Efficacy and safety of intravenous glucocorticoid therapy for IgG4-related ophthalmic disease

Min Kyu Yang; Gye Jung Kim; Yeong A. Choi; Ho-Seok Sa

doi:10.1371/journal.pone.0284442

Peer Review History

Original SubmissionJanuary 12, 2023
30 Jan 2023 Decision Letter - Keiko Hosohata, Editor PONE-D-23-01006Efficacy and safety of intravenous glucocorticoid therapy for IgG4-related ophthalmic diseasePLOS ONE Dear Dr. Sa, 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. Please submit your revised manuscript by Mar 16 2023 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. 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The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf Additional Editor Comments: This manuscript is interesting; however, there are few points to be corrected. Importantly, comparisons per patient is confusing; systemic manifestations are compared on a per patient basis, but ‘Head and neck’ was not? [Note: HTML markup is below. Please do not edit.] 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. 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(Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: Auhtors should address the following issues: 1) Abstract: Give sample size (n) for the oral steroid group in the “The complete response rate was significantly higher in the IV steroid group (n = 30 eyes) than in the oral steroid group (66.7% vs. 38.7%, p = 0.041)” sentence. 2) Table-1: a. Although IQR is explained in table footnotes, there is no ‘IQR’ abbreviation on the table. b. Comparisons per patient is confusing. For example systemic manifestations are compared on a per patient basis, but ‘Head and neck’ was not? 3) Table-2: Is the follow-up period comparison based on per patient or per eye? 4) Are the Cox models for relapse based on per eye or per patient? 5) If the Cox models are based on per eye, how was the lack of independency between the two eyes from the same patient were accounted for in the models? 6) Small KM and Cox analysis table presenting total patients/eyes (whichever used) at risk, total number of events/relapses observed for both groups, and hazard ratio estimates from the Cox models on Figure-2 A and B will be very useful. Reviewer #2: The authors applied IV glucocorticoid therapy which is for moderate-to-severe TAO for IgG4-ROD. As the cumulative dose of steroid was significantly higher in the IV steroid group than in the oral steroid group, such important message should be emphasized in the paper as well as the title. ****** 6. 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 #1: No Reviewer #2: Yes: Jian Zhu ******** [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. 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Revision 1
22 Mar 2023 Author Response Reviewer #1: Auhtors should address the following issues: 1) Abstract: Give sample size (n) for the oral steroid group in the “The complete response rate was significantly higher in the IV steroid group (n = 30 eyes) than in the oral steroid group (66.7% vs. 38.7%, p = 0.041)” sentence. � “(n = 31 eyes)” are added just behind the “in the oral steroid group”. Abstract, Line 36: The complete response rate was significantly higher in the IV steroid group (n = 30 eyes) than in the oral steroid group (n = 31 eyes) (66.7% vs. 38.7%, p = 0.041). 2) Table-1: a. Although IQR is explained in table footnotes, there is no ‘IQR’ abbreviation on the table. � The table footnote explaining IQR is deleted. b. Comparisons per patient is confusing. For example systemic manifestations are compared on a per patient basis, but ‘Head and neck’ was not? � Systemic manifestations and serologic features are compared on a per-patient basis. Sorry for confusing mistakes on numbers. We added “If not specified, comparisons were on a per-eye basis.” in table legend. Methods, Line 146/162: If not specified, comparisons are on a per-eye basis. 3) Table-2: Is the follow-up period comparison based on per patient or per eye? � Follow-up periods were calculated on a per-eye basis (Except for adverse effects comparisons, most comparisons were on a per-eye basis). 4) Are the Cox models for relapse based on per eye or per patient? � The Cox models for relapse were on a per-eye basis. 5) If the Cox models are based on per eye, how was the lack of independency between the two eyes from the same patient were accounted for in the models? � Thank you for the good comment. In consultation with the statistics team of our institute, additional analysis considering inter-eye correlation was performed. The results remained unchanged that IV administration of glucocorticoids was associated with a significant reduction in the relapse of IgG4-ROD. Methods, Line 131: Multivariate Cox regression analysis, with robust standard errors that accounted for inter-eye correlation, was used to evaluate the independent association of risk factors with relapse of IgG4-ROD. 6) Small KM and Cox analysis table presenting total patients/eyes (whichever used) at risk, total number of events/relapses observed for both groups, and hazard ratio estimates from the Cox models on Figure-2 A and B will be very useful. � We added tables presenting number of eyes at risk/total number and relapses in both groups. Hazard ratio estimates are presented in figure legends due to the space issue. Results, line 195: (A) In all patients (hazard ratio 5.5; 95% confidence interval 2.4–12.8; p < 0.001). (B) In the subgroups with initial serum IgG4 level > 1.35 g/L (hazard ratio 19.2; 95% confidence interval 6.1–60.9; p < 0.001). Reviewer #2: The authors applied IV glucocorticoid therapy which is for moderate-to-severe TAO for IgG4-ROD. As the cumulative dose of steroid was significantly higher in the IV steroid group than in the oral steroid group, such important message should be emphasized in the paper as well as the title. � Thank you for the good comment. In the abstract, the treatment regimen of oral or IV methylprednisolone was additionally described in detail. Abstract, line 29~31: Glucocorticoids were orally or intravenously administered, according to the date of treatment. � Glucocorticoids were given either oral prednisolone at an initial dose of 0.6 mg/kg/day for four weeks with subsequent tapering or once weekly IV methylprednisolone (500 mg for six weeks, then 250 mg for six weeks), according to the date of treatment. Attachments Attachment Submitted filename: Response to reviewers_f.docx https://doi.org/10.1371/journal.pone.0284442.r002
3 Apr 2023 Decision Letter - Keiko Hosohata, Editor Efficacy and safety of intravenous glucocorticoid therapy for IgG4-related ophthalmic disease PONE-D-23-01006R1 Dear Dr. Sa, 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. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Keiko Hosohata, Ph.D. Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0284442.r003
Formally Accepted
11 Apr 2023 Acceptance Letter - Keiko Hosohata, Editor PONE-D-23-01006R1 Efficacy and safety of intravenous glucocorticoid therapy for IgG4-related ophthalmic disease Dear Dr. Sa: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr Keiko Hosohata Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0284442.r004

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