AI Insight
This study analyzed 601 adverse drug reaction reports from the WHO database and 80 published case reports to characterize the safety profile of camrelizumab, a PD-1 inhibitor used primarily in Asian populations. The most common adverse reactions were hematological disorders (21.8%, including bone marrow suppression and thrombocytopenia) and skin reactions (14.3%, including reactive capillary hyperplasia and severe cases like toxic epidermal necrolysis), with a median onset time of 8 weeks after treatment initiation. Serious but less frequent events included myocarditis, immune hepatitis, and thyroid dysfunction, requiring early detection and corticosteroid intervention.
Why it matters
This comprehensive safety analysis provides clinicians with critical information for monitoring patients receiving camrelizumab, emphasizing the need for vigilance regarding both common hematologic and dermatologic toxicities as well as rare but potentially life-threatening events like myocarditis. The findings support the development of standardized monitoring protocols and early intervention strategies to improve patient outcomes in cancer immunotherapy.
Understand the Science
by Yi Huang, Wei Li
Objective
Real-world studies on the safety of camrelizumab are scarce. This study aimed to investigate the adverse drug reactions (ADRs) associated with camrelizumab and evaluate their clinical characteristics and management.
Methods
We retrieved data on ADRs related to the PD-1 inhibitor camrelizumab from the World Health Organization (WHO) adverse event reporting system database (VigiAccess) for the period from June,2019 to July 2025. Additionally, we conducted a retrospective analysis of case reports and case series on camrelizumab-related ADRs published from 2019 to 2025.
Results
601 ADR reports were included in the VigiAccess database. Asian patients accounted for 99% (597/601), and the majority were male (69%). The most common classification of systemic organs (SOC) is hematological disorders (21.8%), skin reactions (14.3%), and systemic symptoms (8.8%). The main adverse reactions were: Hematological system: bone marrow suppression (10.3%), thrombocytopenia (5.1%); Skin: rash (5.7%), pruritus (4.3%), reactive capillary hyperplasia (RCCEP); systemic: fever (2.6%), chest pain (2.1%); serious events: myocarditis (1.2%), toxic epidermal necrolysis (TEN). Literature analysis included 80 patients (from China), with a median age of 60 years (range 20–84), and 72.5% were male. The main indications are non-small cell lung cancer (20%), nasopharyngeal carcinoma (20%) and hepatocellular carcinoma (11.3%). The median occurrence time of adverse reactions was 8 weeks (ranging from 10 minutes to 88 weeks). Typical ADRs include: cutaneous toxicity (45 cases, 56.3%); RCCEP (32 cases), Stevens-Johnson (SJS)/TEN (5 cases); hematological toxicity (38 cases, 47.5%): bone marrow suppression (22 cases), thrombocytopenia (16 cases); cardiotoxicity (13 cases, 16.25%), mainly myocarditis; Others: immune hepatitis (6 cases), thyroid dysfunction (5 cases).
Conclusion
The ADRs of camrelizumab are primarily hematologic and skin toxicities, with a need to be vigilant for late-onset serious events (e.g., myocarditis, TEN). Early identification and corticosteroid intervention are key management strategies.
Source: Safety profile of camrelizumab: An analysis based on literature and database review