During the word of welcome given at the satellite symposium 'Rapid Action and Lasting Remission - Focus on Disease Progression in Ulcerative Colitis', William Sandborn (America) came directly to the point: the sufficient treatment of UC is essential. In 50% of the patients suffering from the UC, the disease takes an adverse course.
A lack of direct operational measures that counter the progression of the disease possibly contributes to the suboptimal treatment of UC. This is all the more regrettable because early, lasting remission is associated with more favourable long-term outcomes. For this reason, Sandborn advocated timely, yet personalised treatment in which the needs of the patient are taken into account. Fast action, a high level of effectiveness, long-working activity and a favourable safety profile are important aspects for UC patients, while the manner of administering medicine and the frequency of doses are less so.
In addition, there often seems to be a discrepancy between the perception of the patients with respect to their illness and the actual remission status, says Geert d'Haens (the Netherlands). A similar situation pertains to doctors: an American study revealed that doctors generally have a rosier picture of the impact of UC on the lives of their patients than the patients themselves. D'Haens then wondered aloud why biological medical products are still used too infrequently within the treatment of UC. If they are used, their use is often suboptimal. He summarised four strategies for achieving early, lasting remission: early intervention, treat-to-target, individualised treatment and close monitoring. The fact that timely treatment produces positive outcomes was shown by Feagan et al. in a study in which vedolizumab was more effective the shorter the illness had been present. When vedolizumab is given to UC patients who are sick ≥1 to <3 years, then the estimated difference in clinical response in week 6 between vedolizumab and a placebo is no less than 30.1%. If the illness lasts ≥3 to <7 years, then this difference decreases to 18.5%, and if the illness lasts ≥7 years, it is 18.9%. Earlier treatment with other remedies, such as anti-TNFs, also influence the outcomes: the fewer remedies tried, the better.
Remo Panaccione (Canada) stated that the optimal use of biological therapy to achieve early, lasting remission means that it is given in the correct dosage, at the correct time and for the correct length of time, so that the benefit/risk is kept in balance. This represents exactly what is important to the patient. For moderate to severe UC, a choice can be made from systemic anti-TNFs or an intestine-specific biological medical product (since May 2014, vedolizumab has been the only intestine-specific biological medical product registered to treat moderate/severe UC/CD in Europe). Although in the past anti-TNFs were seen as an innovation, over time it has been learned that disease control using anti-TNFs can be limited. With respect to vedolizumab, the view is different: in the GEMINI I-study, a separation point could be seen as early as week 2 with respect to clinical remission between responders to vedolizumab and patients given a placebo, with a visible lasting effect. With respect to endoscopic remission, too, vedolizumab scores high: in week 6, the average difference with the placebo among anti-TNF-naive patients was 23.9% (9.9% among those that failed earlier with respect to anti-TNF). In week 52, for patients that were responders in week 6, this was 35.9% and 34.9%, respectively. Biological naive patients, in particular, benefit enormously from vedolizumab; according to Panaccione, it can safely be said that 70-75% of the patients that perform well in the first year have long-term (5 years of) clinical remission. Five-year cumulative data show that vedolizumab provides lasting, corticosteroid-free clinical remission to 95% of all patients.
As already stated by d'Haens, the number of anti-TNFs given earlier influences the treatment process. Real-world data on vedolizumab clarify that the number of anti-TNFs given earlier is associated with a reduction in the achievement of mucosal healing (HR 0,697). Anti-TNFs are also associated with problems such as severe infections. The intestine-specific biological medical product vedolizumab has a different operating mechanism than anti-TNFs, which means a better safety profile can be expected. Data pooled from six studies (vedolizumab n=2.830/placebo n=504) confirm this. So it seems that the incidence of infections corrected for exposure is lower for vedolizumab than it is for the placebo group. There was also no increase of AE incidence in the 5-year safety analysis (4,811 patient years). These findings are supported by real-world data. Since August 2017, there have been 143,127 patient years of post-marketing exposure with vedolizumab.
Panaccione concluded therefore that, based on the findings mentioned above, vedolizumab is a suitable remedy for early, long-term use that meets the treatment goals for UC and provides what patients want in their UC therapy.