PMID- 28058024 OWN - NLM STAT- MEDLINE DCOM- 20170608 LR - 20220318 IS - 2219-2840 (Electronic) IS - 1007-9327 (Print) IS - 1007-9327 (Linking) VI - 22 IP - 47 DP - 2016 Dec 21 TI - Short-term effectiveness of golimumab for ulcerative colitis: Observational multicenter study. PG - 10432-10439 LID - 10.3748/wjg.v22.i47.10432 [doi] AB - AIM: To evaluate the real-world effectiveness of golimumab in ulcerative colitis (UC) and to identify predictors of response. METHODS: We conducted an observational, prospective and multi-center study in UC patients treated with golimumab, from September 2014 to September 2015. Clinical activity was assessed at week 0 and 14 with the physician's global clinical assessment (PGA) and the partial Mayo score. Colonoscopies and blood tests were performed, following daily-practice clinical criteria, and the results were recorded in an SPSS database. RESULTS: Thirty-three consecutive patients with moderately to severely active UC were included. Among them, 54.5% were female and 42 years was the average age. Thirty percent had left-sided UC (E2) and 70% had extensive UC (E3). All patients had an endoscopic Mayo score of 2 or 3 at baseline. Twenty-seven point three percent were anti-tumor necrosis factor (TNF) treatment naive, whereas 72.7% had previously received infliximab and/or adalimumab. Sixty-nine point seven percent showed clinical response and were steroid-free at week 14 (a decrease from baseline in the partial Mayo score of at least 3 points). Based on PGA, the clinical remission and clinical response rates were 24% and 55% respectively. Withdrawal of corticosteroids was observed in 70.8% of steroid-dependent patients at the end of the study. Three out of 10 clinical non-responders needed a colectomy. Mean fecal calprotectin value at baseline was 300 mug/g, and 170.5 mug/g at week 14. Being anti-TNF treatment naive was a protection factor, which was related to better chances of reaching clinical remission. Twenty-seven point three percent of the patients required treatment intensification at 14 wk of follow-up. Only three adverse effects (AEs) were observed during the study; all were mild and golimumab was not interrupted. CONCLUSION: This real-life practice study endorses golimumab's promising results, demonstrating its short-term effectiveness and confirming it as a safe drug during the induction phase. FAU - Bosca-Watts, Marta Maia AU - Bosca-Watts MM AD - Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain. FAU - Cortes, Xavier AU - Cortes X AD - Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain. FAU - Iborra, Marisa AU - Iborra M AD - Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain. FAU - Huguet, Jose Maria AU - Huguet JM AD - Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain. FAU - Sempere, Laura AU - Sempere L AD - Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain. FAU - Garcia, Gloria AU - Garcia G AD - Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain. FAU - Gil, Rafa AU - Gil R AD - Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain. FAU - Garcia, MariFe AU - Garcia M AD - Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain. FAU - Munoz, Marga AU - Munoz M AD - Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain. FAU - Almela, Pedro AU - Almela P AD - Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain. FAU - Maroto, Nuria AU - Maroto N AD - Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain. FAU - Paredes, Jose Maria AU - Paredes JM AD - Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain. 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 (Adrenal Cortex Hormones) RN - 0 (Anti-Inflammatory Agents) RN - 0 (Antibodies, Monoclonal) RN - 0 (Gastrointestinal Agents) RN - 0 (Tumor Necrosis Factor-alpha) RN - 91X1KLU43E (golimumab) SB - IM MH - Adrenal Cortex Hormones/therapeutic use MH - Adult MH - Anti-Inflammatory Agents/adverse effects/*therapeutic use MH - Antibodies, Monoclonal/adverse effects/*therapeutic use MH - Colitis, Ulcerative/diagnosis/*drug therapy/immunology MH - Colonoscopy MH - Drug Therapy, Combination MH - Female MH - Gastrointestinal Agents/adverse effects/*therapeutic use MH - Humans MH - Male MH - Middle Aged MH - Prospective Studies MH - Remission Induction MH - Severity of Illness Index MH - Spain MH - Time Factors MH - Treatment Outcome MH - Tumor Necrosis Factor-alpha/antagonists & inhibitors/immunology PMC - PMC5175256 OTO - NOTNLM OT - Golimumab OT - Real-life results OT - Ulcerative colitis COIS- Conflict-of-interest statement: None of the authors has any conflict of interest to declare. EDAT- 2017/01/07 06:00 MHDA- 2017/06/09 06:00 PMCR- 2016/12/21 CRDT- 2017/01/07 06:00 PHST- 2016/08/09 00:00 [received] PHST- 2016/09/25 00:00 [revised] PHST- 2016/10/31 00:00 [accepted] PHST- 2017/01/07 06:00 [entrez] PHST- 2017/01/07 06:00 [pubmed] PHST- 2017/06/09 06:00 [medline] PHST- 2016/12/21 00:00 [pmc-release] AID - 10.3748/wjg.v22.i47.10432 [doi] PST - ppublish SO - World J Gastroenterol. 2016 Dec 21;22(47):10432-10439. doi: 10.3748/wjg.v22.i47.10432.