P2606 - Patient Reported Outcomes (PRO2) Are a Sensitive Measure of Endoscopic Disease Activity in Ulcerative Colitis

Sarah A. Lechner, MD¹, Shishir Dube, PhD¹, Gregory J. Botwin, BS², Valeriya Pozdnyakova, BS², Justina Ibrahim, BA², Mary Hanna, BS², Philip Debbas, BS², Emebet Mengesha, BS³, Carol Landers, ¹, Nirupama Bonthala, MD¹, Gil Melmed, MD¹, Gaurav Syal, MD, MHDS¹, Dermot McGovern, MD, PhD, FACG, FRCP¹, Christina Ha, MD, FACG^4
1Cedars-Sinai Medical Center, Los Angeles, CA; ²F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute, Cedars-Sinai Medical Center, Los Angeles, CA; ³CSMC, Los Angeles, CA; ⁴Inflammatory Bowel Disease Center, Cedars-Sinai Medical Center, Los Angeles, CA

Introduction: Patient reported outcomes (PRO2) are an easily obtained, non-invasive measure of disease activity for patients diagnosed with ulcerative colitis (UC). However, PRO2 scores have variable reliability with endoscopic activity scoring systems such as the Mayo Endoscopic Score (MES). The aim of this study was to determine if there were differences in the correlation between PRO2 assessments and the MES and UC endoscopic index of severity (UCEIS).

Methods: Patients with UC seen at a tertiary IBD referral center were enrolled in a prospective UC registry to investigate clinical and endoscopic outcomes. At the time of colonoscopy, patients were asked to provide rectal bleeding (RB) and stool frequency (SF) scores for the 24 hours preceding bowel prep as PRO2 assessments. Five IBD-specialist endoscopists reported a UCEIS and a MES for each patient. Clinical remission was defined as a PRO2 ≤ 1 with RB score = 0 and SF score ≤ 1. Endoscopic remission was defined as UCEIS ≤ 1 or MES of 0. Spearman correlation coefficients were calculated to measure strength of association between endoscopic scores and PRO2. A Fisher r-to-z transformation was used to assess for significant differences of correlation coefficients between providers.

Results: Ninety-eight UC patients with PRO2 and endoscopic scoring data were evaluated. The UCEIS and MES were strongly correlated (r=0.97, p < 0.001). The correlation between PRO2 and the endoscopic scores did not differ significantly between endoscopists. A PRO2 score ≤ 1, clinical remission, identified endoscopic remission with a sensitivity of 98.5%, specificity of 52.6%, positive predictive value (PPV) of 78.3%, and negative predictive value (NPV) of 95.2% using the UCEIS (x² 36.0, p < 0.001). A PRO2 score of ≤ 1 identified endoscopic remission with a sensitivity of 100%, specificity of 45%, PPV of 38.9%, and NPV of 100% using the MES (x² 16.9, p < 0.001).

Discussion: We confirmed that UCEIS and MES are strongly correlated. The PRO2 was a highly sensitive test for endoscopic remission measured by the UCEIS and MES, suggesting that the PRO2 is effective in predicting endoscopically active colitis. The PRO2 had only modest specificity with both the UCEIS and MES and so is less reliable for identifying patients in endoscopic remission. In the future, we plan to investigate whether adding biomarkers such as CRP and fecal calprotectin will increase specificity of the model. We will also add histological assessments of disease activity.



Disclosures:


Sarah A. Lechner, MD¹, Shishir Dube, PhD¹, Gregory J. Botwin, BS², Valeriya Pozdnyakova, BS², Justina Ibrahim, BA², Mary Hanna, BS², Philip Debbas, BS², Emebet Mengesha, BS³, Carol Landers, ¹, Nirupama Bonthala, MD¹, Gil Melmed, MD¹, Gaurav Syal, MD, MHDS¹, Dermot McGovern, MD, PhD, FACG, FRCP¹, Christina Ha, MD, FACG⁴. P2606 - Patient Reported Outcomes (PRO2) Are a Sensitive Measure of Endoscopic Disease Activity in Ulcerative Colitis, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.