AB0839 The efficacy and safety of denosumab local experience

• Published in: Annals of the rheumatic diseases Vol. 76; no. Suppl 2; p. 1350
• Main Authors: Al-Saleh, J, Salah, N, Hasan, AS, Mohamad, S, ElBadawi, FA, Khamashta, M
• Format: Journal Article
• Language: English
• Published: London BMJ Publishing Group LTD 01.06.2017
• Subjects: Bone density; Bone mineral density; Dual energy X-ray absorptiometry; Femur; Fractures; Immunotherapy; Medical records; Monoclonal antibodies; Osteopenia; Osteoporosis; Patients; Rheumatic diseases; Safety; Spine (lumbar); Statistical analysis; Statistics; Vitamin D
• ISSN: 0003-4967; 1468-2060
• DOI: 10.1136/annrheumdis-2017-eular.6791

BackgroundDenosumab 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.ObjectivesTo 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.Results143 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 baselineVariablesNumberPercentage Age (yrs) median, (1st Quartile- 3rd Quartile)65, (58–67)51- 654835%>657655%Female12691%UAE12187%Comorbidities7252%Received 4 Denosumab doses or more8662%DEXA scan in DHA at Baseline13698%Osteopenia129%Osteoporosis12491%Fractures129%Table 2.Comparison between the appropriate Response group “Responders” and inadequate response group “Non-responders”VariablesRespondersNon-respondersOdds RatioP-value95% CI Number5214Rheumatic Diseases6360.10.00010.05–0.2Fracture030.2NSPre-treatment fractures919.50.022.0–70ConclusionsDenosumab was effective and safe in our patients. Long-term follow up is required to verify these findings in our population.References Diez-Perez and Gonzalez-Macias. Inadequate responders to osteoporosis treatment: proposal for an operational definition. Osteoporos Int. 2008 Nov;19(11):1511–6.E. M. Lewiecki & N. B. Watts. Assessing response to osteoporosis therapy Osteoporos Int (2008) 19:1363–1368. Disclosure of InterestNone declared