PONE-D-20-16022

The effects of selected biologics and a small molecule on Health-Related Quality of Life (HRQoL) in adult plaque psoriasis patients measured by Dermatology Life Quality Index (DLQI) – systematic review and meta-analysis

PLOS ONE

Dear Dr. Karpinska-Mirecka,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

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Ahmed Negida, MD

Academic Editor

PLOS ONE

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Partly

Reviewer #5: Yes

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: Yes

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3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: Yes

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4. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: No

Reviewer #4: No

Reviewer #5: Yes

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5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: The present meta-analysis aims to assess the utility of biological agents and one small molecule inhibitor (Tocafitinib) in improving the quality of life of Psoriasis patients (as measured by the DLQI). Psoriasis can be a highly debilitating condition, and the advent of a number of new therapeutic options does call into need a systematic analysis of the different treatments. There is a recent network meta-analysis (2017) by Lopez et al. covering the same biological agents (infliximab, adalimumab, ixekizumab, Secukinumab). Due to the network structure of the analysis, it was able to better compare the different biological agents. In addition, it had a somewhat wider coverage of outcomes, as it was not restricted solely to the DLQI as an outcome measure. There is also one recent meta-analysis (2019) by Tian et al. conducted specifically on the small molecule inhibitor Tocafitinib (assessing outcomes other than the DLQI; namely Physician global assessment response, PASI75 and PASI90) in which a significant improvement was seen.

In addition, I believe correcting the following points of methodology would probably improve the overall value of the manuscript and hopefully improve the chances of a successful publication:

1. The authors state that 423 studies qualified for full-text screening; however, the PRISMA diagram shows that only 150 articles were assessed for eligibility.

2. The authors’ PRISMA diagram shows a total of 43 included studies; however, they then proceed to choose 17 papers for evaluation of select biologic agents without clarifying the rationale as to why these 17 studies were the chosen ones. This may well be justified due to the nature of the selected studies, but I believe it would be best for the authors to clearly outline the justification for their selection.

3. The authors included a network diagram despite the fact that no network analysis was done. I think, for the sake of brevity, the diagram should probably be removed.

4. I do not believe the “citations” column in tables 1-3 serve to add much value, as the number of citations of included studies is not directly relevant to the review.

In addition, as the quality of writing greatly affects publication chances, and as the manuscript contains some linguistic errors, the paper would probably benefit from a grammatical revision to improve readability.

The aforementioned previous Meta-Analyses:

1. Quantitative Evaluation of Biologic Therapy Options for Psoriasis: A Systematic Review and Network Meta-Analysis

2. Efficacy and Safety of Tofacitinib for the Treatment of Chronic Plaque Psoriasis: A Systematic Review and Meta-Analysis

Reviewer #2: This is a systematic review and meta-analysis in which the authors investigates the effects and efficiency of different biologics and many biological drugs on Health-Related Quality of Life (HRQoL) in adult plaque psoriasis patients measured by Dermatology Life Quality Index (DLQI). DLQI is commonly used tool to assess quality of life of patients with skin diseases. The authors found that Infliximab, adalimumab, ixekizumab, secukinumab and tofacitinib in adult plaque psoriatic patients improved HRQOL measured by DLQI. The manuscript is well-written and structured. It also provides a tool for the physician to choose the right biological agent to improve the quality of life in patients with psoriasis.

Reviewer #3: The authors performed a systematic review and meta-analysis to investigate the effect of infliximab, adalimumab, ixekizumab, secukinumab, and tofacitinib on Health-Related Quality of Life (HRQOL) measured by DLQI in adult plaque psoriatic patients.

Although the overall approach of this review is proper, I have few comments:

1. Title: abbreviations should be avoided. Also, replace (– systematic) with (: A systematic).

2. The short title is missing.

3. Abstract

a) Main Objectives: remove (Aim of the study)

b) Material and Methods

- Searched through XX, insert the last date searched.

- clearly outline the eligibility criteria

- Insert the software used for analysis.

c) The results are inadequately reported, please add data of the pooled effect estimates.

d) Keywords are missing.

4. Introduction: place references at the end of sentences.

5. Methods

- The authors searched databases until October 2019. I would suggest updating the searching process for recently published relevant articles.

- No data on how the risk of bias assessment was performed.

6. Results

- Data on the screening process are incomplete and wrongly placed. Please move it to “Methods.”

- Data in Table 1 and Figure 2 are the same. Repeating data is not preferred; thus, I would recommend that one of them can be submitted as a supplementary file. The same is true for other tables and figures of the same outcome.

7. A completed PRISMA checklist is missing.

8. Figures should be submitted in better resolutions.

9. Language: The entire manuscript needs extensive professional revision for grammatical errors and stylistic editing to improve the quality of English. For example,

- Page 1: (to assess the quality), not (to assess quality); (confirm the positive effect) not (confirm positive effect); (with an overall DLQI score) not (with overall DLQI score); (The random-effects model) not (Random effects model). (Scopus, ClinicalTrials.gov and manual searching) & (ixekizumab, secukinumab and tofacitinib), a comma should be placed before (and), etc.

Reviewer #4: Dear Author,

There are some points to consider when you revise your manuscript.

The title of your study is too long. It would be better to make it short such as following;

(The effects of selected biologics and a small molecule on Health-Related Quality of Life: systematic review and meta-analysis.)

The affiliation sentence needs revision.

The reference need to be revised according to the journal guideline.

It also need English editing.

Why did you include 43 studies while only 17 of them assessed the DQLI of patients on biologic treatments? based on your objective you should only include these 17 studies.

Reviewer #5: Title

I believe it is unnecessary to put in the title of the article that Health-Related Quality of Life was measured by DLQI.

I think that would be enough: The effects of selected biologics and a small molecule on Health-Related Quality of Life (HRQoL) in adult plaque psoriasis patients – systematic review and meta-analysis". Quality of Life can be a keyword.

Methods

In "Search strategy":... papers of all languages. In "Eligibility criteria" ..... 2. non-English language...

Please clarify this.

Results: ".....the 43 studies, which met our inclusion criteria, the total of 25,898 individuals were evaluated by DLQI and....... (15,16,17,18,19) .......(20,21,22,23)" ......

Strengths and Limitations of the study (24, 26, 28, 35, 37, 38, 39 )

You should quote the references of sequential numbers by placing only a hyphen between the first and the last number and not mentioning all the numbers, as follows: 15-19 and 20-23 and 24, 26, 28, 35, 37-39

"As for ethnicity of the evaluated cases, most of the studies demonstrated differentiation in the patients’ race. Only 13/43 studies evaluated single-ethnic group (8 studies enrolled only Asian and 5 studies only Caucasian patients). Moreover, 11/43 papers suffered from the lack of data concerning the patients’ race."

Race and ethnicity have different meanings. You need to standardize the term. See also table 1

Conclusion

"This meta-analysis also compares biologics, a small molecule and placebo effect on DLQI in psoriatic patients."

You didn't say the conclusion about this small molecule

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Reviewer #1: No

Reviewer #2: No

Reviewer #3: No

Reviewer #4: No

Reviewer #5: No

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The effects of selected biologics and a small molecule on Health-Related Quality of Life in adult plaque psoriasis patients: A systematic review and meta-analysis.

PONE-D-20-16022R1

Dear Dr. Karpinska-Mirecka,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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Kind regards,

Ahmed Negida, MD

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #3: All comments have been addressed

Reviewer #4: All comments have been addressed

Reviewer #5: All comments have been addressed

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2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: (No Response)

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3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: (No Response)

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: (No Response)

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5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #3: Yes

Reviewer #4: Yes

Reviewer #5: (No Response)

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #3: The authors have addressed all my comments/suggestions.

Reviewer #4: None

Reviewer #5: (No Response)

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7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #3: No

Reviewer #4: No

Reviewer #5: Yes: Marilda Aparecida Milanez Morgado de Abreu