Observational Study
Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Dec 21, 2016; 22(47): 10432-10439
Published online Dec 21, 2016. doi: 10.3748/wjg.v22.i47.10432
Short-term effectiveness of golimumab for ulcerative colitis: Observational multicenter study
Marta Maia Bosca-Watts, Xavier Cortes, Marisa Iborra, Jose Maria Huguet, Laura Sempere, Gloria Garcia, Rafa Gil, MariFe Garcia, Marga Muñoz, Pedro Almela, Nuria Maroto, Jose Maria Paredes
Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain
Xavier Cortes, Digestive Disease Department, Hospital of Sagunto, 46010 Valencia, Spain
Marisa Iborra, Gastroenterology Department and CIBEREHD, Hospital Universitari i Politecnic La Fe, 46026 València, Spain
Jose Maria Huguet, Digestive Disease Department, General Hospital of Valencia, 46014 Valencia, Spain
Laura Sempere, Digestive Disease Department, General Hospital of Alicante, 03010 Alacant, Spain
Gloria Garcia, Digestive Disease Department, San Juan University Hospital of Alicante, 46010 Valencia, Spain
Rafa Gil, Digestive Disease Department, Arnau Hospital of Valencia, 46015 València, Spain
MariFe Garcia, Digestive Disease Department, General University Hospital of Elche, 03203 Alicante, Spain
Marga Muñoz, Pedro Almela, Digestive Disease Department, General Hospital of Castellon, 12004 Castellón de la Plana, Spain
Nuria Maroto, Inflammatory Bowel Disease Unit, Digestive Disease Department, Hospital of Manises, 46940 Manises, Spain
Jose Maria Paredes, Digestive Disease Department, Peset University Hospital of Valencia, 46017 València, Spain
Author contributions: All authors included patients for the study, contributed to the review of the medical literature and wrote and/or reviewed the article; all listed authors approved the final version of the manuscript.
Institutional review board statement: This study was approved by the Institutional Review Board.
Conflict-of-interest statement: None of the authors has any conflict of interest to declare.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Marta Maia Bosca-Watts, PhD, MD, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, Avda. Blasco Ibañez 17, 46010 Valencia, Spain. inflamatoriahcuv@gmail.com
Telephone: +34-96-1973500
Received: August 9, 2016
Peer-review started: August 11, 2016
First decision: September 5, 2016
Revised: September 25, 2016
Accepted: October 31, 2016
Article in press: October 31, 2016
Published online: December 21, 2016

To evaluate the real-world effectiveness of golimumab in ulcerative colitis (UC) and to identify predictors of response.


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.


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 naïve, 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 μg/g, and 170.5 μg/g at week 14. Being anti-TNF treatment naïve 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.


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.

Keywords: Golimumab, Ulcerative colitis, Real-life results

Core tip: Golimumab is a fully humanized anti-tumor necrosis factor-alpha monoclonal antibody, which has recently been accepted in clinical practice. Pivotal studies have demonstrated the drug’s benefits, but real-life studies are still scarce. This observational, prospective and multi-center study in moderate-severe ulcerative colitis patients, confirmed golimumab’s short-term (14 wk) effectiveness. A high percentage of patients had responded and were off steroids at the end of follow-up. No severe adverse events were observed. Intensification (reducing the drug administration interval or increasing the dosage) may be useful in many slow-to-respond cases.