Abstract | BACKGROUND AND AIMS:
Golimumab is approved for the treatment of moderate-to-severely active ulcerative colitis. However, there have been no formal trials to assess its utility in Crohn's disease [CD]. Our aim was to determine the efficacy and safety of golimumab in patients with anti-tumour necrosis factor [TNF] refractory CD. METHODS: Patients with CD treated with golimumab between 2010 and 2017 were included in a retrospective observational study. The vast majority of patients failed two anti-TNF agents. Clinical response was defined as a significant reduction in symptoms and biochemical markers of CD, and no requirement for surgery or introduction of immune-suppressants. RESULTS: Forty-five patients were included, with a median follow-up of 22 months [interquartile range 12-34] following initiation of golimumab. Induction and maintenance regimens were generally higher than standard dosing with first month cumulative doses of 400 mg and above in 75% of the patients. Monthly maintenance doses ≥200 mg were administered in 52% of patients. Clinical response at 3 months was achieved in 35/45 [77.7%] patients. The cumulative probabilities that patients with an initial response maintained their clinical response for 12 and 36 months after introduction of golimumab were 81% and 64%, respectively. Endoscopic improvement and mucosal healing at 12 months was achieved in 73% and 47% of patients, respectively. CONCLUSIONS: This study demonstrates the efficacy of golimumab in anti-TNF refractory CD patients. Further studies should be performed in CD to formally assess the efficacy of golimumab in a randomized controlled trial and to establish the optimal dosing regimen.
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Authors | Tomer Greener, Karen Boland, A Hillary Steinhart, Mark S Silverberg |
Journal | Journal of Crohn's & colitis
(J Crohns Colitis)
Vol. 12
Issue 4
Pg. 458-464
(Mar 28 2018)
ISSN: 1876-4479 [Electronic] England |
PMID | 29293965
(Publication Type: Journal Article, Observational Study)
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Chemical References |
- Antibodies, Monoclonal
- Gastrointestinal Agents
- Tumor Necrosis Factor-alpha
- golimumab
- Infliximab
- Adalimumab
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Topics |
- Adalimumab
(therapeutic use)
- Adult
- Antibodies, Monoclonal
(adverse effects, therapeutic use)
- Crohn Disease
(diagnostic imaging, drug therapy)
- Endoscopy, Gastrointestinal
- Female
- Gastrointestinal Agents
(adverse effects, therapeutic use)
- Humans
- Induction Chemotherapy
- Infliximab
(therapeutic use)
- Maintenance Chemotherapy
- Male
- Remission Induction
- Retreatment
- Retrospective Studies
- Tumor Necrosis Factor-alpha
(antagonists & inhibitors)
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