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


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.


Randomized controlled trial Registries Real-world data Big data Rheumatology 



ANCA-associated vasculitis


Anti-neutrophil cytoplasmic antibody




Anti-proteinase 3


Ankylosing spondylitis


Biological disease-modifying antirheumatic drug


Conventional disease-modifying antirheumatic drug


British Isles Lupus Assessment Group


Body mass index


Disease activity score using 28 joints with C-reactive protein


Disease activity score using 28 joints with erythrocyte sedimentation rate


Disease-modifying anti-rheumatic drug


Evidence-based medicine


Electronic medical records


European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis


Giant cell arteritis


General data protection regulation


Idiopathic inflammatory myositis


Interstitial lung disease


Low disease activity


Lupus Foundation of America: rapid evaluation of activity in lupus


Latent tuberculosis infection


Minimal disease activity


Mycophenolate mofetil


non-radiographic axial spondyloarthritis


Non-steroidal anti-inflammatory drug


Pulmonary arterial hypertension


positron emission tomography computerized tomography


Psoriatic arthritis


Rheumatoid arthritis


Randomized controlled trial


Real-world evidence


Simplified disease activity index


Systemic lupus erythematosus


Systemic lupus erythematosus disease activity index




Tumor necrosis factor alpha


Usual interstitial pneumonia


United Kingdom


United States of America


Very early rheumatoid arthritis


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.


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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