Abstract
BACKGROUND AND AIMS: It is unclear whether early symptom improvement in Crohn's disease [CD] provides any prognostic information for patients long-term. This paper aims to investigate the relationship between early patient-reported outcomes [PROs] after completion of induction of infliximab, and their relationship with long-term clinical remission [CR] and endoscopic remission [ER]. METHODS: This post-hoc analysis [Clinicaltrials.gov: NCT02096861] used data from 220 CD patients to evaluate the relationship of Weeks 6 and 14 PRO variables and Week 54 clinical remission (Crohn's Disease Activity Index [CDAI <150), PRO2 remission (mean score abdominal pain [AP] ≤1 and stool frequency [SF] ≤1.5), and endoscopic remission (Simple Endoscopic Score-CD [SES-CD <3). Multivariable logistic regression models adjusted for confounders were used to assess the relationships between post-induction PROs and outcomes of interest. RESULTS: Patients with moderate or severe AP after induction had reduced odds of achieving 1-year CR and PRO2 remission compared with those with mild AP (adjusted odds ratio [aOR] for CR 0.31, 95% confidence interval [CI] 0.17-0.57, p = 0.0002). Similarly, patients with moderately to severely elevated SF after induction had reduced odds of 1-year CR and PRO2 remission compared with patients with less SF [aOR for CR 0.31, 95% CI 0.16-0.58, p = 0.0003]. No significant differences were found when comparing higher Weeks 6 or 14 PRO scores of AP and/or SF with lower PRO scores in the odds of achieving 1-year ER. CONCLUSIONS: Post-induction PROs of AP and SF strongly predict likelihood of 1-year CR but are not associated with 1-year ER. Clinical symptoms alone should not be relied upon when assessing response to therapies for CD.