2024 Update on Position Statement by Experts from the Polish Society of Allergology and the Polish Respiratory Society on the Evaluation of Efficacy and Effectiveness of Single Inhaler Triple Therapies in Asthma Treatment

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

Major:

1.       The authors should use the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach to summarize their updates, even if these are all expert opinions.

2.       Besides financial considerations, is there data supporting SITT than biological agents? Particularly in patients with high eosinophil counts or other Th2 activation.

3.       Pulmonary deposition and PKPD profile should be placed before the therapeutic parts. Also, the PKPD data is derived from adult and adolescent observations. Is there a way to separate them and only include adult data in the manuscript?

4.       Incorporating Enerzair and Trimbow data into the same subheadings would be ideal. If the authors want to separate them, they should consider using the same subheadings.

Comments on the Quality of English Language

Minor to moderate editing is required.

Author Response

1. The authors should use the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach to summarize their updates, even if these are all expert opinions. 

Thank you for your valuable comments. The GRADE approach is among several solutions but by decision of the top Polish experts in asthma field from two scientific societies it was established that the methodology of this position statement will be based on an expert opinion and not on the GRADE methodology. This is an update of two previously published position statements on this topic. Hence, it is not possible to use the GRADE methodology at present because these would be completely new recommendatoins. 

2. Besides financial considerations, is there data supporting SITT than biological agents? Particularly in patients with high eosinophil counts or other Th2 activation. 

To our knowledge, there are no studies comparing SITT therapy ”head to head” with biological therapy. In the opinion of experts, SITT therapy should be introduced first before biological therapy, among others for financial reasons and availability in our country. However, this suggestion does not exclude the patient from qualifying for biological therapy, including a patient with elevated eosinophil count. 

3. Pulmonary deposition and PKPD profile should be placed before the therapeutic parts. Also, the PKPD data is derived from adult and adolescent observations. Is there a way to separate them and only include adult data in the manuscript? 

Pulmonary deposition and PKPD profile were placed before the therapeutic parts. We have no way of separating the PKPD data from adult and adolescent observations. 

4. Incorporating Enerzair and Trimbow data into the same subheadings would be ideal. If the authors want to separate them, they should consider using the same subheadings.

The same subheadings were introduced. 

Please see the attachment. 

 

Author Response File: Author Response.pdf

Reviewer 2 Report

Comments and Suggestions for Authors

The peer-reviewed manuscript "2024 Update on Position Statement by Experts from the Polish Society of Allergology and the Polish Respiratory Society on the Evaluation of Efficacy and Effectiveness of Single Inhaler Triple Therapies in Asthma Treatment" is devoted to the current topic of asthma treatment with triple therapy, which includes a combination inhaler with glucocorticosteroids (ICS), long-acting beta-2 agonists (LABA) and long-acting muscarinic receptor antagonists (LAMA). The authors of the article, experts from the Polish Society of Allergology and the Polish Respiratory Society, discuss current data on the prevalence of asthma in Poland, problems with treatment adherence and the benefits of triple therapy.

Asthma is a common disease, and the search for effective treatment methods is a current issue. Triple therapy is a new approach that can improve the quality of life of patients. The authors provide up-to-date data on the prevalence of asthma in Poland, highlighting issues with adherence to treatment, making triple therapy a promising solution. The authors explain how triple therapy works and why it may be more effective than traditional treatments. The manuscript provides recommendations for the use of triple therapy in clinical practice.

Although the article mentions the results of clinical trials, detailed information on them is lacking. It would be useful to see a more in-depth analysis of clinical trial data to assess the efficacy and safety of triple therapy. The manuscript does not describe the potential side effects of triple therapy in sufficient detail. The peer-reviewed manuscript noted a reduced risk of ICS-associated side effects, it does not discuss potential LAMA-associated side effects that may occur in some patients. It is important that doctors and patients are aware of the risks and benefits of any treatment. 

Author Response

The peer-reviewed manuscript "2024 Update on Position Statement by Experts from the Polish Society of Allergology and the Polish Respiratory Society on the Evaluation of Efficacy and Effectiveness of Single Inhaler Triple Therapies in Asthma Treatment" is devoted to the current topic of asthma treatment with triple therapy, which includes a combination inhaler with glucocorticosteroids (ICS), long-acting beta-2 agonists (LABA) and long-acting muscarinic receptor antagonists (LAMA). The authors of the article, experts from the Polish Society of Allergology and the Polish Respiratory Society, discuss current data on the prevalence of asthma in Poland, problems with treatment adherence and the benefits of triple therapy.

Asthma is a common disease, and the search for effective treatment methods is a current issue. Triple therapy is a new approach that can improve the quality of life of patients. The authors provide up-to-date data on the prevalence of asthma in Poland, highlighting issues with adherence to treatment, making triple therapy a promising solution. The authors explain how triple therapy works and why it may be more effective than traditional treatments. The manuscript provides recommendations for the use of triple therapy in clinical practice.

Although the article mentions the results of clinical trials, detailed information on them is lacking. It would be useful to see a more in-depth analysis of clinical trial data to assess the efficacy and safety of triple therapy. The manuscript does not describe the potential side effects of triple therapy in sufficient detail. The peer-reviewed manuscript noted a reduced risk of ICS-associated side effects, it does not discuss potential LAMA-associated side effects that may occur in some patients. It is important that doctors and patients are aware of the risks and benefits of any treatment. 

Detailed information on the data suggested by the reviewer are available in the publications describing the clinical trials. The aim of this position statement was to provide a practical/clinical presentation of the place of SITT therapy in the treatment of asthma. Description of the detailed data suggested by the reviewer, including adverse events, was considered by the experts but ultimately it was decided that these recommendations should be concise and not described in detail. These data can be found in other publications. The aim of this position statement was to focus on the use of SITT therapy in asthma in clinical practice.

Reviewer 3 Report

Comments and Suggestions for Authors

There are established and prestigious international guidelines as GINA which have clearly mentioned indication of SITT, I don’t feel there is a need of separate country based expert consensus statement specially when nothing new has been added in this manuscript.

Author Response

There are established and prestigious international guidelines as GINA which have clearly mentioned indication of SITT, I don’t feel there is a need of separate country based expert consensus statement specially when nothing new has been added in this manuscript. 

Thank you for this concise opinion. However, we do not agree with it that this position statement does not contain new information compared to the GINA recommendations. Please, pay special attention to the figure 2 in which we position SITT therapy as central treatment at level 5 and partially at level 4 (no separate paths 1 and 2 at these levels), which is a new approach compared to the GINA recommendations. We also emphasize that our recommendations are based on many scientific studies included in the text of the recommendations, while the GINA recommendations in path 1 at level 5 and partially 4 (indications for LAMA) are not based on the results of scientific studies or commonly used therapeutic practice. 

Round 2

Reviewer 1 Report

Comments and Suggestions for Authors

The authors have been largely responsive to the comments, although tables and figures need some editing to meet publication standard, particular figure 1.

Comments on the Quality of English Language

No major concerns

Author Response

Thank you for comments and suggestions. Tables and figures have been corrected to meet publication standard as discussed with Editor-in-Chief. 

Reviewer 3 Report

Comments and Suggestions for Authors

The use of triple therapy in asthma reduces the risk of exacerbation and frequent hospitalisation as shown in many studies thus your study is a brilliant study, although in contrast to the step wise approach as mentioned in GINA Guidelines. 

Comments on the Quality of English Language

Minor changes in english 

Author Response

Thank you for a valuable and supportive comment which is consistent with our experience and opinion that use of triple therapy in asthma reduces the risk of exacerbation and frequent hospitalisation.