China's first biological agent for the treatment of ulcerative colitis was approved

Medical Network February 19, Xi'an Janssen Pharmaceutical Co., Ltd. announced today that the National Drug Administration has approved REMICADE®, the infliximab for injection, which is not effective or tolerant to traditional treatment. Adult patients with moderate to severe active ulcerative colitis who are medically contraindicated can be used to relieve symptoms and signs, induce and maintain clinical remission and mucosal healing, and reduce or discontinue the use of glucocorticoids [1]. This is the first biological preparation approved in China for the treatment of ulcerative colitis.

Ulcerative colitis is a chronic non-specific intestinal inflammatory disease whose cause is not well understood. It can occur at any age and most often occurs in young and middle-aged people. According to statistics from China, the peak age of onset is 20 to 49 years old [ 2]. The main manifestations include diarrhea, mucus and bloody stools, urgency and weight, abdominal pain, etc., which may be accompanied by systemic symptoms such as fever and weight loss [3]. Ulcerative colitis has a high incidence in developed areas of Europe and the United States. In recent years, with the increasing living standards in China, the incidence rate has increased year by year [4]. It is estimated that the prevalence of ulcerative colitis in China is 11.6/100,000 [5].

Professor Chen Yuhu, Chairman of the Digestive Diseases Branch of the Chinese Medical Association and Director of the Department of Gastroenterology, the First Affiliated Hospital of Sun Yat-sen University, said: "Europe and the United States have used infliximab (like grams) to treat ulcerative colitis (UC) for 14 years. Its efficacy and safety have been widely recognized, and the approval of this class of UC indications will provide new treatments for UC patients, especially refractory UC patients."

The approval of gram® is based primarily on two global phase III clinical trials and a phase III clinical trial for Chinese patients. ACT 1 and ACT 2 are two international, multicenter, randomized, double-blind, placebo-controlled clinical trials of patients with moderate to severe active ulcerative colitis who have been poorly treated with conventional therapy [1] (n = 728). In the ACT 1 study, 44.9% of patients in the infliximab-treated group achieved clinical outcome at week 54 compared with 19.8% in the placebo-treated group (p < 0.001); infliximab treatment with infliximab The proportion of patients with clinical remission and mucosal healing was higher in the group than in the placebo group (34.6% vs. 16.5%, p < 0.001 and 46.1% vs. 18.2%, p < 0.001); combined with infliximab treatment The proportion of patients with sustained response and sustained remission was higher than that of the placebo group (37.9% vs. 14.0%, p < 0.001; and 20.2% vs. 6.6%, p < 0.001).

Week 30 (22.3% vs. 7.2%, p < 0.001, summary ACT 1 and ACT 2 data) and week 54 (21.0% vs. 8.9%, p=0.022, ACT 1 data), combined with infliximab The proportion of patients in the treatment group who were able to maintain clinical remission while stopping glucocorticoids was higher than in the placebo group.

Phase III clinical studies in China [6] (n = 99) also showed that infliximab was safe and effective in the treatment of patients with moderate to severe ulcerative colitis in China. The 8-week clinical response rate of the infliximab group (n = 50) compared with the placebo group (n = 49) [n = 32 (64%) vs. n = 16 (33%); P = 0.0021] and Mucosal healing rate [n = 17 (34%) vs. n = 8 (16%); P = 0.0451] was higher, and the clinical remission rate was higher at week 26 [ n = 14 (28%) vs. n = 5 (10%); P=0.0281]. No serious drug-related adverse events occurred during the study.

Asgar Rangoonwala, President of Xi'an Janssen Pharmaceutical Co., Ltd. said: "Xi'an Yangsen has long been committed to solving the unmet needs of patients. We have been working hard to enable Chinese patients with ulcerative colitis to benefit from the innovative treatment of gram-type cols as soon as possible. The approval of the new Indications for Sub-Class® has once again proved our continued commitment to the Chinese patients. In the future, we will continue to work with other medical institutions to improve the accessibility of innovative drugs for patients. Many patients benefit."

As the first tumor necrosis factor (TNF-α) inhibitor approved for use in three different fields of gastroenterology, rheumatism and skin diseases in China, since its approval in China in May 2006, the class has been Approved for patients with moderate to severe active rheumatoid arthritis, moderate to severe active Crohn's disease, fistile Crohn's disease, Crohn's disease in children over 6 years of age, active ankylosing spondylitis, and need Adult patients with chronic severe plaque psoriasis who are treated systemically and who are ineffective, contraindicated or intolerant to other systems such as cyclosporine, methotrexate or photochemotherapy. [1] Ulcerative colitis is the seventh indication approved in China.

As of now, gram has been approved in more than 100 countries and is widely used by more than 3 million patients worldwide.

References :

1. Class gram® instruction manual

2. Department of Inflammatory Bowel Diseases, Chinese Medical Association Digestive Diseases Section. Consensus on the diagnosis and treatment of inflammatory bowel disease (2018, Beijing). Chinese Journal of Digestion, May 2018, Vol. 38, No. 5.

3. Qian Jiaming, Li Wei. Clinical manifestations and classification of ulcerative colitis[J]. Modern Journal of Digestion & Intervention, 2008, 13(2): 111-114.

4. Zheng Hongbin. Comparison of global incidence of ulcerative colitis[J]. Chinese Journal of Digestology, 2001, 21(4): 242-243.

5. Zheng Jiaxuan, Shi Xiaohua, Guo Zhirong. Epidemiological research methods and progress of inflammatory bowel disease[J]. Chinese Journal of Internal Medicine, 2009, 48(6): 522-523.

6. Chen Baili, Qian Jiaming, Wu Kaichun et al. Clinical study on the efficacy and safety of inflixima in the treatment of active ulcerative colitis[J]. Chinese Journal of Inflammatory Bowel Disease, 2017, 1(1): 20-23 .