Infliximab Therapy in Patients With Refractory Polymyalgia Rheumatica
Status:
Unknown status
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
Rheumatic Polymyalgia(PMR) is a relatively common chronic inflammatory disorder of unknown
origin which predominantly develops in elderly subjects and presents with severe pain and
stiffness in the neck, shoulder and pelvic girdles, along with increased acute phase
reactants. Systemic manifestations such as fever, anorexia and weight loss are characteristic
signatures of PMR.
Corticosteroids (CS) constitute the standard treatment of PMR. Although in most patients the
symptoms of the disease disappear after one or two years of treatment, a proportion of
patients remain CS-dependent with the subsequent CS toxicity. Open label studies have
suggested that tumour necrosis factor (TNF) antagonists lead to sustained improvement and CS
sparing effect in patients with refractory PMR.
The investigators conducted a randomised, double-blind, placebo controlled trial with
infliximab in CS-dependent patients with PMR. 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) were randomly assigned to receive Infliximab (5 mg/kg i.v) at
0, 2, 6, 14 and 22 weeks (n = 12) 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 cumulative CS
doses and adverse events proportion.