Introduction
STRIDE-II has underscored the importance of achieving timely, pre-defined therapeutic targets predictive of favorable long-term outcomes in patients with Inflammatory Bowel Disease. Early targets include post-induction clinical response (Clin-Resp), and clinical remission (Clin-Rem), whereas endoscopic healing is, currently proposed as the optimal long-term endpoint.
Aims & Methods
This study aims to record rates of Clin-Resp, Clin-Rem and endoscopical healing and evaluate their predictive value for long-term outcomes in patients with Ulcerative Colitis (UC), in a real-world setting. It is a retrospective cohort study of patients who have been followed up in the GI unit of “Sotiria” hospital, and commenced treatment with either infliximab, vedolizumab, or ustekinumab. We compared patients who achieved Clin-Resp (drop of UC-PRO2≥50%) without Clin-Rem at the end of induction to those with Clin-Rem (UC-PRO2=0) regarding rates of drug continuation, clinical remission, steroid-free clinical remission, and mucosal healing at one year on treatment. Additionally, we compared patients with endoscopic MAYO score (endo-MAYO) of 0 or 1 on treatment, regarding drug continuation rates 1, 2, 3 and 4 years post-endoscopy. SPSS 23 (IBM, Armonk, NY, USA) was used for the statistical analysis.
Results
In total, 145 patients were included [mean age=41.6 years (SD=16.6), men: 50.3% (n=73)]. Sixty-eight (46.9%) received infliximab, 41 (28.3%) vedolizumab and 36 (24.8%) ustekinumab. At the end of induction, 90 patients (62.1%) had Clin-Resp and 72 (49.7%) Clin-Rem. After one year of treatment, higher rates of drug continuation (94.4% vs 55.6%, P<0.001), clinical remission (87.5% vs 44.4%, P<0.001), steroid-free clinical remission (85.9% vs 33.3%, P<0.001) and mucosal healing (57.6% vs 23.5%, P=0.001) were reported for patients in Clin-Rem at the end of induction compared to those with sole Clin-Resp. Patients with endo-MAYO=0, at their first endoscopic evaluation after drug commencement, demonstrated higher rates of 1- (100% vs 70.6%, log-rank P=0.007) and 2-year (81.6% vs 41.7%, log-rank P=0.033) drug continuation, compared to those with endo-MAYO=1. No statistically significant difference was recorded regarding their 3- (61.5% vs 22.2%, log-rank P=0.088) and 4-year (33.3% vs 22.2%, log-rank P=0.254) drug continuation rates.
Conclusion
In ulcerative colitis, the achievement of clinical remission at the end of induction is a major predictive factor of long-term effectiveness of treatment. Simultaneously, our analysis shows the importance of optimal control of inflammation as a therapeutic target, since patients with complete endoscopic healing have a higher probability of prolonged drug continuation.
Disclosure
GB: Advisor/lecturer for Janssen, Pfizer, Takeda, Abbvie, MSD, Mylan, Genesis Pharma, Adacyte Therapeutics, Amgen, Ferring, Cooper; Funding (Grants/Honoraria): Pfizer, Takeda, Abbvie, Aenorasis; Research/Clinical Trials: Abbvie, Takeda.