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Clinical Effectiveness and Safety of Initial Combination Therapy with Corticosteroids and Rituximab in Bullous Pemphigoid: A Retrospective Cohort Study

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Abstract

Background

Rituximab is a potential initial adjuvant therapy for bullous pemphigoid, yet clinical experience is scarce.

Objective

We aimed to examine the clinical outcomes and safety of initial combination therapy with systemic corticosteroids and adjuvant rituximab for the treatment of bullous pemphigoid.

Methods

A retrospective cohort study was performed on 84 patients with bullous pemphigoid, who received systemic corticosteroids with or without initial adjuvant rituximab therapy (defined as rituximab use within 12 weeks after initiation of systemic corticosteroids).

Results

Among the 84 patients included (37 received systemic corticosteroids with rituximab and 47 were treated with systemic corticosteroids without rituximab), the median time to complete remission on minimal therapy or off therapy was 215 days (95% confidence interval 176.9–253.1) in patients receiving rituximab vs 529 days (95% confidence interval 338.6–719.4) in those not receiving rituximab. A Cox regression analysis showed an increased probability of reaching complete remission on minimal therapy or off therapy with the combined therapy (hazard ratio = 2.28 [1.28–4.07], p = 0.005) after age, Bullous Pemphigoid Disease Activity Index score, and underlying diseases were controlled. In multivariate logistic/linear regressions, initial adjuvant rituximab therapy was associated with a higher complete remission rate (odds ratio = 6.63 [2.09–21.03]) and lower cumulative prednisolone (mg)/body weight (kg) (B = −24.86 [−44.06 to −8.29]) within 48 weeks. Risk of hospitalization for infection was not elevated in the group treated with adjuvant rituximab.

Conclusions

Rituximab use as adjuvant therapy within 12 weeks after initiation of systemic corticosteroids was associated with a faster and higher rate of achieving complete remission on minimal therapy or off therapy, as well as a significant corticosteroid-sparing effect and a comparable safety profile in this retrospective study. Hence, initial combination therapy with corticosteroids and adjuvant rituximab could serve as an effective treatment option for bullous pemphigoid, but this requires confirmation in randomized controlled studies.

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Author information

Authors and Affiliations

  1. Department of Dermatology, National Taiwan University Hospital Hsin-Chu Branch, Hsinchu, Taiwan

    Yun-Ju Tsai

  2. Department of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, 15F, No. 7, Chung-Shan South Road, Taipei, Taiwan

    Yun-Ju Tsai, Yung-Tsu Cho & Chia-Yu Chu

Authors
  1. Yun-Ju Tsai
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  2. Yung-Tsu Cho
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  3. Chia-Yu Chu
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Corresponding author

Correspondence to Chia-Yu Chu.

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Funding

No sources of funding were received for the preparation of this article.

Conflict of interest

Yung-Tsu Cho and Chia-Yu Chu have received lecture fees from Roche Taiwan Co. Ltd. Yun-Ju Tsai has no conflicts of interest directly relevant to the content of this article.

Ethics Approval

The study was approved by the National Taiwan University Hospital Research Ethics Committee (201703053RIND).

Consent to Participate

Not applicable. The results presented in the current study do not risk compromising the complete anonymity of patients included.

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Not applicable.

Availability of Data and Material

The datasets analyzed during the current study are not publicly available because of the regulations of our institute on patient confidentiality and anonymity, but are available from the corresponding author on reasonable request.

Code Availability

All codes for statistical data analysis were performed with either publicly or commercially available statistical software or modules, including IBM SPSS Statistics 19, GraphPad Prism, and modules in R language.

Author Contributions

All authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed by Yun-Ju Tsai. The first draft of the manuscript was written by Yun-Ju Tsai and all authors contributed to the critical revision and editing on previous versions of the manuscript. All authors read and approved the final manuscript.

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Tsai, YJ., Cho, YT. & Chu, CY. Clinical Effectiveness and Safety of Initial Combination Therapy with Corticosteroids and Rituximab in Bullous Pemphigoid: A Retrospective Cohort Study. Am J Clin Dermatol 23, 571–585 (2022). https://doi.org/10.1007/s40257-022-00688-x

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  • DOI: https://doi.org/10.1007/s40257-022-00688-x

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