Adalimumab in patients with hand osteoarthritis refractory to analgesics and NSAIDs: a randomised, multicentre, double-blind, placebo-controlled trial.
In: ISSN: 0003-4967, 2015
academicJournal
Zugriff:
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.
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Adalimumab in patients with hand osteoarthritis refractory to analgesics and NSAIDs: a randomised, multicentre, double-blind, placebo-controlled trial.
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Autor/in / Beteiligte Person: | Chevalier, X. ; Ravaud, P ; Maheu, E ; Baron, G ; Rialland, A ; Vergnaud, P ; Roux, Caroline ; Maugars, Y ; Mulleman, D ; Lukas, C ; Wendling, D ; Lafforgue, P ; Loeuille, Damien ; Foltz, V ; Richette, P ; 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) ; CHU Saint-Antoine AP-HP ; 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) ; Synarc, Laboratoire ; 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) ; Service de rhumatologie Nantes ; Université de Nantes (UN)-Hôtel-Dieu-Centre Hospitalier Universitaire de Nantes = Nantes University Hospital (CHU Nantes) ; CHU Trousseau, APHP ; Service de Rhumatologie CHU de Montpellier ; Montpellier, CHU ; 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) ; CHU Pitié-Salpêtrière AP-HP ; 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) |
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Zeitschrift: | ISSN: 0003-4967, 2015 |
Veröffentlichung: | HAL CCSD ; BMJ Publishing Group, 2015 |
Medientyp: | academicJournal |
DOI: | 10.1136/annrheumdis-2014-205348 |
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