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Tocilizumab in Refractory ASS-ILD

2026年6月17日 更新者：Hu Yinan

Tocilizumab for Refractory Anti-Synthetase Syndrome-Associated Interstitial Lung Disease: A Real-World Retrospective Cohort Study

Refractory anti-synthetase syndrome-associated interstitial lung disease (ASyS-ILD) lacks targeted therapy. Interleukin-6 drives both inflammation and fibrosis. We evaluated the real-world efficacy and safety of tocilizumab, an IL-6 receptor antagonist.

This single-center retrospective cohort study included patients with refractory ASyS-ILD treated between January 2020 and July 2025. Tocilizumab recipients were compared with those receiving standard of care (SOC) immunosuppressants. Overlap weighting based on propensity scores was used to balance 11 baseline variables. The primary outcome was improvement in symptoms and HRCT findings at ≥3 months. Secondary outcomes included changes in biomarkers and pulmonary function, progression-free survival (PFS), and adverse events. Cox regression identified independent predictors of symptom progression. Generalized additive models (GAM) explored nonlinear relationships, and XGBoost-SHAP machine learning assessed variable importance.

調査の概要

状態

完了

条件

介入・治療

研究の種類

観察的

入学 (実際)

111

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100000
        • China-Japan Friendship Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

We reviewed electronic medical records of all adult patients diagnosed with ASyS-ILD at our institution between January 1, 2020, and July 30, 2025.

Inclusion criteria were: (1) age ≥18 years; (2) fulfillment of the 2017 EULAR/ACR classification criteria for ASyS; (3) HRCT-confirmed ILD; (4) refractory disease, defined as active disease despite prior treatment with glucocorticoids and at least one first-line immunosuppressant (including methotrexate, mycophenolate mofetil, azathioprine, cyclosporine, cyclophosphamide, baricitinib, or upadacitinib); and (5) availability of baseline and follow-up clinical data at ≥3 months.

Exclusion criteria were: (1) pregnancy or lactation; (2) pre-existing psychiatric disorders that would preclude study participation; (3) prior lung transplantation; (4) missing key outcome data; (5) Patients with Anti-MDA5 dermatomyositis.

Patients who received tocilizumab (8 mg/kg intravenously every 4 weeks) were assigned to the tocilizumab group (N=41). Patients who

説明

Inclusion Criteria:

  • age ≥18 years;
  • fulfillment of the 2017 EULAR/ACR classification criteria for ASyS;
  • HRCT-confirmed ILD;
  • refractory disease, defined as active disease despite prior treatment with glucocorticoids and at least one first-line immunosuppressant (including methotrexate, mycophenolate mofetil, azathioprine, cyclosporine, cyclophosphamide, baricitinib, or upadacitinib);
  • availability of baseline and follow-up clinical data at ≥3 months.

Exclusion Criteria:

  • pregnancy or lactation;
  • pre-existing psychiatric disorders that would preclude study participation;
  • prior lung transplantation;
  • missing key outcome data;
  • Patients with Anti-MDA5 dermatomyositis.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
Refractory anti-synthetase syndrome-associated interstitial lung disease

Inclusion criteria were: (1) age ≥18 years; (2) fulfillment of the 2017 EULAR/ACR classification criteria for ASyS; (3) HRCT-confirmed ILD; (4) refractory disease, defined as active disease despite prior treatment with glucocorticoids and at least one first-line immunosuppressant (including methotrexate, mycophenolate mofetil, azathioprine, cyclosporine, cyclophosphamide, baricitinib, or upadacitinib); and (5) availability of baseline and follow-up clinical data at ≥3 months.

Exclusion criteria were: (1) pregnancy or lactation; (2) pre-existing psychiatric disorders that would preclude study participation; (3) prior lung transplantation; and (4) missing key outcome data.
薬：Tociliuzumab
Tocilizumab, a humanized monoclonal antibody against the IL-6 receptor, is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, and giant cell arteritis. In patients with rheumatoid arthritis-associated ILD, tocilizumab has been shown to reduce KL-6 levels, a biomarker of alveolar epithelial injury. However, evidence for tocilizumab in ASyS-ILD is limited to isolated case reports, and no systematic evaluation of its efficacy and safety in this specific population has been published.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Disease progression
時間枠：From the start of tocilizumab treatment or second-line treatment to disease progression, the longest possible duration is until October 31, 2025.
Disease progression is classified data, which included the number of patients with symptoms progression（Symptom progression was defined as worsening of dyspnea, cough or rash requiring escalation of therapy or hospitalization） or with the worsening of pattern demonstrated on CT scans (defined as an increase in the extent of reticulation, traction bronchiectasis, or honeycombing on follow-up HRCT ) or the number of the patients with FVC% decline >10% or with DLCO% decline >15%.
From the start of tocilizumab treatment or second-line treatment to disease progression, the longest possible duration is until October 31, 2025.

二次結果の測定

結果測定
メジャーの説明
時間枠
serum test of CK
時間枠：From the start of tocilizumab treatment or the start of second-line treatment, within 3 months (within 2 weeks before or after), up to October 31, 2025.
The level of CK (U/L) in patients' serum
From the start of tocilizumab treatment or the start of second-line treatment, within 3 months (within 2 weeks before or after), up to October 31, 2025.
Serum test of ferritin
時間枠：From the start of tocilizumab treatment or the start of second-line treatment, within 3 months (within 2 weeks before or after), up to October 31, 2025.
The value of the ferritin (ng/ml) with serum test.
From the start of tocilizumab treatment or the start of second-line treatment, within 3 months (within 2 weeks before or after), up to October 31, 2025.
Serum test of IL6
時間枠：From the start of tocilizumab treatment or the start of second-line treatment, within 3 months (within 2 weeks before or after), up to October 31, 2025.
The value of the IL6 (pg/ml) with serum test.
From the start of tocilizumab treatment or the start of second-line treatment, within 3 months (within 2 weeks before or after), up to October 31, 2025.
Serum test of LDH
時間枠：From the start of tocilizumab treatment or the start of second-line treatment, within 3 months (within 2 weeks before or after), up to October 31, 2025.
The value of the LDH (U/L) with serum test.
From the start of tocilizumab treatment or the start of second-line treatment, within 3 months (within 2 weeks before or after), up to October 31, 2025.
Serum test of CRP
時間枠：From the start of tocilizumab treatment or the start of second-line treatment, within 3 months (within 2 weeks before or after), up to October 31, 2025.
The value of the CRP (mg/L) with serum test.
From the start of tocilizumab treatment or the start of second-line treatment, within 3 months (within 2 weeks before or after), up to October 31, 2025.
PFS
時間枠：The time from the start of tocilizumab treatment or the first disease progression after second-line treatment, up to October 31, 2025.
progression-free survival (PFS), defined as the time (months) from second-line treatment initiation to symptom progression, CT progression, lung function decline, or death from any cause, whichever occurred first;
The time from the start of tocilizumab treatment or the first disease progression after second-line treatment, up to October 31, 2025.
DLCO% predicted
時間枠：Before the treatment with tocilizumab or the second-line treatment, and from the start of tocilizumab treatment or the start of second-line treatment, within 3 months (within 2 weeks before or after), up to October 31, 2025.
The DLCO% predicted of thre patients
Before the treatment with tocilizumab or the second-line treatment, and from the start of tocilizumab treatment or the start of second-line treatment, within 3 months (within 2 weeks before or after), up to October 31, 2025.
FVC % predicted
時間枠：Before the treatment with tocilizumab or the second-line treatment, and from the start of tocilizumab treatment or the start of second-line treatment, within 3 months (within 2 weeks before or after), up to October 31, 2025.
FVC % predicted of the patient
Before the treatment with tocilizumab or the second-line treatment, and from the start of tocilizumab treatment or the start of second-line treatment, within 3 months (within 2 weeks before or after), up to October 31, 2025.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Hu Yinan

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2022年1月1日

一次修了 (実際)

2025年10月31日

研究の完了 (実際)

2025年10月31日

試験登録日

最初に提出

2026年6月3日

QC基準を満たした最初の提出物

2026年6月17日

最初の投稿 (実際)

2026年6月23日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月23日

QC基準を満たした最後の更新が送信されました

2026年6月17日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 2026-KY-238

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

The study methods will be made publicly available after article publication.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

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