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IWO Meeting 16 November 2022 - Real world data: denosumab

S
Stichting Interdisciplinaire Werkgroep Osteoporose

This document discusses real-world evidence on denosumab for osteoporosis treatment and fracture prevention. It summarizes several studies, including one that found denosumab reduced fracture risk by 38% compared to placebo in over 25,000 postmenopausal women. Another study showed good long-term persistence with denosumab therapy in over 800 patients. Additional studies observed that zoledronic acid can prevent bone loss following denosumab discontinuation, and bisphosphonate treatment after denosumab provides protection against new vertebral fractures.

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Real world evidence omtrent denosumab Antoon van Lierop IWO Webinar 16 november 2022 Copyright Dr. A van Lierop
(potenti谷le) belangenverstrengeling Geen / Zie hieronder Voor bijeenkomst mogelijk relevante relaties met bedrijven Bedrijfsnamen Sponsoring of onderzoeksgeld Honorarium of andere (financi谷le) vergoeding Aandeelhouder Andere relatie, namelijk Amgen, UCB Disclosure belangen spreker Copyright Dr. A van Lierop
Real world evidence Randomized controlled trials Real world evidence Copyright Dr. A van Lierop
Real world evidence denosumab 1. Fractuurpreventie Lai et al. Osteoporosis International 2022 May 33(5):1155-1164 2. Persistentie Boschitsch et al. Osteoporosis International 2022 Jan 33(1):263-272 3. Effect van bisfosfonaten op rebound effect Evert-Graber et al. Bone 2022 Oct 163:11498 Burckhardt et al. J of Bone and Mineral Research 2021 Sep 36(9):1717-1728 Copyright Dr. A van Lierop
FREEDOM trial: effect denosumab op fractuur risico Cummings SR, et al. N Engl J Med. 2009; 361: 756-765 Copyright Dr. A van Lierop
FREEDOM extension trial: effect denosumab op fractuur risico 0,0 1,0 2,0 3,0 4,0 1 2 3 4/5 6 7/8 9/10 0 0 0 0 1 1 1 3,1 3,1 2,2 Years of Study Treatment Yearly Incidence of New Vertebral Fractures, % Pivotal Phase 3 Fracture Trial Extension Study Placebo (n=3906) Continued denosumab (n=2343) 1.5 1.2 1.4 1.3 Copyright Dr. A van Lierop
Effectiveness of denosumab for fracture prevention in realworld postmenopausal women with osteoporosis: a retrospective cohort study Lai et al. Osteoporosis International 2022 May 33(5):1155-1164 25.059 ptn 13.847 ptn 13.419 ptn Propensity score matching 13.419 ptn Copyright Dr. A van Lierop
Effectiveness of denosumab for fracture prevention in realworld postmenopausal women with osteoporosis: a retrospective cohort study Lai et al. Osteoporosis International 2022 May 33(5):1155-1164 1.0 per 100 vs 1.7 per 100 patientjaren Risico reductie van 38% Copyright Dr. A van Lierop
Longterm persistence with denosumab: realworld data from the Austrian Osteoporosis Clinic (AOC). A retrospective data analysis Boschitsch et al. Osteoporosis Int 2022 Jan 33(1):263-272 851 patienten - 630 intern - 221 extern Copyright Dr. A van Lierop
Rebound effect denosumab Bone et al. J Clin Endocrinol Metab, April 2011, 96(4):972980 Copyright Dr. A van Lierop
Effects of zoledronate on bone mineral density and bone turnover after long-term denosumab therapy: Observations in a real-world setting Evert-Graber et al. Bone 2022 Oct 163:11498 Copyright Dr. A van Lierop
Effects of zoledronate on bone mineral density and bone turnover after long-term denosumab therapy: Observations in a real-world setting Evert-Graber et al. Bone 2022 Oct 163:11498 Copyright Dr. A van Lierop
Effects of zoledronate on bone mineral density and bone turnover after long-term denosumab therapy: Observations in a real-world setting Evert-Graber et al. Bone 2022 Oct 163:11498 Copyright Dr. A van Lierop
Fractures After Denosumab Discontinuation: A Retrospective Study of 797 Cases Gemiddeld 6 injecties FU: 26 maanden Vooraf 48% bisfosfonaat Achteraf 63% bisfosfonaat 81 patienten (10%) 215 wervelfracturen Burckhardt et al. JBMR 2021 Sep 36(9):1717-1728 Copyright Dr. A van Lierop
Fractures After Denosumab Discontinuation: A Retrospective Study of 797 Cases Burckhardt et al. JBMR 2021 Sep 36(9):1717-1728 Copyright Dr. A van Lierop
Samenvatting Denosumab geeft ook in real world setting adequate fractuur reductie Behandeling wordt in merendeel patienten gecontinueerd Nabehandeling met zoledoninezuur voorkomt ten delen botverlies tgv rebound fase Nabehandeling met bisfosfonaten geven adequate bescherming tegen nieuwe wervelfracturen na staken van denosumab Copyright Dr. A van Lierop
Vragen Copyright Dr. A van Lierop

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IWO Meeting 16 November 2022 - Real world data: denosumab

  • 1. Real world evidence omtrent denosumab Antoon van Lierop IWO Webinar 16 november 2022 Copyright Dr. A van Lierop
  • 2. (potenti谷le) belangenverstrengeling Geen / Zie hieronder Voor bijeenkomst mogelijk relevante relaties met bedrijven Bedrijfsnamen Sponsoring of onderzoeksgeld Honorarium of andere (financi谷le) vergoeding Aandeelhouder Andere relatie, namelijk Amgen, UCB Disclosure belangen spreker Copyright Dr. A van Lierop
  • 3. Real world evidence Randomized controlled trials Real world evidence Copyright Dr. A van Lierop
  • 4. Real world evidence denosumab 1. Fractuurpreventie Lai et al. Osteoporosis International 2022 May 33(5):1155-1164 2. Persistentie Boschitsch et al. Osteoporosis International 2022 Jan 33(1):263-272 3. Effect van bisfosfonaten op rebound effect Evert-Graber et al. Bone 2022 Oct 163:11498 Burckhardt et al. J of Bone and Mineral Research 2021 Sep 36(9):1717-1728 Copyright Dr. A van Lierop
  • 5. FREEDOM trial: effect denosumab op fractuur risico Cummings SR, et al. N Engl J Med. 2009; 361: 756-765 Copyright Dr. A van Lierop
  • 6. FREEDOM extension trial: effect denosumab op fractuur risico 0,0 1,0 2,0 3,0 4,0 1 2 3 4/5 6 7/8 9/10 0 0 0 0 1 1 1 3,1 3,1 2,2 Years of Study Treatment Yearly Incidence of New Vertebral Fractures, % Pivotal Phase 3 Fracture Trial Extension Study Placebo (n=3906) Continued denosumab (n=2343) 1.5 1.2 1.4 1.3 Copyright Dr. A van Lierop
  • 7. Effectiveness of denosumab for fracture prevention in realworld postmenopausal women with osteoporosis: a retrospective cohort study Lai et al. Osteoporosis International 2022 May 33(5):1155-1164 25.059 ptn 13.847 ptn 13.419 ptn Propensity score matching 13.419 ptn Copyright Dr. A van Lierop
  • 8. Effectiveness of denosumab for fracture prevention in realworld postmenopausal women with osteoporosis: a retrospective cohort study Lai et al. Osteoporosis International 2022 May 33(5):1155-1164 1.0 per 100 vs 1.7 per 100 patientjaren Risico reductie van 38% Copyright Dr. A van Lierop
  • 9. Longterm persistence with denosumab: realworld data from the Austrian Osteoporosis Clinic (AOC). A retrospective data analysis Boschitsch et al. Osteoporosis Int 2022 Jan 33(1):263-272 851 patienten - 630 intern - 221 extern Copyright Dr. A van Lierop
  • 10. Rebound effect denosumab Bone et al. J Clin Endocrinol Metab, April 2011, 96(4):972980 Copyright Dr. A van Lierop
  • 11. Effects of zoledronate on bone mineral density and bone turnover after long-term denosumab therapy: Observations in a real-world setting Evert-Graber et al. Bone 2022 Oct 163:11498 Copyright Dr. A van Lierop
  • 12. Effects of zoledronate on bone mineral density and bone turnover after long-term denosumab therapy: Observations in a real-world setting Evert-Graber et al. Bone 2022 Oct 163:11498 Copyright Dr. A van Lierop
  • 13. Effects of zoledronate on bone mineral density and bone turnover after long-term denosumab therapy: Observations in a real-world setting Evert-Graber et al. Bone 2022 Oct 163:11498 Copyright Dr. A van Lierop
  • 14. Fractures After Denosumab Discontinuation: A Retrospective Study of 797 Cases Gemiddeld 6 injecties FU: 26 maanden Vooraf 48% bisfosfonaat Achteraf 63% bisfosfonaat 81 patienten (10%) 215 wervelfracturen Burckhardt et al. JBMR 2021 Sep 36(9):1717-1728 Copyright Dr. A van Lierop
  • 15. Fractures After Denosumab Discontinuation: A Retrospective Study of 797 Cases Burckhardt et al. JBMR 2021 Sep 36(9):1717-1728 Copyright Dr. A van Lierop
  • 16. Samenvatting Denosumab geeft ook in real world setting adequate fractuur reductie Behandeling wordt in merendeel patienten gecontinueerd Nabehandeling met zoledoninezuur voorkomt ten delen botverlies tgv rebound fase Nabehandeling met bisfosfonaten geven adequate bescherming tegen nieuwe wervelfracturen na staken van denosumab Copyright Dr. A van Lierop