PMID- 32550760
OWN - NLM
STAT- MEDLINE
DCOM- 20210331
LR  - 20210331
IS  - 2219-2840 (Electronic)
IS  - 1007-9327 (Print)
IS  - 1007-9327 (Linking)
VI  - 26
IP  - 21
DP  - 2020 Jun 7
TI  - Golimumab in real-world practice in patients with ulcerative colitis: 
      Twelve-month results.
PG  - 2852-2863
LID - 10.3748/wjg.v26.i21.2852 [doi]
AB  - 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 (P 
      < 0.0001). In addition, disease-specific QoL and HRQoL, as measured by the SF-12 
      questionnaire, improved significantly with golimumab at all evaluation times (P < 
      0.0001 in each case vs baseline). 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.
CI  - (c)The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights 
      reserved.
FAU - Teich, Niels
AU  - Teich N
AD  - Internistische Gemeinschaftspraxis fur Verdauungs-und Stoffwechselkrankheiten 
      Leipzig und Schkeuditz, Leipzig 04105, Germany. teich@igvs.de.
FAU - Grummer, Harald
AU  - Grummer H
AD  - Praxis fur Innere Medizin/Gastroenterologie, Potsdam 14471, Germany.
FAU - Jorgensen, Eric
AU  - Jorgensen E
AD  - Magen-Darm-Zentrum Remscheid, Remscheid 42859, Germany.
FAU - Liceni, Thomas
AU  - Liceni T
AD  - MVZ fur Gastroenterologie am Bayerischen Platz, Berlin 10825, Germany.
FAU - Holtkamp-Endemann, Frank
AU  - Holtkamp-Endemann F
AD  - Gastroenterologische Gemeinschaftspraxis am Germania-Campus, Munster 48159, 
      Germany.
FAU - Fischer, Tim
AU  - Fischer T
AD  - Medical Affairs, MSD Sharp and Dohme GmbH, Haar 85540, Germany.
FAU - Hohenberger, Susanne
AU  - Hohenberger S
AD  - Medical Affairs, MSD Sharp and Dohme GmbH, Haar 85540, Germany.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PL  - United States
TA  - World J Gastroenterol
JT  - World journal of gastroenterology
JID - 100883448
RN  - 0 (Antibodies, Monoclonal)
RN  - 91X1KLU43E (golimumab)
SB  - IM
MH  - Activities of Daily Living
MH  - Adult
MH  - Antibodies, Monoclonal/*therapeutic use
MH  - Colitis, Ulcerative/complications/*drug therapy/psychology
MH  - Female
MH  - Germany
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - *Quality of Life
MH  - Severity of Illness Index
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
PMC - PMC7284175
OTO - NOTNLM
OT  - Golimumab
OT  - Non-interventional study
OT  - Quality of life
OT  - Ulcerative colitis
OT  - Work Productivity Activity Impairment (WPAI) Questionnaire
OT  - Work productivity
COIS- 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 Grummer has received personal fees from MSD and 
      AbbVie; Eric Jorgensen 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.
EDAT- 2020/06/20 06:00
MHDA- 2021/04/01 06:00
PMCR- 2020/06/07
CRDT- 2020/06/20 06:00
PHST- 2020/02/06 00:00 [received]
PHST- 2020/05/08 00:00 [revised]
PHST- 2020/05/23 00:00 [accepted]
PHST- 2020/06/20 06:00 [entrez]
PHST- 2020/06/20 06:00 [pubmed]
PHST- 2021/04/01 06:00 [medline]
PHST- 2020/06/07 00:00 [pmc-release]
AID - 10.3748/wjg.v26.i21.2852 [doi]
PST - ppublish
SO  - World J Gastroenterol. 2020 Jun 7;26(21):2852-2863. doi: 
      10.3748/wjg.v26.i21.2852.