Table 3 Comparison of clinical remission rates at week 8 for the TNF-naive ustekinumab (UST) cohort and TNF-naive adalimumab (ADA) cohort for the SEAVUE study, our primary analysis (simulation of SEAVUE), sensitivity analyses, and negative control. Because missing week 8 CDAI values were highest for trials PRECISE1 and ENACT, their participant-level data was removed (N = 1482) from the first sensitivity analysis to account for potential bias. In the complete case sensitivity analysis, all participants with missing week 8 CDAI values (N = 361) were removed. In the information leakage sensitivity analysis, participants from an ustekinumab study (N = 1191) were removed from training the placebo-attributable model to avoid potential information leakage when simulating the adalimumab (ADA) arm (Fig. 1c). The negative control summarizes the clinical remission rates at week 8 for TNF-naive participants from the adalimumab studies without applying our regression-based correction method. The final column corresponds to the results of null hypothesis testing, that of no statistically significant difference between each simulated result and the published SEAVUE results

From: Sequential regression and simulation: a method for estimating causal effects from heterogeneous clinical trials without a common control group