Raphaèle Seror1, Gabriel Baron2, Eric Hachulla3, Michel Debandt4, Claire Larroche5, Xavier Puéchal6, François Maurier7, Benoît de Wazieres8, Thomas Quéméneur9, Philippe Ravaud2, Xavier Mariette1. 1. Department of Rheumatology, Université Paris-Sud, AP-HP, Hôpitaux Universitaires Paris-Sud, Le Kremlin Bicêtre, France. 2. Faculty of Medicine, Assistance Publique-Hopitaux de Paris, Hôtel Dieu Hospital, Centre of Clinical Epidemiology, University of Paris Descartes, Paris, France. 3. Department of Internal Medicine, National Referral Centre for Rare Systemic Auto-immune Diseases, Hôpital Claude Huriez, Université de Lille 2, Lille, France. 4. Department of Rheumatology, CHU de La Meynard, Fort de France, France. 5. Department of Internal Medicine, Hôpital Avicenne, APHP, Bobigny, France. 6. 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. 7. Department of Internal Medicine, HP-Metz Site HSB, Metz, France. 8. Department of Internal Medicine and Gerontology, CHU de Nîmes, Nîmes, France. 9. Department of Internal Medicine, Centre Hospitalier Valenciennes, Valenciennes, France.
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 theadalimumab 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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
RCT Entities:
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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Authors: Chie Miyabe; Yoshishige Miyabe; Klemen Strle; Nancy D Kim; John H Stone; Andrew D Luster; Sebastian Unizony Journal: Ann Rheum Dis Date: 2016-12-07 Impact factor: 19.103
Authors: Antoine G Sreih; Fatma Alibaz-Oner; Tanaz A Kermani; Sibel Z Aydin; Peter F Cronholm; Trocon Davis; Ebony Easley; Ahmet Gul; Alfred Mahr; Carol A McAlear; Nataliya Milman; Joanna C Robson; Gunnar Tomasson; Haner Direskeneli; Peter A Merkel Journal: J Rheumatol Date: 2017-09-01 Impact factor: 4.666