Abstract

Closely monitoring disease activity using a tight control algorithm improves endoscopic and clinical outcomes in patients with moderate to severe Crohn's disease, the phase 3 CALM study suggests. Jean-Frederic Colombel and colleagues randomly assigned patients to be managed with a traditional clinical management algorithm (n=122) or with a tight control algorithm that used clinical symptoms and biomarkers (n=122). At 48 weeks, a significantly higher proportion of patients in the tight control group achieved the study's primary endpoint of mucosal healing (56 [46%] of 122 patients) than in the clinical management group (37 [30%] of 122 patients; Cochran–Mantel–Haenszel test-adjusted risk difference of 16·1% [95% CI 3·9–28·3]; p=0·010). Patients in the tight control group also had absence of deep ulcers and improved clinical outcomes compared with those who underwent traditional clinical management of symptoms. Effect of tight control management on Crohn's disease (CALM): a multicentre, randomised, controlled phase 3 trialCALM is the first study to show that timely escalation with an anti-tumour necrosis factor therapy on the basis of clinical symptoms combined with biomarkers in patients with early Crohn's disease results in better clinical and endoscopic outcomes than symptom-driven decisions alone. Future studies should assess the effects of such a strategy on long-term outcomes such as bowel damage, surgeries, hospital admissions, and disability. Full-Text PDF Efficacy and safety of selective internal radiotherapy with yttrium-90 resin microspheres compared with sorafenib in locally advanced and inoperable hepatocellular carcinoma (SARAH): an open-label randomised controlled phase 3 trialIn patients with locally advanced or intermediate-stage hepatocellular carcinoma after unsuccessful transarterial chemoembolisation, overall survival did not significantly differ between the two groups. Quality of life and tolerance might help when choosing between the two treatments. Full-Text PDF

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