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AB0839 The efficacy and safety of denosumab local experience)
  1. J Al-Saleh,
  2. N Salah,
  3. AS Hasan,
  4. S Mohamad,
  5. FA ElBadawi,
  6. M Khamashta
  1. Rheumatology Department, Dubai Hospital, Dubai, United Arab Emirates

Abstract

Background Denosumab was introduce to the United Arab Emirates Market in 2013.Given the limited experience in using Denosumab in the region we have explored it efficacy and safety in daily practice.

Objectives To assess the efficacy and safety of Denosumab in our practice.

Methods Inclusion criteria: All patients received Denosumab in a dose of 60mg every six months. Underwent DEXA scan in Dubai Health Authority. Exclusion from analysis: Other Doses of Denosumab, who received less than 3 doses, and those with no follow up DEXA scan. Outcome measures: 1) Efficacy: Proposed Criteria for Assessing Clinical Response [1,2]. a) “inadequate”: incident fracture and significant BMD decrease. b) “possible inadequate”: incident fracture or significant BMD decrease. c) “appropriate”: no fracture and stability or increase in BMD. 2) Safety: Reviewing the medical records and conduct patients interview for occurrence of the following adverse events. Statistical analysis: Descriptive statistical analysis, Graphpad Prism 6 was used.

Results 143 patient identified. Out 139 patients 86 were eligible for analysis (See table 1). At baseline 39% had normal vitamin D level, 57% had insufficiency and 4% had deficiency. 20 of 86 did not undergo repeated DEXA scan. 9% had osteopenia and 91% had osteoporosis before initiating Denosumab in comparison 8% had normal bone mineral density, 45% had osteopenia and 47% post four injections of Denosumab. Table 2 summarize the comparison between the responders and non-responders. There was a significant positive correlation in the increase in bone mineral density among the responders at the femoral neck and the lumbar spine, (r=0.56, 95% confidence interval: 0.31–0.74, P-value <0.0001 No report of any of the adverse events 86 patients who completed 2 years or more on treatment.

Table 1.

Patients characteristics at baseline

Table 2.

Comparison between the appropriate Response group “Responders” and inadequate response group “Non-responders”

Conclusions Denosumab was effective and safe in our patients. Long-term follow up is required to verify these findings in our population.

References

  1. Diez-Perez and Gonzalez-Macias. Inadequate responders to osteoporosis treatment: proposal for an operational definition. Osteoporos Int. 2008 Nov;19(11):1511–6.

  2. E. M. Lewiecki & N. B. Watts. Assessing response to osteoporosis therapy Osteoporos Int (2008) 19:1363–1368.

References

Disclosure of Interest None declared

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