Siltuximab in Idiopathic Multicentric Castleman Disease: Real-World Experience
Ciprian Jitaru1,2, Argyris Symeonidis3, Sorina Badelita4
1Department of Haematology/Medfuture Research Centre for Translational Medicine, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj Napoca, Romania.
Insights
Siltuximab therapy effectively treated idiopathic multicentric Castleman disease (iMCD) in real-world European settings, showing a 71.1% overall response rate and a 3-year survival of 74%. This study offers valuable insights into siltuximab
Area of Science:
- Hematology
- Oncology
- Immunology
Background:
- Castleman disease (CD) is a rare lymphoproliferative disorder, with multicentric MCD (MCD) presenting systemic symptoms due to cytokine dysregulation, primarily IL-6.
- Idiopathic MCD (iMCD) treatment guidelines recommend siltuximab, an anti-IL-6 monoclonal antibody, as frontline therapy.
- Limited real-world data exist on siltuximab's efficacy and safety in routine clinical practice for iMCD.
Purpose of the Study:
- To assess the real-world effectiveness and survival outcomes of siltuximab in patients with iMCD.
- To evaluate disease response and safety profiles of siltuximab therapy in Greece and Romania.
- To contribute to the understanding of siltuximab's role in managing iMCD in diverse European populations.
Main Methods:
- A retrospective cohort study of adult iMCD patients treated with siltuximab between January 2017 and December 2022 in Greece and Romania.
- Primary endpoint: overall response rate. Secondary endpoints: survival and safety outcomes, assessed per Castleman Disease Collaborative Network guidelines.
- Patient follow-up extended until death, loss to follow-up, or study conclusion in October 2023.
Main Results:
- Forty-eight iMCD patients were included; mean age 65 years, 68.8% male. Significant age variations noted between Greek (74 years) and Romanian (54 years) cohorts.
- Siltuximab treatment yielded a 71.1% overall response rate in 38 evaluable patients, with 55.3% achieving complete response and 15.8% partial response.
- Estimated 3-year overall survival rate was 74%, with a median survival of 123 months. Common adverse events included elevated liver enzymes, anxiety, and gastrointestinal issues; 16.7% experienced serious adverse events.
Conclusions:
- Siltuximab demonstrates significant efficacy in treating iMCD within real-world clinical settings in Greece and Romania.
- This study represents the largest real-world analysis of siltuximab in European iMCD patients to date.
- Findings support siltuximab as an effective treatment option for iMCD, providing crucial data for clinical decision-making.
Background:
Castleman disease (CD) is a very rare, non-malignant lymphoproliferative disorder that can be classified as unicentric or multicentric (MCD). MCD is associated with systemic symptoms, including organ dysfunction due to cytokine dysregulation, primarily interleukin-6 (IL-6). The anti-IL-6 monoclonal antibody siltuximab is recommended as a frontline treatment for idiopathic MCD (iMCD), but real-world data on its use in routine clinical practice are limited. This study aimed to assess disease response and survival outcomes in patients with iMCD treated with siltuximab therapy in real-world settings in Greece and Romania.
Methods:
This retrospective cohort study included adult patients with iMCD treated with siltuximab in clinical practice across Greece and Romania between January 2017 and December 2022. The primary endpoint was overall response rate and secondary endpoints included survival and safety outcomes. Response assessments were performed according to the Castleman Disease Collaborative Network guidelines. Patients were followed until death, loss to follow-up or study conclusion (October 2023).
Results:
Forty-eight patients with iMCD were included in the study. Mean age at baseline was 65 years, with significant age differences between patients from Greece (74 years) and Romania (54 years). The majority of patients were male (68.8%) and received one prior line of therapy (75%). Patients included in the study received a median of nine cycles of siltuximab. Response data were available for 38 patients. The overall response to siltuximab was 71.1%, with 55.3% of patients achieving a complete response, and 15.8% a partial response. The estimated overall survival rate at 3 years was 74% and the median survival was 123 months. The most common adverse events (> 5%) included elevated liver enzymes, anxiety, allergic reactions and nausea/diarrhea. Serious adverse events were experienced by 16.7% of the patients.
Conclusions:
Our results suggest that siltuximab-based therapy is effective in treating iMCD in real-world settings in Greece and Romania. To our knowledge, this study represents the largest real-world analysis of siltuximab in European patients with iMCD so far.
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