Short-term effectiveness of golimumab for ulcerative colitis: Observational multicenter study
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 ass...
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| Published in: | World journal of gastroenterology : WJG Vol. 22; no. 47; pp. 10432 - 10439 |
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| Main Authors: | , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
United States
Baishideng Publishing Group Inc
21-12-2016
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| Subjects: | |
| Online Access: | Get full text |
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| Summary: | 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 wk 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 na?ve, whereas 72.7% had previously received infliximab and/or adalimumab. Sixty-nine point seven percent showed clinical response and were steroid-free at wk 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 wk 14. Being anti-TNF treatment na?ve 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 followup. 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. |
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| Bibliography: | Marta Maia Bosca-Watts;Xavier Cortes;Marisa Iborra;Jose Maria Huguet;Laura Sempere;Gloria Garcia;Rafa Gil;Mari Fe Garcia;Marga Mu?oz;Pedro Almela;Nuria Maroto;Jose Maria Paredes;Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia;Digestive Disease Department, Hospital of Sagunto;Gastroenterology Department and CIBEREHD, Hospital Universitari i Politecnic La Fe;Digestive Disease Department, General Hospital of Valencia;Digestive Disease Department, General Hospital of Alicante;Digestive Disease Department, San Juan University Hospital of Alicante;Digestive Disease Department, Arnau Hospital of Valencia;Digestive Disease Department, General University Hospital of Elche;Digestive Disease Department, General Hospital of Castellon;Inflammatory Bowel Disease Unit, Digestive Disease Department, Hospital of Manises;Digestive Disease Department, Peset University Hospital of Valencia ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-3 content type line 23 ObjectType-Undefined-2 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 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. |
| ISSN: | 1007-9327 2219-2840 |
| DOI: | 10.3748/wjg.v22.i47.10432 |