A108 Ustekinumab Iv Induction Results in Crohn’s Disease Symptom Improvement Within the First Week in Anti-TNF Refractory Patients

Sandborn, William J.; Yeager, Benjamin; Gasink, C; Hoops, Timothy; Gao, L-L; Wang, Y; Jacobstein, Douglas; Lee, S D; Hanauer, Stephen B.

doi:10.1093/jcag/gwy009.108

Cited by 3 publications

(3 citation statements)

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“…1 Additionally, the Psoriasis Longitudinal Assessment and Registry (PSOLAR) demonstrated cumulative incidence infection rates per 100 patient-years of 0.83 for ustekinumab versus 2.49 for infliximab versus 1.97 for adalimumab. 8 For this patient, ustekinumab at 390 mg IV (based on the weight-tiered dose regimen of ˜6 mg/kg) was started based on the infection-rate data, 1,9 onset of action, 1,10 no requirement for immunomodulators, 4 and low incidence of anti-drug antibodies. 1 Azathioprine was discontinued.…”

Section: Doctor Tim Rainementioning

confidence: 99%

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IL-12/23 in IBD: Making the Best Use of Available Evidence

Fricker¹

2019

EMJ Gastroenterol

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Prof Ghosh presented data from the UNITI studies exploring ustekinumab in primary or secondary nonresponders to TNF agonists (UNITI-1) and conventional therapy failures (UNITI-2). The data demonstrate that ustekinumab shows higher efficacy in patients who have failed conventional therapy compared to those who have failed anti-TNF therapy. Further sub-studies showed similar efficacy for ustekinumab 90 mg every 8 weeks (q8w) and ustekinumab 90 mg every 12 weeks (q12w) subcutaneous (SC) regimens, except for in patients with high inflammatory burdens, who did better with q8w regimens. No new safety signals were identified for ustekinumab between Week 96 and Week 156, with overall rates of adverse events and serious adverse events being comparable to placebo. Rates of antibody formation remained low. Dr Raine described two case studies involving Crohn’s disease patients treated with ustekinumab. The first case described a female patient with luminal Crohn’s disease who had secondary nonresponse to an anti-TNF with signs of intestinal and systemic inflammation. The second case considered a patient with bio-naïve luminal Crohn’s disease who had a previous history of opportunistic infections (coughs, colds, and recurrent herpes simplex). Prof Armuzzi presented the results of the induction part of the UNIFI study, which randomised patients with moderate-to-severe ulcerative colitis (UC) to placebo, ustekinumab 130 mg, or a weight-tiered ustekinumab dose (˜6 mg/kg). Results showed clinical remission at Week 8 was 5.3% for placebo, 15.6% for ustekinumab 130 mg intravenous (IV) (p<0.001), and 15.5% for ustekinumab at ˜6 mg/kg IV (p<0.001). Furthermore, ustekinumab IV induced clinical response and endoscopic and mucosal healing, improved health related quality of life, and had an adverse event profile consistent with known safety profiles.

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Section: Doctor Tim Rainementioning

confidence: 99%

“…Based on a post-hoc analysis, he stated that ustekinumab's onset of action could take a few days. 10…”

Section: Doctor Tim Rainementioning

confidence: 99%

IL-12/23 in IBD: Making the Best Use of Available Evidence

Fricker¹

2019

EMJ Gastroenterol

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“…Ustekinumab has been shown to lead to improvements in abdominal pain starting from day 6, stool frequency from day 7, and improvements in general well-being from day 8. 6 It is a subject of debate as to whether therapies influencing lymphocyte trafficking have a slower onset of action, particularly in CD. However, the data presented by Feagan et al 1 suggest that particularly in anti-TNF-naïve CD patients, a significantly greater percentage of patients given vedolizumab achieved the predefined symptom score (involving abdominal pain and stool frequency) at early time points of 2 and 4 weeks than patients given placebo did.…”

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confidence: 99%