Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.
A Double-Blind Placebo Controlled Trial of Infliximab in Patients with Corticosteroid-Dependent Polymyalgia Rheumatica.
Martinez-Taboada11, Victor M., Lopez-Longo10, Francisco Javier, Vicuna8, Rosario García de, Gratacos5, Jordi, Espigol-Frigole2, Georgina, Medina6, Julio, Narvaez3, Javier
Hospital Clinic, Barcelona, Spain
Hospital Universitario Gregorio Maranón, Spain
Hospital Universitario Marqués de Valdecilla, Santander, Spain
Hospital Clinic, Spain
Hospital de Bellvitge, Barcelona, Spain
Hospital Doctor Negrín, Spain
Hospital Parc Taulí, Barcelona, Spain
Hospital Río Carrión, Palencia, Spain
Hospital San Jorge de Huesca, Spain
Hospital Universitario de la Princesa, Madrid, Spain
Hospital Universitario Gregorio Maranón, Madrid, Spain
Corticosteroids (CS) constitute the standard treatment of polymyalgia rheumatica (PMR). However, a significant proportion of patients remain CS-dependent. Open label studies have suggested that tumour necrosis factor (TNF) antagonists led to sustained improvement and CS sparing effect in patients with refractory PMR. To confirm these observations, we conducted a randomised, double-blind, placebo controlled trial with infliximab in CS-dependent patients with PMR.
We randomly assigned patients with CS-dependent PMR (defined as requiring >= 5 mg/day after at least 2 years of treatment to maintain remission or >= 7.5 mg/day after at least 6 months) to receive Infliximab (5 mg/kg i.v) at 0, 2, 6, 14 and 22 weeks (n = 11) or placebo (n = 11) together with CS that were reduced according to a predefined schedule. The primary outcome was the proportion of responder patients - defined as individuals with both complete clinical and analytical remission without receiving CS for at least three months- at 24 weeks. Secondary outcomes were cumulated CS doses and adverse events
Baseline characteristics were similar in the two groups. The majority of patients were women (81.8% in infliximab versus 63.6% in placebo, p=0.6) with a mean age of 68.5±10.4 years in infliximab and 74.7±5.3 years in placebo group (p=0.3). PMR duration (median: 30.0 months and 36.0 months in infliximab and placebo groups, respectively; p=0.8) and CS dose at baseline (7.4±3.2 mg in infliximab versus 8.1±3.0 mg in placebo group; p=0.5) were also similar. At week 24, 17 patients continued in the trial (8 in infliximab and 9 in placebo group), and only 1 patient in the infliximab group and 2 in the placebo group fulfilled the definition of responder (p, NS). During the 24-week period, CS dose was increased according to physician judgment at least once in 36.4% of patients in the infliximab group compared with 72.72% in the placebo group (p=0.2). Patients in the infliximab group tended to have lower cumulated dose of prednisone during the first 24 weeks of treatment (533.7±366.8 mg versus 901.1±522.4 mg; p=0.1) and received lower CS dose at week 24 (1.1±1.4 mg versus 3.6±2.6 mg; p=0.06). There were 26 adverse events (24 mild/moderate) in patients treated with infliximab and 7 (all mild/moderate) in those patients treated with placebo.
The limited number of patients included in this trial does not allow definitive conclusions. The therapeutic role of infliximab in patients with CS-dependent PMR should be evaluated in trials enrolling larger patient cohorts.
The medication of the study (infliximab) was provided by Schering-Plough S.A.
To cite this abstract, please use the following information:
Martinez-Taboada, Victor M., Lopez-Longo, Francisco Javier, Vicuna, Rosario García de, Gratacos, Jordi, Espigol-Frigole, Georgina, Medina, Julio, et al; A Double-Blind Placebo Controlled Trial of Infliximab in Patients with Corticosteroid-Dependent Polymyalgia Rheumatica. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :1276