奥扎莫德治疗克罗恩效果怎么样？

A trial to evaluate the effect of ozanimod, an oral drug that selectively targets sphingosine-1-phosphate receptor subtypes 1 and 5, on endoscopic disease activity in Crohn's disease.

STEPSTONE (NCT02531113) is a Phase 2, uncontrolled, multicenter trial enrolling adults with moderate to severe Crohn's disease at 28 hospitals and community research centers in Canada, the United States, Hungary, Poland, and Ukraine. All patients started treatment with a 7-day dose increase (ozanimod 0.25 mg daily for 4 days, followed by 0.5 mg daily for 3 days). Patients then received ozanimod 1.0 mg oral capsule daily for 11 weeks, followed by a 12-week induction phase followed by a 100-week extension. The primary endpoint was change from baseline to week 12 in the Simple Endoscopic Score for Crohn's Disease (SES-CD), as determined by a blinded central reader. Data are reported from the intention-to-treat population.

Survey results: From November 17, 2015 to August 18, 2016, a total of 69 patients were selected. At week 12, the mean change in SES-CD from baseline was -2·2 (SD 6.0); 16 patients (23.2%) had endoscopic reactions. Crohn's Disease Activity Index (CDAI) scores also decreased from baseline (mean change -130.4 [SD 103·9]). 27 patients (39.1%) achieved clinical remission (CDAI<150 points), and 39 patients (56.5%) achieved clinical remission (CDAI<100 points).

The mean change from baseline in two patient-reported outcomes (PRO2, stool frequency, abdominal pain score) was -66.1 (SD 65.4). The mean change from baseline was -5.9 (SD 11.0) in the Geboes Histological Activity Score (GHAS) and -10.6 (25.1) in the Robart Histopathology Index (RHI). The most common events were those attributed to Crohn's disease, most commonly Crohn's disease (relapse) in 18 (26%) patients. The most commonly reported serious treatment-related adverse events were Crohn's disease (6 [9%]) and abdominal abscess (2 [3%]).

Conclusions: Endoscopic, histological, and clinical improvement occurred within 12 weeks of initiating treatment with ozanimod in patients with moderately to severely active Crohn's disease.

Ozamod is an oral capsule that is approved for the treatment of relapsing multiple sclerosis (RMS) in adults, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. It can also be used to treat adult patients with moderately to severely active ulcerative colitis. It is recommended that patients take medication under the guidance of a doctor and receive symptomatic treatment.

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References

Feagan BG, Sandborn WJ, Danese S, Wolf DC, Liu WJ, Hua SY, Minton N, Olson A, D'Haens G. Ozanimod induction therapy for patients with moderate to severe Crohn's disease: a single-arm, phase 2, prospective observer-blinded endpoint study. Lancet Gastroenterol Hepatol. 2020 Sep;5(9):819-828. doi: 10.1016/S2468-1253(20)30188-6. Epub 2020 Jun 15. PMID: 32553149.