Weighing Real-World Data on Infection Risk in CLL

Danielle M. Brander, MD, of Duke University School of Medicine, asks how much weight to give real-world and comparative effectiveness data on infection risk in chronic lymphocytic leukemia (CLL), noting that trials do not answer every question and that cross-trial comparison should be avoided. Marc J. Braunstein, MD, PhD, of NYU Grossman Long Island School of Medicine, values real-world studies because that is how most patients are treated, without the research nurse, sponsor, and oversight scrutiny of a clinical trial. These larger cohorts include patients who would not meet trial inclusion criteria, so they more accurately reflect infection and efficacy outcomes once drugs are approved, and he finds them particularly helpful for adverse events. Dr Brander adds that real-world signals can spark further study, citing atrial fibrillation on Bruton tyrosine kinase (BTK) inhibitors as a toxicity first seen in patients trials had excluded, and expects similar lessons on infection and vaccine responsiveness.