Inhibitor development is a major complication of treatment with factor VIII concentrates in nonsevere haemophilia A. It has been suggested that plasma‐derived factor VIII (FVIII) concentrates elicit fewer inhibitors than recombinant FVIII concentrates, but studies in severe haemophilia A patients have shown conflicting results. We designed a case‒control study to investigate the clinical and genetic risk factors for inhibitor development in nonsevere haemophilia A patients. We investigated whether the type of FVIII concentrate was associated with inhibitor development in nonsevere haemophilia A patients. This nested case‒control study includes 75 inhibitor patients and 223 controls, from a source population of the INSIGHT study, including all nonsevere haemophilia A patients (FVIII:C 2–40%) that were treated with FVIII concentrates in 33 European and one Australian centre. Cases and controls were matched for date of birth and cumulative number of exposure days (CED) to FVIII concentrate. A conditional logistic regression model was used to calculate unadjusted and adjusted odds ratios. No increased risk for inhibitor development was found for any type of FVIII concentrate; either when comparing recombinant FVIII concentrates to plasma‐derived FVIII concentrates (adjusted odds ratio 0·96, 95% confidence interval (CI) 0·36–2·52) or for specific types of FVIII concentrates.

中文翻译：

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非严重血友病A患者的产品类型和抑制剂发展的风险：一项病例对照研究。

抑制剂的开发是在非严重血友病A中使用VIII因子浓缩物治疗的主要并发症。有人提出血浆来源的VIII因子（FVIII）浓缩物引起的抑制剂比重组FVIII浓缩物少，但是针对严重血友病A的研究显示出矛盾的结果。我们设计了一项病例对照研究，以研究非严重A型血友病患者中抑制剂形成的临床和遗传危险因素。我们调查了在非严重A型血友病患者中FVIII浓缩物的类型是否与抑制剂的发展有关。该嵌套病例对照研究包括INSIGHT研究的来源人群中的75例抑制剂患者和223例对照，包括所有非严重A型血友病患者（FVIII：用FVIII处理的C 2–40％）集中在33个欧洲和一个澳大利亚中心。病例和对照的出生日期和FVIII浓缩物的累积接触天数（CED）相匹配。使用条件逻辑回归模型来计算未调整和调整后的优势比。对于任何类型的FVIII浓缩物，未发现抑制剂发展的风险增加；在将重组FVIII浓缩物与血浆FVIII浓缩物进行比较时（调整后的优势比为0·96、95％置信区间（CI）0·36-2·52）或针对特定类型的FVIII浓缩物。对于任何类型的FVIII浓缩物，未发现抑制剂发展的风险增加；在将重组FVIII浓缩物与血浆FVIII浓缩物进行比较时（调整后的优势比为0·96、95％置信区间（CI）0·36-2·52）或针对特定类型的FVIII浓缩物。对于任何类型的FVIII浓缩物，未发现抑制剂发展的风险增加；在将重组FVIII浓缩物与血浆FVIII浓缩物进行比较时（调整后的优势比为0·96、95％置信区间（CI）0·36-2·52）或针对特定类型的FVIII浓缩物。