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Romosozumab clinical data
Pr. Dr. B. Langdahl, Aarhus, DK
Friday, May 13, 2022 · 11:50 a.m. · 30m 27s
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thank you thank you very much so it's for the young kind introduction and of
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course thank you to the side c. n. u. c. b. for inviting me um
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i've really been looking forward are it's it's such a pleasure to be among people again among colleagues in disgust
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uh so um seceded sweetie great so um i was side are asked
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to talk a little bit about technical experience and data as so um
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so i'll try to do that um so here off first my disclosures
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so i'm i'm sure your way or but i thought we had to start somewhere
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as so i just wanted to remind yeah everybody about the bowl of steve austin
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which actually has a dual role uh if not more but at least that your role uh in ball
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so first of all uh it's a inhibits uh the activity of austin last
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but at the same time it also a stimulus to the to mend our and activity uh of plastic
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class by stimulating the release of rank like and uh from the austin sites and probably also asked a blast
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so therefore it's obvious if we can find a something that that
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can inhibits crossed in a like sorry like us to boston antibody
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that will all still a inhibits the recruitment of austin class that their bible nice option
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but we will also and probably most importantly stimulate of all
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information because it leaves the cost of last to remain active
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and and that's actually been shown um this is um i just had these are data from monkeys
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out but they also just reason was also publication in human beings are from human beings actually showing
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uh the thing thing which is when you treat 'em with this crossed in inhibition and has crossed in antibody
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what you see here on typically services is that you
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increase bone formation a a lot but it's it's predominantly
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model in baseball information so that is confirmation taking place
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at sites whether it hasn't been absorption a happening before
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and that is even more a striking when you look at the in the cortical services
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so a lot of modelling baseball information uh in fact probably thirty five uh seventy five percent
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of the new ball information is modelling based which is
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a whole new concept um for us um in balm
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so i thought i would just quickly say choose to some of
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the important findings uh from the up if it's all a fracture trials
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and then we'll look at some additional new data um that has just kate come out actually
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so this is from the frame trial um and the important thing but the frames are of
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course as you know is that there was a placebo group are for the first twelve months
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so from that tribal where able to see the difference in changes
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in bone turnover marcus between actually treated women and the placebo treated women
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so you can see exactly uh that you action
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so first of all we have inhibition own resorts
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in here may shared by c. t. x. and that is stable throughout the twelve months a of treatment
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whereas you can also see the guy stimulation all p. one and p. as an indicator of new poll informed
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but you can also see which actually was a surprise especially when the fees to trial came up
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to see that that increase wears off despite continuing treatment and in fact after six
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months or approximately there about then there's no further stimulation of p. one and p.
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we need to rely so that bone biopsy showed that still after twelve months in
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the frame file that will lots of all information going on especially a cortical sites
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so maybe the markers mostly tells us about what is going on in spectrum
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um so so that's important to keep in mind but never less
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of course in the frame file very prominent increases here in los blindly
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indeed thirteen point three percent after the first year and that continues
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doing the second year with all the women received the news them out
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six point eight percent at the hip continued with another two percent uh later on during uh to use map
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so uh teletext on this huge increases with every scene in treatment of osteoporosis
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and i lead a two also uh quite impressive reductions in the cheapo fractures of
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uh during uh the first twelve months with the placebo a controlled a period
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but also um that was maintained during the second year we're all uh all the whole period
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the two years altogether uh including uh the period where the women received a dinner so that
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probably also where at that in this the total original frame trial
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uh there was no significant difference in um in on the table factions between the two treatment alms
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we have recently and taking a look i'm at this uh in european patients
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so approximately half of the patient in all in total frame study were european
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um and if we look here at the um at the european court only
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you can see that uh we confirmed that there was a very prominent a reduction
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in you which people fractures but we also in this uh in the european patients
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we also soul a significant reduction in a
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non vertical fractures and all clinical fractures and
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so important we still that's who are uh the three years out of this study
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um and we also uh saw a reduction in hip fractures of course the very few hip fractures in this
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low risk a lot uh but anyway uh of adoption with a broom source map followed by the news that
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of course then also uh of of major cost a product
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fracture so i think for us as europeans treating mostly european
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uh women um this is um this is really a good data to have in the back of your mind
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um this was just i'll just skip this in the interest of time but it was actually just
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to show you if you just look at bone formation here a minute i seem so simple information rate
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two months there's a very prominent increase simple information uh in the freight
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in the wrong so smart treated women where's that is completely reversed at
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the typical of services um after twelve months but then you data coming
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ops is showing that this is not the case at the cortical sites
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and and also just new data here showing uh again in the human biopsies after two months
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it's predominantly modelling based on information that is going on uh at the typical of services
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also at the in the cortical uh in the little nothing much is
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happening at at the p. are still in the low after two months
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so moving on to the art style um so i just uh i present you
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some of the um important fact today some uh so after uh the first year
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where a treatment with a broom so some at hearing blue is compared to treatment with eliminate
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that's a significant reduction in new rich people fractures and also in clinical fractures so why is this
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important it is important when we treat patients at high risk and probably even high imminent fracture risk
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it is important to choose the treatment that art has an effect
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early on a and therefore can reduce this high even and fracture risk
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of course is also important that they tore continues to work so therefore
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we also looked at the fracture reached doing are the entire double blinded period
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which was approximately thirty three months because this was an event driven a trial
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uh so here you see that after the stage three months that was the twenty seven
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percent reduction in clinical nineteen percent reduction in and it's evil and thirty eight percent reduction
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in a hip fractures in women treaty for one year with promo
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followed by eliminate compared shouldn't make throughout the whole um study period
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so we're showing data uh early on a very prominent effect but
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also the fact that stays uh at least helpful for almost three years
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we also just had a reason poppy casing coming out um wait where we looked at patients with
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different levels of of of kidney function and this is um this is a very busy a slice
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uh but on top you have data from the frame file and
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on the bottom you have from the art and it's all uh it
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within the first year uh or post file so here it's a
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promises matt compared with placebo and here to missus mac compared to undertake
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and we actually did see slightly a small increases in p. m. d. in
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the patients uh with uh the the lower part of the lower the kidney function
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your fast between uh thirty and fifty nine and there was a significant that into action
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so but again i the differences were quite a small
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uh and and in all cases that the increases were larger
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compared to the compared to add in in all uh sites um e. respective of kidney function
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but also tried hard to have a look at the fracture risk of reduction
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and then and and there were no interaction with kidney function in the production uh in fracture risk
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uh you respected or whether it was look i can frame a hole in the arch a trial
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so that's good to know the other important finding in that uh analysis was that there was no all
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a further a decrease in kidney function in either up to treat or
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that was the same in in old treatment group so there's no indication that
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treatment with promises and that would affect the kidney function of our patients
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um so um so now i consented the key data we
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have on bombs was matt from the clinical trials of course now
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it's time to consider in which patients should actually use
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this uh treatment um and how should i use it
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so uh in order to try to address that we put together
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a this paper that was also recently um pop based at least online
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where we compared changes in p. m. d. uh in in different scenarios so first we had
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to to uh to to fit a pivotal fracture trials like arch and frame
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where we treated treatment naive patients with normal first and then and
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then to resort to treatment have afterwards either eliminate all the news matt
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with two other studies the structure study um which i'll come back to in a minute but that's the study
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will be to patients who had been on all this fascinates for at least three years on average actually six years
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and then randomised inside the room so some aperture parasite and then we could also
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have low have some data from the phase two trial whether someplace into it been treated
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with a t. news matt after the first round of normal and then had the second ah treatment period with normal
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so we look at the increases in b. m. d. a. depending on how a role model
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was used and he you can clearly see so this is a this is still to flip
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and t. you can see that the increases in between
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the naive women were approximately six percent after one year
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they were pretty treated with lender nate uh it was only half that they say that that increase
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and if it was after one year dinners and that uh the increase was very a subtle
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and and you see the same pattern and at the longest time so based on these dates and probably
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especially total hip data that we now know from the if and i ate working group on bomb quality
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that sort of hippie indy is a very important predictor up the production in fracture risk
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uh so although these two studies do not have a fact chow come
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just because the increases so much last larger when you treat in treatment that you patients with normal first
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it's probably most likely to be the most efficient way of using um the stock if we want to prevent fractures
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so then of course you say what about uh what about the money um and of
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course that needs to be calculated in in every country individually but there's actually a recent publication
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uh from canada so of course uh based on on health care cost in canada
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um but they did this mark all models um of outcome
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and the population the models of were very similar
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to the population included in march so post menopausal women
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like every seventy four years of age uh with the previous fragility fractures
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in fifty percent of the patient it was a single of previous fatuous fifty percent had multiple uh
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previous fractures and then they needed to have a t. score less than mine is two point five
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and their treatment model was either roms was a map for one year followed by an internet for four years
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or eliminate for five years or was it an eight for five years
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and then yeah so treatment for five years and then
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the model it also included that this treatment effect would disappear
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a lot following a straight line from where it was after five
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years to zero um when you reach the ten year time point
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and then uh they use the the usual uh mark all the model of um of assessing the effect here
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this is um this is like the complicated um but that first um they calculated
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the risk of fractures in this model a lifetime fracture risk to a thousand patients
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and what you can see is that uh the fracture is is lower
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at in the room so some apple and donate um uh it's scenario
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compared to the l. internet only an compared to precision it only so you
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can see how many fractures i saved a lifetime uh in a thousand patients
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and next they calculated the cost and of course these are depending on where you live and how
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and how expensive it is to repair and we have really taken a hip fracture pacing for example
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but they calculated that um get that if the cost of treating the fractures of course would be low or
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in in this um because if you were fractures so this is the saving a cost wise in repairing fractures
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uh and of course then you have to at the cost of the docks um which it
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is it more expensive if you use normal compared to generic eliminate which is not surprised anyone
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but the bottom line here is um that i'm actually the costs are
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the war i'm in total fractures repairs and everything uh cost of the dog
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with the homo followed by linda make compared to the two other uh regimen so you actually save money
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and uh on top of that you also gain more
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politic collies are if you uh prevent these fractures um
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and so you save money and you gain police uh
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by treating more aggressively in this group of high risk patients
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the other thing of course that would be of interest are to hugh as position and and probably also uh to the patient
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is you know how how well i'm doing and and one that can be different things we're aiming for
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first of all it's important to keep all patients feel fractures but um many of physicians and patients are very
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interested in at calvary to tease goal above minus
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two point five um and because that's kind of
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signals that something is going really well and you can see
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after three years of treatment uh depending on where you start
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so again this is hip p. m. d. so if you start at the top of the heap immediate minus three
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what is your chance of reaching other hip india minus two point five after three years
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so you can see if you use a lemonade it's it's very close to on lightly very unlikely that that will happen
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uh if you use a ball roll well followed by lyndon h. r.
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it's approximately of fifty percent of the patients that would be is that
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if you use normal followed by the news matt it's probably seventy five percent so
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this is a reminder to me at least a that um that
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you know if we're far away from the cold we have in our mind and maybe have discuss with the patient
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we should treat we should choose a treatment that is most likely
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to get the patient close to the target uh that we're aiming for
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uh and and you can of course also look after one yeah but but you know
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nobody probably really expects to a peak your after one year treatment so maybe not so interesting
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i also just wanted to mention um the um the um as the structure study
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um because that is a slightly different approach because these are the patients
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that we have already treated with an active sorted light or does fascinate
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effort here is uh in this case they had to be treated for three
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years before we randomised into either will will or to a chair appeared side
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so of course the spacing so also uh in alternate because not all fulfilled the
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criteria for bone anabolic of a treatment first but what can be then expect um
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so in this study um of course we also measured as your markers and and i'm sure you're
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well aware if you treat which they appeared side you will see an increase in c. t. x. um
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whereas that is not happening uh if you go from london eight to um room so so matt
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you might see a small did a in c. checks but it will mostly
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be main along the same uh suppression level as patients coming off or intimate
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so the the more important difference is actually she uh uh with uh p. one and p. um because that
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really goes very high off with say okay outside but it follows the same
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pattern as we've seen uh in in the uh other studies i showed you
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so what about this important difference what is the most important is this the
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increase in p. one and p. or is it the increase in c. t. x.
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so when we look at our total hip uh p. m. d.
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uh ariel uh or or you give this bind using a texan
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with a a difference um so we see a
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bigger increases with a broom so smart approximately three percent
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uh compared it to a very small a small decrease or or a mutual effect we'd say okay outside
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of course both treatments uh increase typical uh uh be better to better bone and you
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get this fine but still uh almost twice as big an increase with them so so that
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um we also do accusative hip in the study and that kind of open our eyes to where
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b. um difference is a really big and that is in court when we look at the cortical ball
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because here you see a small increase of one percent with a broom so smart but you see a
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decrease of three point six percent which is what we all see when which reply to appear tight because
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to have air tight is so depending on getting a remodel in going so that
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you can over field to resort to look cool that but uh we now know that
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the primary effect of promises maps actually modelling so
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it's not a depending on remote link to steve effect
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and we also are then tried to see what is the project so
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obvious change in in in hip uh cortical w. me to be empty
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and um as you can see here we were able to show
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that it's actually the area under the curve of the c. t. x.
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that is the strongest predictor of um of the change in um in cortical volume a to b. d.
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so it is probably increasing c. t. x. that is the
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most important difference between the two treatments following energy resort to treatment
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it does also wanted to let you know that there's another
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new um publication uh coming out uh from uh can pull 'em
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so so this is actually a post hoc analysis up the
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face to try out um where uh the web page since i
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treated with airfare type also in randomised out fashion was actually
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also know lemonade on but that was not included in this study
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so it's a small a sub study as you can see with only um seventeen to nineteen
00:19:11
in each arm but uh apart from that they were asked u. p. nick a patient's post menopausal women
00:19:17
and what they analysed in this study was actually uh
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changes uh in uh especially some of the cortical parameters
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using a a very complicated um model but i don't even understand
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the full um impede implications all what they use q. c. t.
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fine and so they were able to model the changes in cortical thickness
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and i have to re write you get these baited with different from the structure paces because these are treatment naive patients
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but you can still see that in the women are treated with a promise was matt
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they were very prominent increases ten percent increase in cortical thickness in vertical bodies
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uh compared to only four percent uh in the to appear tight actually to women
00:20:00
and they also look at can sell us a p. m. d. uh in these uh but
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space so it was a long bus find a a number one other to be number one
00:20:10
twenty two percent increase uh in consoles p. m. d. uh with whom so's
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matt eighteen with to appear twice a very prominent increases with both three means
00:20:19
and then they designed more compound a
00:20:22
measurement which they call cortical mass surface density
00:20:26
and and it's derived uh from uh from how density changes when the cities
00:20:31
scan is is or when you analysed the c. t. scan the mass uh across the the vertebrate
00:20:37
and he you so is is kind of a combined measure of a strength of the vertebrate
00:20:42
so it's increased by twelve percent with well well compared to
00:20:46
have four percent to appear type which was also significantly different
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so i think we have some indications uh both in
00:20:54
treatment naive but also especially maybe in previous treated patients
00:20:58
that that is a benefit uh two rooms as map over
00:21:01
to appeared site um if you can if you had the choice
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and then i just wanted to finish off out with another a new publication um it's a joint adventure
00:21:12
between a german a group and a british a group and so the included too
00:21:18
um population based studies um lose big conference
00:21:23
a brisk cardiovascular health study called you right
00:21:26
uh which comprises a thirty four percent female uh on every
00:21:30
average age sixty three and and a pretty school boards uh
00:21:34
be even longitudinal study of parents and children at b. out
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spark a study and they only included he of course the mothers
00:21:41
so they were on average of forty eight years and associate so
00:21:46
the the interest was here to look at associations between
00:21:49
c. arms crossed them and cardiovascular a wrist parameters and safety
00:21:55
and want to able to show was that a there is an increased risk
00:21:59
uh of uh diabetes um and a high glucose uh
00:22:04
if you have a high levels of us to austin
00:22:08
uh and that there was no uh effect on hypertension uh there is a further uh
00:22:14
there's a reduction in uh each year far out with high levels of a scroll boston
00:22:19
and and they also so that every protein a one
00:22:23
h. t. l. uh were reduced uh in patients with high levels um of a sky boston
00:22:30
uh where student cyclists rights was borderline that increased in in these analysis
00:22:36
and in in the um especially in the to the direct a
00:22:40
cool what they had a lot of investigations of of other parameters
00:22:44
and and so they didn't see anything with with a score of
00:22:48
um which is a score of a classifications in the core coronary arteries
00:22:53
uh and also not with a corner arches the noses out but it wasn't it um
00:22:58
an increased risk of death from cardiac disease if you have higher levels um of
00:23:04
has crossed it of course this is an association story it's not prove or anything
00:23:09
but um but from this study um uh it seems to be that um big it could be associated
00:23:14
high levels of service include it at least in the
00:23:17
school boards be associated with increased cardiovascular uh a brisk
00:23:23
so to sum up i think we've learned a lot uh from the frames mouse
00:23:27
uh from the frame in the art trials and the additional analysis that been done
00:23:31
so treatment with promises to map for twelve months reduces the risk of rich people factors compared to placebo and the lender nate
00:23:37
um treatment for twelve months followed by the news that reduces the risk of which evil an
00:23:42
unbeatable factors compared to placebo for twelve months a followed by the news map in european patients
00:23:48
and a three hundred rooms was my for twelve months followed by lyndon it reduces the risk of which
00:23:53
you will not be similar hip fractures compared to lyndon eight uh in post menopausal women high risk of fracture
00:24:00
and i didn't show you that but i wanted to mention it it is also recent publication that
00:24:04
the incidence of pitiable factors of all grades of superior to ease we'd use bible verses of that
00:24:09
compared to placebo and donate and effect is maintained after transition to anti receptive therapy
00:24:16
including functions affect uh the p. d. game during
00:24:19
treatment with promo but the fracture risk reduction is maintained
00:24:25
observation all studies are i didn't show them at him so much in in in due to time
00:24:30
have but they generally confirm the findings of the clinical trials they're mostly coming out of japan still
00:24:35
have to remember that are actually the cost effectiveness analysis from canada
00:24:40
uh that seems to indicate that it is cost effective to use
00:24:43
treatment with promo for the first year in patients that high risk
00:24:47
and then i just your duties reason paper um that seems to indicate that seems crossed in is associated
00:24:53
with an increased risk of cardiovascular death and that
00:24:56
might feed into the um to be um general discussion
00:25:01
to have five minutes more because i want to share a couple of cases out from
00:25:05
mike in it because we have had a promo in denmark since the october uh twenty twenty
00:25:11
uh so this was actually my absolute first patient um she was the sixty old
00:25:16
uh post menopausal women referred from her g. p. uh in uh october last year
00:25:22
and she presented with the keep back pain after lifting apart and uh
00:25:26
in spring of ninety that wasn't after many placing by the cure proctor
00:25:31
at x. rays actually showed um five which people
00:25:34
fractures jet non non but people should know knowledgeable fractures
00:25:38
very low beauty as you can see minus five minus two point five um at the hip
00:25:45
she was relatively healthy actually was a smoker um see
00:25:48
a normal uh biochemistry including controlling cholesterol and and so on
00:25:54
also does mean d. r. and of course she was put on between d. r. supplement tasted
00:25:58
before we source i don't know if you could have that is midi deficiency at some point
00:26:03
she had as like the elevated blood pressure so we sent it back to the t. p. to get some treatment for that
00:26:09
um but my all evaluation was that she was severely affected
00:26:13
multiple reason pitiable fractures and they will be and yet this mine
00:26:17
and we evaluated that her cardiovascular risk was not extremely
00:26:21
low but still low um after controlling up the hypertension
00:26:26
so we started wrong so smart uh on november a third and completed it that year after
00:26:31
and here you can see ah how her b. m. d. increased by a nine
00:26:36
point two percent at the hip and eighteen point five percent at at the longest time
00:26:41
cause coming from a very low um value but still um that was um that was very uh impressive
00:26:48
um and soul and if so i that's i think
00:26:51
what we didn't measure uh markers um before starting almost all
00:26:55
so i don't get these probably don't tell us very much but just to let you know that
00:26:59
c. t. x. was suppressed a doing um the second uh part of the of the of the treatment
00:27:05
so she did very well so the way we do it exactly are we have
00:27:08
now is is in the outpatient clinic i'm giving the first injections to the patients
00:27:13
and then they come back for the second and if the okay kidnapping they do all the rest of them at home
00:27:18
uh we do decks that after six months i know that's not indicated it anyway
00:27:22
but we just so curious to see what happens so we do that as well
00:27:26
um and so i've discussed with the space in about fall on a and to be salty therapy but i think
00:27:33
so we reverse course discussing whether she should have dinners amount or also detonate but i think that
00:27:38
is relatively young post menopausal women she might need
00:27:42
anabolic treatment again uh in the meaning um lifetime
00:27:46
so um so i wanted to give so we gave us a later date um and then we'll see how it goes
00:27:51
i saw the other patient a slightly older i see seventy five yes uh old um and she was referred
00:27:58
from the or to be exerted which is very very unusual in denmark i would say we hardly get any referrals
00:28:03
has to be really really bad uh for the or speaker tends to be very patients to us
00:28:09
uh it's you've been treated with elaborate as things eleven
00:28:12
at based on our backs that and their family history
00:28:16
but see now presented with three new fragility fractures
00:28:18
on alan great form factor in seventeen pelvic factory eighteen
00:28:23
and the femur fracture approximate femur fracture in uh so hip fracture in twenty twenty
00:28:28
do you still have very low beauty as you can see uh
00:28:31
he was actually um apart from have factors he was quite healthy
00:28:35
uh and she also had a normal biochemistry easy to use and so on
00:28:41
so we thought okay shit too severe uh videos or factors on the
00:28:45
linden i still below b. d. uh so we need to do something
00:28:48
and uh we estimated cardiovascular is to be very low uh so um we
00:28:53
started for a little where you go and see completed at february this year
00:28:58
and uh so you can see 'em increases in b. m. d. a lumbar spine
00:29:03
during a an internet treatment and hip as would expect
00:29:06
only a few percent increase up with eliminate at the hip
00:29:11
and and and that actually very uh much like what we saw in the structure study
00:29:15
i hate being d. didn't increase very much uh over the over the year of um
00:29:20
a promo but certainly um last mine you di did increase up by nine cents
00:29:25
and and that is um where her biggest uh oh well hello speedy was
00:29:30
still so she was quite happy and i was quite happy with this the outcome
00:29:34
and um and you couldn't because now we figured out that we should probably make sure the markers before we start
00:29:39
so here you can see how c. t. x. is clearly reduced or during um the course of the treatment
00:29:44
and you can also see how p. one and p. after six months and a twelve months that
00:29:48
is lower compared to the baseline level which is actually on a an intimate you to remember that
00:29:55
so this patient i also uh started on 'em solid only gas that's all
00:30:01
we'll see how this goes so one these are two of my patients we have fifty patients at
00:30:05
that either by a complete it off on to mend and it's going quite well thank you very much
Conference Program
Introduction
Pr. Dr. S. Ferrari, Geneva
May 13, 2022 · 11:45 a.m.
Romosozumab clinical data
Pr. Dr. B. Langdahl, Aarhus, DK
May 13, 2022 · 11:50 a.m.
118 views
Romosozumab limitation (CH): challenges and opportunities
Pr. Dr. S. Ferrari, Geneva
May 13, 2022 · 12:25 p.m.
Questions & Answers Session
May 13, 2022 · 12:40 p.m.
Short- or long-term denosumab therapy? Part 1
Dr. J. Everts-Graber, Bern
May 13, 2022 · 1:37 p.m.
401 views
Short- or long-term denosumab therapy? Part 2
Pr. Dr. S. Ferrari, Geneva
May 13, 2022 · 1:52 p.m.
Clinical debate: Short- or long-term denosumab therapy?
May 13, 2022 · 2:02 p.m.
113 views
