Arthritis & Rheumatism, Volume 60,
October 2009 Abstract Supplement
The 2009 ACR/ARHP Annual Scientific Meeting
Philadelphia October 16-21, 2009.
Adding Hydroxychloroquine to Prednisone Does Not Improve the Outcome in Giant Cell Arteritis: A Double Blind Randomized Controlled Trial
Sailler1, Laurent, Lapeyre-Mestre2, Maryse, Geffray3, Loïck, Letellier4, Philippe, Liozon5, Eric, de La Roque6, Philippe Montané, Hamidou7, Mohamed
Université de Toulouse, Laboratoire de Pharmacoépidémiologie, EA3696, Toulouse, France,
CHU Purpan, Toulouse,, France,
Université de Toulouse, Laboratoire de Pharmacologie Médicale et Clinique, Toulouse, France
Université de Toulouse, Laboratoire de Pharmaco-épidémiologie, EA3696, Toulouse, France,
CHG de Lisieux, Lisieux, France,
CHU Côte de Nacre, Caen, France,
CHU de Limoges, Limoges, France,
CHG du Val d'Ariège, Foix, France,
Hôtel Dieu, Nantes, France,
CHG, Béziers, France,
CHU, Hôpital jean Minjoz, Besançon, France,
Few drugs have corticosteroid sparing effects in the treatment of giant cell arteritis (GCA). Hydroxychloroquine is a well tolerated immunomodulatory drug that may have a corticosteroid sparing potential according to its immuno-pharmacological properties and previous clinical data (Le Guennec et al, Rev Rhum 1994). Our objective was to evaluate the glucocorticosteroid (GC) sparing effect of hydroxychloroquine (HCQ) in the treatment of non-complicated GCA.
This was a double blind randomized controlled trial. Patients with a non-complicated, newly diagnosed, biopsy confirmed GCA randomly received corticosteroids plus placebo or plus 400 mg HCQ per day for up to 96 weeks. The primary end point was being in remission with 5 mg prednisone or less for at least 3 months at the end of the follow-up. Analysis was made on an intent-to-treat basis using the Kaplan-Meier method and the log-rank test to compare the survival curves, and the Cox proportional hazard ratio to identify variables associated with the outcome. All patients have given their informed consent. The study has been registered on the clinicaltrial.gov web site (identifier: NCT00430807).
74 patients were randomized to receive placebo (n=38) or hydroxychloroquine (n=36). Among them, 10 were excluded before beginning the study drug (7 for cancellation of earlier approval, 1 for a severe GC-induced psychosis, 2 due to a major deviation). Among the 64 remaining patients (mean age: 74.4 ± 6.5 years), 32 received the placebo and 32 HCQ. Fourteen out of 32 HCQ and 21 out of 32 placebo patients reached the primary endpoint (log-rank test: p= 0.22). Twenty HCQ patients and 14 placebo patients experienced at least one relapse (p=0.13). The median cumulative corticosteroid doses were 7146 mg (range: 46439493) in the HCQ group and 6687 mg (range: 456310444) in the placebo group (p=0.9). The study drug was stopped due to adverse reactions in 8 HCQ patients (skin eruption in 6). In a post hoc analysis, receiving HCQ was independently associated with an increased risk of relapse after week 24 (HR = 2.52 [IC95% 1.145.57], p = 0.02). Polymyalgia rheumatica symptoms at the baseline (HR: 0.38 [0.150.96], p=0.04) and male gender (HR: 0.44 [0.170.93], p=0.03) were associated with a lower risk of relapse.
The early administration of hydroxychloroquine did not improve the outcome in non-complicated giant cell arteritis and was not always well-tolerated.
To cite this abstract, please use the following information:
Sailler, Laurent, Lapeyre-Mestre, Maryse, Geffray, Loïck, Letellier, Philippe, Liozon, Eric, de La Roque, Philippe Montané, et al; Adding Hydroxychloroquine to Prednisone Does Not Improve the Outcome in Giant Cell Arteritis: A Double Blind Randomized Controlled Trial [abstract]. Arthritis Rheum 2009;60 Suppl 10 :1972