Extent of Early Clinical Response to Infliximab Predicts Long-term Treatment Success in Active Ulcerative Colitis

The impact of endoscopic and histological mucosal healing on outcomes in adult settings is impressive. Despite many clinical parallels, pediatric ulcerative colitis (UC) is set apart from adult disease in several respects. Many frequently used indices are not fully validated, especially in pediatric settings, and consensus on precise definitions in clinical settings are lacking. Endoscopic mucosal healing is an acceptable long-term treatment goal in pediatrics, but not histologic normalization. Early prediction of disease course in UC may allow treatment stratification of patients according to risks of relapse, acute severe colitis, and colectomy. Putative endoscopic and histologic predictors of poor clinical outcomes in adults have not held true in pediatric settings, including baseline endoscopic extent, endoscopic severity, and specific histologic characteristics which are less prevalent in pediatrics at diagnosis. In this mini-review we appraise predictive endoscopic and histologic factors in pediatric UC with reference to relapse, severe colitis, and colectomy risks. We recommend that clinicians routinely use endoscopic and histologic sores to improve the quality of clinical and research practice. The review summarizes differences between adult and pediatric prediction data, advises special consideration of those with primary sclerosing cholangitis, and suggests areas for future study in this field.

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Long-term, Real-life, Observational Study in Treating Outpatient Ulcerative Colitis with Golimumab

Journal of Gastrointestinal and Liver Diseases ◽

10.15403/jgld-3992 ◽

2021 ◽

Author(s):

Antonio Tursi ◽

Giammarco Mocci ◽

Walter Elisei ◽

Leonardo Allegretta ◽

Raffaele Colucci ◽

...

Keyword(s):

Ulcerative Colitis ◽

Clinical Response ◽

Clinical Remission ◽

Real Life ◽

Mucosal Healing ◽

Term Treatment ◽

Short Term Treatment ◽

Mayo Score

Background and Aims: Several studies have found Golimumab (GOL) effective and safe in the short-term treatment of ulcerative colitis (UC), but few long-term data are currently available from real world. Our aim was to assess the long-term real-life efficacy and safety of GOL in managing UC outpatients in Italy. Methods: A retrospective multicenter study assessing consecutive UC outpatients treated with GOL for at least 3-month of follow-up was made. Primary endpoints were the induction and maintenance of remission in UC, defined as Mayo score ≤2. Several secondary endpoints, including clinical response, colectomy rate, steroid free remission and mucosal healing, were also assessed during the follow-up. Results: One hundred and seventy-eight patients were enrolled and followed up for a median (IQR) time of 9 (3-18) months (mean time follow-up: 33.1±13 months). Clinical remission was achieved in 57 (32.1%) patients: these patients continued with GOL, but only 6 patients (3.4%) were still under clinical remission with GOL at the 42nd month of follow-up. Clinical response occurred in 64 (36.4%) patients; colectomy was performed in 8 (7.8%) patients, all of them having primary failure. Steroid-free remission occurred in 23 (12.9%) patients, and mucosal healing was achieved in 29/89 (32.6%) patients. Adverse events occurred in 14 (7.9%) patients. Conclusions: Golimumab does not seem able to maintain long-term remission in UC in real life. The safety profile was good.

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Early Viral Suppression Predicting Long-term Treatment Success Among HIV Patients Commencing NNRTI-based Antiretroviral Therapy

Journal of Antivirals & Antiretrovirals ◽

10.4172/jaa.1000019 ◽

2010 ◽

Vol 02 (02) ◽

Cited By ~ 1

Author(s):

Aung Naing Soe Somsit ◽

Tansuphasawadikul Benjaluck Phonrat ◽

Lamom Boonpok Sirima Tepsupa

Keyword(s):

Antiretroviral Therapy ◽

Viral Suppression ◽

Treatment Success ◽

Term Treatment ◽

Hiv Patients ◽

Long Term Treatment

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Ozanimod, an Oral S1P Receptor Modulator, Is Effective and Well-Tolerated in the Long-Term Treatment of Moderate to Severe Ulcerative Colitis

The American Journal of Gastroenterology ◽

10.14309/00000434-201802001-00012 ◽

2018 ◽

Vol 113 ◽

pp. S3

Author(s):

Feagan Brian ◽

Sandborn William ◽

DʼHaens Geert ◽

Hanauer Stephen ◽

Wolf Douglas ◽

...

Keyword(s):

Ulcerative Colitis ◽

Term Treatment ◽

Severe Ulcerative Colitis ◽

Receptor Modulator ◽

Long Term Treatment ◽

S1p Receptor

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Randomized, Ascending Dose, Phase 2 Study of KHK4083, an Anti-OX40 Monoclonal Antibody, in Moderately Active Ulcerative Colitis

Crohn's & Colitis 360 ◽

10.1093/crocol/otaa049 ◽

2020 ◽

Vol 2 (3) ◽

Author(s):

Jaroslaw Kierkus ◽

Marina Pesegova ◽

Maria Klopocka ◽

Marija Brankovic ◽

Noriyuki Kasai ◽

...

Keyword(s):

Ulcerative Colitis ◽

Monoclonal Antibody ◽

Mucosal Healing ◽

Term Treatment ◽

Active Ulcerative Colitis ◽

Phase 2 ◽

Double Blind ◽

Parallel Group ◽

Phase 2 Study ◽

Long Term Treatment

Abstract Background OX40 (CD134) plays a role in the maintenance of late T-cell proliferation and survival. KHK4083 is a monoclonal antibody directed against OX40. We aimed to assess the safety and preliminary efficacy of KHK4083 in patients with moderately active ulcerative colitis (UC). Methods In this multicenter, double-blind, parallel-group, phase 2 study, patients with moderately active UC patients were randomized to ascending doses of intravenous KHK4083 (1, 3, or 10 mg/kg) or placebo every 2 weeks for 12 weeks. The primary endpoint was safety. The primary efficacy end point was the change from baseline in mean modified Mayo endoscopy subscore at week 12. Treatment with KHK4083 or placebo was continued every 4 weeks for up to 52 weeks in responders. Results Long-term treatment with KHK4083 was well tolerated, with treatment-related adverse events being predominantly transient mild-to-moderate infusion-related reactions. Exploratory analysis of biopsy samples showed the virtually complete elimination of OX40+ cells in colon mucosa after 12 weeks of KHK4083 treatment. There were no significant differences between any of the randomized KHK4083 dose groups and placebo for the mean change in Mayo endoscopy subscore from baseline to week 12. Conclusions KHK4083 can be safely administered intravenously at doses up to 10 mg/kg every 2 or 4 weeks for up to 52 weeks. Proof of pharmacodynamic action was confirmed by depletion of the elevated levels of the OX40+ cells associated with UC at all tested doses. Clinical response and mucosal healing (endoscopic improvement) in this population was not correlated with ablation of OX40+ T cells.

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