title: Adalimumab for steroid sparing in patients with giant-cell arteritis: results of a multicentre randomised controlled trial.
abstract: OBJECTIVE
  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.
  
  
  BACKGROUND
  NCT00305539.
authors.affiliation: Department of Rheumatology, Université Paris-Sud, AP-HP, Hôpitaux Universitaires Paris-Sud, Le Kremlin Bicêtre, France.
authors.forename: Raphaèle
authors.initials: R
authors.lastname: Seror
authors.affiliation: Faculty of Medicine, Assistance Publique-Hopitaux de Paris, Hôtel Dieu Hospital, Centre of Clinical Epidemiology, University of Paris Descartes, Paris, France.
authors.forename: Gabriel
authors.initials: G
authors.lastname: Baron
authors.affiliation: Department of Internal Medicine, National Referral Centre for Rare Systemic Auto-immune Diseases, Hôpital Claude Huriez, Université de Lille 2, Lille, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Hachulla
authors.affiliation: Department of Rheumatology, CHU de La Meynard, Fort de France, France.
authors.forename: Michel
authors.initials: M
authors.lastname: Debandt
authors.affiliation: Department of Internal Medicine, Hôpital Avicenne, APHP, Bobigny, France.
authors.forename: Claire
authors.initials: C
authors.lastname: Larroche
authors.affiliation: Department of Rheumatology, Hôpital du Mans, Le Mans, France National Referral Centre for Rare Systemic Auto-immune Diseases, Cochin Hospital, AP-HP, Paris Descartes University, Paris, France.
authors.forename: Xavier
authors.initials: X
authors.lastname: Puéchal
authors.affiliation: Department of Internal Medicine, HP-Metz Site HSB, Metz, France.
authors.forename: François
authors.initials: F
authors.lastname: Maurier
authors.affiliation: Department of Internal Medicine and Gerontology, CHU de Nîmes, Nîmes, France.
authors.forename: Benoît
authors.initials: B
authors.lastname: de Wazieres
authors.affiliation: Department of Internal Medicine, Centre Hospitalier Valenciennes, Valenciennes, France.
authors.forename: Thomas
authors.initials: T
authors.lastname: Quéméneur
authors.affiliation: Faculty of Medicine, Assistance Publique-Hopitaux de Paris, Hôtel Dieu Hospital, Centre of Clinical Epidemiology, University of Paris Descartes, Paris, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Ravaud
authors.affiliation: Department of Rheumatology, Université Paris-Sud, AP-HP, Hôpitaux Universitaires Paris-Sud, Le Kremlin Bicêtre, France.
authors.forename: Xavier
authors.initials: X
authors.lastname: Mariette
mesh_terms: D000068879:Adalimumab; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D013700:Giant Cell Arteritis / Q000188:drug therapy*; D006801:Humans; D008297:Male; D011241:Prednisone / Q000008:administration & dosage* / Q000627:therapeutic use; D012074:Remission Induction / Q000379:methods; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D061067:Antibodies, Monoclonal, Humanized; D000068879:Adalimumab; D011241:Prednisone
keywords: Anti-TNF; Corticosteroids; Giant Cell Arteritis