AD/PD 2023 | Long-term follow up of LECIG use in Sweden

So LECIG is a further development of the old levodopa-carbidopa intestinal gel which has been used in many countries for a long time now and it was developed here in Uppsala, in Sweden. So now we have further developed that gel infusion by adding entacapone, which is a COMT inhibitor. So now there are three substances in the gel and it’s abbreviated LECIG which means levodopa-entacapone-carbidopa intestinal gel. So it’s intended for intestinal infusion in Parkinson’s disease where the patients have severe fluctuations.

LECIG was actually remarkably easily approved by the authorities after only one clinical trial in 11 patients. I think that’s quite remarkable. But on the other hand, it’s natural because the substances are well known and the method of delivery is also well known from before. But that means also that we have very little information in the literature. So 11 patients treated with this therapy for one day, that’s not much to lean on. It was introduced in Sweden in 2019 as the first country in the world and after that several other countries in in Europe have started using LECIG.

So, what we have done now is that we have looked into our national Swedish registry, which is called Parkinson’s Registry, simply, but in Swedish, and there we have now tried to collect all the data that we have entered into the registry and are about to publish that. So this is what I will present at the AD/PD conference. We have 150 patients treated with LECIG since 2019 so that’s quite a high number as compared to the 11 original patients. 39 of these 150 patients were switched from LCIG, the original levodopa gel, to LECIG. Simply because they wanted to try the new method and the new pump because for the patients it’s important that the pump is smaller with LECIG than with LCIG. So it was on their demand mostly that we that we did the switches. And it seems to work well, both for patients who switched and the other more than 100 patients were not switched. So they started LECIG therapy as the first pump therapy but not in all cases, some of them had also used apomorphine infusion before and also some patients had used DBS, deep brain stimulation, before, some in ongoing combination with the two treatments.

The problem with the registry data is that we don’t have full coverage. We as doctors are not always entering the full data, not always doing the clinical scales that we have included in the registry. But there are at least some parameters that are important to look at, for example, quality of life. Actually the PDQ-8 quality of life measure in Parkinson’s disease is the single rating scale that is mostly used in our patients. So there we have quite robust data, actually showing that there is an improvement in quality of life in patients that have started LECIG. And of course it can be different depending on what treatment the patient had before, so if the patient has had a good treatment with a levodopa infusion already, we don’t expect much to happen with the quality of life or other aspects either. But for patients with severe fluctuations that are intended for this therapy, we have shown now that their quality of life is improved. Generally regarding motor scales and non-motor scales, the results look good as well. Quite stable in many aspects, but that’s also as expected.

We also have some safety data which is also as expected. It’s a therapy that requires access via a PEG tube so there may be problems with the PEG stoma and the jejunal tubes but that’s well known from the previous treatment as well. Regarding other side effects there are nothing new that has appeared really, so this is a patient group which is quite vulnerable in many ways, some of them have dementia, some have not, there are some hallucinations. One important thing to think of when it comes to entacapone is that diarrhea is a quite common side effect. When we started this in 2019, we didn’t know how the patients would react, but we now know that if the patient has developed diarrhea on oral entacapone, they will also develop diarrhea with the infusion. So now actually in our registered data there is only one patient who had diarrhea but that’s a selection bias because we have had several patients before where we know that they got diarrhea from the treatment so that’s an important side effect to bear in mind.

I don’t think that this is a replacement for any therapy, it’s good that we have different alternatives. There are some patients who when we ask the patients to choose the pump, most of them would choose the smaller pump which is with a LECIG treatment, but some also choose the old pump the LCIG pump because it looks more robust, it’s bigger and different. So I think it’s very good for the patients to have alternatives. And then, as I said, regarding diarrhea, some patients don’t tolerate entacapone and of course it’s very good that they still have the option with LCIG. So I think that the LECIG treatment has now come into the market as an alternative for advanced Parkinson’s treatment, along with deep brain stimulation, apomorphine, and LCIG infusion.