Golimumab effectiveness and safety in clinical practice for moderately active ulcerative colitis
| Autor: | Nasir Mahmud, Catherine Rowan, Stephen E. Patchett, Grace Chan, Jan Leyden, David Kevans, Juliette Sheridan, Barbara Ryan, Padraic MacMathuna, Cara Dunne, Frank E. Murray, Glen A. Doherty, Niall Breslin, Eoin Slattery, F MacCarthy, Gavin C. Harewood, J O'Connell, Garret Cullen, Aoibhlinn O'Toole, Grace Harkin, Laurence J. Egan, Deirdre McNamara, Anthony O'Connor, Vikrant Parihar, H. Mulcahy, Roisin Stack, Susan McKiernan |
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| Rok vydání: | 2018 |
| Předmět: |
Oncology
Adult Male medicine.medical_specialty Time Factors Anti-Inflammatory Agents Severity of Illness Index 03 medical and health sciences Young Adult 0302 clinical medicine Maintenance therapy Gastrointestinal Agents Adrenal Cortex Hormones Internal medicine Severity of illness medicine Humans Young adult Colitis Aged Retrospective Studies Academic Medical Centers Hepatology business.industry Tumor Necrosis Factor-alpha Remission Induction Gastroenterology Antibodies Monoclonal Retrospective cohort study Middle Aged medicine.disease Ulcerative colitis Golimumab Clinical Practice C-Reactive Protein Treatment Outcome 030220 oncology & carcinogenesis 030211 gastroenterology & hepatology Colitis Ulcerative Female business Ireland Biomarkers medicine.drug |
| Zdroj: | European journal of gastroenterologyhepatology. 30(9) |
| ISSN: | 1473-5687 |
| Popis: | Golimumab (GLB) is an antitumour necrosis factor-α (anti-TNF) therapy that has shown efficacy as induction and maintenance therapy for ulcerative colitis (UC). We aimed to describe the outcome of GLB therapy for UC in a real-world clinical practice.Consecutive patients receiving GLB for UC in six Irish Academic Medical Centres were identified. The primary study endpoint was the 6-month corticosteroid-free remission rate. The secondary endpoints included the 3-month clinical response, time free of GLB discontinuation and adverse events.Seventy-two patients were identified [57% men; median (range) age of 41.4 years (20.3-76.8); disease duration 6.6 years (0-29.9); follow-up 8.7 months (0.4-39.2)]. Sixty-four percent of patients were anti-TNF naive. The 3-month clinical response and the 6-month corticosteroid-free remission rates were 55 and 39%, respectively. Forty-four percent of patients discontinued GLB during the follow-up, median (95% confidence interval) time to GLB discontinuation 18.7 months (9.2-28.1). A C-reactive protein more than 5 mg/l at baseline was associated with failure to achieve 6-month corticosteroid-free remission and a shorter time to GLB discontinuation, odds ratio 0.2 (0.1-0.7), P=0.008, and hazard ratio (95% confidence interval) 2.8 (1.3-5.7), P=0.007, respectively. Adverse events occurred in 7% of patients (n=5), all of which were minor and self-limiting.These real-world clinical data suggest that GLB is an effective and safe therapy for a UC cohort with significant previous anti-TNF exposure. An elevated baseline C-reactive protein, likely reflective of increased inflammatory burden, is associated with a reduced likelihood of a successful outcome of GLB therapy. |
| Databáze: | OpenAIRE |
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