P0366Computer vision endoscopy scoring for ulcerative colitis disease severity (ARGES-CMES): A comparison between adult and paediatric clinical trials

Abstract Background Accurate severity scoring in paediatric ulcerative colitis (UC) clinical trials is crucial for management and monitoring of the disease. We previously developed a novel, computer-vision-based, continuous endoscopic endpoint (ARGES-CMES) which improves upon the limited granularity of the Mayo endoscopic subscore (MES). In this study, we use ARGES-CMES to compare endoscopic severity in adult and paediatric populations. Methods UNIFI (NCT02407236) and UNIFI-JR (NCT04630028) are phase 3 clinical trials assessing ustekinumab (UST) as treatment of UC in adult and paediatric patients, respectively. To allow for comparisons between the placebo-controlled UNIFI and the open-label UNIFI-JR trials, UNIFI participants receiving placebo were excluded from the analysis. The ARGES-UC pipeline, previously trained on colonoscopy videos from adult UC trial populations, including UNIFI participants, was used without any further parameter tuning to compute CMES across both trials. UNIFI and UNIFI-JR CMES scores were compared at screening, week 8 (end of induction) and week 52 (end of maintenance). Scores between maintenance UST delivery 8-weekly (q8w) and 12-weekly (q12w) groups were further compared. No adjustments for differences in baseline characteristics were made. Two-sided permutation tests were used to evaluate differences in the median CMES scores between the two trials at each time point. Results In total, 561 UNIFI participants and 70 UNIFI-JR participants were included in the analysis (Figure 1). The maintenance analysis q8w dose regimen included 222 participants from UNIFI and 40 patients from UNIFI-JR, while the q12w dose regimen included 98 participants from UNIFI and 30 from UNIFI-JR. The mean ± SD of CMES scores for UNIFI and UNIFI-JR were 2.78±0.62 vs 2.55±0.57 for the screening visit, 2.10±0.97 vs 1.72±0.77 for week 8, 1.46±0.98 vs 1.36±0.85 for week 52 q8w, and 1.30±0.91 vs 1.62±0.68 for week 52 q12w, respectively. The CMES and MES scores showed similar dose response to UST for both clinical trials. The CMES score demonstrated similar improvements in endoscopic disease severity over time in both adult and paediatric participants. In UNIFI-JR, participants treated with q12w dosing had higher CMES scores at week 52 than UNIFI-JR participants on q8w dosing or UNIFI adult participants on q8w dosing (Figure 2). Permutation tests showed p 0.001 for all time points, except for the screening visit. Conclusion A computer-vision continuous scoring system for UC severity in endoscopy videos demonstrates similar behavior between paediatric and adult patients undergoing the same UC treatment regimen. This tool standardizes endoscopic assessment and supports the extrapolation of results between adult and paediatric populations. Conflict of interest: Ms. Alves, Natália: Employed by Johnson & Johnson Chaitanya, Krishna: Employed by Johnson & Johnson Mobadersany, Pooya: Employed by Johnson & Johnson Parmar, Chaitanya: Employed by Johnson & Johnson Griffiths, Anne: Grant: Abbvie Personal Fees: Abbvie, Alfasigma, Amgen, Janssen, Lilly, Merck, Pfizer, Roche, Takeda Russell, Richard K.: Grant: Nestec Other: Abbvie, Celltrion, Janssen, Lilly, Nestle, Pharmacosmos, Pfizer Turner, Dan: Consultation fee: Janssen, Pfizer, Ferring, Abbvie, Takeda, Prometheus Biosciences, Lilly, SorrisoPharma, Boehringer Ingelheim, Galapagos, BMS, AlfaSigma, Merck, Gentech Research support: Janssen, Abbvie, Takeda, Pfizer Royalties: Shaare Zedek Medical Center, Hospital for Sick Children Hyams, Jeffrey: Abbvie: Advisory Board Janssen: Advisory Board Roche/Genentech: Consultant Takeda: Consultant Ghanem, Louis: Employed by Johnson & Johnson Richmond, Camilla: Employed by Johnson & Johnson Van Limbergen, Els: Employed by Johnson & Johnson Ufberg, Paul: Employee of Johnson & Johnson and may hold stock or stock options in Johnson & Johnson Strauss, Richard: Employed by Johnson & Johnson Skomrock, Nicholas: Employed by Johnson & Johnson Cula, Gabriela Oana: Employed by Johnson & Johnson Standish, Kristopher: Employed by Johnson & Johnson F. Damasceno, Pablo: Employed by Johnson & Johnson