Background/Purpose: Excluding clinical trials, there is limited evidence on the effect of 12 months of romosozumab treatment on increasing bone mineral density (BMD) in real-world clinical practice due to its recent approval. In Spain, romosozumab (ROMO) was authorized in September 2022. Furthermore, real-life data are needed for subpopulations such as patients with osteoporosis due to glucocorticoids (GC), or those with rheumatoid arthritis. The objective of this study was to describe the clinical-analytical, bone density, and safety characteristics at 12 months in patients with a very high risk of fracture treated with ROMO.

Methods: This was a multicenter observational descriptive study developed in rheumatology clinics across Spain, including women with OP who initiated ROMO treatment from September 2022. The baseline characteristics of 97 patients with a very high risk of fracture were analyzed. Collected characteristics included age, sex, risk factors for OP (early menopause, previous fractures or parental hip), cardiovascular risk factors -CVRF- (smoking, high blood pressure -HBP-, dyslipidemia -DLP-, diabetes mellitus -DM-), gloremular filtration rate, disease requiring GC, major FRAX and hip score, BMD before and after ROMO treatment previous therapies, and safety data at 6 and 12 months (MACE). Statistical analysis was performed using R software, and the study was conducted with the approval of the local ethics committee.

Results: The average age was 70.3 years. 78 cases (80,4%) had previous vertebral fractures and 32 cases (33.3%) had other fracture; 9 patients (9.3%) had no fractures prior to ROMO treatment. All 97 patients (100% women) were analyzed; 16.7% had not received prior treatment. More than 60% of patients were treated with previous therapies. The most used prior medications were bisphosphonates -BP- (n = 26), followed by denosumab -DMAb- (n = 9) and teriparatide -TPTD- (n = 6). Up to 11.5% of patients (n = 11) had previously received up to three drugs.

Cardiovascular risk factors included: 33% HBP; 33% DLP; 4.1% DM, and 12.4% active smoking. Seventeen patients (17.5%) had OP due to glucocorticoids (GC-induced OP). Reasons for GC treatment included 6 cases of asthma, 4 hematological diseases, and 6 rheumatic diseases (2 polymyalgia rheumatica, 2 rheumatoid arthritis, 1 systemic lupus erythematosus, and 1 Sjögren’s syndrome). See table 1.

Of the 97 patients, 12-month safety data were available for 35 patients; none had suffered a major adverse cardiovascular event (MACE) during treatment. Twelve-month densitometric data (BMD) were available for 16 patients. The difference in pre-post lumbar spine T-score was +0.74 and in the femoral neck was +0.52. Both figures show a statistically significant improvement after one year with ROMO (See Table 2, and Figure 1).

Conclusion: This real-world dataset demonstrates rapid progress in a Spanish patient population. After one year of treatment, the T-scores of the lumbar spine and femoral neck increased significantly. Not a single case of MACE nor any other safety issues were detected. More studies are needed to assess the efficacy of ROMO in treating glucocorticoid-induced osteoporosis and in patients with rheumatoid arthritis or other rheumatologic diseases.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/analysis-of-effectiveness-and-safety-of-romosozumab-in-patients-with-very-high-risk-of-fracture-in-a-spanish-population/