Ozanimod treatment shows maintained response in ulcerative colitis

Ozanimod demonstrated long-term durability of efficacy in participants with active ulcerative colitis (UC). Moreover, results from the open-label, extension study of the phase 3 True North trial did not display new safety issues associated with the long-term use of ozanimod.

Ozanimod is an S1P receptor modulator, approved for the treatment of patients with moderately to severely active UC based on the 52-week results of the True North trial (NCT02435992) [1]. An open-label extension study was initiated to assess the long-term efficacy of ozanimod [2]. In total, 823 participants entered the open-label extension study of the True North trial, of whom 64%, 34%, and 14% completed the week 46, week 94, and week 142 time points, respectively. Lack of efficacy (21%) and withdrawal by subject (13%) were the main reasons for treatment discontinuations. Prof. Silvio Danese (Vita-Salute San Raffaele University, Italy) presented the results.

Observed-case analysis showed maintained clinical remission^a rates at week 46 (45%, n=203/452), week 94 (51%, n=109/213), and week 142 (45%, n=39/87). Among participants who displayed a clinical response^b upon open-label extension entry, clinical remission rates were sustained at week 46 (70%, n=107/152) and week 94 (69%, n=42/61). Furthermore, clinical responses, endoscopic improvement rates, and corticosteroid-free remission rates demonstrated similar patterns of maintained efficacy of ozanimod in the study population.

No new safety issues were reported with the long-term use of ozanimod. The most commonly reported treatment-emergent adverse events (TEAEs) were lymphopoenia (10.3%; n=119), anaemia (7.9%; n=91), and nasopharyngitis (7.5%; n=87). Serious TEAEs were observed in 14% (n=162) of the participants. UC worsening (3.9%; n=45) was the only serious TEAE that occurred in more than 1% of the participants.

In conclusion, the current interim analysis of the True North open-label extension study demonstrated the long-term durability of efficacy and safety of ozanimod therapy in participants with moderately-to-severely active UC.

a. Clinical remission is defined as a rectal-bleeding subscore of 0; a stool-frequency subscore of ≤1 or less, with a decrease of at least 1 point from baseline; and an endoscopy subscore of 1 or less (all on scales from 0 [none] to 3 [most severe]).

b. Clinical response is defined as a reduction in the total Mayo score of ≥3 points and ≥30% from baseline or in the three-component Mayo score of ≥2 points and ≥35% from baseline, as well as a reduction in the rectal-bleeding subscore of ≥1 point or an absolute rectal-bleeding subscore of ≤1 point.

1. Sandborn WJ, et al. NEJM. 2021;385:1280–1291.
2. Danese S, et al. Long-term use of ozanimod in patients with moderately to severely active Ulcerative Colitis. DOP44, ECCO 2022, 16­–19 February.

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Posted on 12 April 20228 April 2024