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Nintedanib Therapy Alone and Combined with Mycophenolate in Patients with Systemic Sclerosis-associated Interstitial Lung Disease: Systematic Reviews and Meta-analysis.
Herman, Derrick; Ghazipura, Marya; Barnes, Hayley; Macrea, Madalina; Knight, Shandra L; Silver, Richard M; Montesi, Sydney B; Raghu, Ganesh; Hossain, Tanzib.
Afiliación
  • Herman D; Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, The Ohio State Wexner Medical Center, Columbus, Ohio.
  • Ghazipura M; ZS Associates, Global Health Economics and Outcomes Research, New York, New York.
  • Barnes H; Division of Epidemiology and.
  • Macrea M; Division of Biostatistics, Department of Population Health and.
  • Knight SL; Central Clinical School and.
  • Silver RM; Centre for Occupational and Environmental Health, Monash University, Melbourne, Australia.
  • Montesi SB; Department of Respiratory Medicine, Alfred Hospital, Melbourne, Australia.
  • Raghu G; Division of Pulmonary and Sleep Medicine, Salem Veterans Affairs Medical Center, Salem, Virginia.
  • Hossain T; Department of Medicine, University of Virginia, Charlottesville, Virginia.
Ann Am Thorac Soc ; 21(3): 474-485, 2024 Mar.
Article en En | MEDLINE | ID: mdl-37773000
ABSTRACT

Background:

The American Thoracic Society convened an international multidisciplinary panel to develop clinical practice guidelines for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD).

Objective:

To conduct a systematic review and evaluate the literature to determine whether patients with SSc-ILD should be treated with nintedanib alone or with the combination of nintedanib plus mycophenolate. Data Sources Literature searches were conducted across MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials databases through June 2022 for studies using nintedanib or nintedanib plus mycophenolate to treat patients with SSc-ILD. Data Extraction Mortality, disease progression, quality of life, and adverse event data were extracted, and meta-analysis was performed when possible. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Working Group method was used to assess the quality of evidence.

Synthesis:

For nintedanib therapy alone, the systematic review included three total studies and revealed that disease progression was less in the nintedanib arm (the annual rate of decline in forced vital capacity [FVC] was 44.5 ml less, the absolute change from baseline was 46.4 ml less, and FVC% predicted was 1.2% less in the nintedanib arm) compared with placebo. However, gastrointestinal side effects and treatment discontinuation were double in the nintedanib arm compared with placebo. For combination therapy, the systematic review also included three total studies and revealed that changes in the annual rate of decline in FVC favored combination therapy over placebo (mean difference, 79.1 ml). Combination therapy was, however, associated with increased gastrointestinal adverse effects compared with placebo. The quality of evidence for all outcomes was very low as per GRADE.

Conclusions:

The use of nintedanib alone and in combination with mycophenolate in patients with SSc-ILD is associated with a significant reduction in disease progression compared with placebo but at the cost of increased gastrointestinal side effects and treatment discontinuation. The quality of evidence is very low.
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Esclerodermia Sistémica / Enfermedades Pulmonares Intersticiales / Indoles Tipo de estudio: Clinical_trials / Guideline / Prognostic_studies / Risk_factors_studies / Systematic_reviews Límite: Humans Idioma: En Revista: Ann Am Thorac Soc Año: 2024 Tipo del documento: Article

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Esclerodermia Sistémica / Enfermedades Pulmonares Intersticiales / Indoles Tipo de estudio: Clinical_trials / Guideline / Prognostic_studies / Risk_factors_studies / Systematic_reviews Límite: Humans Idioma: En Revista: Ann Am Thorac Soc Año: 2024 Tipo del documento: Article