Trial reportArthritis research & therapy2017
A somatization comorbidity phenotype impacts response to therapy in rheumatoid arthritis: post-hoc results from the certolizumab pegol phase 4 PREDICT trial.
Trial report in Arthritis research & therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01255761 (Phase 4, Randomized, 52-Week Study To Evaluate Two Assessment Tools To Predict Treatment Success At 52 Weeks Based On A Treatment Decision At Week 12 In Subjects With Moderate To Severe Rheumatoid Arthritis Receiving Cimzia), which is not on this map. Cited by 10 papers.
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Phase 4, Randomized, 52-Week Study To Evaluate Two Assessment Tools To Predict Treatment Success At 52 Weeks Based On A Treatment Decision At Week 12 In Subjects With Moderate To Severe Rheumatoid Arthritis Receiving Cimzia
Who cites it
10 citing papers in PubMed.
- Trial
- Beyond Joints: Neuropsychiatric Benefits of TNF-α and IL-6 Inhibitors in Rheumatoid Arthritis-Narrative Review.International journal of molecular sciences · 2025Review
- Pathogenic Crosstalk Between the Peripheral and Central Nervous System in Rheumatic Diseases: Emerging Evidence and Clinical Implications.International journal of molecular sciences · 2025Review
- Influence of Multimorbidity on New Treatment Initiation and Achieving Target Disease Activity Thresholds in Active Rheumatoid Arthritis: A Cohort Study Using the Rheumatology Informatics System for Effectiveness Registry.Arthritis care & research · 2023Article
- Identification of Multimorbidity Patterns in Rheumatoid Arthritis Through Machine Learning.Arthritis care & research · 2023Article
- Machine Learning Applied to Patient-Reported Outcomes to Classify Physician-Derived Measures of Rheumatoid Arthritis Disease Activity.ACR open rheumatology · 2022Article
- Exposure-Response Relationship of Certolizumab Pegol and Achievement of Low Disease Activity and Remission in Patients With Rheumatoid Arthritis.Clinical and translational science · 2020Article
- Fibromyalgia interferes with disease activity and biological therapy response in inflammatory rheumatic diseases.Rheumatology international · 2020Review
- Uptake and Clinical Utility of Multibiomarker Disease Activity Testing in the United States.The Journal of rheumatology · 2019Article
- Response to: "A somatization comorbidity phenotype impacts response to therapy in rheumatoid arthritis: post hoc results from the certolizumab pegol phase 4 PREDICT trial".Arthritis research & therapy · 2019Article
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5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundComorbidities may contribute to disease activity and treatment response in rheumatoid arthritis (RA) patients. We defined a somatization comorbidity phenotype (SCP) and examined its influence on response to certolizumab pegol (CZP) using data from the PREDICT trial.
methodsPatients in PREDICT were randomized to the patient-reported Routine Assessment of Patient Index Data 3 (RAPID3) or physician-based Clinical Disease Activity Index (CDAI) for treatment response assessment. Post-hoc analyses identified patients with the SCP, which included diagnosis of depression, fibromyalgia/myalgias, and/or use of medications indicated for treatment of depression, anxiety, or neuropathic pain. The effect of the SCP on RAPID3 or CDAI response at week 12 and low disease activity (LDA; Disease Activity Score in 28 joints based on erythrocyte sedimentation rate ≤ 3.2) at week 52, in week-12 responders, was analyzed using non-parametric analysis of covariance (ANCOVA).
resultsAt baseline, 43% (313/733) of patients met the SCP classification. Patients with the SCP were 9% more likely to withdraw from the trial. American College of Rheumatology 20% (ACR20), ACR50, and ACR70 responses were 5-14% lower among those with the SCP, and 11% more patients reported adverse events (AEs). Patients without SCP in the CDAI arm were twice as likely to achieve LDA at week 52 compared with those with SCP (32% versus 16%). No differentiation by SCP was observed in the RAPID3 arm (pooled result 21.5%).
conclusionsWe operationalized a potentially important somatization comorbidity phenotype in a trial setting that was associated with a substantially lower likelihood of treatment response and a higher frequency of AEs. Including large numbers of patients with this phenotype in RA trials may reduce the measured clinical effectiveness of a new molecule.
trial registrationClinicalTrials.gov, NCT01255761 . Registered on 6 December 2010.
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