Fig. 6.

Approximate power curves to estimate the required amount of drug exposure (PYs) to detect a statistically significant ratio of 1.5 (weak association), 2 (moderate association), 4 (strong association), and 6 (very strong association) between the IR of a given safety outcome in users of biological drugs approved for IMIDs vs. the general population, using one-sided significant level α = 0.05 and a power of 80% (β = 0.2). Note: The following background IRs were considered based on scientific literature: 175 for 100,000 PYs for congestive heart failure, 95 for 100,000 PYs for tuberculosis, 10.4 for 100,000 PYs for optic neuritis, 382 for 100,000 PYs for neoplasms, 164.1 for 100,000 PYs for SARS-CoV-2 infection, 4312 for 100,000 PYs for severe infections. IMID immune-mediated inflammatory diseases, IR incidence rate, PYs person-years, SARS-CoV-2 severe acute respiratory syndrome coronavirus 2