We know that a perianal fistula is a pathological connection between the wall of the intestine and the skin of the anal area. We also know that it is one of the common and extremely physically, professionally and socially disabling complications of Crohn's disease. What are complex perianal fistulas and what impact do they have on a patient's life?
This is a situation in which we are dealing with more complicated fistulas, i.e. fistulas that have several external outlets, very large, extensive cavities, purulent conditions on their course or escape in a few places on the intestine, so they have several internal outlets. These are the kind of fistulas in which the scale of damage is much greater, and unfortunately this translates into the patient's functioning.
The formation of fistulas is accompanied by acute discomfort, such as pain, discomfort, a spreading sensation, difficulty finding a suitable place to sit or stand. These local discomforts also begin to be associated with leakage, secretion of contents. This is often stool content, which is not only extremely embarrassing and aesthetically difficult for the patient, but also leads to constant irritation of the skin and perineal area. The last set of complaints are septic conditions, a prolonged inflammatory process, with all the consequences for the body.
What are the currently available treatments for perianal fistulas?
We are unable to surgically reconstruct the anatomical situation, i.e. perform a repair procedure, primarily because of the extent of tissue damage and the fact that it is covered by a chronic autoimmune process. The first, basic element, is decompression of the fistula, or drainage. This is a situation in which we try to eliminate these septic conditions, both local and systemic. The second step, which we can also do surgically, and which is very good for starting further treatment, is the conversion of a complex, multi-channel fistula into a simple fistula. We try to make it as uncomfortable as possible and have as few outlets as possible. These are the conditions for starting treatment to promote healing. In Crohn's disease, this treatment is crucial. There are standard drug therapies, but their effectiveness is low. Such treatment is already historic.
First of all, biological treatments are now being used, which are extremely effective in some patients and can give spontaneous closure of fistulas. There are also new treatments coming in, primarily related to stem cells, which are able to create the conditions for the most physiological healing. It is worth saying that stem cells injected topically are not a kind of glue, meant to close fistulas, but to promote natural healing. This is a very effective method. Methods such as negative pressure therapy are becoming increasingly popular, although still supportive in nature. This is a form of drainage, but it gives very good conditions for reducing the fistula and sometimes even healing it spontaneously. The panel of measures is very large, and only by using all of these possibilities do we get the target results, which can be as high as 70 percent.
In 2018, an allogeneic stem cell preparation was registered in the EU for the treatment of complex perianal fistulas in adult patients. In Poland, this treatment is not covered by reimbursement. What opportunities does it provide and for which patients is it recommended?
Indeed, it is not reimbursed, which is a great pity for patients, because we know that this method works. In Poland, we also already have our own experience. There are two centers where you can get this treatment. One of them, certified for administration, is the clinic where I work. It meets all the world standards required for the implementation of this method, and I have already used it successfully with us.
It's a method dedicated primarily to patients at the stage of relatively early treatment - until there are no irreversible changes and destruction, and it's worth noting that fistulas lead to damage to the sphincter apparatus, chronic fibrosis or stiffening. Then it may be too late, and unfortunately we still have a system in Poland of treating complications and dramas rather than treating early conditions. Crohn's fistula is a prime example.
Patients are young patients with a good chance of returning to full activity. If such a person does not receive appropriate treatment early on, he is likely to be a patient with a stoma later on. A stoma, of course, is not a drama and cannot be stigmatized. However, the paradox of the system is that ineffective treatment will consume incomparably more money over the patient's lifespan than treating it with a good preparation at the beginning of the disease. We don't know how to save money. We are a poor country, and it turns out that we are terribly wasteful.
To sum up: stem cell treatment is directed to patients who are young, at an early stage of the disease, and have a chance to return to full activity. If the patient is 80 years old and we will be fighting a battle for a sphincter that will no longer be completely ideal due to age, then the emergence of a stoma will be the best option in such a case, if only from a hygienic and dressing point of view. Patients who are young, who are aware of their disease and have learned to function with it, stem cells can bring them back to full activity. Studies show that after this treatment, quality of life and functionality is similar to what people had before the disease. They return to three dimensions of activity: social, professional and personal. A huge advantage of administering stem cells is that no tissue is lost. Any excision, any invasive action, involves a certain deficit, and one has to ask oneself what will happen if the procedure fails.
What actions should be taken to ensure that the unmet health need of Polish patients with perianal fistulas is addressed?
This is, of course, to include such treatment in reimbursement. At the same time, however, we do not expect stem cells to suddenly become a universally available method for everyone. They must be subject to patient eligibility rules. So we are talking about a number closing in on hundreds of patients a year, treated in certified centers, with a guarantee that the method will be used in the most correct way and there will be no waste of the preparation, which is not cheap.
Thank you for the interview.
