the effectiveness of newer biologics such as abatacept is essential in real-world practice. METHODS: RA patients administered infusions of abatacept via the Orencia Response Program network with at least one follow-up evaluation were included. The number needed to treat (NNT) to improve HAQ by at least the minimal clinically important difference (MID ≥ 0.22) and abatacept survival and differences between biologic-naïve and TNFi-experienced patients were assessed...
April 2015: Seminars in Arthritis and Rheumatism
Elena Krayukhina, Kouhei Tsumoto, Susumu Uchiyama, Kiichi Fukui
Currently, polymer-based prefillable syringes are being promoted to the pharmaceutical market because they provide an increased break resistance relative to traditionally used glass syringes. Despite this significant advantage, the possibility that barrel material can affect the oligomeric state of the protein drug exists. The present study was designed to compare the effect of different syringe materials and silicone oil lubrication on the protein aggregation. The stability of a recombinant fusion protein, abatacept (Orencia), and a fully human recombinant immunoglobulin G1, adalimumab (Humira), was assessed in silicone oil-free (SOF) and silicone oil-lubricated 1-mL glass syringes and polymer-based syringes in accelerated stress study...
February 2015: Journal of Pharmaceutical Sciences
Hiroto Tsuboi, Isao Matsumoto, Shinya Hagiwara, Tomoya Hirota, Hiroyuki Takahashi, Hiroshi Ebe, Masahiro Yokosawa, Chihiro Hagiya, Hiromitsu Asashima, Chinatsu Takai, Haruka Miki, Naoto Umeda, Yuya Kondo, Hiroshi Ogishima, Takeshi Suzuki, Shintaro Hirata, Kazuyoshi Saito, Yoshiya Tanaka, Yoshiro Horai, Hideki Nakamura, Atsushi Kawakami, Takayuki Sumida
Abstract Objective. To assess the efficacy and safety of abatacept for secondary Sjögren's syndrome (SS) associated with rheumatoid arthritis (RA). Methods. The primary endpoint of this 1-year, open-labeled, prospective, observational multicenter study of RA-associated secondary SS was the rate of SDAI remission at 52 weeks after initiation of abatacept therapy. The secondary endpoints included that of Saxson's test and Schirmer's test. Adverse events during the study period were also analyzed. Results. Thirty-two patients (all females) were enrolled in this study...
March 2015: Modern Rheumatology
Yoshiya Tanaka, Satoshi Kubo, Hisashi Yamanaka, Koichi Amano, Shintaro Hirata, Eiichi Tanaka, Hayato Nagasawa, Hidekata Yasuoka, Tsutomu Takeuchi
OBJECTIVE: To investigate the efficacy and safety of abatacept for treating patients with rheumatoid arthritis (RA) in routine clinical practice. METHODS: We performed a retrospective study of 137 RA patients who were treated with abatacept for 24 weeks between October 2010 and June 2011 at four rheumatology centers in Japan. Outcomes were compared between biologic-naïve and biologic-experienced patients. Disease activity was assessed using the Simplified Disease Activity Index (SDAI) and the 28-joint Disease Activity Score based on the erythrocyte sedimentation rate (DAS28-ESR)...
September 2014: Modern Rheumatology
Jeffrey L Kaine
BACKGROUND: Rheumatoid arthritis (RA) is a chronic, inflammatory disease affecting synovial joints. Patients with persistent, active disease have traditionally been treated with disease-modifying antirheumatic drugs (DMARDs) (eg, methotrexate) or biologic agents (eg, tumor necrosis factor [TNF] antagonists). However, patients may discontinue these treatments due to toxicity, infection, or lack of efficacy. Two additional biologic therapies-rituximab and abatacept-are currently available for TNF-antagonist inadequate responders...
November 2007: Current Therapeutic Research, Clinical and Experimental
Gillian M Keating
The biological disease-modifying antirheumatic drug abatacept (Orencia) has a novel mechanism of action; its activity is mediated via the selective modulation of T cell co-stimulation. This article reviews the clinical efficacy and tolerability of intravenous and subcutaneous abatacept in patients with rheumatoid arthritis (RA) and intravenous abatacept in patients with juvenile idiopathic arthritis (JIA), as well as summarizing its pharmacological properties. In patients with RA, the beneficial effects of intravenous or subcutaneous abatacept on signs and symptoms, disease activity, the progression of structural damage, physical function and/or health-related quality of life were seen in a number of well-designed trials, including in methotrexate-naive patients with early RA and poor prognostic factors and in patients with established RA and an inadequate response to either methotrexate or anti-tumour necrosis factor therapy...
July 2013: Drugs
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