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Adalimumab for steroid sparing in patients with giant-cell arteritis: results of a multicentre randomised controlled trial
  1. Raphaèle Seror1,
  2. Gabriel Baron2,
  3. Eric Hachulla3,
  4. Michel Debandt4,
  5. Claire Larroche5,
  6. Xavier Puéchal6,7,
  7. François Maurier8,
  8. Benoît de Wazieres9,
  9. Thomas Quéméneur10,
  10. Philippe Ravaud2,
  11. Xavier Mariette1
  1. 1Department of Rheumatology, Université Paris-Sud, AP-HP, Hôpitaux Universitaires Paris-Sud, Le Kremlin Bicêtre, France
  2. 2Faculty of Medicine, Assistance Publique–Hopitaux de Paris, Hôtel Dieu Hospital, Centre of Clinical Epidemiology, University of Paris Descartes, Paris, France
  3. 3Department of Internal Medicine, National Referral Centre for Rare Systemic Auto-immune Diseases, Hôpital Claude Huriez, Université de Lille 2, Lille, France
  4. 4Department of Rheumatology, CHU de La Meynard, Fort de France, France
  5. 5Department of Internal Medicine, Hôpital Avicenne, APHP, Bobigny, France
  6. 6Department of Rheumatology, Hôpital du Mans, Le Mans, France
  7. 7National Referral Centre for Rare Systemic Auto-immune Diseases, Cochin Hospital, AP-HP, Paris Descartes University, Paris, France
  8. 8Department of Internal Medicine, HP-Metz Site HSB, Metz, France
  9. 9Department of Internal Medicine and Gerontology, CHU de Nîmes, Nîmes, France
  10. 10Department of Internal Medicine, Centre Hospitalier Valenciennes, Valenciennes, France
  1. Correspondence to Dr Xavier Mariette, Department of Rheumatology, Hôpital Bicêtre, 78 rue du Général Leclerc, Le Kremlin Bicêtre 94275, France; xavier.mariette{at}bct.aphp.fr

Abstract

Objectives To evaluate the effect of adding a 10-week treatment of adalimumab to a standardised treatment with corticosteroids on the ability to taper more rapidly corticosteroid doses in patients with newly diagnosed giant cell arteritis (GCA).

Methods Patients included in this double-blind, multicentre controlled trial were randomly assigned to receive a 10-week subcutaneous treatment of adalimumab 40 mg every other week or placebo in addition to a standard prednisone regimen (starting dose 0.7 mg/kg per day). The primary endpoint was the percentage of patients in remission on less than 0.1 mg/kg of prednisone at week 26. Analysis was performed by intention to treat (ITT).

Results Among the 70 patients enrolled (adalimumab, n=34; placebo, n=36), 10 patients did not receive the scheduled treatment, seven in the adalimumab and three in the placebo group. By ITT, the number of patients achieving the primary endpoint was 20 (58.9%) and 18 (50.0%) in the adalimumab and placebo arm, respectively (p=0.46). The decrease in prednisone dose and the proportion of patients who were relapse free did not differ between the two groups. Serious adverse events occurred in five (14.7%) patients on adalimumab and 17 (47.2%) on placebo, including serious infections in three patients on adalimumab and five on placebo. Two patients died in the placebo arm (septic shock and cancer) and one in the adalimumab group (pneumonia).

Conclusions In patients with newly diagnosed GCA, adding a 10-week treatment of adalimumab to prednisone did not increase the number of patients in remission on less than 0.1 mg/kg of corticosteroids at 6 months.

Clinical trial registration number NCT00305539.

  • Giant Cell Arteritis
  • Anti-TNF
  • Corticosteroids

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