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. 2024 Nov 25;16(11):e74454.
doi: 10.7759/cureus.74454. eCollection 2024 Nov.

Rituximab Safety Profile: A Seven-Year Retrospective Analysis From Southern India

Lakshmi Jayasree  1 , Princy L Palatty  1 , Laxmi Govindraj  1 , Gokul A Anand  1 , Gokul B Dev  1 , Bharath Shabu  1 , Tinu T S  2   3 , Abhishek A Nair  2
Affiliations

Rituximab Safety Profile: A Seven-Year Retrospective Analysis From Southern India

Lakshmi Jayasree et al. Cureus. .

Abstract

Objective: This study aimed to analyze the pattern, severity, and outcomes of adverse drug reactions (ADRs) associated with rituximab use reported to a regional pharmacovigilance center in Kerala, India.

Methods: This retrospective study analyzed rituximab-associated ADRs reported from 2017 to 2023. ADRs were assessed using the WHO-UMC criteria for causality and the Modified Hartwig Siegel Scale for severity.

Results: A total of 74 patients reported ADRs, with 49 being female. The majority (27 patients) were in the 51- to 60-year age group. Malignancies accounted for 58 cases of rituximab use. Most ADRs (69 cases) occurred with the first dose, with infusion reactions being the most common. Causality assessment revealed that 48 ADRs were probably related to rituximab. Severity analysis using the Modified Hartwig Siegel Scale showed that 67 ADRs were level two (mild), while two were level seven (severe). The majority of patients (72) recovered. However, rituximab-induced lung disease, observed in two cases, was associated with higher mortality.

Conclusion: Rituximab demonstrated an acceptable safety profile, with most ADRs being non-serious and manageable. The high recovery rate reflects effective ADR management. However, the potential for serious complications, particularly rituximab-induced lung disease, highlights the need for vigilant monitoring, especially during the first infusions. These findings enhance understanding of rituximab's real-world safety profile and underscore the importance of standardized protocols for ADR mitigation.

Keywords: adverse drug reactions; causality assessment; infusion related reactions; modified hartwig siegel scale; pharmacovigilance; rituximab; rituximab-induced lung disease; safety profile; who-umc criteria.

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Conflict of interest statement

Human subjects: Consent for treatment and open access publication was obtained or waived by all participants in this study. Ethics Committee of Amrita School of Medicine issued approval ECASM-AIMS-2024-403. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.

Figures

Figure 1
Figure 1. Indications of rituximab in the study population.
NHL: non-Hodgkins lymphoma, TTP: thrombotic thrombocytopenic purpura, ITP: immune thrombocytopenic purpura.
Figure 2
Figure 2. Infusion-related reactions graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (N=49).
Figure 3
Figure 3. Severity of adverse drug reactions (ADR) using Modified Hartwig Siegel Scale for severity assessment (N=74).
Figure 4
Figure 4. Statistically significant association (p < 0.001) between adverse drug reaction (ADR) types and patient outcomes in rituximab treatment.
See this image and copyright information in PMC

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