Pediatrik Hastalarda Rituksimab İlişkili Aşırı Duyarlılık Reaksiyonları: Risk Profili ve İlaç Desensitizasyonu Sonuçlarının Gerçek Yaşam Analizi

Öz

Pediatrik popülasyonda rituksimaba bağlı aşırı duyarlılık reaksiyonlarının (ADR) sıklığı, klinik fenotipi ve risk faktörlerine ilişkin veriler sınırlıdır. Bu çalışmada, rituksimab ilişkili ADR'lerin sıklığı, klinik fenotipi, şiddeti, ortaya çıkış zamanı ve yönetim sonuçlarının değerlendirilmesi ile çocuklarda ADR gelişimi ile ilişkili faktörlerin araştırılması amaçlandı. Bu tek merkezli retrospektif kohort çalışmasına, Mart 2019 ile Nisan 2026 arasında rituksimab tedavisi alan 0-18 yaş arası tüm hastalar dahil edildi. Demografik özellikler, atopik komorbiditeler, eş zamanlı immünosüpresif tedaviler, infüzyon öncesi laboratuvar parametreleri ve ADR ayrıntıları kaydedildi. Reaksiyonlar Brown anafilaksi derecelendirme sistemine göre sınıflandırıldı ve Tip I, sitokin salınım sendromu (SSS) ya da infüzyonla ilişkili reaksiyon (İİR) olarak fenotiplendirildi. Toplam 30 hastaya (%56,7 kız; medyan yaş 12,6 yıl) 129 rituksimab infüzyonu uygulandı. Hasta başına ADR oranı %13,3 (n=4), infüzyon başına oran ise %3,1 idi. İki hastada Tip I reaksiyon (anafilaksi), bir hastada SSS ve bir hastada İİR gelişti. Tüm ADR'ler ilk iki tedavi kürü içinde ortaya çıktı ve ADR gelişen grupta medyan doz sayısı anlamlı olarak daha düşüktü (2vs4; p=0,044). Hiçbir demografik, klinik veya laboratuvar parametresi ADR gelişimi ile anlamlı ilişki göstermedi. Üç hastada (11 işlem) hızlı ilaç desensitizasyonu (HİD) başarıyla uygulanarak tedavinin kesintisiz sürdürülmesi sağlandı.Rituksimaba bağlı erken tip ADR'ler pediatrik hastalarda dikkate değer bir sıklıkta ve ağırlıklı olarak erken tedavi kürleri sırasında görülmektedir. Pediatrik alerji rehberliğinde uygulanan HİD, anafilaksi öyküsü olan çocuklarda dahi tedavinin güvenle sürdürülmesine olanak tanımaktadır. Bu bulgular, ilk infüzyonlar sırasında klinik dikkatin artırılmasının ve multidisipliner bir risk yönetimi yaklaşımının benimsenmesinin önemini vurgulamaktadır.

Anahtar Kelimeler

• anaphylaxis
• hypersensitivity
• pediatric
• rapid drug desensitization
• rituximab

Rituximab-Associated Hypersensitivity Reactions in Pediatric Patients: A Real-World Analysis of Risk Profile and Desensitization Outcomes

Öz

Data regarding the incidence, clinical phenotype, and risk factors of hypersensitivity reactions (HSRs) associated with rituximab in pediatric populations remain limited. This study aimed to evaluate the frequency, clinical phenotype, severity, timing, and management outcomes of rituximab-associated HSRs and to investigate the factors for HSR development in children. This single-center retrospective cohort study included all patients aged 0–18 years who received rituximab between March 2019 and April 2026. Demographic characteristics, atopic comorbidities, concomitant immunosuppressive therapies, pre-infusion laboratory parameters, and HSR details were recorded. Reactions were classified according to Brown’s anaphylaxis grading system and phenotyped as Type I, cytokine release syndrome (CRS), or infusion-related reaction (IRR). A total of 30 patients (56.7% female; median age 12.6 years) received 129 rituximab infusions. The per-patient HSR rate was 13.3% (n=4), and the per-infusion rate was 3.1%. Two patients experienced Type I reactions (anaphylaxis), one had CRS, and one had an IRR. All HSRs occurred within the first two treatment courses, with a significantly lower median dose number in the HSR group (2 vs. 4; p=0.044). No demographic, clinical, or laboratory parameter was significantly associated with HSR development. Rapid drug desensitization (RDD) was successfully performed in three patients (11 procedures), enabling uninterrupted treatment continuation. Immediate HSRs to rituximab occur at a notable frequency in pediatric patients, predominantly during early treatment courses. RDD under pediatric allergy guidance allows safe treatment continuation even in children with a history of anaphylaxis. These findings underscore the importance of enhanced clinical vigilance during initial infusions and the integration of a multidisciplinary risk management approach.

Anahtar Kelimeler

• anafilaksi
• aşırı duyarlılık reaksiyonu
• çocuk
• ilaç desensitizasyonu
• rituksimab

Destekleyen Kurum

This research received no external funding.

Etik Beyan

Ethical approval was obtained from the Institutional Review Board.

Teşekkür

The authors would like to thank all individuals who contributed to this study.

Kaynakça

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