TY - JOUR
T1 - Impact of certolizumab pegol on patient-reported outcomes in rheumatoid arthritis and correlation with clinical measures of disease activity
AU - Pope, Janet
AU - Bingham, Clifton O.
AU - Fleischmann, Roy M.
AU - Dougados, Maxime
AU - Massarotti, Elena M.
AU - Wollenhaupt, Jürgen
AU - Duncan, Benjamin
AU - Coteur, Geoffroy
AU - Weinblatt, Michael E.
N1 - Funding Information:
The authors thank the patients, as well as the investigators and their teams who took part in this study. The authors also thank all site participants for their contributions to the study. The authors acknowledge ‘Matladi N. Ndlovu, PhD, UCB Pharma, Brussels, Belgium, for publication management and Costello Medical Consulting, Cambridge, UK, for editorial and administrative assistance, which was funded by UCB Pharma. The following ethics committees that approved the study: Capital Health, Halifax, NS, Canada; CEIC Hospital Clinic I Provincial, Barcelona, Spain; CHU Pontchaillou, Rennes, France; College of Physicians and Surgeons of Alberta, Edmonton, AB, Canada; Comitato Etico locale per Sperimentazione Clinica dei Medicinali Azienda Ospedaliera Universitaria Senese, Siena, Italy; Commissie Medische Ethiek, Leiden, the Netherlands; Conjoint Health Research Ethics Board, Calgary, AB, Canada; Ethikkommission der Ärztekammer Hamburg, Hamburg, Germany; Hôpital Maisonneuve-Rosemont, Montreal, QC, Canada; Institutional Board of Research Associates, New York, NY, USA; Indiana University–Purdue University (IUPUI) Clarian Institutional Review Board, Indianapolis, IN, USA; Johns Hopkins Office of Human Subjects Research Institutional Review Board, Baltimore, MD, USA; Loyola University Medical Center, May-wood, IL, USA; Mayo Foundation Institutional Review Board, Rochester, MN, USA; McGuire Institutional Review Board, Richmond, VA, USA; Mount Sinai Hospital, Toronto, ON, Canada; Oklahoma Medical Research Foundation, Oklahoma City, OK, USA; Partners Human Research Committee, Boston, MA, USA; Quorum Review, Seattle, WA, USA; Robert Wood Johnson Medical School, New Brunswick, NJ, USA; St. Joseph’s Mercy Health Center, Hot Springs, AZ, USA; St. Luke’s Institutional Review Board, Duluth, MN, USA; Sutter Health Central Area, Sacramento, CA, USA; Texas Health Resources Institutional Review Board, Arlington, TX, USA; University of Arizona, Tucson, AZ, USA; University of North Carolina, Chapel Hill, NC, USA; University of Texas, Houston, TX, USA; University of Western Ontario, London, ON, Canada; Thomas Jefferson University Institutional Review Board, Philadelphia, PA, USA; University of California San Diego, La Jolla, CA, USA; University Health Network, Toronto, ON, Canada; University of British Columbia, Vancouver, BC, Canada; University of Illinois College of Medicine at Peoria, Peoria, IL, USA; University of Manitoba Bannatyne Campus, Winnipeg, MB, Canada; University of North Texas Health Science Center, Fort Worth, TX, USA; University of Utah, Salt Lake City, UT, USA; Western Institutional Review Board, Olympia, WA, USA.
Publisher Copyright:
© 2015 Pope et al.
PY - 2015/11/27
Y1 - 2015/11/27
N2 - Introduction: The effect of certolizumab pegol (CZP) on patient-reported outcomes (PROs) was investigated in 1063 patients with rheumatoid arthritis (RA) from the REALISTIC trial (double-blind, placebo-controlled to week 12, open-label to week 28; randomized 4:1 [CZP:placebo]). Correlations between PROs and RA signs and symptoms, and the relative efficacy of these measures, were examined. Methods: Adults with RA and an inadequate response to at least one disease-modifying antirheumatic drug were enrolled. PROs assessed included physical function (using the Health Assessment Questionnaire-Disability Index), pain, fatigue, sleep disturbance, Patient Global Assessment of Disease Activity (PtGA), Routine Assessment of Patient Index Data 3 (RAPID3), and Rheumatoid Arthritis Disease Activity Index (RADAI). Results: Early significant and clinically meaningful improvements in all PROs were observed to week 12 with CZP vs. placebo and were maintained to the end of the trial (week 28). At week 12, up to one-third more CZP patients showed improvements compared with placebo that were greater than or equal to the minimal clinically important difference (MCID) in fatigue, sleep problems, pain, PtGA, RADAI, and RAPID3. The changes in PROs were correlated with clinical measures of disease activity, including the Disease Activity Score in 28 joints using C-reactive protein as well as tender and swollen joint counts. Conclusions: Rapid improvements in PROs were seen in patients with RA treated with CZP. The magnitude of improvement exceeded the MCID in multiple domains and demonstrated that CZP improves aspects of health-related quality of life that are meaningful to patients and superior to placebo. PROs provide information complementary to clinical outcomes in assessment of treatment benefits. Trial registration: ClinicalTrials.gov identifier: NCT00717236. Registered on 15 July 2008.
AB - Introduction: The effect of certolizumab pegol (CZP) on patient-reported outcomes (PROs) was investigated in 1063 patients with rheumatoid arthritis (RA) from the REALISTIC trial (double-blind, placebo-controlled to week 12, open-label to week 28; randomized 4:1 [CZP:placebo]). Correlations between PROs and RA signs and symptoms, and the relative efficacy of these measures, were examined. Methods: Adults with RA and an inadequate response to at least one disease-modifying antirheumatic drug were enrolled. PROs assessed included physical function (using the Health Assessment Questionnaire-Disability Index), pain, fatigue, sleep disturbance, Patient Global Assessment of Disease Activity (PtGA), Routine Assessment of Patient Index Data 3 (RAPID3), and Rheumatoid Arthritis Disease Activity Index (RADAI). Results: Early significant and clinically meaningful improvements in all PROs were observed to week 12 with CZP vs. placebo and were maintained to the end of the trial (week 28). At week 12, up to one-third more CZP patients showed improvements compared with placebo that were greater than or equal to the minimal clinically important difference (MCID) in fatigue, sleep problems, pain, PtGA, RADAI, and RAPID3. The changes in PROs were correlated with clinical measures of disease activity, including the Disease Activity Score in 28 joints using C-reactive protein as well as tender and swollen joint counts. Conclusions: Rapid improvements in PROs were seen in patients with RA treated with CZP. The magnitude of improvement exceeded the MCID in multiple domains and demonstrated that CZP improves aspects of health-related quality of life that are meaningful to patients and superior to placebo. PROs provide information complementary to clinical outcomes in assessment of treatment benefits. Trial registration: ClinicalTrials.gov identifier: NCT00717236. Registered on 15 July 2008.
KW - Biological therapy
KW - Certolizumab pegol
KW - PROs
KW - Rheumatoid arthritis
KW - TNF inhibitor
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U2 - 10.1186/s13075-015-0849-1
DO - 10.1186/s13075-015-0849-1
M3 - Article
C2 - 26614481
AN - SCOPUS:84948777260
SN - 1478-6354
VL - 17
JO - Arthritis Research and Therapy
JF - Arthritis Research and Therapy
IS - 1
M1 - 343
ER -