Open debate:
Dr. Beatriz Lagos (HAL allergy): In the talk given by Dr. Tabar, she has emphasized the importance of the variability among different batches, and its impact in efficacy and safety. Some European companies perform an in-house double validation, which is also sent to the Paul Erlich Institute. What is the relevance that prescriptors give to such procedure?
Dr. Ana Tabar: It is quite important, the more variables that are under our control, the best treatments we will have. For instance, in the last four years, our knowledge in mite allergens has drastically increased with more than 30 allergens being described. The mite trials shown during my presentation were published in 2016, and there are another 2 more trials currently in press but not publicly available.
If an extract contains a certain allergen, it should be acknowledged, in the same way that we know the amount of Ole e 9 included in certain olive extracts. In other context, it is a similar situation as what happens with the Api m 10, which amount in the extracts should be stated, because it has shown to be crucial in the efficacy of bee venom allergy. If the Immunotherapy companies are aware of allergens and their amount in their products, it should be included in the labelling of each product since it will mean an added value for it.
Dr. Anna Cisteró: when talking about safety and cost, it is also mentioned the patient's preference towards different therapeutic options. When a decision on a patients’ treatment has to be taken, in daily practice, should the different options be proposed to the patient?
Dr. Désiree Larennas: In my place of practice, Mexico, it is indeed a relevant issue. I am confident in the better efficacy profile of subcutaneous immunotherapy when adherence is high compared to that of sublingual immunotherapy, although it should be balanced with its poorer safety profile. Thus, it depends on the patient, if he/she is able to accomplish with all the visits to correctly perform SCIT for 3 years or if he/she will miss appointments and doses, with a detrimental impact in the real life efficacy. If such is the case, I would rather prefer to administer SLIT.
Dr. Ana Tabar: If you had made me the same question 2 years ago, my answer would have been pretty much the same to what Dr. Larennas just said. However, I’m not that confident now because of the great quality of some SLIT products currently available. There are several publications supporting the efficacy of these products that really push me to think their level of evidence is similar to that of SCIT. My concern is to differentiate evidence-based products from those without such support, what drives to the need of a proper regulation. Lack of evidence does not necessarily mean lack of efficacy, but those products that have already proven their efficacy, must be acknowledged. In the end it is not a route-selection decision, but a product-selection decision making.
Dr. Marcel Libero: regarding mite allergy, we have identified a subgroup of patients showing poor efficacy with mite AIT. We performed a study of 3 different products and found out that only 2 of them accounted in their composition with the allergens needed to match and treat the allergenic profile displayed by most of our patients, who predominantly are reactive to Der p 2, without any reactivity to Der p 1.
Dr. Ana Tabar: From my point of view, in nowadays’ AIT, there are some products that you can use in big groups of patients, allergic to certain very common and frequent allergens, unless you specifically have in your geographical area minor allergens with high relevance. In the other hand, there are other products harder to standardize because they are aimed for less frequent allergies, and it is debatable whether if these should undergo the same quality standards or not. And there is finally the “special” use of some products, which can be compared to the use it is given in certain circumstances to Biologicals. These drugs, with clear-cut indications, are occasionally used outside the package-insert indications, but if such is the case, the patient is properly informed of its exceptional use, which is based upon my knowledge of some published case-reports in the same topic. This approach allowed us to widen the indications of Biologicals to different allergic diseases.
Dr. Desiree Larennas: regarding the allergenic content in mite immunotherapy products, some of them indeed are lacking mites’ group 2 of allergens, and thus these products will not be efficacious.