歐洲在腸道疾病的生物仿製藥方面傲視同儕


  【24drs.com】根據發表於歐洲克隆氏症與結腸炎組織2016年研討會(European Crohn's and Colitis Organisation 2016 Congress)的研究結果,歐洲研究顯示,發炎性腸道疾病患者從比較昂貴的抗體治療換成生物仿製藥之後,結果並無顯著改變。
  
  會議共同主持人、羅馬Complesso Integrato Columbus Catholic大學的Alessandro Armuzzi醫師表示,在短期和中期都很好,反應率高且免疫調節作用和對照抗體一致。
  
  Armuzzi醫師表示,我們還不知道的是,對於免疫原性的長期影響,要等2年到4年後的結果出爐時,再做最後判斷;我不預期有任何令人驚訝的事情,但是,我們需要有長期數據。
  
  在美國,生物仿製藥很快就可以超越臨床前研究階段。美國食品藥物管理局的諮詢小組最近支持核准infliximab (商品名Remicade, Janssen Biotech藥廠)的生物仿製藥- CTP-13,而該局一般會遵循此一小組的指導。
  
  因為歐洲目前已核准20個生物仿製藥,美國醫師試圖從已經用這些製劑治療發炎性腸道疾病患者的歐洲醫師們獲取資料,一般而言,結果看起來很有希望。
  
  匈牙利一篇有291名患者的一年期前瞻研究中,CTP-13在克隆氏症患者的臨床反應率為47%、潰瘍性結腸炎患者則是46%。
  
  布達佩斯Semmelweis大學的Krisztina Gecse博士表示,CTP-13有效維持克隆氏症與潰瘍性結腸炎患者之臨床緩解與反應。
  
  她報告指出,從未接受anti-TNF-alpha治療的患者效果更好,在第14週時,克隆氏症與潰瘍性結腸炎患者的平均C-反應蛋白質顯著降低;且在為期54週的整個研究期間維持 。
  
  Gecse博士表示,不良反應方面沒有令人意外的訊息。事實上,不良反應資料和比率與歷史世代資料相當。最常見的事件依序是呼吸道感染、有8例,胃腸炎、有6例,病毒感染、有3例。
  
  荷蘭進行的、87名患者的前瞻觀察型研究也獲得正面結果,16週時,生活品質、治療的大致情況、不良事件並無顯著改變。
  
  Nijmegen Radboud大學醫學中心研究生Lisa Smits表示,發炎性腸道疾病患者從Remicade換成CTP-13,對於短期結果並無顯著影響。她指出, 根據這些資料,轉換是可行的。
  
  疾病活性分數的平均變化值為0,克隆氏症的Harvey-Bradshaw Index (HBI)、潰瘍性結腸炎的Simple Clinical Colitis Activity Index (SCCAI)的絕對變化都是。
  
  演講後的討論時提到,5個患者停用CTP-13, Smits 報告指出,停用的5名患者中,3名在研究開始時既有的抗藥性抗體增加。另外,1人移居國外,另1人因為疾病緩解而退出研究。
  
  捷克進行的一篇研究的結果與其他研究大多相似。
  
  布拉格Charles大學的Martin Kolar醫師表示,74名發炎性腸道疾病患者從infliximab換成生物仿製藥治療24週後,疾病活性分數或檢驗數據都沒有差異。
  
  更重要的是,免疫原性沒有增加;2名患者停止治療,1人是因為急性復發,另1人是因為嗜酸性細胞發炎。
  
  換成生物仿製藥之後的主要副作用是關節疼痛,有7名患者發生,不過它是慢性情況,不是新發生的關節痛。
  
  Kolar醫師解釋,我們持續監測到48週,迄今為止,沒有證據顯示患者換藥之後發生狀況惡化或任何不良事件。
  
  資料來源: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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