Routine Assessment of Patient Index Data 3 (RAPID3) in Patients with Rheumatoid Arthritis Treated with Long-Term Upadacitinib Therapy in Five Randomized Controlled Trials
Martin Bergman, Maya H. Buch, Yoshiya Tanaka, Gustavo Citera, Sami Bahlas, Ernest Wong, Yanna Song, Patrick Zueger, Mira Ali and Vibeke Strand
Published, Version of Record (VoR)CC BY-NC V4.0, Open
Abstract
Family Medicine General Practice Internal Medicine Medicine Medicine & Public Health NCT NCT02629159 NCT02675426 NCT02706847 NCT02706873 NCT02706951 Original Research Orthopedics Quality of Life Research Rheumatology
Introduction
The Routine Assessment of Patient Index Data 3 (RAPID3) is a patient-reported outcome tool recommended for the assessment of disease activity in patients with rheumatoid arthritis (RA) in clinical practice. This analysis evaluated the long-term effect of upadacitinib vs. comparators on RAPID3 scores in patients with RA in the phase 3 SELECT clinical trial program.
Methods
This post hoc analysis included data from five randomized controlled trials (RCTs) in patients receiving upadacitinib 15 mg or 30 mg once daily (QD) as monotherapy or in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). The proportions of patients reporting RAPID3 remission (scores ≤ 3) were assessed at week 60. Correlations between absolute scores for RAPID3 and Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI), and 28-joint Disease Activity Score with C-reactive protein (DAS28[CRP]) at week 60 were assessed using Spearman correlation coefficients.
Results
A total of 3117 patients were included from the SELECT-NEXT, -BEYOND, -MONOTHERAPY, -COMPARE, and -EARLY trials. By week 60, 32–52% of methotrexate-naïve and csDMARD inadequate responder (IR) patients treated with either upadacitinib 15 mg QD or upadacitinib 30 mg QD reported RAPID3 scores consistent with remission. The proportions were slightly lower in the biologic DMARD-IR SELECT-BEYOND population (19–28%). RAPID3 scores highly correlated (Spearman correlation values ≥ 0.58) with CDAI, SDAI, and DAS28(CRP) scores through week 60 (all
p
< 0.001).
Conclusions
Upadacitinib, as monotherapy or in combination with csDMARDs, was associated with patient-reported remission assessed by RAPID3 over 60 weeks across the SELECT RCTs in patients with RA.
Trial registration
SELECT-BEYOND (NCT02706847); SELECT-NEXT (NCT02675426); SELECT-MONOTHERAPY (NCT02706951); SELECT-EARLY (NCT02706873); SELECT-COMPARE (NCT02629159).
Plain Language Summary
Rheumatoid arthritis (RA) is a disease that causes inflammation of the joints. Doctors have several ways of assessing how bad a patient’s disease is, and these often use a combination of signs and symptoms to develop a ‘score’. One method is called RAPID3, which is a score based on an overall assessment of the disease by the patient, the level of pain, and the amount of physical disability. An advantage of RAPID3 is that it is quick and easy to use, and since it uses only patient-reported symptoms, it can be measured easily via telemedicine, without the need for an in-person consultation. In this study, we decided to look into the effect of upadacitinib, a drug used for the treatment of RA, on RAPID3 score in patients with RA. We also investigated whether RAPID3 correlates with other ways of measuring RA severity, including scores that use physician-measured factors such as number of affected joints, as this can help show whether RAPID3 is a valid and useful tool. We found that upadacitinib led to long-term improvements in RAPID3 score, and that results were the same in different studies and patient groups, including patients who had not responded well to other treatments. We also found that RAPID3 correlated well with other measures, i.e., improvements in RAPID3 happened in parallel with improvements in other scores. Overall, these results suggest that RAPID3 can be a useful tool in patients with RA.
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Details
Title
Routine Assessment of Patient Index Data 3 (RAPID3) in Patients with Rheumatoid Arthritis Treated with Long-Term Upadacitinib Therapy in Five Randomized Controlled Trials
Creators
Martin Bergman - Drexel University
Maya H. Buch - NIHR Manchester Biomedical Research Centre
Yoshiya Tanaka - University of Occupational and Environmental Health Japan
Gustavo Citera - Instituto Nacional de Rehabilitación Psicofísica
Sami Bahlas - King Abdulaziz University
Ernest Wong - Queen Alexandra Hospital
Yanna Song - AbbVie
Patrick Zueger - AbbVie
Mira Ali - AbbVie
Vibeke Strand - Stanford University
Publication Details
Rheumatology and therapy, v 9(6), pp 1517-1529
Publisher
Springer Healthcare
Grant note
AbbVie (http://dx.doi.org/10.13039/100006483)
Resource Type
Journal article
Language
English
Academic Unit
Medicine (Graduate)
Web of Science ID
WOS:000855641300001
Scopus ID
2-s2.0-85138357475
Other Identifier
991019173766004721
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