P2644 - Correlation Between Patient-Reported Outcomes (Pros) and Patient-Reported Disease Activity in Ulcerative Colitis (UC): Findings From the ICONIC Study
Subrata Ghosh, MD, FRCP, FRCPE, FRCPC, FCAHS1, Francesc Casellas, MD2, Kristina Kligys, PhD3, Yuri Sanchez-Gonzalez, PhD3, Laurent Peyrin-Biroulet, MD4 1Institute of Translational Medicine, College of Medical and Dental Sciences, University of Birmingham, Cork, Cork, Ireland; 2Hospital Universitari Vall d’Hebron, Barcelona, Catalonia, Spain; 3AbbVie Inc., North Chicago, IL; 4University Hospital of Nancy, Lorraine University, Nancy, Lorraine, France
Introduction: This analysis aimed to examine the correlation of patient-reported outcomes (PROs) with patient-reported disease activity, and to identify individual questions of the Patient Simple Clinical Colitis Activity Index (P-SCCAI) associated with Work Productivity and Activity Impairment (WPAI) questionnaire domains in patients from the ICONIC study.
Methods: ICONIC enrolled unselected outpatients (N=1804) with recent-onset UC. Correlations between PRO measures (Rating Form of Inflammatory Bowel Disease Patient Concerns [RFIPC], Patient Health Questionnaire-9 [PHQ-9], and Short Inflammatory Bowel Disease Questionnaire [SIBDQ]) at baseline (visit [V]1) and 2 years (V5) were assessed using Spearman’s rank correlation coefficient. WPAI domains and PHQ-9 were evaluated at V1 and V5 using a multivariable logistic regression model with individual P-SCCAI questions.
Results: Significantly higher work productivity impairment scores, lower reported quality of life (QoL), and higher worries/concerns at V1 and V5 were observed in patients with active disease (P-SCCAI ³5) vs inactive disease (P-SCCAI < 5) (Figure a,b). A strong correlation (0.70–0.89) was found between the SIBDQ and the P-SCCAI and PHQ-9 (Figure c). WPAI presenteeism, total activity impairment and total work productivity impairment were moderately correlated (0.40–0.69) with P-SCCAI and PHQ-9 (Figure c). At V1, a significant positive association of disease severity and nocturnal bowel urgency was observed with WPAI presenteeism, absenteeism, and total activity impairment. At V1 and V5, lower patient-assessed PHQ-9 scores were significantly associated with female gender, no bowel urgency, and no joint pain.
Discussion: These observational data in patients with UC suggest strong correlations between some PRO measures and patient-reported disease activity. Nocturnal bowel urgency was a key driver of total work productivity impairment, suggesting it is an important PRO to monitor when assessing overall patient QoL.
Figure: Figure. a. WPAI by patient-reported disease activity at V1 and V5 b. PRO scores by patient-reported disease activity at V1 and V5 c. Spearman correlation coefficients for PROs.
P-SCCAI, Patient Simple Clinical Colitis Activity Index; WPAI, Work Productivity and Activity Impairment questionnaire; V, visit; SIBDQ scores range from 10 (poor QoL) to 70 (optimal QoL); RFIPC mean scores range from 0 to 10 PHQ-9, Patient Health Questionnaire-9; PRO, patient-reported outcome; P-SCCAI, Patient Simple Clinical Colitis Activity Index; QoL, quality of life; RFIPC, Rating Form of IBD Patient Concerns; SIBDQ, Short Inflammatory Bowel Disease Questionnaire; V, visit
Disclosures:
Subrata Ghosh: AbbVie, Boehringer Ingelheim, Celgene and Janssen – Advisory Committee/Board Member, Consultant, Speaker's Bureau. Eli Lilly, Gilead and Roche – Consultant. Pfizer, Takeda – Speaker's Bureau.
Laurent Peyrin-Biroulet: AbbVie, MSD, Takeda – Consultant, Grant/Research Support, Other Financial or Material Support, Honoraria. Allergan, Alma, Amgen, Applied Molecular Transport, Arena – Consultant, Other Financial or Material Support, Honoraria. Biogen, BMS, Boehringer Ingelheim, Celgene, Celltrion – Consultant, Other Financial or Material Support, Honoraria. Enterome, Enthera, Ferring, Fresenius Kabi, Genentech – Consultant, Other Financial or Material Support, Honoraria. Gilead, Hikma, Index Pharmaceuticals, Janssen, Lilly – Consultant, Other Financial or Material Support, Honoraria. Mylan, Nestle, Norgine, Oppilan Pharma, OSE – Consultant, Other Financial or Material Support, Honoraria. Pfizer, Pharmacosmos, Roche, Samsung Bioepis, Sandoz – Consultant, Other Financial or Material Support, Honoraria. Sterna, Sublimity Therapeutics, Theravance – Consultant, Other Financial or Material Support, Honoraria. Tillotts, Takeda and Vifor – Consultant, Other Financial or Material Support, Honoraria.
Subrata Ghosh, MD, FRCP, FRCPE, FRCPC, FCAHS1, Francesc Casellas, MD2, Kristina Kligys, PhD3, Yuri Sanchez-Gonzalez, PhD3, Laurent Peyrin-Biroulet, MD4. P2644 - Correlation Between Patient-Reported Outcomes (Pros) and Patient-Reported Disease Activity in Ulcerative Colitis (UC): Findings From the ICONIC Study, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.
