"Customized version" biological agents bring hope for more patients with ulcerative colitis to return to normal life!

China-News - Health November 22, 2020, 5:41 pm Wang Ying's avatar Wang Ying

At present, the only intestinal selective biological agent, considering the efficacy and safety, Ta is the right choice!

Ulcerative colitis (UC) is a difficult and serious disease recognized in the field of digestion. It is known to many people that ulcerative colitis (UC) is difficult to cure and needs lifelong medication. Data display, The number of bloody stools in patients with severe UC ≥ 6 times a day [1], about 1 / 5 of patients can not work or go to school due to illness [2], and about 50% of patients need hospitalization at a certain stage of the course of disease [3] UC has undoubtedly overburdened patients, families and society. To explore better methods and means of UC treatment and improve the level of diagnosis, treatment and management of UC is what digestive scholars have been working hard for.

At present, the only intestinal selective biological agent, vitellizumab, has been approved for marketing in China in March 2020. Recently, there have been "milestone" reports. UC patients in many hospitals, such as Peking Union Medical College Hospital, Zhejiang run run run run hospital, Sun Yat sen University Sixth Affiliated Hospital, have started using the drug. As the old saying goes, "anyone who is independent must have something extraordinary"! At the same time, it also plays a role in the inhibition of systemic inflammation and other biological agents, such as the treatment of UC Vitellizumab has a unique mechanism of action, targeting integrin α 4 β 7, which is specific to intestinal lymphocytes, acts precisely on the intestinal tract to inhibit its inflammatory response It provides a "customized version" treatment option for UC patients, which is unique, and also reflects the overall excellent efficacy and safety.

2.86% of the patients' response rate was improved by 2 weeks

Gemini 1 study [4] is a randomized, double-blind, placebo-controlled phase III clinical study conducted worldwide to evaluate the efficacy of vitrizumab in the induction and maintenance treatment of moderate to severe UC. The results show that, After 2 weeks of treatment, patients with UC core symptoms (rectal bleeding and diarrhea) were substantially improved, and the efficacy was better in patients who had not received anti-tumor necrosis factor (TNF) drugs before

Figure 1. Substantial improvement of UC core symptoms after 2 weeks of treatment with vitrizumab

In phase III, the efficacy of civiride was also confirmed in a phase II study The overall clinical response rate was as high as 86.2% after 2-3 times of intravenous infusion [5]

After 5 years of maintenance treatment, the clinical remission rate was still as high as 90%

A total of 572 patients with newly diagnosed uc-old were enrolled in this study.

The results showed that, as the first-line biological agents in the treatment of UC, the clinical response, clinical remission and mucosal healing rate of long-term treatment with vitrizumab were similar to those of anti TNF drugs, but the value was higher; and the continuous treatment rate was significantly higher than that of anti TNF drugs.

Figure 2. The cumulative continuous treatment rate of vitrizumab in 24 months was significantly higher than that of anti TNF drugs

In addition, the 5-year efficacy of vitellizumab in UC patients who have completed Gemini 1 and are included in the Gemini open label extended study (Gemini LTS) was reported at the 2017 annual meeting of the European Organization for Crohn's disease and colitis (Ecco) [7-8]. The 5-year cumulative drug use data showed that up to 90% of UC patients could get clinical remission after long-term treatment and follow-up

Figure 3. Long term outcomes in UC patients with cumulative exposure to vitellizumab for 248 weeks

"Challenge" classic anti TNF drugs, head to head PK is better

Varsity study [9] is the first clinical trial to compare the efficacy and safety of different biological agents in the treatment of UC. The results show that, The rate of mucosal healing was 39.7% in patients treated with vitellizumab and 27.7% in adalimumab group at 52 weeks (P < 0.01), and the effect was better in patients who had not used anti TNF drugs before.

Figure 4. The rate of mucosal healing after 52 weeks of treatment with vitellizumab was significantly better than that of adalimumab

Long term peace and stability, providing patients with a full "sense of security"

At present, UC can not be cured and patients need to take medicine for life. Therefore, safety is one of the important factors affecting the choice of IBD patients. A survey of 640 patients with IBD showed that up to 54% of patients were more concerned about safety when choosing biological agents for treatment [10]. As a "customized" biological preparation, vitellizumab has intestinal selectivity, avoids systemic adverse reactions caused by systemic immunosuppression, and shows good tolerance and safety [11].

A comprehensive evaluation study was conducted to analyze the safety data of 2830 patients with moderate to severe UC and CD who were treated with vitellizumab for up to five years. The results show that, The safety and immunogenicity of vitellizumab was similar to that of placebo It was not associated with increased risk of severe infection or opportunistic infection, and did not increase the risk of canceration [12].

The incidence of IBD was similar to that of IBD

It is worth mentioning that, In the drug management recommendations for IBD patients with tumor, lymphoma, non melanoma and melanoma, if the biological agent used in the past is vitrizumab, they can continue to use without stopping the drug This also reflects the clinician's trust in the safety of vidrizumab [13].

Table 1. Recommended treatment for IBD patients with malignant tumor

Summary

The treatment of UC has entered the era of biological agents, and clinicians and patients are facing a variety of treatment options. In this case, comprehensive evaluation and in-depth analysis of the efficacy and safety of the treatment program, according to the characteristics of the disease, the willingness of patients to treat, doctors and patients can jointly make treatment decisions, and ultimately make a scientific and appropriate final decision for patients, not only conducive to improving the quality of daily life of patients, improve the final treatment outcome of the disease, but also optimize the diagnosis and treatment of UC, and promote the disease of UC in China Management is moving to a higher level. The new intestinal selective biological agent, vitellizumab, has good efficacy and safety, which provides a new choice for the treatment of UC.

reference:

[1] Spleen and stomach disease branch of Chinese Medicine Association. Expert consensus on diagnosis and treatment of ulcerative colitis (2017). Chinese Journal of traditional Chinese medicine (former Chinese Medical Journal). 2017; 32 (8): 3585-3589

[2] Ford AC, Moayyedi P, et al. Ulcerative colitis[J]. BMJ. 2013 Feb 5;346:f432.

[3] Fumery M, Singh S, Dulai PS, et al. Natural History of Adult Ulcerative Colitis in Population-based Cohorts: A Systematic Review[J]. Clin Gastroenterol Hepatol. 2018 Mar;16(3):343-356.e3.

[4]. Feagan BG, Lasch K, Lasch T, et al. Rapid Response to Vedolizumab Therapy in Biologic-Naive Patients With Inflammatory Bowel Diseases[J]. Clin Gastroenterol Hepatol. 2019;17(1):130-138.e7.

[5]. LoftusEV, SandbornWJ, WolfDC, et al. Tu1713—efficacy and safety of 2 or 3 vedolizumab intravenous infusions as induction therapy for ulcerative colitis and Crohn′s disease: results from visible 1 and 2[J]. Gastroenterology, 2019, 156(6Suppl 1): S1095.

[6]. Yarur A, Mantzaris G, Silverberg M, et al. Real-world effectiveness and safety of vedolizumab and anti-TNF in biologic-naïve ulcerative colitis patients: results from the EVOLVE study [ECCO abstract P573]. J Crohns Colitis. 2019;13(suppl 1).

[7]. Loftus EV Jr, Colombel JF, Feagan BG, et al. J Crohns Colitis. 2017 Apr 1;11(4):400-411.

[8]. Loftus EV Jr, Colombel JF, Feagan B, et al. Long-term effectiveness and safety of vedolizumab in patients with ulcerative colitis: 5-year cumulative exposure of GEMINI 1 completers rolling into the GEMINI open-label extension study ECCO 2017. Poster presentation P209.

[9] Sands BE, Peyrin-Biroulet L, Loftus EV Jr, et al. Vedolizumab versus Adalimumab for Moderate-to-Severe Ulcerative Colitis. N Engl J Med. 2019 Sep 26;381(13):1215-1226.

[10]. Almario CV, Keller MS, Chen M, et al. Optimizing Selection of Biologics in Inflammatory Bowel Disease: Development of an Online Patient Decision Aid Using Conjoint Analysis[J]. Am J Gastroenterol. 2018 Jan; 113(1): 58-71.

[11] Zhou Qingyang, Qian Jiaming. Research progress of novel intestinal selective biological agents in the treatment of inflammatory bowel disease [J]. Chinese Journal of Gastroenterology, 2020,40 (02): 141-144

[12]. ColombelJF, SandsBE, RutgeertsP, et al. The safety of vedolizumab for ulcerative colitis and Crohn′s disease[J].Gut. 2017; 66(5): 839-851.

[13]. Click B, Regueiro M. A Practical Guide to the Safety and Monitoring of New IBD Therapies[J]. Inflamm Bowel Dis. 2019 Apr 11;25(5):831-842.

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