Abstract | BACKGROUND: METHODS: A retrospective chart review was performed including patients (pts) from 2 academic medical centers with complicated, refractory CD started on ustekinumab between June 2011 and June 2014. Pts were treated based on a novel subcutaneous dosing schedule designed to simulate the intravenous load used in clinical trials. RESULTS: Forty-five pts were treated with ustekinumab during this study period. Of the pts who had clinical parameters available before and after medication start, 46% achieved clinical response (Harvey-Bradshaw index decrease ≥ 3) and 35% achieved clinical remission (Harvey-Bradshaw index ≤ 3). Short inflammatory bowel disease questionnaire scores increased significantly (46 [20, 68] to 55 [32, 70], P < 0.05). Erythrocyte sedimentation rate decreased significantly (20 [3, 54] to 12 [0, 42] mm/h, P < 0.05). C-reactive protein decreased significantly (4.9 [0.3, 111] to 3.3 [0.2, 226] mg/L, P < 0.05). Seventy-six percent of patients demonstrated an endoscopic response and 24% achieved complete endoscopic remission. Twelve patients (26%) were hospitalized for IBD-related issues. Four pts had infection-related complications. Six pts (13%) underwent surgery for IBD-related issues. Three pts stopped ustekinumab, 1 for pt preference and 2 for the lack of response. CONCLUSIONS: Using a novel subcutaneous dosing schedule, ustekinumab was successful in improving clinical, laboratory, and endoscopic markers of disease activity in patients with severe, refractory CD.
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Authors | Kimberly A Harris, Sara Horst, Akash Gadani, Anne Nohl, Kim Annis, Caroline Duley, Dawn Beaulieu, Leyla Ghazi, David A Schwartz |
Journal | Inflammatory bowel diseases
(Inflamm Bowel Dis)
Vol. 22
Issue 2
Pg. 397-401
(Feb 2016)
ISSN: 1536-4844 [Electronic] England |
PMID | 26752468
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Dermatologic Agents
- Ustekinumab
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Topics |
- Adolescent
- Adult
- Aged
- Child
- Child, Preschool
- Crohn Disease
(drug therapy)
- Dermatologic Agents
(therapeutic use)
- Drug Resistance
(drug effects)
- Female
- Follow-Up Studies
- Humans
- Male
- Middle Aged
- Prognosis
- Retrospective Studies
- Ustekinumab
(therapeutic use)
- Young Adult
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