Self-injection of denosumab in clinical practice in the french pilote study

ABSTRACT

Objective: Describe characteristics of patients who self-inject denosumab and patterns of self-injection in France. Methods: PILOTE was a prospective observational study that evaluated persistence to denosumab over 24 months in France in postmenopausal women. Clinical information obtained through routine practice was recorded onto an eCRF, including the individual who injected subcutaneous denosumab (physician, nurse, patient, other). We conducted an ad hoc analysis of the patients in the study who self-injected denosumab. Results: In total, 478 patients were enrolled between June 2105 and February 2016. 27 patients self-injected denosumab at least once, with these patients distributed across multiple sites. Those who self-injected appeared slightly younger with longer duration of osteoporosis, and a higher proportion had a prior fracture and previous glucocorticoid and teriparatide treatment than the overall population (Table). Self-injected patients were also more likely to be living at home with family, have a University education, and be seen by a rheumatologist than a GP. Twelve patients self-injected from the beginning of the study, 15 self-injected after receiving injection from an HCP and 8 switched back to HCP injections after self-injection. Eleven of the 12 patients who self-injected from the beginning were persistent at 24 months. Six ADRs occurred in three self-injecting patients one vertebral fracture, bone pain, muscle fatigue, myalgia, asthenia, pyelonephritis. Conclusion: Although numbers were small, self- administration of denosumab appeared feasible for women with postmenopausal osteoporosis and may be a valuable option, particularly in the context of the COVID-19 pandemic when office visits are restricted. (Table Presented).