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TOUCHSTONE: Ozanimod Provides Long-term Benefit in Moderate-to-Severe UC
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HONOLULU — The long-term safety and efficacy of ozanimod for moderate-to-severe ulcerative colitis was confirmed by data from the maintenance period of the TOUCHSTONE study, according to a presenter at ACG 2015.
“At week 32, ozanimod 1 mg showed significant improvements in clinical remission, clinical response and mucosal improvement compared to placebo. The increase in the proportion of patients in clinical remission at week 32 when compared to week 8 in the ozanimod groups suggests that longer treatment may be associated with improving and sustained response rates,” Stephen B. Hanauer, MD, Clifford Joseph Barborka professor in medicine-gastroenterology and hepatology, Northwestern University Feinberg School of Medicine, Chicago, said during his presentation. “This is somewhat similar to what we’ve seen with other lymphocyte-trafficking agents.”
Stephen B. Hanauer
To determine the long-term safety, tolerability and efficacy of two orally administered doses of ozanimod (0.5 mg and 1 mg RPC1063, Receptos), a selective sphingosine 1-phosphate 1 and 5 receptor modulator, in patients with moderate-to-severe UC, Hanauer and colleagues evaluated patients who entered the maintenance period for an additional 24 weeks after achieving clinical response at week 8 of the induction period of the TOUCHSTONE trial.
“At the end of the maintenance phase, greater proportions of patients at both doses were in clinical remission at the end of week 32,” Hanauer said. “There was a greater proportion of patients at the 1 mg dose who were in clinical response at 8 weeks and as the patients continued out to week 32, there was a greater proportion of patients in both the 0.5- and the 1-mg group who were in clinical response at the end of 32 weeks.”
At week 32, 20.9% of the 67 patients in the high-dose group achieved clinical remission (P = .0108 compared with placebo), as did 26.2% of the 65 patients in the low-dose group (P = .0021) and 6.2% of the 65 patients in in the placebo group. Clinical response was achieved by 50.7% of the high-dose group (P = .0002), 35.4% of the low-dose group (P = .0571) and 20% of the placebo group.
“As far as endoscopic improvement or healing, again, greater proportions of patients treated with ozanimod had achieved mucosal improvement by the end of 8 weeks and in both groups, there was a greater proportion of patients who achieved clinical mucosal improvement or healing at the end of the study,” Hanauer said.
Mucosal improvement was achieved by 32.8% (P = .0046), 32.3% (P = .0064) and 12.3%, respectively. At week 32, improvement in total Mayo score from baseline was 3.4 (P = .0004), 2.2 (P = 0.1932) and 1.6, respectively.
“Happily, these results were achieved with an excellent safety profile,” he said.
Adverse events occurred in 26.2%, 11.1% and 32%, respectively, the most common of which were worsened UC and urinary tract infection. No adverse events of special interest occurred.
Considering recent FDA proposals regarding a change in remission definition, Hanauer also showed that a greater proportion of patients were in remission at the end of 32 weeks in both groups.
“Ozanimod was well tolerated with a favorable benefit-risk profile, which supports the planned phase 3 trial in ulcerative colitis and the phase 2 trial in Crohn’s disease,” Hanauer concluded.
– by Adam Leitenberger
Reference:
Hanauer SB, et al. Abstract 19. Presented at: ACG 2015; Oct. 19-21, 2015; Honolulu, HI.
Disclosures: Hanauer reports a consultancy relationship with Receptos. Please see the abstract for a list of all other researchers’ relevant financial disclosures.