Clinical Rheumatology

, Volume 39, Issue 1, pp 19–26 | Cite as

Risk of bleeding events among patients with systemic sclerosis and the general population in the UK: a large population-based cohort study

  • Alexander MichelEmail author
  • Antonio González-Pérez
  • María E. Sáez
  • Luis A. García Rodríguez
Original Article
Part of the following topical collections:
  1. Updates in Systemic Sclerosis



To compare the risk of different bleeding outcomes between patients with systemic sclerosis (SSc) and the general population free of SSc.


Using UK electronic primary care data (2000–2012), 1314 patients with SSc and a matched SSc-free comparison cohort (n = 19,992) were followed until December 2013 to identify bleeding, confirmed following manual review of patient records including free text comments. Incidence rates were calculated and Cox regression used to estimate adjusted hazard ratios (HRs; SSc cohort vs. matched general population cohort) adjusted for confounders.


One hundred and twenty-seven bleeding events occurred in the SSc cohort and 1762 in the general population cohort; incidence rates per 1000 person-years for the SSc cohort and general population cohort were 0.5 versus 0.3 for hemorrhagic stroke, 4.1 versus 3.3 for gastrointestinal bleeding, 2.5 versus 1.7 for pulmonary hemorrhage, 8.4 versus 7.5 for urogenital bleeding, and 15.5 versus 12.9 for any of the aforementioned bleedings. Adjusted HRs (95% confidence intervals) were 1.21 (1.00–1.46) for any bleeding, 1.51 (0.54–4.21) for hemorrhagic stroke, 1.50 (0.96–2.35) for pulmonary hemorrhage, 1.08 (0.75–1.54) for gastrointestinal bleeds, and 1.28 (1.00–1.64) for urogenital bleeds. HRs were more often higher in SSc patients with organ involvement than without organ involvement and in those with diffuse cutaneous SSc.


Our results are consistent with a moderately increased risk of bleeding in SSc patients. Further evidence from large SSc patient cohorts is needed to confirm this finding.

Key Points

The risk of experiencing a major bleed may be higher among patients with SSc than the general population.

Further large and well-designed studies are needed to corroborate our findings.

Keywords (MeSH)

Cohort studies Hemorrhage Scleroderma Systemic United Kingdom 



The authors acknowledge and thank Susan Bromley, EpiMed Communications Ltd. (Oxford, UK) for editorial support funded by Bayer AG.


This study was funded by Bayer AG.

Compliance with ethical standards

Conflict of interest

AM is a full-time employee of Bayer Consumer Care AG, Basel, Switzerland. LAGR, AG-P, and MES work for CEIFE, which have received research funding from Bayer AG. LAGR has received honoraria for serving on advisory boards for Bayer AG. The authors declare no non-financial conflict of interests.

Ethical standards

This study used anonymized primary care electronic health records. No clinical subjects were involved and therefore informed consent was not applicable.

Supplementary material

10067_2019_4588_MOESM1_ESM.docx (25 kb)
Supplementary Table 1 (DOCX 24 kb)
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Supplementary Table 2 (DOCX 21 kb)
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Supplementary Table 3 (DOCX 33 kb)
10067_2019_4588_MOESM4_ESM.docx (24 kb)
Supplementary Table 4 (DOCX 24 kb)


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Copyright information

© International League of Associations for Rheumatology (ILAR) 2019

Authors and Affiliations

  • Alexander Michel
    • 1
    Email author
  • Antonio González-Pérez
    • 2
    • 3
    • 4
  • María E. Sáez
    • 2
    • 3
  • Luis A. García Rodríguez
    • 2
  1. 1.Epidemiology, Division PharmaceuticalsBayer Consumer Care AGBaselSwitzerland
  2. 2.Spanish Centre for Pharmacoepidemiologic Research (CEIFE)MadridSpain
  3. 3.Andalusian Bioinformatics Research Centre (CAEBi)SevilleSpain
  4. 4.Pharmacoepidemiology Research GroupInstitute for Health Research IRYCISMadridSpain

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