title: Adalimumab in patients with hand osteoarthritis refractory to analgesics and NSAIDs: a randomised, multicentre, double-blind, placebo-controlled trial.
abstract: OBJECTIVE
  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).
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  Adalimumab was not superior to placebo to alleviate pain in patients with hand OA not responding to analgesics and NSAIDs.
  
  
  BACKGROUND
  NCT00597623.
authors.affiliation: Department of Rheumatology, Henri Mondor Hospital, Creteil, France.
authors.forename: X
authors.initials: X
authors.lastname: Chevalier
authors.affiliation: INSERM, AP-HP (Assistance Publique des Hôpitaux de Paris), Hôpital Hôtel Dieu, Centre d'Epidémiologie Clinique, Univ. Paris Descartes, Sorbonne Paris Cité, Faculté de Médecine, Paris, France.
authors.forename: P
authors.initials: P
authors.lastname: Ravaud
authors.affiliation: Department of Rheumatology, Hopital Saint Antoine University Paris VI, Paris, France.
authors.forename: E
authors.initials: E
authors.lastname: Maheu
authors.affiliation: INSERM, AP-HP (Assistance Publique des Hôpitaux de Paris), Hôpital Hôtel Dieu, Centre d'Epidémiologie Clinique, Univ. Paris Descartes, Sorbonne Paris Cité, Faculté de Médecine, Paris, France.
authors.forename: G
authors.initials: G
authors.lastname: Baron
authors.affiliation: Unité de Recherche Clinique, Hopital Henri Mondor, UPEC Paris XII.
authors.forename: A
authors.initials: A
authors.lastname: Rialland
authors.affiliation: Laboratoire Synarc, Lyon, France.
authors.forename: P
authors.initials: P
authors.lastname: Vergnaud
authors.affiliation: Department of Rheumatology, Hopital de l'Archet, University Nice, France.
authors.forename: C
authors.initials: C
authors.lastname: Roux
authors.affiliation: Department of Rheumatology, University Nantes, France.
authors.forename: Y
authors.initials: Y
authors.lastname: Maugars
authors.affiliation: Department of Rheumatology, Hopital Trousseau, University Tours, France.
authors.forename: D
authors.initials: D
authors.lastname: Mulleman
authors.affiliation: Department of Rheumatology, Hopital Lapeyronnie, University Montpellier, France.
authors.forename: C
authors.initials: C
authors.lastname: Lukas
authors.affiliation: Department of Rheumatology, Centre Hospitalier Universitaire de Besançon, Université de Franche-Comté, Besançon, University of Besancon, France.
authors.forename: D
authors.initials: D
authors.lastname: Wendling
authors.affiliation: Department of Rheumatology, Hopital de la Conception, University of Marseille, France.
authors.forename: P
authors.initials: P
authors.lastname: Lafforgue
authors.affiliation: Department of Rheumatology, Hopital Brabois, University of Nancy, France.
authors.forename: D
authors.initials: D
authors.lastname: Loeuille
authors.affiliation: Department of Rheumatology, Hopital La Pitié, University Paris VI, France.
authors.forename: V
authors.initials: V
authors.lastname: Foltz
authors.affiliation: Université Paris Diderot, Assistance Publique-Hôpitaux de Paris, Hôpital Lariboisière, Fédération de Rhumatologie, Paris, France.
authors.forename: P
authors.initials: P
authors.lastname: Richette
mesh_terms: D000068879:Adalimumab; D000368:Aged; D000700:Analgesics / Q000627:therapeutic use; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D050823:Hand Joints; D006801:Humans; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000150:complications / Q000188:drug therapy*; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D010147:Pain Measurement; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D000700:Analgesics; D000894:Anti-Inflammatory Agents, Non-Steroidal; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D000068879:Adalimumab
keywords: Anti-TNF; Hand Osteoarthritis; Treatment