Sa1207 Pharmacokinetics/Pharmacodynamics (PK/PD), Efficacy, and Safety of AMG 181 in Subjects With Active, Mild to Moderate Ulcerative Colitis - An Initial Assessment

Pan, Wei‐Jian; Radford-Smith, Graham; Andrews, Jane M.; Schwartz, Howard; Sullivan, Barbara A.; Evangelista, Christine M.; Rees, William; Doherty, David R.; Prince, Peter J.; Reynhardt, Kai O.; Zhou, Kefei; Johnson, Justo Sierra; Treacy, Anthony M.; Zhang, Yu; Borie, Dominique C.

doi:10.1016/s0016-5085(13)60813-6

Cited by 2 publications

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“…Abrilumab is a monoclonal antibody that selectively blocks α4β7 and can be administered subcutaneously, with high bioavailability and a long half-life. 30,31 A recently published randomized, phase IIb study showed that treatment with abrilumab significantly improved 8-week remission rates (13.5%) when compared with placebo (4.4%) in patients with moderate-to-severe UC who had failed conventional therapies. Clinical response was seen in almost half of all patients and mucosal healing in one third of patients treated with a dose of either 70 mg or 210 mg, compared with 26% and 16.8% who received placebo, respectively.…”

Section: Anti-adhesion Biologicsmentioning

confidence: 99%

Emerging treatments for inflammatory bowel disease

Hazel

OʼConnor

2020

Therapeutic Advances in Chronic Disease

134

100

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Inflammatory bowel disease (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), is characterized by chronic inflammation, a relapsing and remitting clinical course, requirement for lifelong medication and often, significant morbidity. While multiple effective therapeutic options exist for the treatment of IBD, a proportion of patients will either fail to respond or lose response to therapy. Advances in therapeutics, such as the gut-specific anti-integrins, now offer patients an alternative option to systemic immunosuppression. Anti-interleukin 12 (anti-IL-12)/IL-23 agents offer new and effective treatment options for CD, while the oral small molecules now offer an oral alternative for the treatment of moderate-to-severe disease, previously requiring subcutaneous injection or intravenous infusion. Alternatives to pharmacological treatment such as stem-cell transplant and faecal microbiota transplant are also showing some promise in the treatment of both CD and UC.

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Section: Anti-adhesion Biologicsmentioning

confidence: 99%

Emerging treatments for inflammatory bowel disease

Hazel

OʼConnor

2020

Therapeutic Advances in Chronic Disease

134

100

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Efficacy and Safety of Abrilumab in a Randomized, Placebo-Controlled Trial for Moderate-to-Severe Ulcerative Colitis

et al. 2019

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BACKGROUND & AIMS: The a 4 b 7 integrin is a validated target in inflammatory bowel disease. This randomized, phase 2b, placebo-controlled, double-blind study evaluated the efficacy and safety of the anti-a 4 b 7 antibody abrilumab in patients with moderate-to-severe ulcerative colitis despite treatment with conventional therapies. METHODS: Patients (total Mayo Score 6-12, recto-sigmoidoscopy score !2) with inadequate response or intolerance to conventional therapies were randomized to receive subcutaneous abrilumab (7, 21, or 70 mg) on day 1, weeks 2 and 4, and every 4 weeks; abrilumab 210 mg on day 1; or placebo. The primary end point was remission (total Mayo Score 2 points, no individual sub-score >1 point) for the 2 highest dosages at week 8. Key secondary end points were response and mucosal healing (centrally read) at week 8. RESULTS: For 354 patients who received !1 dose of investigational product (placebo, n ¼ 116; 7 mg, n ¼ 21; 21 mg, n ¼ 40; 70 mg, n ¼ 98; 210 mg, n ¼ 79), non-adjusted remission rates at week 8 were 4.3%, 13.3%, and 12.7% for the placebo and abrilumab 70-mg and 210-mg groups, respectively (P < .05 for 70 and 210 mg vs placebo); odds of achieving remission were significantly greater with abrilumab 70 mg (odds ratio 3.35; 90% CI 1.41-7.95; P ¼ .021) and 210 mg (odds ratio 3.33; 90% confidence interval 1.34-8.26; P ¼ .030) than with placebo. Response and mucosal healing rates with these dosages also were significantly greater than with placebo. Higher baseline a 4 b 7 levels on naïve CD4 þ T cells were a prognostic indicator for overall outcome, but not a predictive biomarker of abrilumab response. There were no cases of progressive multifocal leukoencephalopathy or deaths. CONCLUSIONS: Abrilumab treatment for 8 weeks induced remission, clinical response, and mucosal healing in patients with moderate-to-severe ulcerative colitis. ClinicalTrials.gov, number NCT01694485.

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Sa1207 Pharmacokinetics/Pharmacodynamics (PK/PD), Efficacy, and Safety of AMG 181 in Subjects With Active, Mild to Moderate Ulcerative Colitis - An Initial Assessment

Cited by 2 publications

References 0 publications

Emerging treatments for inflammatory bowel disease

Emerging treatments for inflammatory bowel disease

Efficacy and Safety of Abrilumab in a Randomized, Placebo-Controlled Trial for Moderate-to-Severe Ulcerative Colitis

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