USA: A study published in The Lancet has concluded for patients which a history of moderate to severe active ulcerative colitis, Etrasimod is proven to be effective and well tolerated as an induction and maintenance therapy based on the study’s findings. They highlighted the therapeutic option further, saying, Etrasimod is a treatment capable of addressing the persistent unmet needs of such patients.
Etrasimod is a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator. It selectively activates S1P receptor subtypes 1, 4, and 5. It has no detectable activity on S1P2,3. The drug is also in development for managing immune-mediated diseases, including ulcerative colitis.
Considering this background, the researchers of the present study, In two phase 3 trials, evaluated the safety and efficacy of etrasimod in patients with moderately to severely active ulcerative colitis.
The study design could be summarised as follows:
There were two independent trials: ELEVATE UC 52 (screened 820 patients) and ELEVATE UC 12 (screened 602 patients).Active moderate-to-severe ulcerative colitis patients and loss of response or intolerance to minimum one approved therapy were randomly assigned to once-daily oral etrasimod 2 mg or placebo in the ratio of 2:1In ELEVATE UC 52, 289 patients were assigned to etrasimod and 144 to placebo, while In ELEVATE UC 12, 238 and 116 patients were assigned to etrasimod and placebo respectively. ELEVATE UC 52 and ELEVATE UC 12 patients were enrolled from 315 centres in 40 and 407 centres in 37 countries, respectively.Yes vs no: The stratification was based on previous exposure to biologicals or Janus kinase inhibitor therapy (baseline corticosteroid use, disease activity.With a treat-through design, ELEVATE UC 52 comprised a 12-week induction period which was followed by a 40-week maintenance period.ELEVATE UC 12 assessed induction at week 12 independently.Patient proportions with clinical remission at weeks 12 and 52 in ELEVATE UC 52 and ELEVATE UC 12 were the endpoints of primary efficacy.
In ELEVATE UC 52, patients in the etrasimod group achieved clinical remission in greater proportion than the placebo group; 74/ 274 patients vs 10/135 patients in week 12 and at week 52 (88 /274 patients vs 9/135 patients, respectively.
In ELEVATE UC 12, 55/222 patients in the etrasimod group had clinical remission than 17/112 patients in the placebo group (12-week induction period).
Two hundred-six patients in the etrasimod and 81 in the placebo group in ELEVATE UC 52 and 112 in the etrasimod group, and 54 in the placebo group in ELEVATE UC 12 had adverse events.
No deaths or malignancies were reported in the study. Arena Pharmaceuticals funded the study.
Researchers said that our study had limitations like study duration, and due to the COVID-19 pandemic, patient behaviour may have affected the investigation results.
Etrasimod 2 mg is effective as an induction and maintenance therapy for moderate to severe active ulcerative colitis based on our findings, they wrote.
Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies