Adalimumab in patients with hand osteoarthritis refractory to analgesics and NSAIDs: a randomised, multicentre, double-blind, placebo-controlled trial
| Autor: | Damien Loeuille, Emmanuel Maheu, P. Lafforgue, Y. Maugars, Gabriel Baron, Philippe Ravaud, Xavier Chevalier, P. Vergnaud, Violaine Foltz, Pascal Richette, Cédric Lukas, Caroline Roux, Denis Mulleman, Daniel Wendling, A. Rialland |
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| Přispěvatelé: | Service de rhumatologie [CHU Henri Mondor], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor, Institut National de la Santé et de la Recherche Médicale (INSERM), AP-HP - Hôpital Cochin Broca Hôtel Dieu [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de rhumatologie [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), Centre d'Investigation Clinique Henri Mondor (CIC Henri Mondor), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Laboratoire Synarc, Hôpital Archet 2 [Nice] (CHU), Archéologie, Terre, Histoire, Sociétés [Dijon] (ARTeHiS), Centre National de la Recherche Scientifique (CNRS)-Université de Bourgogne (UB)-Ministère de la Culture et de la Communication (MCC), Service de rhumatologie [Nantes], Université de Nantes (UN)-Hôtel-Dieu-Centre hospitalier universitaire de Nantes (CHU Nantes), CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service de Rhumatologie [CHU de Montpellier], CHU Montpellier, Service de Rhumatologie, Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Service de Rhumatologie [Hôpital de la Conception - APHM], Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Ingénierie Moléculaire et Physiopathologie Articulaire (IMoPA), Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), Service de rhumatologie [CHU Pitié Salpêtrière] (GRC-08 EEMOIS), 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), Ministère de la Culture et de la Communication (MCC)-Université de Bourgogne (UB)-Centre National de la Recherche Scientifique (CNRS), Service de Rhumatologie [CHU Pitié Salpêtrière], CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Henri Mondor, Institut National de la Santé et de la Recherche Médicale ( INSERM ), Service de rhumatologie, inflammation-immunopathologie- biothérapie [CHU Saint-Antoine] ( DHU i2B ), CHU Saint-Antoine [APHP]-Assistance publique - Hôpitaux de Paris (AP-HP), Centre d'Investigation Clinique Henri Mondor ( CIC Henri Mondor ), Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Henri Mondor-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université Paris-Est Créteil Val-de-Marne - Paris 12 ( UPEC UP12 ), Hôpital Archet 2 [Nice] ( CHU ), Archéologie, Terre, Histoire, Sociétés [Dijon] ( ARTeHiS ), Ministère de la Culture et de la Communication ( MCC ) -Université de Bourgogne ( UB ) -Centre National de la Recherche Scientifique ( CNRS ), Université de Nantes ( UN ) -Hôtel-Dieu-Centre hospitalier universitaire de Nantes ( CHU Nantes ), Service de rhumatologie [Tours], Service de Rhumatologie [CHRU de Besançon], Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ), Assistance Publique - Hôpitaux de Marseille ( APHM ) -Hôpital de la Conception [CHU - APHM] ( LA CONCEPTION ), Centre Hospitalier Régional Universitaire de Nancy ( CHRU Nancy ), Ingénierie Moléculaire et Physiopathologie Articulaire ( IMoPA ), Université de Lorraine ( UL ) -Centre National de la Recherche Scientifique ( CNRS ), Service de Rhumatologie [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Pitié-Salpêtrière [APHP], Hôpital Lariboisière |
| Rok vydání: | 2014 |
| Předmět: |
Male
MESH: Antirheumatic Agents MESH: Analgesics MESH: Treatment Failure MESH : Aged Placebo-controlled study MESH: Pain Measurement Osteoarthritis MESH: Adalimumab Anti-TNF [ SDV.BBM.BC ] Life Sciences [q-bio]/Biochemistry Molecular Biology/Biomolecules [q-bio.BM] 0302 clinical medicine MESH: Osteoarthritis MESH : Anti-Inflammatory Agents Non-Steroidal Immunology and Allergy MESH : Pain Measurement MESH : Female MESH: Double-Blind Method Treatment Failure Pain Measurement MESH: Treatment Outcome MESH: Aged Analgesics 0303 health sciences MESH: Middle Aged Anti-Inflammatory Agents Non-Steroidal Middle Aged MESH : Antirheumatic Agents MESH: Anti-Inflammatory Agents Non-Steroidal 3. Good health Treatment Outcome Antirheumatic Agents MESH : Analgesics Female MESH: Pain MESH : Pain medicine.drug MESH: Hand Joints medicine.medical_specialty Hand Joints Visual analogue scale MESH : Male Immunology Pain MESH : Treatment Outcome [ SDV.BBM.BM ] Life Sciences [q-bio]/Biochemistry Molecular Biology/Molecular biology MESH : Hand Joints Antibodies Monoclonal Humanized Placebo MESH : Antibodies Monoclonal Humanized General Biochemistry Genetics and Molecular Biology MESH : Adalimumab 03 medical and health sciences MESH : Treatment Failure Double-Blind Method Rheumatology Refractory [ SDV.MHEP ] Life Sciences [q-bio]/Human health and pathology Internal medicine Adalimumab medicine Humans MESH : Double-Blind Method MESH : Middle Aged [SDV.BBM.BC]Life Sciences [q-bio]/Biochemistry Molecular Biology/Biochemistry [q-bio.BM] Adverse effect Aged 030304 developmental biology 030203 arthritis & rheumatology MESH: Humans business.industry MESH : Humans [SDV.BBM.BM]Life Sciences [q-bio]/Biochemistry Molecular Biology/Molecular biology medicine.disease MESH : Osteoarthritis MESH: Male Surgery Treatment MESH: Antibodies Monoclonal Humanized Hand Osteoarthritis business MESH: Female [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology Hand osteoarthritis |
| Zdroj: | Annals of the Rheumatic Diseases Annals of the Rheumatic Diseases, BMJ Publishing Group, 2015, 74 (9), pp.1697-705. ⟨10.1136/annrheumdis-2014-205348⟩ Annals of the Rheumatic Diseases, BMJ Publishing Group, 2015, 74 (9), pp.1697-705. 〈10.1136/annrheumdis-2014-205348〉 |
| ISSN: | 1468-2060 0003-4967 |
| DOI: | 10.1136/annrheumdis-2014-205348 |
| Popis: | International audience; To test the efficiency of tumour necrosis factor blockers (adalimumab) in patients with painful refractory (non-responders to analgesics and non-steroidal anti-inflammatory drugs (NSAIDs)) hand osteoarthritis (OA).We performed a randomised, double-blind, placebo-controlled, parallel group, multicentre study. Patients were randomised to: 1/1 adalimumab 40 mg for two subcutaneous injections at a 15-day interval or placebo and monitored for 6 months. The primary outcome was the percentage of patients with an improvement of more than 50% in global pain (Visual Analogue Scale) between week 0 (W0) and week 6 (W6). Secondary outcomes included the number of painful joints, swollen joints, morning stiffness duration, patient and practitioner global assessments, functional indexes for hand OA, and consumption of analgesics. Analysis on the mean primary outcome measure was done on patients who received at least one injection.99 patients were recruited and 85 patients were randomised. Among them, 37 patients in the placebo group and 41 in the adalimumab group received at least one injection and were evaluated at W6 (n=78) on the main efficacy outcome. Mean age was 62 years, 85% were women, and mean level of pain was 62 mm at W0. At W6, 35.1% in the adalimumab group versus 27.3% in the placebo group had a pain reduction ≥50% (RR 1.12 (95% CI 0.82 to 1.54; p=0.48). There were no statistical differences for all secondary end points. The rate of adverse events was similar in the two groups.Adalimumab was not superior to placebo to alleviate pain in patients with hand OA not responding to analgesics and NSAIDs. |
| Databáze: | OpenAIRE |
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