Adalimumab in patients with hand osteoarthritis refractory to analgesics and NSAIDs: a randomised, multicentre, double-blind, placebo-controlled trial
- X Chevalier1,
- P Ravaud2,
- E Maheu3,
- G Baron2,
- A Rialland4,
- P Vergnaud5,
- C Roux6,
- Y Maugars7,
- D Mulleman8,
- C Lukas9,
- D Wendling10,
- P Lafforgue11,
- D Loeuille12,
- V Foltz13,
- P Richette14,
- On behalf of the French section of osteoarthritis
- 1Department of Rheumatology, Henri Mondor Hospital, Creteil, France
- 2INSERM, 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
- 3Department of Rheumatology, Hopital Saint Antoine University Paris VI, Paris, France
- 4Unité de Recherche Clinique, Hopital Henri Mondor, UPEC Paris XII
- 5Laboratoire Synarc, Lyon, France
- 6Department of Rheumatology, Hopital de l'Archet, University Nice, France
- 7Department of Rheumatology, University Nantes, France
- 8Department of Rheumatology, Hopital Trousseau, University Tours, France
- 9Department of Rheumatology, Hopital Lapeyronnie, University Montpellier, France
- 10Department of Rheumatology, Centre Hospitalier Universitaire de Besançon, Université de Franche-Comté, Besançon, University of Besancon, France
- 11Department of Rheumatology, Hopital de la Conception, University of Marseille, France
- 12Department of Rheumatology, Hopital Brabois, University of Nancy, France
- 13Department of Rheumatology, Hopital La Pitié, University Paris VI, France
- 14Université Paris Diderot, Assistance Publique-Hôpitaux de Paris, Hôpital Lariboisière, Fédération de Rhumatologie, Paris, France
- Correspondence to Professor Xavier Chevalier, Department of Rheumatology, Henri Mondor Hospital, Creteil 94010, France;
- Received 4 February 2014
- Revised 31 March 2014
- Accepted 13 April 2014
- Published Online First 9 May 2014
Aim 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.
Trials registration number NCT00597623.