Bavbek Sevim, Kendirlinan Reşat, Çerçi Pamir, Altıner Seda, Soyyiğit Şadan, Çelebi Sözener Zeynep, Aydın Ömür, Gümüşburun Reyhan
Division of Immunology and Allergy, Department of Chest Diseases, School of Medicine, Ankara University, Ankara, Turkey.
Int Arch Allergy Immunol. 2016;171(3-4):227-233. doi: 10.1159/000454808. Epub 2017 Jan 4.
Rapid drug desensitization (RDD) induces a temporary tolerance to biologics which induce hypersensitivity reactions (HSRs). Data are limited regarding the use of RDD outside the USA. Our purpose was to report our data on RDD to rituximab, infliximab, cetuximab, and trastuzumab.
The study was conducted as a retrospective chart review of patients with symptoms of HSRs to biologics. HSRs were classified as grades I, II, and III, based on their severity. Skin-prick tests/intradermal tests (IDTs) were performed with the implicated biologics. The 12-step RDD protocol was used.
The study group comprised 11 women and 6 men (mean age: 47 ± 11.7 years). Fourteen patients experienced HSRs to rituximab; 3 had HSRs to cetuximab, infliximab, and trastuzumab, respectively. HSRs to cetuximab, infliximab, and trastuzumab occurred during the first infusion and were all grade III. Twelve of the 14 patients with rituximab hypersensitivity had a reaction during the first infusion; 10 patients had grade II reactions and 4 had grade III reactions. Respiratory symptoms were the most frequent presentation of HSR. Skin tests with rituximab were performed on 10 patients; only 3 resulted in positive IDTs (with 1:100 dilutions) and the other tests were negative as were those performed with the other biologics. Of 96 RDDs, 89 desensitizations were performed with rituximab, 5 with cetuximab, 1 with infliximab, and 1 with trastuzumab. There were 12 (13.5%) breakthrough reactions, all of which were associated with rituximab and were less severe than the initial reactions.
RDD was found to be safe and effective in the largest case series of RDDs with biologics in our country, Turkey.
快速药物脱敏(RDD)可诱导对引起超敏反应(HSR)的生物制剂产生暂时耐受性。在美国以外地区使用RDD的数据有限。我们的目的是报告我们关于对利妥昔单抗、英夫利昔单抗、西妥昔单抗和曲妥珠单抗进行RDD的数据。
该研究通过对有生物制剂超敏反应症状患者的回顾性病历审查进行。根据严重程度,HSR分为I级、II级和III级。使用相关生物制剂进行皮肤点刺试验/皮内试验(IDT)。采用12步RDD方案。
研究组包括11名女性和6名男性(平均年龄:47±11.7岁)。14名患者发生利妥昔单抗超敏反应;3名患者分别发生西妥昔单抗、英夫利昔单抗和曲妥珠单抗超敏反应。西妥昔单抗、英夫利昔单抗和曲妥珠单抗超敏反应均发生在首次输注期间,且均为III级。14名利妥昔单抗超敏患者中有12名在首次输注期间出现反应;10名患者为II级反应,4名患者为III级反应。呼吸道症状是HSR最常见的表现形式。对10名患者进行了利妥昔单抗皮肤试验;只有3例IDT结果为阳性(1:100稀释度),其他试验以及使用其他生物制剂进行的试验均为阴性。在96次RDD中,89次使用利妥昔单抗进行脱敏,5次使用西妥昔单抗,1次使用英夫利昔单抗,1次使用曲妥珠单抗。有12次(13.5%)突破性反应,均与利妥昔单抗有关,且严重程度低于初始反应。
在我国土耳其最大的生物制剂RDD病例系列中,RDD被发现是安全有效的。