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What matters most in IBD? Part 7/7

– Lisa. – Are you more likely, based
on what we talked about especially with the
infliximab levels up and down. If the patient’s not responding well do you prefer to shorten
the interval of infusion or increase the dose?
– That’s… – I know that’s like a
64,000 dollar question. – Yeah, make it 65,000. Yeah. Well, I mean, it’s a very good question and it was not the topic of my talk what we have to do in Belgium, actually is to decrease interval, because we cannot increase
the dose, but we do. We have some tricks to do that and we go by the response of the patient. If the patient comes in and says “Well I was good for six weeks, doc and then it’s winding off,” we would just decrease the interval. If they say we had no response whatsoever, we try a shot of ten
milligrams to bring them back. So that’s how we go by that. I mean, it depends also. I mean if your patient
is living in Grand Rapids or beyond they might not
want to come every six weeks. I mean, they have to travel a lot. So, it’s a bit tailored to the patient. But, if you ask us, “What
criteria do you use?” That would be the main criteria. – I think what we do is pretty similar. And this question maybe
you or Ellen probably know are we close to having a commercial adalimumab level test? We don’t have that. We only have infliximab levels. – Have you guys patented yours? – We’re not patented, ours.
The university is doing it. Where’s the microphone of adalimumab. I mean, any infliximab
assay is a adalimumab assay. They’re using an antibody against… Your, they’re using anti-TNF in there so anything that binds, that will bind an anti-TNF agent. So it’s just an IgG-1 against TNF assay. So if you run another standard curve, you can make your infliximab assay look like an adalimumab assay. So that’s how we did that and so it’s not “patented” yet. But, university is working on our IP so we cannot send it out. You’ll see more and more I mean, you will see
more and more companies, also in the US and Canada come up. By now, it’s patented by Prometheus These guys are even cleverer, they’re doing solid fluid phase assays so it’s even beyond. But I say you will see other companies, and the price will come down for sure. It’s too expensive now and I’m sure it’ll come
down in the next years. – The data is also not as good with adalimumab levels are not as predictive as clinical response or mucosal
healing as infliximab levels and I don’t know if it’s the
peculiarity of the assay itself or if there’s really something
different about the delivery. – It’s good what Ellen says. I mean it’s probably pharmacokinetics, and also Abbot has shown
data from CHARM, I think, but there’s no good correlation between clinical response and trough levels. Mind you, that was not also true in SONIC. In SONIC, the trough levels also didn’t correlate with clinical remission. I think that’s why Ellen’s
point is making it clear that you shouldn’t measure
anyone’s trough levels if they’re doing well. It’s only when they’re losing response and they had good response before, that’s when the trough levels come in. Otherwise not for infliximab,
neither for adalimumab and this data are weaker
for adalimumab, I agree. You shouldn’t measure it. It’s become “fashionable” to
measure trough levels but, know what you’re doing. – It raises the question, how
important are peak levels? And I wonder about using UC in particular. The differential, apparent differential, between infliximab and
adalimumab make me wonder if part of the issue with UC is that drug delivery
to the mucosa because of microvascular issues in UC might make it hard to accomplish. – I’ve no data, but if you ask my opinion I think that severe colitis is a sump, is really a sump for anti-TNF drug, and we were not realizing that in the past and the data from Toronto showed that if you have measurable trough levels patient have less like… Of course it’s infliximab
again, Ellen’s argument. But I think it’s just a sump for your drug and if you don’t give enough drug it’s not gonna work. We’ve been increasing patients with infliximab and rescued them from colectomy just by giving them an extra
infusion, five days afterwards or even four days
afterwards and it worked. It’s not an indirect indication
of your point, Peter. I think you’re completely right but if I would be working at Abbott and I would work to design
another trial for UC, I would go for probably 160, 160, 80, 80. It’s not gonna kill the patient. – They’re afraid. – Yeah, they’re afraid
for cost issues, I know but I mean that would be probably the better trial to do. But, I mean, there’s no going back. These trials were designed 5 years ago So, I can’t blame them for that. – Well, thank you very much. – Thank you. (applause)

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