People with ulcerative colitis and Crohn’s disease who have failed with standard treatments, such as corticosteroids or immunosuppressants, can choose Takeda’s Kynteles as the first-line biologic treatment, the company said.
The Ministry of Food and Drug Safety recently granted the nod to Kynteles (ingredient: vedolizumab) as the first-line therapy for ulcerative colitis and Crohn’s disease.
Inflammatory bowel diseases, mainly ulcerative colitis and Crohn's disease, tend to show improvement and recurrence repeatedly. Half of the patients with inflammatory bowel disease suffer chronic symptoms, relapses, or worsening of the disease despite treatment.
Many patients receive surgery due to bowel injuries and complications.
Scientists have recently set a new goal “to heal intestinal mucosa,” besides clinical remission, in inflammatory bowel disease.
“As of 2018, Korea had more than 40,000 ulcerative colitis patients and over 20,000 people with Crohn's disease. The incidence rate in Asia, including Korea, has been increasing rapidly,” said Kim Joo-sung, president of the Korean Association for the Study of Intestinal Diseases.
As long-term treatment is necessary, symptom relief alone is not enough. Physicians should treat inflammatory bowel disease, considering the intestinal mucosa healing and the safety of drugs, Kim said,
Kynteles demonstrated long-term effects, including clinical remission up to 152 weeks in the GEMINI LTS study in patients with Crohn's disease and ulcerative colitis. In the VERSIFY study in patients with moderate or more severe Crohn's disease, the drug also showed 15 percent complete mucosal healing and 12 percent endoscopic remission at the 26th week.
In recent trials, Kynteles showed statistically superior clinical remission, compared to existing TNF-alpha inhibitors.
In the VARSITY study that directly compared Kynteles with adalimumab in patients with moderate to severe ulcerative colitis, 31.3 percent of Kynteles-treated patients reached clinical remission, versus 22.5 percent of the adalimumab group.
Takeda Pharmaceutical Korea CEO Moon Hee-seok said, “We are pleased that Kynteles, which confirmed the effect of mucosal healing with less risk of infection, became an early treatment option for mucosal healing of local patients with inflammatory bowel disease.”
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