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Background/Aims: In patients receiving ustekinumab (UST) for treatment of Crohn's disease, there is no proven strategy to enhance or re-capture response. We assessed the utility of UST intravenous (IV) reinduction (~6 mg/kg) to achieve clinical, biochemical and endoscopic response or remission, in patients with partial or loss of response to UST maintenance therapy. Methods: A multicentre, retrospective cohort study was performed. Adults who received an IV reinduction dose of UST for either partial response or secondary loss of response to UST were assessed. The primary outcome was clinical remission off corticosteroids (Harvey Bradshaw Index <5), with biochemical response (defined as ≥ 50% decrease of CRP or FCP and/or endoscopic response (defined as a decrease in Simple Endoscopic Score-CD ≥ 50%). Secondary outcomes included clinical, biomarker and endoscopic response/remission, as well as safety. Results: Sixty-five patients (median age 38 years, 54.7% women) underwent IV UST reinduction between January 2017 and April 2019. Most patients (88.3%) were already on escalated maintenance dosing of UST 90 mg subcutaneous every 4 weeks. Clinical outcomes were assessed at a median of 14 weeks (IQR: 12-19) post-reinduction. The primary outcome of clinical remission off corticosteroids with biochemical and/or endoscopic response was achieved in 31.0% (n = 18). Pre-reinduction UST concentrations were ≥1 µg/mL in 88.6% (mean 3.2 ± 2.0 µg/mL). No serious adverse events were reported. Conclusions: UST IV reinduction can be effective in patients with Crohn's disease with partial or loss of response to UST maintenance therapy. Further studies evaluating this strategy are warranted.
RESUMO
BACKGROUND/OBJECTIVE: Inflammatory bowel disease (IBD) is a chronic relapsing illness primarily including Crohn disease and ulcerative colitis. The disease course often fluctuates over time, and requires maintenance therapy and acute interventions to target disease flares. IBD management requires a multidisciplinary approach, with care from physicians, nurses, dieticians, social workers and psychologists. Because nurses play a pivotal role in managing chronic disease, the aim of the present study was to assess and determine how many nurses work primarily with IBD patients in Canada. METHODS: A 29-question survey was developed using an Internet-based survey tool (www.surveymonkey.com) to investigate nursing demographics, IBD nursing roles and nursing services provided across Canada. Distribution included the Canadian Society of Gastroenterology Nurses and Associates, the Canadian Association of Gastroenterology, Progress (AbbVie Corporation, USA) and BioAdvance (Janssen Inc, USA) coordinators (via e-mail), and online availability for 15 weeks. RESULTS: Of 275 survey respondents, 98.2% were female nurses, with 68.7% employed in full-time positions. Among them, 42.5% were between 51 and 60 years of age, and 32.4% were between 41 and 50 years of age. In addition, 53.8% were diploma-prepared registered nurses, 35.3% were Baccalaureate-prepared nurses and 4.4% were Masters-prepared nurses. Almost one-half (44% [n=121]) were employed in Ontario, followed by 19.6% (n=54) in Alberta and 9.1% (n=25) in British Columbia. All provinces were represented with the exception of Nunavut and the Northwest Territories. Forty-three per cent (n=119) of nurses identified as working in endoscopy units. Of the 90% who responded as working with IBD patients, only 30% (n=79) had a primary role in IBD care. Among these 79 nurses with a primary role in IBD care, 79.7% worked with the adult population, 10.1% with the pediatric population, and 10.1% worked with both adult and pediatric patients. Their major service was an outpatient setting (67.1%). CONCLUSIONS: Survey results showed that only a small percentage of Canadian gastroenterology nurses provide clinical IBD care. Many have multiple roles and responsibilities, and provide a variety of services. The exact depth of care and service is unclear and further study is needed.
