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1. Tocilizumab in treatment-naïve patients with Takayasu arteritis: TOCITAKA French prospective multicenter open-labeled trial

Author

Arsene Mekinian, David Saadoun, Eric Vicaut, Sara Thietart, Bertrand Lioger, Patrick Jego, Alexandre Bleibtreu, Nicolas Limal, Jerome Connault, Jacques-Eric Gottenberg, Pauline Lhorte, Jean Pierre Bertola, Juliette Delforge, Nicole Ferreira-Maldent, Antoinette Perlat, Zohra Talib, Matthieu Vautier, Léa Savey, Isabelle Quiere, Patrice Cacoub, Olivier Fain, and for the French Takayasu network

Subjects
Takayasu arteritis, Tocilizumab, Vasculitis treatment, Diseases of the musculoskeletal system, RC925-935
Abstract

Abstract Objectives To assess long-term efficacy of tocilizumab in treatment-naive patients with Takayasu arteritis (TAK). Methods Prospective open-labeled trial in naïve patients with TAK who received steroids at the dose of 0.7 mg/kg/day and 7 infusions of 8 mg/kg/month of tocilizumab. The primary endpoint was the number of patients who discontinued steroids after 7 infusions of tocilizumab. Secondary endpoints included disease activity and the number of relapses during 18-month follow-up. Results Thirteen patients with TAK were included, with a median age of 32 years [19–45] and 12 (92%) females. Six (54%) patients met the primary end-point. A significant decrease of disease activity was observed after 6 months of tocilizumab therapy: decrease of median NIH scale (3 [3, 4] at baseline, versus 1 [0–2] after 6 months; p

Published
2020
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2. Efficacy of tocilizumab in patients with hand osteoarthritis: double blind, randomised, placebo-controlled, multicentre trial

Author

Augustin Latourte, Jérémie Sellam, Muriel Piperno, Yves-Marie Pers, Florent Eymard, Pascal Richette, Jean Pierre Bertola, Olivier Peyr, René-Marc Flipo, Philippe Goupille, Eric Vicaut, Xavier Chevalier, Bruno Fautrel, Daniel Wendling, Paul Ornetti, Sébastien Ottaviani, Service de Rhumatologie [CHU Lariboisière], Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Pathologies biliaires, fibrose et cancer du foie [CHU Saint-Antoine], Centre de Recherche Saint-Antoine (CR Saint-Antoine), Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service de Rhumatologie, Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon, CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Cellules Souches, Plasticité Cellulaire, Médecine Régénératrice et Immunothérapies (IRMB), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Service de rhumatologie [CHU Henri Mondor], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor, Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de Rhumatologie (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Service de rhumatologie[Lille], Hôpital Roger Salengro [Lille]-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Chugai Pharma France, Paris La Défense, Pathologies biliaires, fibrose et cancer du foie [CRSA], Centre de Recherche Saint-Antoine (CRSA), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)

Subjects
musculoskeletal diseases, Male, medicine.medical_specialty, Visual analogue scale, Immunology, Pain, Osteoarthritis, Placebo, Antibodies, Monoclonal, Humanized, General Biochemistry, Genetics and Molecular Biology, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Tocilizumab, Rheumatology, Double-Blind Method, Internal medicine, medicine, Clinical endpoint, therapeutics, Immunology and Allergy, Humans, In patient, Adverse effect, 030304 developmental biology, 030203 arthritis & rheumatology, 0303 health sciences, business.industry, Middle Aged, medicine.disease, cytokines, 3. Good health, Treatment Outcome, chemistry, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Female, business, Hand osteoarthritis
Abstract

ObjectiveTo evaluate the efficacy of tocilizumab, an antibody against IL-6 receptor, in patients with hand osteoarthritis.MethodsThis was a multicentre, 12-week, randomised, double-blind, placebo-controlled study from November 2015 to October 2018. Patients with symptomatic hand osteoarthritis (pain ≥40 on a 0–100 mm visual analogue scale (VAS) despite analgesics and non-steroidal anti-inflammatory drugs; at least three painful joints, Kellgren-Lawrence grade ≥2) were randomised to receive two infusions 4 weeks apart (weeks 0 and 4) of tocilizumab (8 mg/kg intravenous) or placebo. The primary endpoint was changed in VAS pain at week 6. Secondary outcomes included the number of painful and swollen joints, duration of morning stiffness, patients’ and physicians’ global assessment and function scores.ResultsOf 104 patients screened, 91 (45 to tocilizumab and 46 to placebo; 82% women; mean age 64.4 (SD 8.7) years) were randomly assigned and 79 completed the 12-week study visit. The mean change between baseline and week 6 on the VAS for pain (primary outcome) was −7.9 (SD 19.4) and −9.9 (SD 20.1) in the tocilizumab and placebo groups (p=0.7). The groups did not differ for any secondary outcomes at weeks 4, 6, 8 or 12. Overall, adverse events were slightly more frequent in the tocilizumab than placebo group.ConclusionTocilizumab was no more effective than placebo for pain relief in patients with hand osteoarthritis.

Published
2020

3. Tocilizumab in treatment-naïve patients with Takayasu arteritis: TOCITAKA French prospective multicenter open-labeled trial

Author

Jean Pierre Bertola, Léa Savey, Juliette Delforge, David Saadoun, Patrick Jego, Olivier Fain, Matthieu Vautier, Pauline Lhorte, Nicole Ferreira-Maldent, Patrice Cacoub, Arsène Mekinian, Jérôme Connault, Jacques-Eric Gottenberg, Nicolas Limal, Bertrand Lioger, Zohra Talib, Eric Vicaut, Sara Thietart, Isabelle Quiere, Alexandre Bleibtreu, Antoinette Perlat, Gestionnaire, Hal Sorbonne Université, Service de médecine interne [CHU Saint-Antoine], CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service de rhumatologie [CHU Saint-Antoine], Service de Département de médecine interne et immunologie clinique [CHU Pitié-Salpêtrière] (DMIIC), CHU Pitié-Salpêtrière [AP-HP], Departement Hospitalo- Universitaire - Inflammation, Immunopathologie, Biothérapie [Paris] (DHU - I2B), Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Immunologie - Immunopathologie - Immunothérapie [CHU Pitié Salpêtrière] (I3), CHU Charles Foix [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Centre National de Référence Maladies auto-immunes Systémiques Rares [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Pitié-Salpêtrière [AP-HP], Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), CHU Pontchaillou [Rennes], Hôpital Jean Verdier [AP-HP], CHU Henri Mondor, Centre hospitalier universitaire de Nantes (CHU Nantes), Immuno-Rhumatologie Moléculaire, Université de Strasbourg (UNISTRA)-Institut National de la Santé et de la Recherche Médicale (INSERM), Fédération de Médecine Translationnelle de Strasbourg (FMTS), Université de Strasbourg (UNISTRA), Les Hôpitaux Universitaires de Strasbourg (HUS), CHU Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Sorbonne Université (SU)-CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Trousseau [APHP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service de médecine interne et d'immunologie clinique [CHU Pitié-Salpêtrière], CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Saint-Antoine [AP-HP], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP]

Subjects
Adult, musculoskeletal diseases, medicine.medical_specialty, lcsh:Diseases of the musculoskeletal system, [SDV]Life Sciences [q-bio], Takayasu arteritis, 030204 cardiovascular system & hematology, Antibodies, Monoclonal, Humanized, Gastroenterology, Therapy naive, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Tocilizumab, Maintenance therapy, Internal medicine, medicine, Clinical endpoint, Humans, Prospective Studies, skin and connective tissue diseases, 030203 arthritis & rheumatology, business.industry, Rheumatology, 3. Good health, Discontinuation, [SDV] Life Sciences [q-bio], Treatment Outcome, chemistry, Orthopedic surgery, Female, lcsh:RC925-935, business, Vasculitis treatment, Research Article
Abstract

Objectives To assess long-term efficacy of tocilizumab in treatment-naive patients with Takayasu arteritis (TAK). Methods Prospective open-labeled trial in naïve patients with TAK who received steroids at the dose of 0.7 mg/kg/day and 7 infusions of 8 mg/kg/month of tocilizumab. The primary endpoint was the number of patients who discontinued steroids after 7 infusions of tocilizumab. Secondary endpoints included disease activity and the number of relapses during 18-month follow-up. Results Thirteen patients with TAK were included, with a median age of 32 years [19–45] and 12 (92%) females. Six (54%) patients met the primary end-point. A significant decrease of disease activity was observed after 6 months of tocilizumab therapy: decrease of median NIH scale (3 [3, 4] at baseline, versus 1 [0–2] after 6 months; p p = 0.002), and ITAS-A score (7 [4–10] versus 4 [1–15]; p = 0.0001)]. During the 12-month follow-up after tocilizumab discontinuation, a relapse occurred among 5 patients (45%) out of 11 in which achieved remission after 6 months of tocilizumab. Conclusion Tocilizumab seems an effective steroid sparing therapy in TAK, but maintenance therapy is necessary. Trial registration ClinicalTrials.gov NCT02101333. Registered on 02 April 2014.

Published
2020

4. Effect of Brain-Dead Donor Resuscitation on Delayed Graft Function: Results of a Monocentric Analysis

Author

Magali Giral, Georges Karam, Evelyne Bironneau, Yvonnick Blanloeil, Pascal Daguin, Lydie Lerat, Jean-Paul Soulillou, Jean Pierre Bertola, Yohann Foucher, and Daniel Villers

Subjects
Adult, Male, Brain Death, medicine.medical_specialty, Resuscitation, Time Factors, Adolescent, Epinephrine, Population, Delayed Graft Function, Hydroxyethyl starch, Lower risk, Logistic regression, Hydroxyethyl Starch Derivatives, Sex Factors, Risk Factors, Intensive care, Internal medicine, Humans, Medicine, Risk factor, Child, education, Kidney transplantation, Aged, Retrospective Studies, Aged, 80 and over, Transplantation, education.field_of_study, business.industry, Cold Ischemia, Age Factors, Middle Aged, medicine.disease, Kidney Transplantation, Tissue Donors, Surgery, Logistic Models, Child, Preschool, Hypertension, Multivariate Analysis, Cardiology, Female, Kidney Diseases, business, medicine.drug
Abstract

We have previously shown that a delayed graft function (DGF) longer than 6 days was a crucial threshold for long-term graft outcome. The aim of this study was to analyze the correlation of DGFor=6 days with brain-dead donor variables, including those related to resuscitation, in a population of 262 consecutive brain-dead donors from 1990 to 2003.We used a marginal logistic model in which DGF was considered as a binary variable with a cutoff of 6 days.Monovariate analysis of donor parameters showed that male, age above 35 years, primary history of hypertension, hydroxyethyl starch (HES) fluid greater than 1500 mL or epinephrine infusion during resuscitation were risk factors for prolonged DGF. The multivariate logistic regression model showed that epinephrine use during donor resuscitation (P0.001, odds ratio [OR]=4.35), cold ischemia time (CIT)or=16 hr (P=0.01, OR=2.16), and recipient age55 years (P=0.003, OR=2.75), were associated with a risk of prolonged DGF. A long stay (40 hr) in intensive care and a large volume of colloids (1250 mL, except HES) correlated with a lower risk of DGF.Our study shows an impact for only a limited number of brain dead donor resuscitation parameters on DGF duration. We also show that CIT has a much lower threshold (16 hr) for DGF risk than previously described. Importantly, we show that recipient age is clearly a major independent risk factor for prolonged DGF, whereas donor age seems to act mostly as a dependent risk factor.

Published
2007

5. Early prediction of the sensitivity of warfarin in elderly patients by the fall in factor VIIc and protein C at the induction of treatment

Author

Jean François Bergmann, Guy Simoneau, Ludovic Drouet, Jean Pierre Bertola, Isabelle Mahé, and Elisabeth Mazoyer

Subjects
Male, Aging, medicine.medical_specialty, Genotype, medicine.drug_class, Administration, Oral, Hemorrhage, chemistry.chemical_compound, Therapeutic index, Pharmacokinetics, Predictive Value of Tests, Internal medicine, medicine, Humans, International Normalized Ratio, Blood Coagulation, Aged, Cytochrome P-450 CYP2C9, Aged, 80 and over, Polymorphism, Genetic, Factor VII, business.industry, Anticoagulant, Warfarin, Anticoagulants, Atrial fibrillation, Hematology, medicine.disease, Surgery, chemistry, Pharmacodynamics, Cardiology, Female, Aryl Hydrocarbon Hydroxylases, Disease Susceptibility, business, Protein C, medicine.drug
Abstract

Indications of oral anticoagulation (OA) therapy for venous thromboembolism and atrial fibrillation increase with age [1]. Elderly patients are more sensitive to OA [2] and their risk for bleeding complications is increased [3,4]. There is a strong relationship between the intensity of the anticoagulant effect and the risk of bleeding [5,6]. A recommendation for an international normalized ratio (INR) of 2.0 to 3.0 is made for most indications [1]. It is important to maintain INR below 3.0 especially in the elderly [7]. Many authors agree that there is a need to improve the safety of anticoagulants in the elderly by careful monitoring of anticoagulant therapy in order to maximize their time in the optimal therapeutic range [1,2,8]. The start of this treatment is a critical period, as the hemorrhagic risk lies mainly in the induction phase [4]. Warfarin is the most widely used oral anticoagulant. It is a drug with a small therapeutic window and its dose–response curve is complex [9,10]. There is a great interand intraindividual pharmacokinetic and pharmacodynamic variability [11]. For all these reasons, it is difficult to predict the correct induction dose [12]. INR is the

Published
2003

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