OBJECTIVES

The 6-point version of the Mayo score relies on 2 patient-reported outcomes (PRO2): stool frequency and rectal bleeding. The study objective was to assess the feasibility and acceptability of remote online reporting of disease activity using the PRO2 measure for golimumab treated patients with ulcerative colitis (UC).

METHODS

A multi-centre prospective real-world study of UC patients treated with golimumab. Data collection started Q1 17; full data are expected in Q1 18. Eligible patients completed PRO2 scores at baseline and every 4 weeks over 6 months. Questionnaires were also completed at baseline and 6 months to capture quality of life (EQ-5D-5L, SIBDQ) and work productivity (WPAI). Patient-reported data were collected remotely online (mobile, tablet or computer).

RESULTS

A total of 52 patients enrolled in the study, 50% were male; with a mean age of 40 (13.5 SD). 66% of patients reported experiencing a flare 6 months preceding enrolment, with 24% currently experiencing a flare. At baseline, 74% of patients reported being in employment, and 20% reported presenteeism (impairment whilst working) due to their UC. Overall, patients reported experiencing 26% daily activity impairment. A 0.9 EQ-5D 5L utility index, SIBDQ score of 5.1 and PRO2 score of 0.9 was reported at baseline.

Patients provided data on a personal computer (44%), mobile phone (385) or tablet (18%). 90% of patients completed the baseline questionnaire within the accepted time range. Subsequent scores were reported by eligible patients with a success rate of 94%, 94%, 91%, 88%, 96% and 87% at end of months 1 to 6 respectively.

CONCLUSIONS

The results support the feasibility of remote monitoring systems in UC using PRO2 as a measure of disease activity. Long-term this could provide patients with a convenient option for their own disease management.