欧洲在肠道疾病的生物仿制药方面傲视同侪


  【24drs.com】根据发表于欧洲克隆氏症与结肠炎组织2016年研讨会(European Crohn's and Colitis Organisation 2016 Congress)的研究结果,欧洲研究显示,发炎性肠道疾病患者从比较昂贵的抗体治疗换成生物仿制药之后,结果并无显著改变。
  
  会议共同主持人、罗马Complesso Integrato Columbus Catholic大学的Alessandro Armuzzi医师表示,在短期和中期都很好,反应率高且免疫调节作用和对照抗体一致。
  
  Armuzzi医师表示,我们还不知道的是,对于免疫原性的长期影响,要等2年到4年后的结果出炉时,再做最后判断;我不预期有任何令人惊讶的事情,但是,我们需要有长期数据。
  
  在美国,生物仿制药很快就可以超越临床前研究阶段。美国食品药物管理局的咨询小组最近支持核准infliximab (商品名Remicade, Janssen Biotech药厂)的生物仿制药- CTP-13,而该局一般会遵循此一小组的指导。
  
  因为欧洲目前已核准20个生物仿制药,美国医师试图从已经用这些制剂治疗发炎性肠道疾病患者的欧洲医师们获取资料,一般而言,结果看起来很有希望。
  
  匈牙利一篇有291名患者的一年期前瞻研究中,CTP-13在克隆氏症患者的临床反应率为47%、溃疡性结肠炎患者则是46%。
  
  布达佩斯Semmelweis大学的Krisztina Gecse博士表示,CTP-13有效维持克隆氏症与溃疡性结肠炎患者之临床缓解与反应。
  
  她报告指出,从未接受anti-TNF-alpha治疗的患者效果更好,在第14周时,克隆氏症与溃疡性结肠炎患者的平均C-反应蛋白质显著降低;且在为期54周的整个研究期间维持 。
  
  Gecse博士表示,不良反应方面没有令人意外的讯息。事实上,不良反应资料和比率与历史世代资料相当。最常见的事件依序是呼吸道感染、有8例,胃肠炎、有6例,病毒感染、有3例。
  
  荷兰进行的、87名患者的前瞻观察型研究也获得正面结果,16周时,生活质量、治疗的大致情况、不良事件并无显著改变。
  
  Nijmegen Radboud大学医学中心研究生Lisa Smits表示,发炎性肠道疾病患者从Remicade换成CTP-13,对于短期结果并无显著影响。她指出, 根据这些资料,转换是可行的。
  
  疾病活性分数的平均变化值为0,克隆氏症的Harvey-Bradshaw Index (HBI)、溃疡性结肠炎的Simple Clinical Colitis Activity Index (SCCAI)的绝对变化都是。
  
  演讲后的讨论时提到,5个患者停用CTP-13, Smits 报告指出,停用的5名患者中,3名在研究开始时既有的抗药性抗体增加。另外,1人移居国外,另1人因为疾病缓解而退出研究。
  
  捷克进行的一篇研究的结果与其它研究大多相似。
  
  布拉格Charles大学的Martin Kolar医师表示,74名发炎性肠道疾病患者从infliximab换成生物仿制药治疗24周后,疾病活性分数或检验数据都没有差异。
  
  更重要的是,免疫原性没有增加;2名患者停止治疗,1人是因为急性复发,另1人是因为嗜酸性细胞发炎。
  
  换成生物仿制药之后的主要副作用是关节疼痛,有7名患者发生,不过它是慢性情况,不是新发生的关节痛。
  
  Kolar医师解释,我们持续监测到48周,迄今为止,没有证据显示患者换药之后发生状况恶化或任何不良事件。
  
  资料来源:http://www.24drs.com/
  
  Native link:Europe Leading the Way on Biosimilars for Bowel Diseases

Europe Leading the Way on Biosimilars for Bowel Diseases

By Damian McNamara
Medscape Medical News

AMSTERDAM — European studies are showing that there are no significant changes in outcome after patients with inflammatory bowel disease switch to a biosimilar from more expensive antibody therapies, according to results presented during a packed session here at the European Crohn's and Colitis Organisation 2016 Congress.

"In the short- to medium-term, all is fine. The response is high and the immunomodulation is in line" with reference antibodies, said session comoderator Alessandro Armuzzi, MD, from Complesso Integrato Columbus Catholic University in Rome.

"What we do not know is the long-term effect on immunogenicity," Dr Armuzzi told Medscape Medical News. He said he is reserving final judgment until 2-, 3-, and 4- year data come in.

"I'm not expecting anything surprising, but we need to have long-term data," he said.

In the United States, biosimilar agents could soon be moving beyond the preclinical stage. The approval of an infliximab (Remicade, Janssen Biotech) biosimilar, called CTP-13, was recently supported by a US Food and Drug Administration advisory panel, and the agency generally follows the panel's guidance.

Because 20 biosimilars are currently approved in Europe, American physicians are looking for data from their European colleagues who are already using these agents to treat patients with inflammatory bowel disease. In general, the picture looks promising.

'No Surprising Signals'

In a prospective 1-year study of 291 patients in Hungary, the clinical response rate with CTP-13 was 47% in patients with Crohn's disease and was 46% in those with ulcerative colitis.

"CTP-13 effectively maintains clinical remission and response in both Crohn's disease and ulcerative colitis," said Krisztina Gecse, MD, PhD, from Semmelweis University in Budapest.

Efficacy tended to be better in patients naive to anti-TNF-alpha treatment, she reported. There were significant reductions in mean C-reactive protein levels by week 14 in patients with Crohn's disease and in those with ulcerative colitis; this was maintained throughout the 54-week study.

"There were no surprising signals in adverse events," Dr Gecse said. In fact, the "adverse-event profile and rates were comparable to the originator based on historical cohorts." The most common events were respiratory tract infection, reported by eight patients, gastroenteritis, reported by six, and viral infection, reported by three.

The Netherlands Experience

Findings were also positive in a prospective observational study of 78 patients conducted in the Netherlands. There were no significant changes in quality of life, trough levels of the therapy, or adverse events at 16 weeks.

"The switch from Remicade to CTP-13 in a real-life cohort of inflammatory bowel disease patients did not have a significant impact on short-term outcomes," said Lisa Smits, a student researcher at Radboud University Medical Center in Nijmegen. On the basis of these data, switching is feasible, she added.

The median change in disease activity score was zero, as were absolute changes in the Harvey-Bradshaw Index (HBI) for Crohn's disease and the Simple Clinical Colitis Activity Index (SCCAI) for ulcerative colitis.

Five patients discontinued CTP-13, which generated some discussion after the presentation. "Of the five who stopped, three had progression of antidrug antibodies that were already present at baseline," Smits reported. In addition, one participant moved abroad and another withdrew from the study because of disease remission.

'Effective and Safe'

Results from a study conducted in the Czech Republic largely mirrored those from the other studies.

There was no difference in disease activity scores or laboratory measures 24 weeks after 74 patients with inflammatory bowel disease switched from infliximab to biosimilar therapy, said Martin Kolar, MD, from Charles University in Prague.

More important, no increase in immunogenicity was observed. Two patients discontinued therapy — one because of acute relapse and the other because of eosinophilic inflammation.

The leading adverse event after a switch to the biosimilar was joint pain, seen in seven patients, but it was a chronic condition and not new-onset joint pain.

"We continue to monitor up to week48, and so far, there has been no evidence that switching patients leads to worse outcomes or any adverse events," Dr Kolar explained.

Dr Gecse, Ms Smits, Dr Kolar, and Dr Armuzzi have disclosed no relevant financial relationships.

European Crohn's and Colitis Organisation (ECCO) 2016 Congress: AbstractsOP028, OP030, and OP032. Presented March17, 2016.

    
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