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Rheumatology International

, Volume 39, Issue 3, pp 403–416 | Cite as

Real-world evidence in rheumatic diseases: relevance and lessons learnt

  • Durga Prasanna MisraEmail author
  • Vikas Agarwal
Review

Abstract

An emerging trend in the medical literature, including the Rheumatology literature, is that of accumulating large, multicentric, multi-national data based on registries of patients seen in real life situations. Such real-world evidence (RWE) may help provide valuable insights into the long-term outcomes of disease in unselected patients seen in daily practice, including patients belonging to vulnerable populations such as extremes of age, during pregnancy and lactation. Evidences gathered from real life practice settings can help understand drug prescription patterns, including adherence to treatment guidelines, cost-effectiveness of therapy, and real-life long-term outcomes, and adverse effects of treatment with particular medications. Registry-based data also helps analyze comorbidities in patients with rheumatic diseases, and their impact on quality of life, morbidity and mortality. Traditionally, a randomized controlled trial (RCT), or systematic reviews of multiple, homogenous RCTs, have been considered the cornerstone of evidence-based medicine, and RWE does, at times, provide differing viewpoints from the results of particular drugs in clinical trial settings. Therefore, in the present day, it is prudent to consider the complementary nature of information derived from RWE to that obtained from rigorous, clinical trial settings. Future guidelines for disease management may consider it relevant to include information from RWE in addition to that available from clinical trials, to help devise management guidelines that are harmonious with routine practice settings.

Keywords

Randomized controlled trial Registries Real-world data Big data Rheumatology 

Abbreviations

AAV

ANCA-associated vasculitis

ANCA

Anti-neutrophil cytoplasmic antibody

Anti-MPO

Anti-myeloperoxidase

Anti-PR3

Anti-proteinase 3

AS

Ankylosing spondylitis

bDMARD

Biological disease-modifying antirheumatic drug

cDMARD

Conventional disease-modifying antirheumatic drug

BILAG

British Isles Lupus Assessment Group

BMI

Body mass index

DAS28-CRP

Disease activity score using 28 joints with C-reactive protein

DAS28-ESR

Disease activity score using 28 joints with erythrocyte sedimentation rate

DMARD

Disease-modifying anti-rheumatic drug

EBM

Evidence-based medicine

EMR

Electronic medical records

ESCEO

European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis

GCA

Giant cell arteritis

GDPR

General data protection regulation

IIM

Idiopathic inflammatory myositis

ILD

Interstitial lung disease

LDA

Low disease activity

LFA-REAL

Lupus Foundation of America: rapid evaluation of activity in lupus

LTBI

Latent tuberculosis infection

MDA

Minimal disease activity

MMF

Mycophenolate mofetil

nrAxSpA

non-radiographic axial spondyloarthritis

NSAID

Non-steroidal anti-inflammatory drug

PAH

Pulmonary arterial hypertension

PET-CT

positron emission tomography computerized tomography

PsA

Psoriatic arthritis

RA

Rheumatoid arthritis

RCT

Randomized controlled trial

RWE

Real-world evidence

SDAI

Simplified disease activity index

SLE

Systemic lupus erythematosus

SLEDAI

Systemic lupus erythematosus disease activity index

SpA

Spondyloarthritis

TNF

Tumor necrosis factor alpha

UIP

Usual interstitial pneumonia

UK

United Kingdom

USA

United States of America

VERA

Very early rheumatoid arthritis

Notes

Author contributions

The conception and design of the study, or acquisition of data, or analysis and interpretation of data—DPM, VA. Drafting the article—DPM; Revising it critically for important intellectual content—VA. Final approval of the version to be submitted—DPM, VA. Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved—DPM, VA.

Funding

No funding was received for this study.

Compliance with ethical standards

Conflict of interest

Durga Prasanna Misra declares that he has no conflict of interest. Vikas Agarwal declares that he has no conflict of interest.

Ethical approval

This article does not contain any studies with human participants or animals performed by any of the authors.

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Department of Clinical Immunology and RheumatologySanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)LucknowIndia

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