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Research ArticleArticle

Does Including Pain, Fatigue, and Physical Function When Assessing Patients with Early Rheumatoid Arthritis Provide a Comprehensive Picture of Disease Burden?

Sofia Pazmino, Anikó Lovik, Annelies Boonen, Diederik De Cock, Veerle Stouten, Johan Joly, Delphine Bertrand, Kristien Van der Elst, Rene Westhovens and Patrick Verschueren
The Journal of Rheumatology November 2020, jrheum.200758; DOI: https://doi.org/10.3899/jrheum.200758
Sofia Pazmino
The CareRA trial (EudraCT number: 2008-007225-39) was funded by a Flemish governmental grant [Agency for Innovation by Science and Technology (IWT)]. S. Pazmino, MD, D. De Cock, PhD, V. Stouten, MSc, D. Bertrand, MSc, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, Leuven, Belgium; A. Lovik, PhD, I-BioStat Leuven Biostatistics and Statistical Bioinformatics Centre, KU Leuven, Leuven, Belgium; A. Boonen, MD, PhD, Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Centre, and Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands; J. Joly, MSc, K. Van der Elst, PhD, Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium; R. Westhovens, MD, PhD, P. Verschueren, MD, PhD, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, and Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium. PV holds the Pfizer chair for early rheumatoid arthritis management at the KU Leuven. Address correspondence to Dr. S. Pazmino, Division of Rheumatology, University Hospitals Leuven, Herestraat 49, B-3000 Leuven, Belgium. Email: sofia.pazmino@kuleuven.be. Accepted for publication October 27, 2020.
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Anikó Lovik
The CareRA trial (EudraCT number: 2008-007225-39) was funded by a Flemish governmental grant [Agency for Innovation by Science and Technology (IWT)]. S. Pazmino, MD, D. De Cock, PhD, V. Stouten, MSc, D. Bertrand, MSc, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, Leuven, Belgium; A. Lovik, PhD, I-BioStat Leuven Biostatistics and Statistical Bioinformatics Centre, KU Leuven, Leuven, Belgium; A. Boonen, MD, PhD, Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Centre, and Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands; J. Joly, MSc, K. Van der Elst, PhD, Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium; R. Westhovens, MD, PhD, P. Verschueren, MD, PhD, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, and Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium. PV holds the Pfizer chair for early rheumatoid arthritis management at the KU Leuven. Address correspondence to Dr. S. Pazmino, Division of Rheumatology, University Hospitals Leuven, Herestraat 49, B-3000 Leuven, Belgium. Email: sofia.pazmino@kuleuven.be. Accepted for publication October 27, 2020.
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Annelies Boonen
The CareRA trial (EudraCT number: 2008-007225-39) was funded by a Flemish governmental grant [Agency for Innovation by Science and Technology (IWT)]. S. Pazmino, MD, D. De Cock, PhD, V. Stouten, MSc, D. Bertrand, MSc, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, Leuven, Belgium; A. Lovik, PhD, I-BioStat Leuven Biostatistics and Statistical Bioinformatics Centre, KU Leuven, Leuven, Belgium; A. Boonen, MD, PhD, Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Centre, and Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands; J. Joly, MSc, K. Van der Elst, PhD, Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium; R. Westhovens, MD, PhD, P. Verschueren, MD, PhD, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, and Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium. PV holds the Pfizer chair for early rheumatoid arthritis management at the KU Leuven. Address correspondence to Dr. S. Pazmino, Division of Rheumatology, University Hospitals Leuven, Herestraat 49, B-3000 Leuven, Belgium. Email: sofia.pazmino@kuleuven.be. Accepted for publication October 27, 2020.
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Diederik De Cock
The CareRA trial (EudraCT number: 2008-007225-39) was funded by a Flemish governmental grant [Agency for Innovation by Science and Technology (IWT)]. S. Pazmino, MD, D. De Cock, PhD, V. Stouten, MSc, D. Bertrand, MSc, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, Leuven, Belgium; A. Lovik, PhD, I-BioStat Leuven Biostatistics and Statistical Bioinformatics Centre, KU Leuven, Leuven, Belgium; A. Boonen, MD, PhD, Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Centre, and Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands; J. Joly, MSc, K. Van der Elst, PhD, Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium; R. Westhovens, MD, PhD, P. Verschueren, MD, PhD, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, and Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium. PV holds the Pfizer chair for early rheumatoid arthritis management at the KU Leuven. Address correspondence to Dr. S. Pazmino, Division of Rheumatology, University Hospitals Leuven, Herestraat 49, B-3000 Leuven, Belgium. Email: sofia.pazmino@kuleuven.be. Accepted for publication October 27, 2020.
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Veerle Stouten
The CareRA trial (EudraCT number: 2008-007225-39) was funded by a Flemish governmental grant [Agency for Innovation by Science and Technology (IWT)]. S. Pazmino, MD, D. De Cock, PhD, V. Stouten, MSc, D. Bertrand, MSc, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, Leuven, Belgium; A. Lovik, PhD, I-BioStat Leuven Biostatistics and Statistical Bioinformatics Centre, KU Leuven, Leuven, Belgium; A. Boonen, MD, PhD, Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Centre, and Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands; J. Joly, MSc, K. Van der Elst, PhD, Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium; R. Westhovens, MD, PhD, P. Verschueren, MD, PhD, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, and Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium. PV holds the Pfizer chair for early rheumatoid arthritis management at the KU Leuven. Address correspondence to Dr. S. Pazmino, Division of Rheumatology, University Hospitals Leuven, Herestraat 49, B-3000 Leuven, Belgium. Email: sofia.pazmino@kuleuven.be. Accepted for publication October 27, 2020.
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Johan Joly
The CareRA trial (EudraCT number: 2008-007225-39) was funded by a Flemish governmental grant [Agency for Innovation by Science and Technology (IWT)]. S. Pazmino, MD, D. De Cock, PhD, V. Stouten, MSc, D. Bertrand, MSc, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, Leuven, Belgium; A. Lovik, PhD, I-BioStat Leuven Biostatistics and Statistical Bioinformatics Centre, KU Leuven, Leuven, Belgium; A. Boonen, MD, PhD, Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Centre, and Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands; J. Joly, MSc, K. Van der Elst, PhD, Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium; R. Westhovens, MD, PhD, P. Verschueren, MD, PhD, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, and Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium. PV holds the Pfizer chair for early rheumatoid arthritis management at the KU Leuven. Address correspondence to Dr. S. Pazmino, Division of Rheumatology, University Hospitals Leuven, Herestraat 49, B-3000 Leuven, Belgium. Email: sofia.pazmino@kuleuven.be. Accepted for publication October 27, 2020.
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Delphine Bertrand
The CareRA trial (EudraCT number: 2008-007225-39) was funded by a Flemish governmental grant [Agency for Innovation by Science and Technology (IWT)]. S. Pazmino, MD, D. De Cock, PhD, V. Stouten, MSc, D. Bertrand, MSc, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, Leuven, Belgium; A. Lovik, PhD, I-BioStat Leuven Biostatistics and Statistical Bioinformatics Centre, KU Leuven, Leuven, Belgium; A. Boonen, MD, PhD, Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Centre, and Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands; J. Joly, MSc, K. Van der Elst, PhD, Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium; R. Westhovens, MD, PhD, P. Verschueren, MD, PhD, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, and Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium. PV holds the Pfizer chair for early rheumatoid arthritis management at the KU Leuven. Address correspondence to Dr. S. Pazmino, Division of Rheumatology, University Hospitals Leuven, Herestraat 49, B-3000 Leuven, Belgium. Email: sofia.pazmino@kuleuven.be. Accepted for publication October 27, 2020.
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Kristien Van der Elst
The CareRA trial (EudraCT number: 2008-007225-39) was funded by a Flemish governmental grant [Agency for Innovation by Science and Technology (IWT)]. S. Pazmino, MD, D. De Cock, PhD, V. Stouten, MSc, D. Bertrand, MSc, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, Leuven, Belgium; A. Lovik, PhD, I-BioStat Leuven Biostatistics and Statistical Bioinformatics Centre, KU Leuven, Leuven, Belgium; A. Boonen, MD, PhD, Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Centre, and Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands; J. Joly, MSc, K. Van der Elst, PhD, Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium; R. Westhovens, MD, PhD, P. Verschueren, MD, PhD, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, and Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium. PV holds the Pfizer chair for early rheumatoid arthritis management at the KU Leuven. Address correspondence to Dr. S. Pazmino, Division of Rheumatology, University Hospitals Leuven, Herestraat 49, B-3000 Leuven, Belgium. Email: sofia.pazmino@kuleuven.be. Accepted for publication October 27, 2020.
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Rene Westhovens
The CareRA trial (EudraCT number: 2008-007225-39) was funded by a Flemish governmental grant [Agency for Innovation by Science and Technology (IWT)]. S. Pazmino, MD, D. De Cock, PhD, V. Stouten, MSc, D. Bertrand, MSc, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, Leuven, Belgium; A. Lovik, PhD, I-BioStat Leuven Biostatistics and Statistical Bioinformatics Centre, KU Leuven, Leuven, Belgium; A. Boonen, MD, PhD, Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Centre, and Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands; J. Joly, MSc, K. Van der Elst, PhD, Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium; R. Westhovens, MD, PhD, P. Verschueren, MD, PhD, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, and Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium. PV holds the Pfizer chair for early rheumatoid arthritis management at the KU Leuven. Address correspondence to Dr. S. Pazmino, Division of Rheumatology, University Hospitals Leuven, Herestraat 49, B-3000 Leuven, Belgium. Email: sofia.pazmino@kuleuven.be. Accepted for publication October 27, 2020.
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Patrick Verschueren
The CareRA trial (EudraCT number: 2008-007225-39) was funded by a Flemish governmental grant [Agency for Innovation by Science and Technology (IWT)]. S. Pazmino, MD, D. De Cock, PhD, V. Stouten, MSc, D. Bertrand, MSc, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, Leuven, Belgium; A. Lovik, PhD, I-BioStat Leuven Biostatistics and Statistical Bioinformatics Centre, KU Leuven, Leuven, Belgium; A. Boonen, MD, PhD, Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Centre, and Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands; J. Joly, MSc, K. Van der Elst, PhD, Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium; R. Westhovens, MD, PhD, P. Verschueren, MD, PhD, Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, and Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium. PV holds the Pfizer chair for early rheumatoid arthritis management at the KU Leuven. Address correspondence to Dr. S. Pazmino, Division of Rheumatology, University Hospitals Leuven, Herestraat 49, B-3000 Leuven, Belgium. Email: sofia.pazmino@kuleuven.be. Accepted for publication October 27, 2020.
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Abstract

Objective To explore the possibility of integrating patient-important outcomes like pain, fatigue, and physical function into the evaluation of disease status in early rheumatoid arthritis (ERA) without compromising correct disease activity measurement.

Methods Patients from the 2-year Care in Early Rheumatoid Arthritis (CareRA) trial were included. Pain and fatigue (visual analog scales), Health Assessment Questionnaire (HAQ), standard components of disease activity [swollen/tender joint counts (SJC/TJC), C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR), physician (PhGH) and patient (PaGH) global health] were recorded at every visit (n = 10). Pearson correlation and exploratory factor analyses (EFA), using multiple imputation (15×) and outputation (1000×), were performed per timepoint and overall, on standard components of disease activity scores with and without pain, fatigue, and HAQ. Each of the 15,000 datasets was analyzed using EFA with principal component extraction and oblimin rotation to determine which variables belong together.

Results We included 379 patients. EFA on standard composite score components extracted 2 factors with no substantial cross-loadings. Still, pain (0.83), fatigue (0.65), and HAQ (0.59) were strongly correlated with PaGH. When rerunning the EFA with the inclusion of pain, fatigue, and HAQ, the 2-factor model had substantial cross-loadings between factors. However, a 3-factor model was optimal, with Factor 1: patient assessment, Factor 2: clinical assessment (PhGH, SJC, and TJC), and Factor 3: laboratory assessment (ESR/ CRP).

Conclusion PaGH, pain, fatigue, and physical function represent a separate aspect of the disease burden of patients with ERA, which could be further explored as a target for care apart from disease activity. [ClinicalTrials.gov: NCT01172639].

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Does Including Pain, Fatigue, and Physical Function When Assessing Patients with Early Rheumatoid Arthritis Provide a Comprehensive Picture of Disease Burden?
Sofia Pazmino, Anikó Lovik, Annelies Boonen, Diederik De Cock, Veerle Stouten, Johan Joly, Delphine Bertrand, Kristien Van der Elst, Rene Westhovens, Patrick Verschueren
The Journal of Rheumatology Nov 2020, jrheum.200758; DOI: 10.3899/jrheum.200758

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Does Including Pain, Fatigue, and Physical Function When Assessing Patients with Early Rheumatoid Arthritis Provide a Comprehensive Picture of Disease Burden?
Sofia Pazmino, Anikó Lovik, Annelies Boonen, Diederik De Cock, Veerle Stouten, Johan Joly, Delphine Bertrand, Kristien Van der Elst, Rene Westhovens, Patrick Verschueren
The Journal of Rheumatology Nov 2020, jrheum.200758; DOI: 10.3899/jrheum.200758
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