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Efficacy and Safety of Ivarmacitinib in Patients With Moderate-to-Severe, Active, Ulcerative Colitis: A Phase II
Baili Chen1, Jie Zhong2, Xiuling Li3
1Division of Gastroenterology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
Background & Aims:
Current therapies for ulcerative colitis (UC) fail to achieve satisfactory disease control. Selective inhibition of Janus kinase (JAK) type 1 may improve clinical outcomes in patients with UC while avoiding the side effects associated with pan-JAK inhibition. The safety and efficacy of the selective JAK1 inhibitor ivarmacitinib (formerly SHR0302) were evaluated in patients with moderate-to-severe, active UC.
Methods:
AMBER2 was a double-blind, placebo-controlled, phase II trial conducted at 63 clinical centers in China, the United States, and Europe. Patients (N = 164) were randomized 1:1:1:1 to receive oral ivarmacitinib 8 mg once daily (QD), 4 mg twice daily (BID), or 4 mg QD, or placebo for 8 weeks, followed by an 8-week extension period. The primary endpoint was clinical response rate at week 8. Hochberg's procedure was used to control the study-wise type 1 error at alpha=0.1.
Results:
A total of 146 (89.0%) patients completed 8 weeks of treatment. Week 8 clinical response rates were significantly higher in the 8 mg QD (46.3%; P = .066), 4 mg BID (46.3%; P = .059), and 4 mg QD (43.9%; P = .095) groups vs placebo (26.8%). Week 8 rates of clinical remission were 22.0% (P = .020), 24.4% (P = .013), and 24.4% (P = .011) in the 3 ivarmacitinib treatment groups, respectively, vs 4.9% for placebo. During the initial 8-week period, treatment-emergent adverse events occurred in 43.9% to 48.8% of ivarmacitinib-treated patients and in 39.0% of the placebo group, and were predominantly mild. There were no deaths, or major adverse cardiovascular or thromboembolic events.
Conclusion:
Ivarmacitinib demonstrated clinical efficacy and was well tolerated in patients with moderate-to-severe, active, UC. Ivarmacitinib represents a promising new treatment for moderate-to-severe UC.
Clinicaltrials:
gov number, NCT03675477.
Insights
Selective JAK1 inhibition with ivarmacitinib showed significant clinical efficacy and good tolerability in patients with moderate-to-severe ulcerative colitis. This finding suggests ivarmacitinib as a promising new therapeutic option for UC management.
Area of Science:
- Gastroenterology
- Immunology
- Pharmacology
Background:
- Current ulcerative colitis (UC) therapies offer suboptimal disease control.
- Selective Janus kinase (JAK) type 1 inhibition may enhance UC treatment outcomes while mitigating side effects of pan-JAK inhibitors.
Purpose of the Study:
- To evaluate the safety and efficacy of ivarmacitinib, a selective JAK1 inhibitor, in patients with moderate-to-severe active UC.
Main Methods:
- The AMBER2 trial was a phase II, double-blind, placebo-controlled study involving 164 patients across 63 centers.
- Patients received oral ivarmacitinib (8 mg once daily, 4 mg twice daily, or 4 mg once daily) or placebo for 8 weeks.
- The primary endpoint was the clinical response rate at week 8.
Main Results:
- Clinical response rates at week 8 were significantly higher for all ivarmacitinib doses (43.9%-46.3%) compared to placebo (26.8%).
- Clinical remission rates at week 8 were also significantly higher in the ivarmacitinib groups (22.0%-24.4%) versus placebo (4.9%).
- Treatment-emergent adverse events were predominantly mild, with no deaths or major adverse cardiovascular events reported.
Conclusions:
- Ivarmacitinib demonstrated significant clinical efficacy and was well-tolerated in patients with moderate-to-severe active UC.
- Ivarmacitinib represents a promising new treatment option for managing moderate-to-severe UC.
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