Treatment With Leflunomide in Patients With Polymyalgia Rheumatica
Status:
Recruiting
Trial end date:
2022-11-01
Target enrollment:
Participant gender:
Summary
Over the last decades outcome has greatly improved for rheumatoid arthritis (RA) and
spondyloarthritis (SpA). This is in sharp contrast to the situation for polymyalgia
rheumatica (PMR), with a lifetime prevalence of 2.4% for women and 1.7% for men, PMR is the
commonest auto-inflammatory musculoskeletal disease in adults aged ≥50 years. Due to
population ageing, the number of PMR patients will likely double in the decades to come
(CBS). Glucocorticoids (GC) are the mainstay of treatment. However, there is an unmet medical
need of alternatives in the treatment of PMR as 50% of patients will relapse or have
difficulties to reduce the corticosteroid doses. Also, there is increasing awareness of
steroid related toxicity and in addition, long-term toxicity is a well-known side-effect of
glucocorticoids in PMR.
Low dose methotrexate (< 10 mg per week) has been tested in two blinded randomized control
trials and 4 open label studies and has shown low to moderate efficacy as
corticosteroid-sparing agent. Studies on tumor necrosis factor (TNF) blockers yielded
negative results. The effectiveness of leflunomide has only been convincingly demonstrated in
case series.
The high rate of relapses and adverse events in steroid treated patients indicate that
alternative adjuvant agents are needed.
There is evidence that leflunomide could serve as steroid sparing agent and that leflunomide
can be used to prevent relapses in the clinical management of polymyalgia rheumatica.
We will perform a randomized placebo controlled trial. Eligible patients will be randomly
assigned in a 1:1 ratio receiving either leflunomide 20 mg once daily + glucocorticoids , or
placebo + glucocorticoids.
Phase:
Phase 3
Details
Lead Sponsor:
Elisabeth Brouwer
Collaborators:
Dutch Arthritis Foundation Reuma Nederland Reumafonds