Table I.

Recommendations for analysis of respiratory tract infections in clinical trials of psoriasis and related diseases

Recommendation	Rationale
Pool drugs of the same mechanism of action when conducting meta-analyses	Treatments with different biologic targets may have different rates of RTIs
Pool studies within the same disease indication when conducting meta-analyses	Different diseases will have different risk trajectories for RTI and also may vary in use of combination immune modifying treatment vs monotherapy in clinical trials
Use data of approved drugs	The general patient population is not subject to risk profiles of treatments that are not approved, especially as it relates to drug dose
Combine all RTI terms	RTI terms are generally nonspecific and not confirmed using objective testing. Pooling terms increases power for signal detection
Report all adverse events on publicly available domains consistently (for sponsors/investigators)	Threshold-dependent reporting criteria results in variation and missing events that can result in invalid results
Make SARS-CoV-2 testing available to trial subjects (for sponsors/investigators)	COVID-19 is a highly variable illness with nonspecific symptoms. Systematic testing for SARS-CoV-2 in trial subjects presenting with RTI symptoms will allow for robust evaluation of drug safety

COVID-19, Coronavirus disease 2019; RTI, respiratory tract infection; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.