Background Osteoporosis is a common disease consisting of reduced bone mineral density, with a raised fracture risk. Denosumab is the first fully human monoclonal antibody, binding RANK-L, approved for postmenopausal osteoporosis with high fracture risk. Combining biological therapies in rheumatoid arthritis increases adverse events and infections, without improving efficacy1,2.
Objectives The aim of our study is to describe a cohort of patients with osteoporosis (OP) treated with Denosumab and patients diagnosed with chronic arthritis (CA) treated with biological therapies and Denosumab for osteoporosis in daily clinical practice.
Methods Observational and prospective study from January 2013 to December 2014. We included all patients with OP seen at least once at our nurses osteoporosis clinic of a university hospital. The recruitment method was as follows; 1, Patients from our outpatients clinic; 2, By reviewing medical reports of patients with CA treated with biological therapy and osteoporosis treated with Denosumab. CA patients include (Rheumatoid arthritis [RA], Ankylosing spondylitis [AS] and Psoriatic arthritis [PsA]).
At our unit we gave general information related to osteoporosis and we did follow-up visits every 6 months. We asked for demographic information (age, gender, previous fractures and treatments etc.). We also asked about infections, new fractures and spinal pain on a visual analogic scale (VAS) from 0 to 10 every visit.
In patients with follow-ups after 12 months, we compared infections and new fracture rates between patients with OP and patients with AC. We also compared spinal pain on a VAS between baseline and after 12 months.
Results We included 85 patients with an average age of 67, (SD 10.3),76 of whom were women (89.4%). From all 85 patients with osteoporosis, 34 patients (40%) also had CA, 26 RA (30.6% from all patients), 6 AS (7.1%) and 2 PsA (2.4%). Table 1 shows descriptive demographic data. From 42 patients with follow-up safter 12 months, 27 only had OP and 15 had OP and CA. There were not differences between either groups regarding no new fractures or infections. Spinal pain VAS (n:42) improved significantly, on average6.26 at baseline and 4.48 after 12 months (“p”<0.001).
Conclusions Our study shows a significant spinal pain improvement in daily clinical practice in patients with osteoporosis treated with Denosumab at 12 months. With follow-up safter 12 months, the incidence of new fractures or infections is similar between patients treated only with Denosumab and patients treated also with additional biological therapy. Our study is still on-going with the aim of confirming these results in the future.
Weinblatt M, Ann Rheum Dis. 2007
Genovese MC, Arthritis Rheum. 2004
Disclosure of Interest None declared