JAK1 inhibitor induces clinical response in UC
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Selective janus kinase 1 inhibitor, SHR0302, induced clinical response and remission among patients with moderate to severe ulcerative colitis, according to a study at Digestive Disease Week.
“JAK signaling plays an important role in the pathogenesis of UC by blocking the JAK-STAT pathway,” Min-Hu Chen, MD, PhD, The First Affiliated Hospital, Sun Yat-sen University, said. “SHR0302 is a selective JAK1 inhibitor currently under clinical development for the treatment of UC, rheumatoid arthritis, ankylosing spondylitis, atopic dermatitis, Crohn’s disease and alopecia areata.”
In a global, placebo-controlled phase 2 study, researchers randomly assigned 164 patients 1:1:1:1 to receive either SHR0302 8 mg once daily, SHR0302 4 mg twice daily, SHR0302 4 mg once daily or placebo for 8-weeks to investigate the safety and efficacy of SHR0302. Studied endpoints included the percentage of patients achieving clinical response, the percentage of patients achieving clinical remission and the percentage of patients achieving centrally read endoscopic remission.
Study results yielded a clinical response of 46.3% for the 8 mg once daily group, 46.3% for the 4 mg twice daily group, 43.9% for the 4 mg once daily group and 26.8% for the placebo group. The group difference for each active arm was 19.8% (90% CI, 2.8036.7), 20.1% (90% CI, 3.3-37) and 17.7% (90% CI, 0.8-34.5). Clinical remission was achieved in 22% of patients in the 8 mg once daily group, 24.4% of patients in the 4 mg twice daily group, 24.4% of patients in 4 mg once daily group and 4.9% of patients in the placebo group. Investigators reported a similar trend for endoscopic remission (26.8%, 29.3%, 36.6% and 14.6%, respectively).
“Study results indicated that selective JAK1 inhibitor SHR0302 at 8 mg once daily, 4 mg twice daily and 4 mg once daily are superior compared to placebo at induction of clinical response and clinical remission in patients with moderate to severe UC after 8-weeks of treatment,” Chen concluded. “Phase 3 studies are warranted to further confirm the safety and efficacy of SHD0302.”
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Chen M, et al. Abstract 775c. Presented at: Digestive Disease Week; May 21-23, 2021 (virtual meeting).
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