TREATING OSTEOPOROSIS IN 2018: WHAT'S OLD, WHAT'S NEW, WHAT'S UNPROVEN AND WHAT'S TRUE. Nelson B. Watts, MD

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1 TREATING OSTEOPOROSIS IN 2018: WHAT'S OLD, WHAT'S NEW, WHAT'S UNPROVEN AND WHAT'S TRUE Nelson B. Watts, MD OSTEOPOROSIS AND BONE HEALTH SERVICES CINCINNATI, OHIO Honoraria: Amgen, Radius, Shire Consulting : AbbVie, Amgen, Radius, Sanofi

2 TREATING OSTEOPOROSIS IN 2017: WHAT'S OLD, WHAT'S NEW, WHAT'S UNPROVEN AND WHAT'S TRUE Denosumab Long-term data Withdrawal New drugs Abaloparatide Romosozumab

3 Watts NB Osteoporos Int 2017;28:

4 DENOSUMAB (PROLIA ) INHIBITOR OF RANK LIGAND RANKL* Produced by osteocytes, stromal cells and osteoblasts Binds with RANK (receptor) which is expressed on the surface of osteoclast precursors, differentiated and active osteoclasts Denosumab is a human monoclonal antibody that ties up RANKL, preventing binding with its receptor, decreasing osteoclast development, function and survival Given as a subcutaneous injection, 60 mg SQ twice yearly *RANKL = ligand to receptor activator Boyle WJ et al Nature 2003;423: of nuclear factor kappa B Bekker PJ et al J Bone Miner Res 2004;19: Cummings SR et al N Engl J Med 2009;361: Prolia Package Insert

5 DENOSUMAB PHARMACODYNAMICS McClung MR et al N Engl J Med 2006;354:

6 Subjects with New Fractures (%) DENOSUMAB FREEDOM TRIAL 3-YEAR FRACTURE RESULTS ,808 postmenopausal women with osteoporosis 68% 20% Placebo Denosumab 40% Vertebral Non-Vert Hip Cummings SR et al N Engl J Med 2009;361:

7 Percentage Change from Baseline Prepared by Nelson Watts MD YEAR BMD CHANGE WITH DENOSUMAB Lumbar spine Total hip 21.7% % Bone HG et al Lancet Diabet Endocrinol 2017;5:

8 FRACTURES AFER TEN YEARS OF DENOSUMAB Bone HG et al Lancet Diabet Endocrinol 2017;5:

9 Median ng/ml (Q1, Q3) BTM AFTER DISCONTINUING DENOSUMAB PHASE 2 STUDY IN WOMEN WITH LOW BMD Serum CTx Discontinued Placebo Treatment 210 mg Q6M Open-label alendronate * * *P < at month 36 and = 0.05 at month 48 vs placebo. P = at month 36 vs placebo. Months Miller PD et al Bone 2008;43:222-29

10 % Change (LS mean ± SE) BMD CHANGE AFTER STOPPING DENOSUMAB 12 Lumbar Spine BMD All discontinued All discontinued at 36 months Subjects who rec d 30 mg q 3 mos were given 60 mg q 6 mos starting at Month 36 Months Miller PD et al Bone 2008;43:

11 DISCONTINUING DENOSUMAB AFTER 8 YEARS CHANGES IN BMD Year 8 Year Lumbar Spine Lumbar Spine Femoral Neck McClung MR et al Osteoporos Int 2017;28:

12 DENOSUMAB MECHANISM OF ACTION Osteoclast precursors and RANKL are still there and ready to go after denosumab is gone Over.jpg#id=8&iurl=http%3A%2F%2Fimage.slidesharecdn.com%2Fosteoporosis-pathophysiology-and-management-dr-frank2181%2F95%2Fosteoporosispathophysiology-and-management-dr-frank jpg&action=click

13 IS THE RISK FOR NON-VERTEBRAL FRACTURES INCREASED AFTER STOPPING D MAB? 797 subjects d/c study drug in FREEDOM after 2-5 doses (470 placebo, 327 d mab) Other OP Rx begun by 42% former placebo and 28% of former d mab subjects New fractures 9% placebo (13.5 per 100 subject years) 7% denosumab (9.7 per 100 subject years) HR* 0.82 (CI 0.49, 1.38) Short off-treatment period (mean 0.8 mos); effect manifest after longer off-treatment period cannot be excluded *HR adjusted for age and total hip BMD T-score at baseline Brown JP et al J Bone Miner Res 2013;28:746-52

14 VERTEBRAL FRACTURES AFTER DISCONTINUING DENOSUMAB OR PLACEBO IN FREEDOM STUDY Vertebral fractures in patients who discontinued either placebo or denosumab in the FREEDOM study or who stopped denosumab in the FREEDOM Extension study and who had a follow-up at least 7 months after their last dose Vertebral fractures Multiple vertebral fractures On study drug Off study drug Cummings SR et al ASBMR 2016

15 Published online 28 October 2015

16 Published online 28 October 2015

17 Published online 28 October 2015

18 Published online 28 October 2015

19 J Clin Endocrinol Metab 2017;102:

20 J Clin Endocrinol Metab 2017;102:

21 J Clin Endocrinol Metab 2017;102: Athanasios D Anastasilakis, 1 Sterghios A Polyzos, 2 Polyzois Makras, 3 Berengere Aubry-Rozier, 4 Stella Kaori, 5 and Olivier Lamy 4

22 Anastasilakis AD et al J Bone Miner Res 2017;32:

23 MULTIPLE VERTEBRAL FRACTURES AFTER DISCONTINUATION OF D MAB 112 fractures in 24 women 92% with >1 fracture 8-16 months after last dose of d mab Anastasilakis AD et al J Bone Miner Res 2017;32:

24 Prolia PI accessed 04/21/2017

25 McClung MR et al Osteoporos Int 2017;28:

26 BMD LOSS AFTER STOPPING D MAB ALN 7 1 ALN => RIS, d/c due to cost 1 ALN => IBAN Dmab 5 RIS 4 IBAN 2 IBAN => TPTD TPTD 2 8 stopped, 5 attributed to AE McClung MR et al Osteoporos Int.2017;28:

27 TRANSITION STUDIES ORAL BISPHOSPHONATE TO DENOSUMAB n = 1. Prior ALN 2. Prior ALN 3.Suboptimal BP 4. Oral to IV/SQ ALN 251 DMAB 253 RIS 435 DMAB 435 IBAN 416 DMAB 417 ZOL 322 DMAB 321 Age YSM Spine FN TH Prior BP (mos) Kendler DL et al J Bone Miner Res 2010;25: Roux C et al Bone 2014;58: Recknor C et al Obstet Gynecol 2013;121: Miller PD et al J Clin Endocrinol Metab 2016;101:

28 BMD percent change from baseline TRANSITION STUDIES ORAL BISPHOSPHONATE TO DENOSUMAB Lumbar Spine 5.0 DMAB 4.0 DMAB DMAB DMAB 3.0 ALN RIS 2.0 IBAN ZOL Kendler DL et al J Bone Miner Res 2010;25: Roux C et al Bone 2014;58: Recknor C et al Obstet Gynecol 2013;121: Miller PD et al J Clin Endocrinol Metab 2016;101:

29 SEQUENTIAL OR CONCOMITANT COMBINATIONS DENOSUMAB AND TERIPARATIDE ` Years 1-2 Years 3-4 Combination Denosumab Teriparatide Denosumab Denosumab Teriparatide Leder B et al Lancet 2015;336:1147

30 SEQUENTIAL OR CONCOMITANT COMBINATIONS DENOSUMAB AND TERIPARATIDE ` Years 1-2 Years 3-4 Combination Denosumab Teriparatide Denosumab Denosumab Teriparatide Leder B et al Lancet 2015;336:1147

31 SEQUENTIAL OR CONCOMITANT COMBINATIONS DENOSUMAB AND TERIPARATIDE Years 1-2 Years 3-4 Combination Denosumab Teriparatide Denosumab Denosumab Teriparatide Leder B et al Lancet 2015;336:

32 Percent Change From Baseline DENOSUMAB AND ALENDRONATE DENOSUMAB/ALENDRONATE PREFERENCE STUDY (DAPS) Switching from denosumab to alendronate, bone loss did not occur 8 6 Denosumab (n=126) Alendronate (N=115) Lumbar spine 4 2 Total hip Months Based on data from Freemantle N et al Osteoporos Int 2012;23:317-26

33 BMD LOSS AFTER STOPPING D MAB What about zoledronic acid after stopping d mab? Timing is critical bone turnover must be high enough to provide active remodeling sites for bisphosphonates to bind.

34 Management of osteoporosis is a longterm proposition, similar to treatment of hypertension or hypercholesterolemia

35 DENOSUMAB (PROLIA ) SUMMARY In a 3-year placebo-controlled double-blind trial, denosumab was well tolerated and reduced the risk of vertebral (68%), hip (40%) and nonvertebral (20%) fractures After 10 years of treatment, average BMD gains were 22% in the spine and 9% in the femoral neck and total hip In the 7-year extension, ONJ (5.2 per 10,000 person years) and AFF (0.8 per 10,000 person years) were uncommon Patients may be at risk of multiple vertebral fractures if denosumab is discontinued Based on limited data, treatment most likely to be effective if denosumab is stopped is an oral bisphosphonate Cummings SR et al N Engl J Med 2009;361: Papapoulos S et al, ASBMR 2016 Prolia Package Insert

36 TREATING OSTEOPOROSIS IN 2017: WHAT'S OLD, WHAT'S NEW, WHAT'S UNPROVEN AND WHAT'S TRUE Denosumab Long-term data Withdrawal New drugs Abaloparatide (approved 04/2017) Romosozumab (still under FDA evaluation)

37 FDA-APPROVED MEDICATIONS INDICATIONS Postmenopausal Osteoporosis Glucocorticoid-induced Osteoporosis Men Drug Prevention Treatment Prevention Treatment Estrogen Calcitonin (Miacalcin, Fortical ) Raloxifene (Evista ) Ibandronate (Boniva ) Alendronate (Fosamax ) Risedronate (Actonel ) Risedronate (Atelvia ) Zoledronate (Reclast ) Denosumab (Prolia ) Teriparatide (Forteo ) ` Abaloparatide (Tymlos )

38 TREATMENT OF OSTEOPOROSIS Antiresorptive Agents Calcitonin Raloxifene Alendronate Risedronate Ibandronate Zoledronate Denosumab Anabolic Agents Teriparatide Abaloparatide

39 FDA-APPROVED MEDICATIONS EVIDENCE FOR FRACTURE REDUCTION Drug Vertebral Fracture Nonvertebral Fracture Hip Fracture Calcitonin (Miacalcin, Fortical ) No effect demonstrated No effect demonstrated Raloxifene (Evista ) No effect demonstrated No effect demonstrated Ibandronate (Boniva ) No effect demonstrated No effect demonstrated Alendronate (Fosamax ) Risedronate (Actonel, Atelvia ) Zoledronic acid (Reclast ) Denosumab (Prolia ) Teriparatide (Forteo ) Abaloparatide (Tymlos ) No effect demonstrated No effect demonstrated Evidence for effect but not an FDA-approved indication

40 ABALOPARATIDE (TYMLOS ) PTHrP ANALOG Distinct from PTH but same rat findings and warnings regarding osteosarcoma Daily SQ injection (80 mcg) for no longer than 2 years Compared with teriparatide Increases in BMD are greater and faster, esp. at the hip Fracture reduction is at least as good, maybe better Less hypercalcemia Cartridge contains a 30 day supply Does not require refrigeration Transdermal delivery patch currently in Phase 2 trials

41 ANALOG OF HUMAN PTHrP 1-34 hpth 1-34 hpthrp 1-34 PTHrP analog (abaloparatide) % hpthrp 38% hpthrp Functional optimization of abaloparatide based on amino acids Hattersley R et al ENDO 2012 OR08-1

42 ABALOPARATIDE PHASE 3 TRIAL 18 Miller PD et al JAMA 2016;316:

43 BONE TURNOVER MARKERS ABALOPARATIDE vs TERIPARATIDE Miller PD et al JAMA 2016;316:

44 ABALOPARATIDE vs TERIPARATIDE 18-MONTH TRIAL *p< % 78% Miller PD et al JAMA 2016;316:

45 ABALOPARATIDE vs TERIPARATIDE 18-MONTH STUDY: EFFECT ON FRACTURES Nonvert Fx Clinical Fx Major OP fx Teriparatide 28% 29% 55% Abaloparatide 43%* 45%* 70%* + *Significantly different from placebo + Significantly different from teriparatide Miller PD et al JAMA 2016;316:

46 ABALOPARATIDE EFFECT ON NONVERTEBRAL FRACTURES 28% 43% ABAL vs PBO < 0.05 TPTD vs PBO = NS ABAL vs TPTD = NS Miller PD et al JAMA 2016;316:

47 ABALOPARATIDE PHASE 3 TRIAL EXTENSION (ACTIVExtend) Alendronate 70 mg Weekly Alendronate 70 mg Weekly 43 Bone H et al ASBMR 2017

48 ABALOPARATIDE PHASE 3 TRIAL EXTENSION (ACTIVExtend) New Vertebral Fractures Nonvertebral Fractures Bone H et al ASBMR 2017

49 ABALOPARATIDE (TYMLOS ) TRANSDERMAL DELIVERY DEVICE Solid Microstructured Transdermal System (smts) Painless, needle-free administration through skin 5 minute wear time Rapid drug release, peak similar to SQ

50 SCLEROSTIN Produced by osteocytes 1 Inhibits the anabolic Wnt signaling pathway 2 Deficiency results in a sclerosing bone disease (sclerosteosis) 3 1. Van Bezooijen J Bone Miner Res. 2005;20 (Suppl 1):S9 2. Warmington K et al. J Bone Miner Res. 2005;20(Suppl 1):S22 3. Gardner JC et al. J Clin Endocrinol Metab E-pub. Sep 27

51 Wnt SIGNALING PATHWAY Wnt Axin APC Β-catenin L R P CKIα Frizzled Dsh GSK3β Mesenchymal Stem Cell (MSC) Osteoprogenitor Cell Pre-Osteoblast Β-catenin Β-catenin TCF target genes activated

52 SCLEROSTIN INHIBITS THE Wnt SIGNALING PATHWAY Wnt Osteocyte Sclerostin L R P Frizzled Mesenchymal Stem Cell (MSC) APC Axin CKIα Dsh Osteoprogenitor Cell P P P P Β-catenin Β-catenin GSK3β Β-catenin Pre-Osteoblast Groucho CBP TCF target genes activated repressed

53 ANTIBODY TO SCLEROSTIN RELEASES THE Wnt SIGNALING PATHWAY Sclerostin Wnt Axin APC Β-catenin L R P CKIα Frizzled Dsh GSK3β Mesenchymal Stem Cell (MSC) Osteoprogenitor Cell Pre-Osteoblast Β-catenin Β-catenin TCF target genes activated Stimulation of formation without increasing resorption?

54 A NEW ANABOLIC APPROACH: BLOCK AN INHIBITOR OF BONE FORMATION Romosozumab (EVENITY ), an antibody to sclerostin, restores bone mass in rats and monkeys 1,2 Phase 2 study in humans 3 Early, marked, but transient increase in markers of bone formation Modest, persistent reduction in bone resorption Substantial increase in BMD in the spine and hip Two Phase 3 studies 4,5 1. Warmington K et al J Bone Miner Res. 2005;20(Suppl 1):S22 2. Ominsky M et al J Bone Miner Res. 2006;21(Suppl 1):S44 3. McClung MR et al, N Engl J Med Cosman F et al N Engl J Med 2016;375: Saag KG et al N Engl J Med :2017;377:

55 FRAME STUDY PHASE 3 TRIAL WITH ROMOSOZUMAB (EVENITY ) 7180 subjects; romosozumab dose 210 mg SQ monthly Placebo Year 1 Romo* Year 1 D mab Year 2 D mab Year 2 Cosman F et al N Engl J Med 2016;375:

56 FRAME STUDY PHASE 3 TRIAL WITH ROMOSOZUMAB (EVENITY ) 7180 subjects; romosozumab dose 210 mg SQ monthly Placebo Year 1 Romo* Year 1 D mab Year 2 D mab Year 2 Cosman F et al N Engl J Med 2016;375:

57 FRAME STUDY PHASE 3 TRIAL WITH ROMOSOZUMAB (EVENITY ) 7180 subjects; romosozumab dose 210 mg SQ monthly Placebo Year 1 Romo* Year 1 D mab Year 2 D mab Year 2 Cosman F et al N Engl J Med 2016;375:

58 ANTIBODY TO SCLEROSTIN BLOCKS AN INHIBITOR OF BONE FORMATION ROMOSOZUMAB (EVENITY ) FRAME, 2-year trial, n= Placebo Year 1 Romo* Year 1 D mab Year 2 D mab Year 2 ARCH, 2-year trial, n= Alendronate Year 1 Alendronate Year 2 Romo* Year 1 Alendronate Year 2 *Romosuzumab 210 mg SQ monthly 1. Cosman F et al N Engl J Med 2016;375: Saag KG et al N Engl J Med :2017;377:

59 ANTIBODY TO SCLEROSTIN BLOCKS AN INHIBITOR OF BONE FORMATION ROMOSOZUMAB (EVENITY ) FRAME, 2-year trial, n= VFX Clin Fx nvfx Year 1 (ROMO vs PLBO) 73%* 36%* 25% Year 2 (D MAB for all) 75%* 33%* 25% *p< Cosman F et al N Engl J Med 2016;375:

60 ANTIBODY TO SCLEROSTIN BLOCKS AN INHIBITOR OF BONE FORMATION ROMOSOZUMAB (EVENITY ) FRAME, 2-year trial, n= VFX Clin Fx nvfx Year 1 (ROMO vs PLBO) 73%* 36%* 25% Year 2 (D MAB for all) 75%* 33%* 25% ARCH, 2-year trial, n= VFX Clin Fx NVFx Hip fx Year 1 (ROMO vs ALN) 37%* 28%* 26% 36% Year 2 (ALN for all) 48%* 27%* 19%* 38%* *p< Cosman F et al N Engl J Med 2016;375: Saag KG et al N Engl J Med :2017;377:

61 SAFETY FINDINGS WITH ROMOSOZUMAB FRAME Study (ROMO vs PLBO followed by d mab for all) 1 Months 0-12 (romosozumab vs placebo) Injection site reactions 5.25% romo vs 2.9% placebo AEs >10%: arthralgia, nasopharyngitis, back pain No difference in hearing loss or knee OA ONJ: 1 case after 12 mos of romo, 1 after 12 mos romo then 1 dose of dmab AFF: 1 case after 3 mos of romo Hypersensitivity SAE: 7 patients receiving ROMO 1. Cosman F et al N Engl J Med 2016;375:

62 SAFETY FINDINGS WITH ROMOSOZUMAB FRAME Study (ROMO vs PLBO followed by d mab for all) 1 Months 0-12 (romosozumab vs placebo) Injection site reactions 5.25% romo vs 2.9% placebo AEs >10%: arthralgia, nasopharyngitis, back pain No difference in hearing loss or knee OA ONJ: 1 case after 12 mos of romo, 1 after 12 mos romo then 1 dose of dmab AFF: 1 case after 3 mos of romo Hypersensitivity SAE: 7 patients receiving ROMO ARCH Study (ROMO vs ALN followed by ALN for all) 2 6 AFF (4 with ALN alone, 2 with romo followed by ALN) 2 ONJ (1 with ALN alone, 1 with romo followed by ALN) 1. Cosman F et al N Engl J Med 2016;375: Saag KG et al N Engl J Med :2017;377:

63 SAFETY FINDINGS WITH ROMOSOZUMAB FRAME Study (ROMO vs PLBO followed by d mab for all) 1 Months 0-12 (romosozumab vs placebo) Injection site reactions 5.25% romo vs 2.9% placebo AEs >10%: arthralgia, nasopharyngitis, back pain No difference in hearing loss or knee OA ONJ: 1 case after 12 mos of romo, 1 after 12 mos romo then 1 dose of dmab AFF: 1 case after 3 mos of romo Hypersensitivity SAE: 7 patients receiving ROMO ARCH Study (ROMO vs ALN followed by ALN for all) 2 6 AFF (4 with ALN alone, 2 with romo followed by ALN) 2 ONJ (1 with ALN alone, 1 with romo followed by ALN) Cardiovascular SAEs: 2.5% romo, 1.9% ALN 1. Cosman F et al N Engl J Med 2016;375: Saag KG et al N Engl J Med :2017;377:

64 SELECTING AMONG THERAPEUTIC AGENTS Efficacy broad spectrum antifracture efficacy (alendronate, risedronate, zoledronate, denosumab) Route of administration oral (fasting or with food) or parenteral Frequency of administration daily, weekly, monthly, quarterly, twice yearly, once yearly Side effects/tolerability depends on agent and patient Long-term BMD gains, help with fracture healing Non-skeletal effects breast cancer reduction (raloxifene) Cost/insurance coverage Watts NB, personal opinion

65 SPECTRUM OF FRACTURE RISK Teriparatide Abaloparatide?Romosozumab Denosumab Bisphosphonate No need for pharmacologic treatment Watts NB, personal opinion

66 TREATING OSTEOPOROSIS IN 2018: WHAT'S OLD, WHAT'S NEW, WHAT'S UNPROVEN AND WHAT'S TRUE Denosumab Long-term data Withdrawal New drugs Abaloparatide Romosozumab

67 Questions or comments?

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