Golimumab in real-world practice in patients with ulcerative colitis: Twelve-month results.

BACKGROUND

The introduction of biologics has revolutionized the management of the chronic inflammatory bowel disease, ulcerative colitis (UC), with many patients experiencing significant improvements not only in their symptoms but in other outcomes relevant to individuals and society as a whole. In Germany, there are no prospective data > 3 mo that assess the work productivity, daily activities and quality of life (QoL) of patients with moderate-to-severe UC treated with golimumab.

AIM

To assess change in work productivity, capacity for daily activities and QoL in UC patients treated with golimumab in Germany.

METHODS

The validated Work Productivity Activity Impairment (WPAI) Questionnaire was used to analyze the change in work productivity, the capacity for daily activities after three months (primary endpoint) and disease specific and health related QoL (HRQoL) up to 1 year (secondary endpoints). The changes in work productivity and activity impairment were evaluated every three months until month twelve compared to baseline. Disease-specific and health-related QoL were assessed with the inflammatory bowel disease questionnaire and with the short-form 12 health survey questionnaire (SF-12).

RESULTS

This prospective non-interventional study included 287 patients. The analysis population was comprised of 282 patients who had completed at least two visits. At baseline, 61% of patients had moderate UC and 18% had severe UC. Furthermore, 75% of patients worked full-time or part-time at baseline. A total of 212 patients who were employed at the start of the study (employed population) were evaluated for the primary endpoint. Golimumab significantly reduced all WPAI sub-scores compared to baseline after three, six, nine and twelve months after the start of treatment (

CONCLUSION

Treatment of moderate-to-severe UC with golimumab leads to significant improvements in patient´s work productivity, daily activity and QoL over twelve months.

Informations de copyright

©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.

Déclaration de conflit d'intérêts

Conflict-of-interest statement: Niels Teich has served as a speaker, a consultant and/or an advisory board member for AbbVie, Biogen, Falk Foundation, Janssen, MSD, Norgine, Takeda, Tillotts, Vifor and has received research funding from Ferring Arzneimittel GmbH; Harald Grümmer has received personal fees from MSD and AbbVie; Eric Jörgensen has received personal fees from MSD, Thomas Liceni has received personal fees from MSD, Frank Holtkamp-Endemann has received personal fees from MSD, Tim Fischer and Susanne Hohenberger are employees of MSD.