Data analysis
UC-related hospitalizations, corona virus disease of 2019
REGRESSION, DISEASE, SENSITIVITY
Data from patients who achieved a clinical response after 8 or 16 weeks of upadacitinib induction treatment and received upadacitinib maintenance treatment were analyzed in this study. Non-responder imputation was conducted in all Week 52 outcomes with no special data handling for missing data because of corona virus disease of 2019 (COVID-19). Missing data were not imputed for HEMI or HEMR at Week 8/16.To assess the relative importance of HEMR compared with HEMI, cross-sectional and predictive analyses were conducted on the following patient groups: (1) patients who achieved HEMR, (2) patients who achieved HEMI without HEMR, and (3) patients who did not achieve HEMI. The cross-sectional analysis examined the likelihood of achieving long-term clinical and patient-reported outcomes at Week 52 among patients who achieved HEMR or HEMI without HEMR versus those who did not achieve HEMI. Sensitivity analyses compared outcomes in patients with vs without HEMR and with vs without HEMI. Predictive analysis assessed the relationship between achieving HEMR or HEMI without HEMR at the end of induction (Week 8/16) and outcomes at Week 52.Clinically meaningful improvement in patient-reported outcomes was assessed as the likelihood of achieving a change from baseline (before starting treatment) in the patient-reported outcome score ≥ the corresponding meaningful within-patient change threshold (MWPC). The MWPC thresholds for UC-SQ (≥ 10) and FACIT-F (≥ 5) were estimated from anchor- and distribution-based analyses of upadacitinib phase 2 data. MWPC thresholds for IBDQ (≥ 16), [Odds ratios (ORs) with 95% confidence intervals (CIs) were derived from logistic regression adjusting for the following characteristics: histologic score at baseline (continuous), maintenance treatment dosage (high or low), gender (male or female), disease extent (left-sided or extensive), disease duration, and baseline age and weight.The percentages of patients who achieved HEMR or HEMI without HEMR at end of induction (Week 8/16) and attained long-term clinical and patient-reported outcomes at Week 52 were determined. The percentages of patients achieving these histological endpoints at end of maintenance (Week 52) and clinical and patient-reported outcomes at Week 52 were also calculated. Chi-square test was used to determine the significance test for both mucosal healing endpoints (HEMR and HEMI without HEMR) compared with no HEMI.To further assess the benefits of the HEMI/HEMR end points, the number of UC-related hospitalizations and surgeries was tabulated and stratified by mutually exclusive HEMI and HEMR categories at Week 8/16 (end of induction) and Week 52 (end of maintenance). However, it was not feasible to perform logistic regression analyses because of the limited number of hospitalizations and surgeries observed in the upadacitinib trial data.