Display options
Cite
Kuwana M, Allanore Y, Denton CP, et al. Nintedanib in patients with systemic sclerosis-associated interstitial lung disease: subgroup analyses by autoantibody status and skin score. Arthritis Rheumatol. 2021;doi: 10.1002/art.41965.
Kuwana, M., Allanore, Y., Denton, C. P., Distler, J. H., Steen, V., Khanna, D., Matucci-Cerinic, M., Mayes, M. D., Volkmann, E. R., Miede, C., Gahlemann, M., Quaresma Lic, M., Alves, M., & Distler, O. (2021). Nintedanib in patients with systemic sclerosis-associated interstitial lung disease: subgroup analyses by autoantibody status and skin score. Arthritis & rheumatology (Hoboken, N.J.), . https://doi.org/10.1002/art.41965
Kuwana, Masataka, et al. "Nintedanib in patients with systemic sclerosis-associated interstitial lung disease: subgroup analyses by autoantibody status and skin score." Arthritis & rheumatology (Hoboken, N.J.) vol. (2021). doi: https://doi.org/10.1002/art.41965
Kuwana M, Allanore Y, Denton CP, Distler JH, Steen V, Khanna D, Matucci-Cerinic M, Mayes MD, Volkmann ER, Miede C, Gahlemann M, Quaresma Lic M, Alves M, Distler O. Nintedanib in patients with systemic sclerosis-associated interstitial lung disease: subgroup analyses by autoantibody status and skin score. Arthritis Rheumatol. 2021 Sep 12; doi: 10.1002/art.41965. Epub 2021 Sep 12. PMID: 34514739.
Copy Download .nbib Format: NLM
Share it on

Arthritis Rheumatol. 2021 Sep 12; doi: 10.1002/art.41965. Epub 2021 Sep 12.

Nintedanib in patients with systemic sclerosis-associated interstitial lung disease: subgroup analyses by autoantibody status and skin score.

Arthritis & rheumatology (Hoboken, N.J.)

Masataka Kuwana, Yannick Allanore, Christopher P Denton, Jörg Hw Distler, Virginia Steen, Dinesh Khanna, Marco Matucci-Cerinic, Maureen D Mayes, Elizabeth R Volkmann, Corinna Miede, Martina Gahlemann, Manuel Quaresma Lic, Margarida Alves, Oliver Distler

Affiliations

  1. Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan.
  2. Department of Rheumatology A, Descartes University, APHP, Cochin Hospital, Paris, France.
  3. University College London Division of Medicine, Centre for Rheumatology and Connective Tissue Diseases, London, UK.
  4. University of Erlangen-Nuremberg, Erlangen, Germany.
  5. Division of Rheumatology, Georgetown University, Washington, D.C, USA.
  6. Department of Medicine, University of Michigan, Ann Arbor, MI, USA.
  7. University of Florence, Department of Medicine, Florence, Italy.
  8. Division of Rheumatology and Clinical Immunogenetics, University of Texas McGovern Medical School, Houston, TX, USA.
  9. Department of Medicine, Division of Rheumatology, University of California, David Geffen School of Medicine, Los Angeles, CA, USA.
  10. mainanalytics GmbH, Sulzbach (Taunus), Germany.
  11. Boehringer Ingelheim (Schweiz) GmbH, Basel, Switzerland.
  12. Boehringer Ingelheim International GmbH, Ingelheim, Germany.
  13. Department of Rheumatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.

PMID: 34514739 DOI: 10.1002/art.41965

Abstract

OBJECTIVE: We used data from the SENSCIS trial to assess the effects of nintedanib versus placebo in subgroups of patients with SSc-ILD based on characteristics associated with progression of SSc-ILD in previous studies.

METHODS: Patients with SSc-ILD were randomized to receive nintedanib or placebo, stratified by anti-topoisomerase I antibody (ATA) status. We assessed the rate of decline in forced vital capacity (FVC) (mL/year) over 52 weeks in subgroups by baseline ATA status, modified Rodnan skin score (mRSS) (<18 versus ≥18), and SSc subtype (limited cutaneous SSc [lcSSc] versus diffuse cutaneous SSc [dcSSc]).

RESULTS: At baseline, of 576 patients treated, 60.8% were ATA-positive, 51.9% had dcSSc, and 77.5% of 574 patients with mRSS data available had mRSS <18. The effect of nintedanib versus placebo on reducing the rate of decline in FVC (mL/year) was numerically more pronounced in patients who were ATA-negative (difference: 57.2 [95% CI -3.5, 118.0]) than ATA-positive (difference: 29.9 [-19.1, 78.8]), in patients who had mRSS ≥18 (difference: 88.7 [7.7, 169.8]) than mRSS <18 at baseline (difference: 26.4 [-16.8, 69.6]), and in patients with dcSSc (difference: 56.6 [3.2, 110.0]) than lcSSc (difference: 25.3 [-28.9, 79.6]), but exploratory interaction P values did not indicate heterogeneity in the effect of nintedanib versus placebo between these subgroups (P > 0.05 for all).

CONCLUSION: In patients with SSc-ILD, no heterogeneity was detected in the treatment effect of nintedanib in reducing the annual rate of decline in FVC across subgroups based on ATA status, mRSS, and SSc subtype.

© 2021 The Authors. Arthritis & Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.

Publication Types