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As early as week 2, patient-reported symptomatic improvements were achieved among UC patients treated with vedolizumab – including a combined reduction in defecation frequency and rectal blood loss. These findings underline the fast action of vedolizumab in treating UC, particularly when it is used as a first-line biological therapy.
The GEMINI 1 study found that vedolizumab is safe and effective as an induction and maintenance therapy for UC patients. Based on exploratory analyses from this study, Feagan et al. evaluated the speed at which patient-reported symptomatic improvements began. The reduction of rectal blood loss and the decrease in the frequency of defecation, in particular, are significant treatment goals because of the extremely disabling nature of these complaints. Both complaints were evaluated in weeks 2, 4 and 6 among patients with active UC that had been randomised in GEMINI 1 with either a double-blind placebo (n=149, n=75 of which were anti-TNF-naive) or vedolizumab (n=225, n=130 of which were anti-TNF-naive).
In week 2, among the anti-TNF-naive patients that were given vedolizumab, there was a decrease of 29.8% from the baseline in the rectal blood loss subscore vs 19.8% among those patients given the placebo. A comparable picture was seen among the total population, with a respective decrease of 28.6% for patients treated with vedolizumab vs 20.7% for patients given the placebo. This continued in week 4 among the anti-TNF-naive patients, resulting in a decrease of 59.0% for vedolizumab patients vs 27.1% for the placebo patients in week 6. For the total population, the decrease was 49.5% vs 26.8%, respectively. The defecation frequency also fell faster in week 2 with vedolizumab than it did with the placebo among both the anti-TNF-naive patients and the total population (respectively -19.9% vs -5.0% and -12.3% vs -6.4%).
In weeks 2, 4 and 6, the percentage of patients treated with vedolizumab who were anti-TNF-naive and who achieved the elimination of rectal blood loss (RBS=0) or a reduction in defecation frequency (SFS≤1) appeared to be higher than it was among the patients treated with vedolizumab in the total population. This was also the case among patients treated with vedolizumab that were anti-TNF-naive and achieved both RBS=0 and SFS≤1 in comparison with the patients treated with vedolizumab in the total population. In succession, this was 22.3% vs 19.1% in week 2, 31.5% vs 28.0% in week 4 and 40.8% vs 33.8% in week 6.
Feagan decided to stress the aforementioned results in his presentation, which underlined the fast action of vedolizumab, particularly when vedolizumab is deployed as a first-line biological therapy. Timely treatment is therefore crucial. He also said that it is advisable to continue the treatment and assessment up to and including week 14 for those patients that showed a modest initial improvement.