Pneumologie 2020; 74(S 01): 55-56
DOI: 10.1055/s-0039-3403183
Posterbegehung (PO10) – Sektion Klinische Pneumologie
Therapiefortschritte bei Kollagenose-assoziierten ILDs & pulmonaler Hypertonie
Georg Thieme Verlag KG Stuttgart · New York

Dose adjustments in the SENSCIS Trial of nintedanib in patients with systemic sclerosis-associated ILD (SSc-ILD)*

M Kreuter
1   Center for Interstitial and Rare Lung Diseases, Pneumology and Respiratory Care Medicine, Thoraxklinik, University of Heidelberg, Member of the German Center for Lung Research Germany
,
KB Highland
2   Respiratory Institute, Cleveland Clinic, Cleveland, Ohio, USA
,
M Kuwana
3   Dept of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan
,
A Azuma
4   Dept of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan
,
T Maher
5   National Heart and Lung Institute, Imperial College London, UK and National Institute for Health Research Clinical Research Facility, Royal Brompton Hospital, London, UK
,
MD Mayes
6   Division of Rheumatology and Clinical Immunogenetics, University of Texas Mcgovern Medical School, Houston, Texas, USA
,
G Raghu
7   University of Washington, Seattle, USA
,
M Girard
8   Boehringer Ingelheim France S. A. S., Reims, France
,
V Kohlbrenner
9   Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Ct, USA
,
E Clerisme-Beaty
10   Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany
,
M Alves
10   Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany
,
O Distler
11   Department of Rheumatology, University Hospital Zurich, Switzerland
› Institutsangaben
Weitere Informationen

Publikationsverlauf

Publikationsdatum:
28. Februar 2020 (online)

Auch verfügbar auf
 
 

    Background: In the SENSCIS trial, nintedanib reduced the progression of SSc-ILD vs. placebo, with an adverse event (AE) profile comparable to IPF.

    Aim: To evaluate dose adjustments used in the SENSCIS trial to manage AEs.

    Methods: Patients with SSc-ILD were randomised to receive nintedanib 150 mg bid or placebo. Dose reductions to 100 mg bid and treatment interruptions were allowed.

    Results: 576 patients were treated (288 per group). Over 52 weeks, the proportion of patients with dose intensity (amount of drug administered divided by amount that would have been received had 150 mg bid been administered over 52 weeks) > 90% was 63.5% with nintedanib and 96.2% with placebo. The proportions of patients with ≥ 1 dose reduction were 40.6% and 4.5%, and the proportions with ≥ 1 dose reduction and/or treatment interruption were 48.3% and 12.2%, in the nintedanib and placebo groups, respectively. Mean ± SD durations of treatment interruption were 23.1 ± 17.4 and 19.7 ± 19.8 days with nintedanib and placebo, respectively. Diarrhoea was the reason for 59.2% of dose reductions and 41.2% of treatment interruptions in the nintedanib group, and for 30.8% and 19.4% of these dose adjustments in the placebo group, respectively.

    Treatment was permanently discontinued before week 52 due to AEs in 13.9% and 7.3% of patients in the nintedanib and placebo groups, respectively.

    Conclusion: Over 52 weeks of treatment in the SENSCIS trial, most patients remained on therapy, suggesting that the dose adjustments used to manage AEs were effective at minimising treatment discontinuations.

    * presented at ERS 2019; ‡ presenting on behalf of the authors


    #