At Takeda, we never stop striving for innovative patient care and to improve patient outcomes. A cornerstone of science and medicine is the need to assess and reassess, to determine if a theory or approach can be updated or refined. The measures we use to define treatment success are no different. The ‘treat-to-target’ (T2T) concept has become the standard of care for many chronic diseases, where a treatment response target is defined and worked towards to achieve the best long-term clinical outcomes for patients.
In ulcerative colitis (UC), treating beyond symptomatic relief has been shown to reduce disease relapse and hospitalization. This has led some experts to advocate for endoscopic healing or histological remission to be recognized as treatment targets in clinical practice and clinical trials.1 However, no study has proven that treating to these targets is superior to treating symptoms alone.2
In collaboration with Robarts Inc., Takeda has enrolled the first patient into the VERDICT (In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target) study to define the gold standard measure for treatment outcomes in UC.
Taking place across 11 countries over four years, the VERDICT study will investigate whether treating to achieve a target of corticosteroid-free, symptomatic, endoscopic, and histological remission is superior to a treatment target of corticosteroid-free symptomatic remission alone in patients with moderately to severely active UC.3
The findings of the VERDICT study may help to identify treatment targets that correlate to the optimal patient outcomes in UC. We’re looking forward to reporting data from the study and hope that this research will advance future clinical management of the disease.
1 Danese S, Roda G and Peyroulet L. Evolving therapeutic goals in ulcerative colitis: towards disease clearance. Nat Rev Gastroenterol Hepatol. 2020;17:1-2
2 Ungaro R, Colombel J-F, Lissoos T et al. Am J Gastroenterol. 2019;114:874-883
3 Determination of the Optimal Treatment Target in Ulcerative Colitis (VERDICT). Available at: https://clinicaltrials.gov/ct2/show/NCT04259138 . Last updated April 29, 2020. Last accessed October 2020.