Research ArticleArticle
Composite Measures for Clinical Trials in Psoriatic Arthritis: Testing Pain and Fatigue Modifications in a UK Multicenter Study
William Tillett, Oliver FitzGerald, Laura C. Coates, Jon Packham, Deepak R. Jadon, Marco Massarotti, Mel Brook, Suzanne Lane, Paul Creamer, Anna Antony, Eleanor Korendowych, Adwaye Rambojun, Neil J. McHugh and Philip S. Helliwell on behalf of the PROMPT Study Group
The Journal of Rheumatology March 2021, jrheum.201674; DOI: https://doi.org/10.3899/jrheum.201674
William Tillett
As part of the supplement series GRAPPA 2020, this report was reviewed internally and approved by the Guest Editors for integrity, accuracy, and consistency with scientific and ethical standards. This report is independent research funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research (Early detection to improve outcome in patients with undiagnosed PsA [PROMPT], RP-PG-1212-20007). The views expressed are those of the authors and are not necessarily those of the NIHR or the Department of Health and Social Care. W. Tillett, BSc, MBChB, PhD, FRCP, N.J. McHugh, MBChB, MD, FRCP, FRCPath, Department of Pharmacy and Pharmacology, University of Bath, and Royal National Hospital for Rheumatic Diseases, Bath, UK; O. FitzGerald, MD, FRCPI, FRCP, Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland; L.C. Coates, MBChB, PhD, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; J. Packham, DM, FRCP, Haywood Rheumatology Centre, Stoke-on-Trent, UK; D.R. Jadon, MBBCh, MRCP, PhD, University of Cambridge, Cambridge, UK; M. Massarotti, MD, Department of Rheumatology, University Hospitals Dorset NHS Foundation Trust, Christchurch, New Zealand; M. Brook, Patient Research Partner, Royal National Hospital for Rheumatic Diseases, Bath, UK; S. Lane, MBChB, MD, FRCP, Ipswich Hospital NHS Trust, Ipswich; P. Creamer, MBChB, North Bristol NHS Foundation Trust, Bristol, UK; A. Antony, MBBS, School of Clinical Sciences, Monash University, Australia;1E. Korendowych, PhD, MRCP, Royal National Hospital for Rheumatic Diseases, Bath, UK; A. Rambojun, PhD, Department of Pharmacy and Pharmacology, University of Bath, Bath, UK; P.S. Helliwell, MD, PhD, Professor of Clinical Rheumatology, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds, UK. SL has received sponsorship for the European Alliance of Associations for Rheumatology (EULAR) and the American College of Rheumatology conferences in 2020, both from AbbVie, and in 2019 for the EULAR conference in Madrid from Celgene, but no commercial work for any organizations. All other authors declare no conflicts of interest. Address correspondence to Dr. W. Tillett, Department of Rheumatology, Royal National Hospital for Rheumatic Diseases, Coombe Park, Bath BA1 3NG, UK. Email: w.tillett@nhs.net.
Oliver FitzGerald
As part of the supplement series GRAPPA 2020, this report was reviewed internally and approved by the Guest Editors for integrity, accuracy, and consistency with scientific and ethical standards. This report is independent research funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research (Early detection to improve outcome in patients with undiagnosed PsA [PROMPT], RP-PG-1212-20007). The views expressed are those of the authors and are not necessarily those of the NIHR or the Department of Health and Social Care. W. Tillett, BSc, MBChB, PhD, FRCP, N.J. McHugh, MBChB, MD, FRCP, FRCPath, Department of Pharmacy and Pharmacology, University of Bath, and Royal National Hospital for Rheumatic Diseases, Bath, UK; O. FitzGerald, MD, FRCPI, FRCP, Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland; L.C. Coates, MBChB, PhD, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; J. Packham, DM, FRCP, Haywood Rheumatology Centre, Stoke-on-Trent, UK; D.R. Jadon, MBBCh, MRCP, PhD, University of Cambridge, Cambridge, UK; M. Massarotti, MD, Department of Rheumatology, University Hospitals Dorset NHS Foundation Trust, Christchurch, New Zealand; M. Brook, Patient Research Partner, Royal National Hospital for Rheumatic Diseases, Bath, UK; S. Lane, MBChB, MD, FRCP, Ipswich Hospital NHS Trust, Ipswich; P. Creamer, MBChB, North Bristol NHS Foundation Trust, Bristol, UK; A. Antony, MBBS, School of Clinical Sciences, Monash University, Australia;1E. Korendowych, PhD, MRCP, Royal National Hospital for Rheumatic Diseases, Bath, UK; A. Rambojun, PhD, Department of Pharmacy and Pharmacology, University of Bath, Bath, UK; P.S. Helliwell, MD, PhD, Professor of Clinical Rheumatology, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds, UK. SL has received sponsorship for the European Alliance of Associations for Rheumatology (EULAR) and the American College of Rheumatology conferences in 2020, both from AbbVie, and in 2019 for the EULAR conference in Madrid from Celgene, but no commercial work for any organizations. All other authors declare no conflicts of interest. Address correspondence to Dr. W. Tillett, Department of Rheumatology, Royal National Hospital for Rheumatic Diseases, Coombe Park, Bath BA1 3NG, UK. Email: w.tillett@nhs.net.
Laura C. Coates
As part of the supplement series GRAPPA 2020, this report was reviewed internally and approved by the Guest Editors for integrity, accuracy, and consistency with scientific and ethical standards. This report is independent research funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research (Early detection to improve outcome in patients with undiagnosed PsA [PROMPT], RP-PG-1212-20007). The views expressed are those of the authors and are not necessarily those of the NIHR or the Department of Health and Social Care. W. Tillett, BSc, MBChB, PhD, FRCP, N.J. McHugh, MBChB, MD, FRCP, FRCPath, Department of Pharmacy and Pharmacology, University of Bath, and Royal National Hospital for Rheumatic Diseases, Bath, UK; O. FitzGerald, MD, FRCPI, FRCP, Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland; L.C. Coates, MBChB, PhD, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; J. Packham, DM, FRCP, Haywood Rheumatology Centre, Stoke-on-Trent, UK; D.R. Jadon, MBBCh, MRCP, PhD, University of Cambridge, Cambridge, UK; M. Massarotti, MD, Department of Rheumatology, University Hospitals Dorset NHS Foundation Trust, Christchurch, New Zealand; M. Brook, Patient Research Partner, Royal National Hospital for Rheumatic Diseases, Bath, UK; S. Lane, MBChB, MD, FRCP, Ipswich Hospital NHS Trust, Ipswich; P. Creamer, MBChB, North Bristol NHS Foundation Trust, Bristol, UK; A. Antony, MBBS, School of Clinical Sciences, Monash University, Australia;1E. Korendowych, PhD, MRCP, Royal National Hospital for Rheumatic Diseases, Bath, UK; A. Rambojun, PhD, Department of Pharmacy and Pharmacology, University of Bath, Bath, UK; P.S. Helliwell, MD, PhD, Professor of Clinical Rheumatology, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds, UK. SL has received sponsorship for the European Alliance of Associations for Rheumatology (EULAR) and the American College of Rheumatology conferences in 2020, both from AbbVie, and in 2019 for the EULAR conference in Madrid from Celgene, but no commercial work for any organizations. All other authors declare no conflicts of interest. Address correspondence to Dr. W. Tillett, Department of Rheumatology, Royal National Hospital for Rheumatic Diseases, Coombe Park, Bath BA1 3NG, UK. Email: w.tillett@nhs.net.
Jon Packham
As part of the supplement series GRAPPA 2020, this report was reviewed internally and approved by the Guest Editors for integrity, accuracy, and consistency with scientific and ethical standards. This report is independent research funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research (Early detection to improve outcome in patients with undiagnosed PsA [PROMPT], RP-PG-1212-20007). The views expressed are those of the authors and are not necessarily those of the NIHR or the Department of Health and Social Care. W. Tillett, BSc, MBChB, PhD, FRCP, N.J. McHugh, MBChB, MD, FRCP, FRCPath, Department of Pharmacy and Pharmacology, University of Bath, and Royal National Hospital for Rheumatic Diseases, Bath, UK; O. FitzGerald, MD, FRCPI, FRCP, Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland; L.C. Coates, MBChB, PhD, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; J. Packham, DM, FRCP, Haywood Rheumatology Centre, Stoke-on-Trent, UK; D.R. Jadon, MBBCh, MRCP, PhD, University of Cambridge, Cambridge, UK; M. Massarotti, MD, Department of Rheumatology, University Hospitals Dorset NHS Foundation Trust, Christchurch, New Zealand; M. Brook, Patient Research Partner, Royal National Hospital for Rheumatic Diseases, Bath, UK; S. Lane, MBChB, MD, FRCP, Ipswich Hospital NHS Trust, Ipswich; P. Creamer, MBChB, North Bristol NHS Foundation Trust, Bristol, UK; A. Antony, MBBS, School of Clinical Sciences, Monash University, Australia;1E. Korendowych, PhD, MRCP, Royal National Hospital for Rheumatic Diseases, Bath, UK; A. Rambojun, PhD, Department of Pharmacy and Pharmacology, University of Bath, Bath, UK; P.S. Helliwell, MD, PhD, Professor of Clinical Rheumatology, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds, UK. SL has received sponsorship for the European Alliance of Associations for Rheumatology (EULAR) and the American College of Rheumatology conferences in 2020, both from AbbVie, and in 2019 for the EULAR conference in Madrid from Celgene, but no commercial work for any organizations. All other authors declare no conflicts of interest. Address correspondence to Dr. W. Tillett, Department of Rheumatology, Royal National Hospital for Rheumatic Diseases, Coombe Park, Bath BA1 3NG, UK. Email: w.tillett@nhs.net.
Deepak R. Jadon
As part of the supplement series GRAPPA 2020, this report was reviewed internally and approved by the Guest Editors for integrity, accuracy, and consistency with scientific and ethical standards. This report is independent research funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research (Early detection to improve outcome in patients with undiagnosed PsA [PROMPT], RP-PG-1212-20007). The views expressed are those of the authors and are not necessarily those of the NIHR or the Department of Health and Social Care. W. Tillett, BSc, MBChB, PhD, FRCP, N.J. McHugh, MBChB, MD, FRCP, FRCPath, Department of Pharmacy and Pharmacology, University of Bath, and Royal National Hospital for Rheumatic Diseases, Bath, UK; O. FitzGerald, MD, FRCPI, FRCP, Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland; L.C. Coates, MBChB, PhD, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; J. Packham, DM, FRCP, Haywood Rheumatology Centre, Stoke-on-Trent, UK; D.R. Jadon, MBBCh, MRCP, PhD, University of Cambridge, Cambridge, UK; M. Massarotti, MD, Department of Rheumatology, University Hospitals Dorset NHS Foundation Trust, Christchurch, New Zealand; M. Brook, Patient Research Partner, Royal National Hospital for Rheumatic Diseases, Bath, UK; S. Lane, MBChB, MD, FRCP, Ipswich Hospital NHS Trust, Ipswich; P. Creamer, MBChB, North Bristol NHS Foundation Trust, Bristol, UK; A. Antony, MBBS, School of Clinical Sciences, Monash University, Australia;1E. Korendowych, PhD, MRCP, Royal National Hospital for Rheumatic Diseases, Bath, UK; A. Rambojun, PhD, Department of Pharmacy and Pharmacology, University of Bath, Bath, UK; P.S. Helliwell, MD, PhD, Professor of Clinical Rheumatology, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds, UK. SL has received sponsorship for the European Alliance of Associations for Rheumatology (EULAR) and the American College of Rheumatology conferences in 2020, both from AbbVie, and in 2019 for the EULAR conference in Madrid from Celgene, but no commercial work for any organizations. All other authors declare no conflicts of interest. Address correspondence to Dr. W. Tillett, Department of Rheumatology, Royal National Hospital for Rheumatic Diseases, Coombe Park, Bath BA1 3NG, UK. Email: w.tillett@nhs.net.
Marco Massarotti
As part of the supplement series GRAPPA 2020, this report was reviewed internally and approved by the Guest Editors for integrity, accuracy, and consistency with scientific and ethical standards. This report is independent research funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research (Early detection to improve outcome in patients with undiagnosed PsA [PROMPT], RP-PG-1212-20007). The views expressed are those of the authors and are not necessarily those of the NIHR or the Department of Health and Social Care. W. Tillett, BSc, MBChB, PhD, FRCP, N.J. McHugh, MBChB, MD, FRCP, FRCPath, Department of Pharmacy and Pharmacology, University of Bath, and Royal National Hospital for Rheumatic Diseases, Bath, UK; O. FitzGerald, MD, FRCPI, FRCP, Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland; L.C. Coates, MBChB, PhD, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; J. Packham, DM, FRCP, Haywood Rheumatology Centre, Stoke-on-Trent, UK; D.R. Jadon, MBBCh, MRCP, PhD, University of Cambridge, Cambridge, UK; M. Massarotti, MD, Department of Rheumatology, University Hospitals Dorset NHS Foundation Trust, Christchurch, New Zealand; M. Brook, Patient Research Partner, Royal National Hospital for Rheumatic Diseases, Bath, UK; S. Lane, MBChB, MD, FRCP, Ipswich Hospital NHS Trust, Ipswich; P. Creamer, MBChB, North Bristol NHS Foundation Trust, Bristol, UK; A. Antony, MBBS, School of Clinical Sciences, Monash University, Australia;1E. Korendowych, PhD, MRCP, Royal National Hospital for Rheumatic Diseases, Bath, UK; A. Rambojun, PhD, Department of Pharmacy and Pharmacology, University of Bath, Bath, UK; P.S. Helliwell, MD, PhD, Professor of Clinical Rheumatology, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds, UK. SL has received sponsorship for the European Alliance of Associations for Rheumatology (EULAR) and the American College of Rheumatology conferences in 2020, both from AbbVie, and in 2019 for the EULAR conference in Madrid from Celgene, but no commercial work for any organizations. All other authors declare no conflicts of interest. Address correspondence to Dr. W. Tillett, Department of Rheumatology, Royal National Hospital for Rheumatic Diseases, Coombe Park, Bath BA1 3NG, UK. Email: w.tillett@nhs.net.
Mel Brook
As part of the supplement series GRAPPA 2020, this report was reviewed internally and approved by the Guest Editors for integrity, accuracy, and consistency with scientific and ethical standards. This report is independent research funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research (Early detection to improve outcome in patients with undiagnosed PsA [PROMPT], RP-PG-1212-20007). The views expressed are those of the authors and are not necessarily those of the NIHR or the Department of Health and Social Care. W. Tillett, BSc, MBChB, PhD, FRCP, N.J. McHugh, MBChB, MD, FRCP, FRCPath, Department of Pharmacy and Pharmacology, University of Bath, and Royal National Hospital for Rheumatic Diseases, Bath, UK; O. FitzGerald, MD, FRCPI, FRCP, Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland; L.C. Coates, MBChB, PhD, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; J. Packham, DM, FRCP, Haywood Rheumatology Centre, Stoke-on-Trent, UK; D.R. Jadon, MBBCh, MRCP, PhD, University of Cambridge, Cambridge, UK; M. Massarotti, MD, Department of Rheumatology, University Hospitals Dorset NHS Foundation Trust, Christchurch, New Zealand; M. Brook, Patient Research Partner, Royal National Hospital for Rheumatic Diseases, Bath, UK; S. Lane, MBChB, MD, FRCP, Ipswich Hospital NHS Trust, Ipswich; P. Creamer, MBChB, North Bristol NHS Foundation Trust, Bristol, UK; A. Antony, MBBS, School of Clinical Sciences, Monash University, Australia;1E. Korendowych, PhD, MRCP, Royal National Hospital for Rheumatic Diseases, Bath, UK; A. Rambojun, PhD, Department of Pharmacy and Pharmacology, University of Bath, Bath, UK; P.S. Helliwell, MD, PhD, Professor of Clinical Rheumatology, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds, UK. SL has received sponsorship for the European Alliance of Associations for Rheumatology (EULAR) and the American College of Rheumatology conferences in 2020, both from AbbVie, and in 2019 for the EULAR conference in Madrid from Celgene, but no commercial work for any organizations. All other authors declare no conflicts of interest. Address correspondence to Dr. W. Tillett, Department of Rheumatology, Royal National Hospital for Rheumatic Diseases, Coombe Park, Bath BA1 3NG, UK. Email: w.tillett@nhs.net.
Suzanne Lane
As part of the supplement series GRAPPA 2020, this report was reviewed internally and approved by the Guest Editors for integrity, accuracy, and consistency with scientific and ethical standards. This report is independent research funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research (Early detection to improve outcome in patients with undiagnosed PsA [PROMPT], RP-PG-1212-20007). The views expressed are those of the authors and are not necessarily those of the NIHR or the Department of Health and Social Care. W. Tillett, BSc, MBChB, PhD, FRCP, N.J. McHugh, MBChB, MD, FRCP, FRCPath, Department of Pharmacy and Pharmacology, University of Bath, and Royal National Hospital for Rheumatic Diseases, Bath, UK; O. FitzGerald, MD, FRCPI, FRCP, Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland; L.C. Coates, MBChB, PhD, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; J. Packham, DM, FRCP, Haywood Rheumatology Centre, Stoke-on-Trent, UK; D.R. Jadon, MBBCh, MRCP, PhD, University of Cambridge, Cambridge, UK; M. Massarotti, MD, Department of Rheumatology, University Hospitals Dorset NHS Foundation Trust, Christchurch, New Zealand; M. Brook, Patient Research Partner, Royal National Hospital for Rheumatic Diseases, Bath, UK; S. Lane, MBChB, MD, FRCP, Ipswich Hospital NHS Trust, Ipswich; P. Creamer, MBChB, North Bristol NHS Foundation Trust, Bristol, UK; A. Antony, MBBS, School of Clinical Sciences, Monash University, Australia;1E. Korendowych, PhD, MRCP, Royal National Hospital for Rheumatic Diseases, Bath, UK; A. Rambojun, PhD, Department of Pharmacy and Pharmacology, University of Bath, Bath, UK; P.S. Helliwell, MD, PhD, Professor of Clinical Rheumatology, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds, UK. SL has received sponsorship for the European Alliance of Associations for Rheumatology (EULAR) and the American College of Rheumatology conferences in 2020, both from AbbVie, and in 2019 for the EULAR conference in Madrid from Celgene, but no commercial work for any organizations. All other authors declare no conflicts of interest. Address correspondence to Dr. W. Tillett, Department of Rheumatology, Royal National Hospital for Rheumatic Diseases, Coombe Park, Bath BA1 3NG, UK. Email: w.tillett@nhs.net.
Paul Creamer
As part of the supplement series GRAPPA 2020, this report was reviewed internally and approved by the Guest Editors for integrity, accuracy, and consistency with scientific and ethical standards. This report is independent research funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research (Early detection to improve outcome in patients with undiagnosed PsA [PROMPT], RP-PG-1212-20007). The views expressed are those of the authors and are not necessarily those of the NIHR or the Department of Health and Social Care. W. Tillett, BSc, MBChB, PhD, FRCP, N.J. McHugh, MBChB, MD, FRCP, FRCPath, Department of Pharmacy and Pharmacology, University of Bath, and Royal National Hospital for Rheumatic Diseases, Bath, UK; O. FitzGerald, MD, FRCPI, FRCP, Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland; L.C. Coates, MBChB, PhD, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; J. Packham, DM, FRCP, Haywood Rheumatology Centre, Stoke-on-Trent, UK; D.R. Jadon, MBBCh, MRCP, PhD, University of Cambridge, Cambridge, UK; M. Massarotti, MD, Department of Rheumatology, University Hospitals Dorset NHS Foundation Trust, Christchurch, New Zealand; M. Brook, Patient Research Partner, Royal National Hospital for Rheumatic Diseases, Bath, UK; S. Lane, MBChB, MD, FRCP, Ipswich Hospital NHS Trust, Ipswich; P. Creamer, MBChB, North Bristol NHS Foundation Trust, Bristol, UK; A. Antony, MBBS, School of Clinical Sciences, Monash University, Australia;1E. Korendowych, PhD, MRCP, Royal National Hospital for Rheumatic Diseases, Bath, UK; A. Rambojun, PhD, Department of Pharmacy and Pharmacology, University of Bath, Bath, UK; P.S. Helliwell, MD, PhD, Professor of Clinical Rheumatology, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds, UK. SL has received sponsorship for the European Alliance of Associations for Rheumatology (EULAR) and the American College of Rheumatology conferences in 2020, both from AbbVie, and in 2019 for the EULAR conference in Madrid from Celgene, but no commercial work for any organizations. All other authors declare no conflicts of interest. Address correspondence to Dr. W. Tillett, Department of Rheumatology, Royal National Hospital for Rheumatic Diseases, Coombe Park, Bath BA1 3NG, UK. Email: w.tillett@nhs.net.
Anna Antony
As part of the supplement series GRAPPA 2020, this report was reviewed internally and approved by the Guest Editors for integrity, accuracy, and consistency with scientific and ethical standards. This report is independent research funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research (Early detection to improve outcome in patients with undiagnosed PsA [PROMPT], RP-PG-1212-20007). The views expressed are those of the authors and are not necessarily those of the NIHR or the Department of Health and Social Care. W. Tillett, BSc, MBChB, PhD, FRCP, N.J. McHugh, MBChB, MD, FRCP, FRCPath, Department of Pharmacy and Pharmacology, University of Bath, and Royal National Hospital for Rheumatic Diseases, Bath, UK; O. FitzGerald, MD, FRCPI, FRCP, Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland; L.C. Coates, MBChB, PhD, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; J. Packham, DM, FRCP, Haywood Rheumatology Centre, Stoke-on-Trent, UK; D.R. Jadon, MBBCh, MRCP, PhD, University of Cambridge, Cambridge, UK; M. Massarotti, MD, Department of Rheumatology, University Hospitals Dorset NHS Foundation Trust, Christchurch, New Zealand; M. Brook, Patient Research Partner, Royal National Hospital for Rheumatic Diseases, Bath, UK; S. Lane, MBChB, MD, FRCP, Ipswich Hospital NHS Trust, Ipswich; P. Creamer, MBChB, North Bristol NHS Foundation Trust, Bristol, UK; A. Antony, MBBS, School of Clinical Sciences, Monash University, Australia;1E. Korendowych, PhD, MRCP, Royal National Hospital for Rheumatic Diseases, Bath, UK; A. Rambojun, PhD, Department of Pharmacy and Pharmacology, University of Bath, Bath, UK; P.S. Helliwell, MD, PhD, Professor of Clinical Rheumatology, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds, UK. SL has received sponsorship for the European Alliance of Associations for Rheumatology (EULAR) and the American College of Rheumatology conferences in 2020, both from AbbVie, and in 2019 for the EULAR conference in Madrid from Celgene, but no commercial work for any organizations. All other authors declare no conflicts of interest. Address correspondence to Dr. W. Tillett, Department of Rheumatology, Royal National Hospital for Rheumatic Diseases, Coombe Park, Bath BA1 3NG, UK. Email: w.tillett@nhs.net.
Eleanor Korendowych
As part of the supplement series GRAPPA 2020, this report was reviewed internally and approved by the Guest Editors for integrity, accuracy, and consistency with scientific and ethical standards. This report is independent research funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research (Early detection to improve outcome in patients with undiagnosed PsA [PROMPT], RP-PG-1212-20007). The views expressed are those of the authors and are not necessarily those of the NIHR or the Department of Health and Social Care. W. Tillett, BSc, MBChB, PhD, FRCP, N.J. McHugh, MBChB, MD, FRCP, FRCPath, Department of Pharmacy and Pharmacology, University of Bath, and Royal National Hospital for Rheumatic Diseases, Bath, UK; O. FitzGerald, MD, FRCPI, FRCP, Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland; L.C. Coates, MBChB, PhD, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; J. Packham, DM, FRCP, Haywood Rheumatology Centre, Stoke-on-Trent, UK; D.R. Jadon, MBBCh, MRCP, PhD, University of Cambridge, Cambridge, UK; M. Massarotti, MD, Department of Rheumatology, University Hospitals Dorset NHS Foundation Trust, Christchurch, New Zealand; M. Brook, Patient Research Partner, Royal National Hospital for Rheumatic Diseases, Bath, UK; S. Lane, MBChB, MD, FRCP, Ipswich Hospital NHS Trust, Ipswich; P. Creamer, MBChB, North Bristol NHS Foundation Trust, Bristol, UK; A. Antony, MBBS, School of Clinical Sciences, Monash University, Australia;1E. Korendowych, PhD, MRCP, Royal National Hospital for Rheumatic Diseases, Bath, UK; A. Rambojun, PhD, Department of Pharmacy and Pharmacology, University of Bath, Bath, UK; P.S. Helliwell, MD, PhD, Professor of Clinical Rheumatology, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds, UK. SL has received sponsorship for the European Alliance of Associations for Rheumatology (EULAR) and the American College of Rheumatology conferences in 2020, both from AbbVie, and in 2019 for the EULAR conference in Madrid from Celgene, but no commercial work for any organizations. All other authors declare no conflicts of interest. Address correspondence to Dr. W. Tillett, Department of Rheumatology, Royal National Hospital for Rheumatic Diseases, Coombe Park, Bath BA1 3NG, UK. Email: w.tillett@nhs.net.
Adwaye Rambojun
As part of the supplement series GRAPPA 2020, this report was reviewed internally and approved by the Guest Editors for integrity, accuracy, and consistency with scientific and ethical standards. This report is independent research funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research (Early detection to improve outcome in patients with undiagnosed PsA [PROMPT], RP-PG-1212-20007). The views expressed are those of the authors and are not necessarily those of the NIHR or the Department of Health and Social Care. W. Tillett, BSc, MBChB, PhD, FRCP, N.J. McHugh, MBChB, MD, FRCP, FRCPath, Department of Pharmacy and Pharmacology, University of Bath, and Royal National Hospital for Rheumatic Diseases, Bath, UK; O. FitzGerald, MD, FRCPI, FRCP, Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland; L.C. Coates, MBChB, PhD, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; J. Packham, DM, FRCP, Haywood Rheumatology Centre, Stoke-on-Trent, UK; D.R. Jadon, MBBCh, MRCP, PhD, University of Cambridge, Cambridge, UK; M. Massarotti, MD, Department of Rheumatology, University Hospitals Dorset NHS Foundation Trust, Christchurch, New Zealand; M. Brook, Patient Research Partner, Royal National Hospital for Rheumatic Diseases, Bath, UK; S. Lane, MBChB, MD, FRCP, Ipswich Hospital NHS Trust, Ipswich; P. Creamer, MBChB, North Bristol NHS Foundation Trust, Bristol, UK; A. Antony, MBBS, School of Clinical Sciences, Monash University, Australia;1E. Korendowych, PhD, MRCP, Royal National Hospital for Rheumatic Diseases, Bath, UK; A. Rambojun, PhD, Department of Pharmacy and Pharmacology, University of Bath, Bath, UK; P.S. Helliwell, MD, PhD, Professor of Clinical Rheumatology, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds, UK. SL has received sponsorship for the European Alliance of Associations for Rheumatology (EULAR) and the American College of Rheumatology conferences in 2020, both from AbbVie, and in 2019 for the EULAR conference in Madrid from Celgene, but no commercial work for any organizations. All other authors declare no conflicts of interest. Address correspondence to Dr. W. Tillett, Department of Rheumatology, Royal National Hospital for Rheumatic Diseases, Coombe Park, Bath BA1 3NG, UK. Email: w.tillett@nhs.net.
Neil J. McHugh
As part of the supplement series GRAPPA 2020, this report was reviewed internally and approved by the Guest Editors for integrity, accuracy, and consistency with scientific and ethical standards. This report is independent research funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research (Early detection to improve outcome in patients with undiagnosed PsA [PROMPT], RP-PG-1212-20007). The views expressed are those of the authors and are not necessarily those of the NIHR or the Department of Health and Social Care. W. Tillett, BSc, MBChB, PhD, FRCP, N.J. McHugh, MBChB, MD, FRCP, FRCPath, Department of Pharmacy and Pharmacology, University of Bath, and Royal National Hospital for Rheumatic Diseases, Bath, UK; O. FitzGerald, MD, FRCPI, FRCP, Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland; L.C. Coates, MBChB, PhD, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; J. Packham, DM, FRCP, Haywood Rheumatology Centre, Stoke-on-Trent, UK; D.R. Jadon, MBBCh, MRCP, PhD, University of Cambridge, Cambridge, UK; M. Massarotti, MD, Department of Rheumatology, University Hospitals Dorset NHS Foundation Trust, Christchurch, New Zealand; M. Brook, Patient Research Partner, Royal National Hospital for Rheumatic Diseases, Bath, UK; S. Lane, MBChB, MD, FRCP, Ipswich Hospital NHS Trust, Ipswich; P. Creamer, MBChB, North Bristol NHS Foundation Trust, Bristol, UK; A. Antony, MBBS, School of Clinical Sciences, Monash University, Australia;1E. Korendowych, PhD, MRCP, Royal National Hospital for Rheumatic Diseases, Bath, UK; A. Rambojun, PhD, Department of Pharmacy and Pharmacology, University of Bath, Bath, UK; P.S. Helliwell, MD, PhD, Professor of Clinical Rheumatology, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds, UK. SL has received sponsorship for the European Alliance of Associations for Rheumatology (EULAR) and the American College of Rheumatology conferences in 2020, both from AbbVie, and in 2019 for the EULAR conference in Madrid from Celgene, but no commercial work for any organizations. All other authors declare no conflicts of interest. Address correspondence to Dr. W. Tillett, Department of Rheumatology, Royal National Hospital for Rheumatic Diseases, Coombe Park, Bath BA1 3NG, UK. Email: w.tillett@nhs.net.
Philip S. Helliwell
As part of the supplement series GRAPPA 2020, this report was reviewed internally and approved by the Guest Editors for integrity, accuracy, and consistency with scientific and ethical standards. This report is independent research funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research (Early detection to improve outcome in patients with undiagnosed PsA [PROMPT], RP-PG-1212-20007). The views expressed are those of the authors and are not necessarily those of the NIHR or the Department of Health and Social Care. W. Tillett, BSc, MBChB, PhD, FRCP, N.J. McHugh, MBChB, MD, FRCP, FRCPath, Department of Pharmacy and Pharmacology, University of Bath, and Royal National Hospital for Rheumatic Diseases, Bath, UK; O. FitzGerald, MD, FRCPI, FRCP, Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland; L.C. Coates, MBChB, PhD, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; J. Packham, DM, FRCP, Haywood Rheumatology Centre, Stoke-on-Trent, UK; D.R. Jadon, MBBCh, MRCP, PhD, University of Cambridge, Cambridge, UK; M. Massarotti, MD, Department of Rheumatology, University Hospitals Dorset NHS Foundation Trust, Christchurch, New Zealand; M. Brook, Patient Research Partner, Royal National Hospital for Rheumatic Diseases, Bath, UK; S. Lane, MBChB, MD, FRCP, Ipswich Hospital NHS Trust, Ipswich; P. Creamer, MBChB, North Bristol NHS Foundation Trust, Bristol, UK; A. Antony, MBBS, School of Clinical Sciences, Monash University, Australia;1E. Korendowych, PhD, MRCP, Royal National Hospital for Rheumatic Diseases, Bath, UK; A. Rambojun, PhD, Department of Pharmacy and Pharmacology, University of Bath, Bath, UK; P.S. Helliwell, MD, PhD, Professor of Clinical Rheumatology, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, Leeds, UK. SL has received sponsorship for the European Alliance of Associations for Rheumatology (EULAR) and the American College of Rheumatology conferences in 2020, both from AbbVie, and in 2019 for the EULAR conference in Madrid from Celgene, but no commercial work for any organizations. All other authors declare no conflicts of interest. Address correspondence to Dr. W. Tillett, Department of Rheumatology, Royal National Hospital for Rheumatic Diseases, Coombe Park, Bath BA1 3NG, UK. Email: w.tillett@nhs.net.
Abstract
Objective To test the addition of pain and fatigue to the Composite Psoriatic Arthritis Disease Activity (CPDAI) and the Group for Research and Assessment of Psoriasis and PsA (GRAPPA) Composite Exercise (GRACE) composite measures of psoriatic arthritis (PsA).
Methods Clinical and patient-reported outcome measures were assessed in patients with PsA at 3 consecutive follow-up visits over 6 months in a UK multicenter observational study. A pain visual analog scale and Functional Assessment of Chronic Illness Therapy Fatigue scale were added as modifications to the CPDAI and GRACE composite measures. Original and modified versions were tested against the PsA Disease Activity Score (PASDAS) and the Disease Activity Index for PsA (DAPSA). Discrimination between disease states and responsiveness were tested with t-scores, standardized response means (SRMs), and effect sizes. Data were presented to members at the 2020 annual meeting who then voted on the GRAPPArecommended composite and treatment targets for clinical trials.
Results One hundred forty-one patients were recruited with a mean PsA disease duration of 6.1 years (range 0–41 yrs). The SRMs for the GRACE and modified GRACE (mGRACE) were 0.67 and 0.64, respectively, and 0.54 and 0.46, respectively, for the CPDAI and modified CPDAI (mCPDAI). The t-scores for the GRACE and mGRACE were unchanged at 7.8 for both, and 6.8 and 7.0 for the CPDAI and mCPDAI, respectively. The PASDAS demonstrated the best responsiveness (SRM 0.84) and discrimination (t-scores 8.3). Most members (82%) agreed the composites should not be modified and 77% voted for the PASDAS as the GRAPPA-recommended composite for clinical trials, with 90% minimal disease activity (MDA) as the target.
Conclusion Modifying the CPDAI and GRACE with the addition of pain and fatigue does not enhance responsiveness nor the measures’ ability to detect disease status in terms of requiring treatment escalation. GRAPPA members voted for the PASDAS as the composite measure in clinical trials and MDA as the target.
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In this issue
The Journal of Rheumatology
Vol. 48, Issue 4
1 Apr 2021
Composite Measures for Clinical Trials in Psoriatic Arthritis: Testing Pain and Fatigue Modifications in a UK Multicenter Study
William Tillett, Oliver FitzGerald, Laura C. Coates, Jon Packham, Deepak R. Jadon, Marco Massarotti, Mel Brook, Suzanne Lane, Paul Creamer, Anna Antony, Eleanor Korendowych, Adwaye Rambojun, Neil J. McHugh, Philip S. Helliwell
The Journal of Rheumatology Mar 2021, jrheum.201674; DOI: 10.3899/jrheum.201674
Composite Measures for Clinical Trials in Psoriatic Arthritis: Testing Pain and Fatigue Modifications in a UK Multicenter Study
William Tillett, Oliver FitzGerald, Laura C. Coates, Jon Packham, Deepak R. Jadon, Marco Massarotti, Mel Brook, Suzanne Lane, Paul Creamer, Anna Antony, Eleanor Korendowych, Adwaye Rambojun, Neil J. McHugh, Philip S. Helliwell
The Journal of Rheumatology Mar 2021, jrheum.201674; DOI: 10.3899/jrheum.201674
