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Effect of nintedanib on lung function in patients with systemic sclerosis-associated interstitial lung disease: further analyses of the SENSCIS trial.
Maher, Toby M; Mayes, Maureen D; Kreuter, Michael; Volkmann, Elizabeth R; Aringer, Martin; Castellvi, Ivan; Cutolo, Maurizio; Stock, Christian; Schoof, Nils; Alves, Margarida; Raghu, Ganesh.
Afiliação
  • Maher TM; National Heart and Lung Institute, Imperial College London and National Institute for Health Research Clinical Research Facility, Royal Brompton Hospital, London, UK.
  • Mayes MD; Keck School of Medicine, University of Southern California, Los Angeles, California, USA.
  • Kreuter M; Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston, Texas, USA.
  • Volkmann ER; Center for Interstitial and Rare Lung Diseases, Pneumology and Respiratory Care Medicine, University of Heidelberg and German Center for Lung Research, Germany.
  • Aringer M; Department of Medicine, Division of Rheumatology, University of California, David Geffen School of Medicine, Los Angeles, California, USA.
  • Castellvi I; Division of Rheumatology, Department of Medicine III, University Medical Center & Faculty of Medicine Carl Gustav Carus, TU, Dresden, Dresden, Germany.
  • Cutolo M; Department of Rheumatology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
  • Stock C; Research Laboratory and Academic Unit of Clinical Rheumatology, Department of Internal Medicine, University of Genova, IRCCS San Martino Polyclinic Hospital, Genova, Italy.
  • Schoof N; Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.
  • Alves M; Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
  • Raghu G; Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
Arthritis Rheumatol ; 2020 Nov 03.
Artigo em Inglês | MEDLINE | ID: mdl-33142016
ABSTRACT

OBJECTIVE:

In the SENSCIS trial in subjects with systemic sclerosis-associated ILD (SSc-ILD), nintedanib reduced the rate of decline in forced vital capacity (FVC) over 52 weeks by 44% versus placebo. We investigated the effects of nintedanib on categorical changes in FVC and other measures of ILD progression.

METHODS:

In post-hoc analyses, we assessed the proportions of subjects with categorical changes in FVC % predicted at week 52 and the time to absolute decline in FVC ≥5% predicted or death and absolute decline in FVC ≥10% predicted or death.

RESULTS:

A total of 288 subjects received nintedanib and 288 received placebo. At week 52, in subjects treated with nintedanib and placebo, respectively, 55.7% and 66.3% had any decline in FVC % predicted, 13.6% and 20.1% had an FVC decline >5%-≤10% predicted, and 3.5% and 5.2% had an FVC decline >10%-≤15% predicted; 34.5% and 43.8% had a decrease in FVC ≥3.3% predicted (proposed minimal clinically important difference [MCID] for worsening of FVC), while 23.0% and 14.9% had an increase in FVC ≥3.0% predicted (proposed MCID for improvement in FVC). Over 52 weeks, the hazard ratio for an absolute decline in FVC ≥5% predicted or death with nintedanib versus placebo was 0.83 (95% CI 0.66, 1.06) (P=0.14) and the hazard ratio for an absolute decline in FVC ≥10% predicted was 0.64 (95% CI 0.43, 0.95); P=0.029.

CONCLUSION:

These results suggest that nintedanib has a clinically relevant benefit on the progression of SSc-ILD.
Texto completo: Disponível Coleções: Bases de dados internacionais Base de dados: MEDLINE Tipo de estudo: Ensaio clínico controlado / Fatores de risco Idioma: Inglês Ano de publicação: 2020 Tipo de documento: Artigo País de afiliação: Reino Unido

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Texto completo: Disponível Coleções: Bases de dados internacionais Base de dados: MEDLINE Tipo de estudo: Ensaio clínico controlado / Fatores de risco Idioma: Inglês Ano de publicação: 2020 Tipo de documento: Artigo País de afiliação: Reino Unido