Beatrice Edwards, MD: The Future of Monoclonal Antibody Therapy


The monoclonal antibody class of drugs could help osteoporosis patients prevent fractures.

Monoclonal antibodies are a class of drugs that could help reduce the risk of fractures for patients suffering from osteoporosis.

However, there are some risks in taking this class of drugs, as recent studies have focused on the rebound effect from withdrawing from drugs like denosumab.

In an interview with MD Magazine®, Beatrice Edwards, MD, deputy associate chief of staff of geriatrics and extended care for the Central Texas Veterans Health Care System, explained the risk and the reward behind this new class of drugs.

MD Mag: How much caution should doctors exhibit when prescribing denosumab?

Edwards: I think physicians who prescribe these medications, which are very effective medications, should be aware of this element of risk. There are already guidelines coming out of the European Calcified Tissue Society where they say that the analysis has been correct.

So, what needs to go out as is recommendation for clinicians for when you are going to discontinue denosumab. The safety of the denosumab has been shown to be 10 years, so that's pretty long term.

If you're going to discontinue it, you want to overlap it with another antiresorptive with prolonged half-life, for instance a bisphosphonate. So, you don't have that immediate loss that is going to occur, you're going to preserve that from happening.

MD Mag: On the monoclonal antibody class of drugs, including denosumab.

Edwards: Denosumab is number 1, it's been out since 2010 and we have 10 years of data that is very well gathered from the FREEDOM trial and FREEDOM extension.

In terms of the recent publication, in terms of safety, that safety was excellent. The safety issues that were raised in the first 3 years have gone down with time to the point that they're not much greater than the background noise.

There was just 1 case of atypical femur fractures on like 2500 women. On ONJ, I think there were 7 cases, that is very commensurate with what we would expect.

I like it particularly because it's the only agent approved for prevention of fractures in cancer survivors and that is a population that is growing considerably and many of them are seniors.

Denosumab has been shown to reduce fractures in women starting aromatase inhibitors by 50% and then it's been shown to reduce fractures in men who start androgen deprivation therapy by 65%.

So those are some very solid very good numbers in these very high-risk populations.

MD Mag: On the future of romosozumab.

Edwards: The other 1 is Romosozumab, which is just recently been approved. We are going to use it for patients who have probably failed first-line treatment.

It is an anabolic, it's going to be given as a physician supervised medication, which always gives better results because patients adherence not very good.

So, having it supervised is good. The duration is only going to be a year. That's because after 12 months they generate neutralizing antibodies.

But the anabolic effect that it has and also inhibiting resorption at the same time gives us a dual effect of rapid increase in bone mass. it certainly has a place in a specialist’s armamentarium for osteoporosis.

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