[尼妥珠单抗治疗脊柱关节炎的真实世界经验]。

IF 0.3 4区医学 Q3 MEDICINE, GENERAL & INTERNAL Terapevticheskii Arkhiv Pub Date : 2023-12-28 DOI:10.26442/00403660.2023.12.202547

A D Meshkov, N M Vorobyeva, V S Ostapenko, V S Pykhtina, V I Ruzanova, O A Perlova, I S Kordyukova, A V Naumov, N O Khovasova, O N Tkacheva

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引用次数: 0

摘要

目的：研究奈达单抗治疗强直性脊柱炎（AS）和银屑病关节炎（PsA）的实际疗效和安全性：回顾性分析包括23名年龄在23至73岁（中位数42岁，四分位数间距28至52岁）的强直性脊柱炎（n=12）或银屑病关节炎（n=11）患者（13名男性；56.5%），他们在2021年2月至2023年4月期间接受了奈达单抗治疗。根据BASDAI和ASDAS-CRP指数评估所有AS患者的C反应蛋白（CRP）水平，根据DAPSA和PASI评估PsA患者的C反应蛋白（CRP）水平，每3-6个月评估一次疾病活动性。在治疗前和最后一次就诊时对这些指标进行分析，以评估治疗效果。结果以中位数（四分位数间距）表示：在所有接受奈达单抗治疗的患者中（中位治疗时间为11个月），CRP水平从10.6（3.1；17.3）毫克/升降至3.1（1.9；8.9）毫克/升（绝对差值为-7.5毫克/升，中位相对差值为-60%；P=0.008），CRP升高的患者比例从70%降至41%；P=0.039。在强直性脊柱炎患者中（中位治疗时间为9个月），BASDAI评分从5.8（4.7；6.5）分降至3.0（1.9；3.8）分（绝对差异-2.8分，中位相对减少-45%；p=0.008），ASDAS-CRP评分从2.8（1.9；3.9）分降至1.9（1.7；2.6）分（绝对差异-0.9分，中位相对减少-21%；p=0.007）。强直性脊柱炎活动度高（BASDAI≥4）的患者比例从90%降至20%（P=0.031）；但CRP水平没有显著变化（绝对差异-4.9毫克/升，中位相对减少-57%；P=0.110）。PsA患者（中位治疗时间为18个月）的CRP水平从12.0（4.5；17.3）毫克/升降至3.3（2.0；7.8）毫克/升（绝对差异-8.7毫克/升，中位相对减少-80%；P=0.041），DAPSA评分从23.0（19.0；30.5）分降至6.3（5.2；13.5）分（绝对差异-16.7分，中位相对减少-69%；P=0.018）。3名（13%）患者报告了轻度至中度不良反应：获得的数据证实了奈达吉单抗在实际应用中治疗AS和PsA的有效性和安全性。

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[Real-world experience with netakimab in the treatment of spondyloarthritis].

Aim: To study the real-world efficacy and safety of netakimab in the treatment of ankylosing spondylitis (AS) and psoriatic arthritis (PsA).

Materials and methods: The retrospective analysis included 23 patients (13 males; 56.5%) aged 23 to 73 years (median 42, interquartile range 28 to 52 years) with AS (n=12) or PsA (n=11) who received netakimab therapy from February 2021 to April 2023. Disease activity was assessed every 3-6 months based on the C-reactive protein (CRP) level for all patients according to the BASDAI and ASDAS-CRP indices for AS, DAPSA and PASI for PsA. These indicators were analyzed before therapy and at the last visit to assess the effectiveness of treatment. The results are presented as median (interquartile range).

Results: In all patients treated with netakimab (median duration of treatment 11 months), the CRP level decreased from 10.6 (3.1; 17.3) to 3.1 (1.9; 8.9) mg/L (absolute difference -7.5 mg/L, median relative reduction -60%; p=0.008), and the proportion of patients with elevated CRP decreased from 70 to 41%; p=0.039. In patients with AS (median duration of treatment 9 months), BASDAI score decreased from 5.8 (4.7; 6.5) to 3.0 (1.9; 3.8) points (absolute difference -2.8 points, median relative reduction of -45%; p=0.008) and ASDAS-CRP score decreased from 2.8 (1.9; 3.9) to 1.9 (1.7; 2.6) points (absolute difference -0.9 points, median relative reduction -21%; p=0.007). The proportion of patients with high AS activity (BASDAI≥4) decreased from 90% to 20% (p=0.031); however, there was no significant change in the CRP level (absolute difference -4.9 mg/L, median relative reduction -57%; p=0.110). In patients with PsA (median duration of treatment 18 months), the CRP level decreased from 12.0 (4.5; 17.3) to 3.3 (2.0; 7.8) mg/L (absolute difference -8.7 mg/L, median relative reduction -80%; p=0.041), the DAPSA score decreased from 23.0 (19.0; 30.5) to 6.3 (5.2; 13.5) points (absolute difference -16.7 points, median relative reduction -69%; p=0.018). Three (13%) patients reported mild to moderate adverse events.

Conclusion: The obtained data confirm the effectiveness and safety of netakimab in treating AS and PsA in real-world practice.

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来源期刊

Terapevticheskii Arkhiv 医学-医学：内科

CiteScore

1.40

自引率

33.30%

发文量

171

审稿时长

3-8 weeks

期刊介绍： Терапевтический архив The journal was founded by the prominent Russian therapists M.P. Konchalovsky and G.F. Lang in 1923. Then its editors-in-chief were Professors V.N. Vinogradov and A.G. Gukasyan. Since 1972, E.I. Chazov, Academician of the Russian Academy of Sciences, has been heading the editorial board of the journal. Over 90 years, there have been more than 1000 issues where the authors and editorial staff have done their best for readers to keep abreast of current advances in medical science and practice and for physicians to master the advanced principles of recognition and treatment of a wide spectrum of visceral diseases. The papers published in the journal (editorials, original articles, lectures, reviews, etc.) cover both current scientific achievements and practical experience in diagnosing, treating, and preventing visceral diseases. The authors of publications are not only Russian, but also foreign scientists and physicians. All papers are peer-reviewed by highly qualified Russian specialists. The journal is published monthly. Traditionally, each issue has predominantly certain thematic areas covering individual therapy specializations. Every year, one of the issues is devoted to related problems in practical medicine (allergology and immunology, neurology and psychiatry, obstetrics, oncology, etc.). This all draws the attention of the reading public to the journal. The journal is indexed in RSCI (Russian Science Citation Index), PubMed/Medline, Index Medicus, Scopus/EMBASE, Web of Science Core Collection (Science Citation Index Expanded), Web of Science (Russian Science Citation Index - RSCI, Current Contents Connect, BIOSIS Previews), Google Scholar, Ulrich''s Periodicals Directory. The journal is included in the list of periodicals recommended by the Higher Attestation Committee for publishing the papers containing the basic materials of doctoral and candidate dissertations. By the decision of the Presidium of the Russian Academy of Medical Sciences, the “Therapevticheskiy Arkhiv” was awarded the Botkin medal. It was admitted to the European Association of Sciences Editors (EASE). The journal was honored with the Golden Press Fund decoration at the 13th International Press Professional Exhibition.