abstract
- BACKGROUND: It is unclear whether improvement in patient-reported outcomes (PROs) relative to baseline symptom burden in Crohn's disease (CD) is associated with subsequent endoscopic remission. AIM: To evaluate the relationship between dominant PRO resolution post-induction and achievement of clinical and endoscopic remission. METHODS: This post-hoc analysis of clinical trial data from 251 participants evaluated the relationship between the resolution of the dominant PRO (most severely elevated baseline PRO) or clinical response (CDAI ≥100 reduction) after induction therapy with biologics (post-induction) and 1-year clinical remission (CDAI <150) and/or endoscopic remission (SES-CD <3). Multivariate logistic regression models evaluated the relationship between post-induction-dominant PRO resolution and 1-year outcomes adjusted for confounders. RESULTS: Participants with dominant PRO resolution post-induction had higher odds of combined endoscopic and clinical remission compared to those without resolution (aOR: 1.94 [95% CI: 1.01-3.74], P = 0.047). Combining dominant PRO resolution with post-induction endoscopic response (SES-CD ≥50% reduction) was associated with higher odds of 1-year endoscopic and clinical remission (aOR: 6.89 [95% CI: 1.65-28.72], P = 0.008). Clinical and PRO2 response (≥30% decrease in stool frequency and/or ≥30% decrease in abdominal pain score and both not worse than baseline) at post-induction did not predict these outcomes. No significant differences were observed with 1-year endoscopic remission for post-induction-dominant PRO resolution, clinical or PRO2 response. CONCLUSIONS: Post-induction resolution of dominant PRO, but not clinical or PRO2 response, was strongly associated with 1-year endoscopic and clinical remission. Resolution of dominant baseline PRO after induction therapy may be informative for 1-year outcomes. Further validation is required.