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Submitted: 29 Feb 2024
Revision: 22 Oct 2024
Accepted: 02 Nov 2024
ePublished: 08 Apr 2026
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J Res Clin Med. 2026;14: 34789.
doi: 10.34172/jrcm.026.34789
  Abstract View: 33
  PDF Download: 29

Original Article

Unveiling the Safety Profile of Rituximab in Pemphigus Vulgaris: A Cross-Sectional Insight into Adverse Reactions

Faeghe Sheikhalizadeh Nobar 1 ORCID logo, Niloofar Torab Maralani 2 ORCID logo, Mehdi Amirnia 1 ORCID logo, Khazar Raeisnia 1 ORCID logo, Mehrad Amirnia 1* ORCID logo

1 Department of Dermatology, Sina Hospital, Tabriz, Iran
2 Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
*Corresponding Author: Mehrad Amirnia, Email: [email protected], Email: [email protected]

Abstract

Introduction: Pemphigus vulgaris (PV) is one of the most prevalent autoimmune skin-blistering diseases, characteristically emerging between the ages of 40 and 60, caused by antibodies targeting the desmoglein protein in the skin. Rituximab, an anti-CD20 monoclonal antibody, received FDA approval in 2018 for PV treatment, particularly for the patients unresponsive to the conventional therapies. Due to the efficacy, rituximab has been accepted as an effective therapeutic choice for PV.

Methods: This cross-sectional retrospective study analyzed data from medical documentations of pemphigus vulgaris patients who have been treated at Sina Hospital from April 2018 to March 2022. The study was designed to evaluate the incidence of rituximab’s common adverse effects and explore any correlations with patients’ demographics.

Results: Among the patients reviewed, 36.3% received rituximab during at least one hospitalization, with 8.45% experiencing at least one adverse drug reaction, including one life-threatening event. The most prevalent adverse effect was injection-related hypersensitivity reactions, primarily manifesting as pruritus. Other complications, such as opportunistic infections, hepatic dysfunction and leukopenia followed in frequency. There were no reported fatalities attributed to the treatment in the study population.

Conclusion: The predominance of injection-related hypersensitivity reactions among adverse drug reactions aligns with findings from other studies. However, the lower incidence rate at this center suggests that pre-treatment protocols may lessen such reactions. The observed long-term complications were predominantly infections, notably herpes virus reactivations, reflecting the immunosuppressive effect of rituximab, consistent with global reports from similar research.


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