J Pharmacoepidemiol Risk Manage.  2022 Sep;14(2):149-157. 10.56142/jperm.22.0014.

Real-world Data-based Adverse Drug Reactions Analysis of Pomalidomide in Patients with Relapsed or Refractory Multiple Myeloma

• Ko M
• Choi J
• Kim S
• Kim SH
• Cho EJ
• Cho YS
• Koh YI
• Oh JM

• KMID: 2534686
• DOI: http://doi.org/10.56142/jperm.22.0014

Abstract

Objective
Pomalidomide is a latest-approved immunomodulatory drug used with dexamethasone for patients with relapsed or refractory multiple myeloma (RRMM). However, the real-world safety evidence remains unclear. Thus, we evaluated the toxicity of pomalidomide in patients with RRMM in real-world setting.
Methods
This retrospective study included all patients treated with pomalidomide at Seoul National University Hospital between January 2017 and June 2020. We analyzed the incidence and timing of adverse drug reactions (ADRs) based on Common Terminology Criteria for Adverse Events (CTCAE) criteria, cases of dose reduction and discontinuation due to ADRs, and risk factors of grade 3-5 ADRs.
Results
A total of 124 patients were evaluated. The most common all grades ADRs were hematological ADRs, including neutrophil count decreased (71.8%), anemia (52.4%), platelet count decreased (47.6%), and hematologic disorders were the top attributes to reduce, interrupt, and discontinue pomalidomide. Furthermore, grade 3-5 ADRs included pneumonia (11.3%), sepsis (5.6%), and acute kidney injury (4.8%). The median time to onset of grade 3-5 ADRs was 3.0 weeks and 6.6 weeks for platelet count decreased and for pneumonia, respectively. Grade 3-5 hematological ADRs were significantly higher in patients treated with thalidomide previously (OR 4.31, 95% CI 1.19-15.6).
Conclusion
Compared to the phase 3 clinical trial of pomalidomide, MM-003, the incidence of all grades of hematological ADRs was higher, and grade 3-5 infection was lower in real-world settings. Therefore, close monitoring of ADRs in patients treated with pomalidomide is necessary.

Keyword

Pomalidomide; Relapsed/refractory multiple myeloma (RRMM); Adverse drug reactions (ADR); Real World Data (RWD)