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A somatization comorbidity phenotype impacts response to therapy in rheumatoid arthritis: post-hoc results from the certolizumab pegol phase 4 PREDICT trial

Authors
  • Curtis, Jeffrey R.1
  • Herrem, Christopher2
  • Ndlovu, ’Matladi N.3
  • O’Brien, Cathy3
  • Yazici, Yusuf4
  • 1 University of Alabama at Birmingham, Division of Clinical Immunology and Rheumatology, FOT 802, 510 20th Street South, Birmingham, AL, 35294, USA , Birmingham (United States)
  • 2 Mylan, 1000 Mylan Blvd, Canonsburg, PA, 15317, USA , Canonsburg (United States)
  • 3 UCB Pharma, Allée de la Recherche 60, Brussels, 1070, Belgium , Brussels (Belgium)
  • 4 NYU Hospital for Joint Diseases, New York University School of Medicine, 301 East 17th Street, New York, NY, 10003, USA , New York (United States)
Type
Published Article
Journal
Arthritis Research & Therapy
Publisher
Springer Science and Business Media LLC
Publication Date
Sep 29, 2017
Volume
19
Issue
1
Identifiers
DOI: 10.1186/s13075-017-1412-z
Source
Springer Nature
Keywords
License
Green

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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