PMID- 27352964
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20160629
LR  - 20220309
IS  - 1929-0748 (Print)
IS  - 1929-0748 (Electronic)
IS  - 1929-0748 (Linking)
VI  - 5
IP  - 2
DP  - 2016 Jun 28
TI  - Early Monitoring of Response (MORE) to Golimumab Therapy Based on Fecal 
      Calprotectin and Trough Serum Levels in Patients With Ulcerative Colitis: A 
      Multicenter Prospective Study.
PG  - e124
LID - 10.2196/resprot.5791 [doi]
LID - e124
AB  - BACKGROUND: The treatment of ulcerative colitis (UC) patients with moderate to 
      severe inflammatory activity with anti-tumor necrosis factor alpha (TNFalpha) 
      antibodies leads to a clinical remission rate of 10% after 8 weeks of therapy. 
      However, it must be taken into account that patient selection in clinical trials 
      clearly influences both response and remission rates. An unsatisfactory response 
      to anti-TNFalpha medication after week 12 often leads to a discontinuation of 
      treatment. The early prediction of clinical response could therefore help 
      optimize therapy and potentially avoid ineffective treatments. OBJECTIVE: The aim 
      of this study is to develop an algorithm for optimizing golimumab administration 
      in patients with moderate to severe UC by calculating the probability of clinical 
      response in Week 26 based on data from Week 6. METHODS: The study is designed as 
      a prospective, single-arm, multicenter, non-interventional observational study 
      with no interim analyses and a sample size of 58 evaluable patients. The primary 
      outcome is the prediction of clinical response in Week 26 based on a 50% 
      reduction in fecal calprotectin and a positive golimumab trough level in Week 6. 
      RESULTS: Enrollment started in October 2014 and was still open at the date of 
      submission. The study is expected to finish in December 2016. CONCLUSIONS: The 
      early identification of patients who are responding to an anti-TNFalpha antibody is 
      therapeutically beneficial. At the same time, patients who are not responding can 
      be identified earlier. The development of a therapeutic algorithm for identifying 
      patients as responders or non-responders can thus help prescribing physicians to 
      both avoid ineffective treatments and adjust dosages when necessary. This in turn 
      promotes a higher degree of treatment tolerance and patient safety in the case of 
      anti-TNFalpha antibody administration. CLINICALTRIAL: German Clinical Trials 
      Register, Deutsches Register Klinischer Studien DRKS00005940; 
      https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00005940 
      (Archived by WebCite at http://www.webcitation.org/6i4Xoo1sH).
FAU - Drabik, Attyla
AU  - Drabik A
AUID- ORCID: 0000-0001-8413-7626
AD  - Clinical Trial Support, Munster, Germany.
FAU - Sturm, Andreas
AU  - Sturm A
AUID- ORCID: 0000-0002-8759-7342
FAU - Blomacher, Margit
AU  - Blomacher M
AUID- ORCID: 0000-0002-2514-7290
FAU - Helwig, Ulf
AU  - Helwig U
AUID- ORCID: 0000-0001-6205-7633
LA  - eng
PT  - Journal Article
DEP - 20160628
PL  - Canada
TA  - JMIR Res Protoc
JT  - JMIR research protocols
JID - 101599504
PMC - PMC4942680
OTO - NOTNLM
OT  - fecal calprotectin
OT  - golimumab
OT  - tumor necrosis factor alpha
OT  - ulcerative colitis
COIS- Conflicts of Interest: UH has received a Lecture/Advisory board honorarium from 
      MSD; AbbVie, Falk Foundation, Takeda, Mundipharma, Hospira, Ferring. AS has 
      received a Lecture/Advisory board honorarium from Falk Foundation, Recordati, 
      Astellas, Hospira, Mundipharma, MSD, Takeda, Jannsen.
EDAT- 2016/06/30 06:00
MHDA- 2016/06/30 06:01
PMCR- 2016/06/28
CRDT- 2016/06/30 06:00
PHST- 2016/03/23 00:00 [received]
PHST- 2016/05/06 00:00 [accepted]
PHST- 2016/05/06 00:00 [revised]
PHST- 2016/06/30 06:00 [entrez]
PHST- 2016/06/30 06:00 [pubmed]
PHST- 2016/06/30 06:01 [medline]
PHST- 2016/06/28 00:00 [pmc-release]
AID - v5i2e124 [pii]
AID - 10.2196/resprot.5791 [doi]
PST - epublish
SO  - JMIR Res Protoc. 2016 Jun 28;5(2):e124. doi: 10.2196/resprot.5791.