LONG-TERM MAINTENANCE OF IMPROVEMENTS IN PATIENT-REPORTED OUTCOMES WITH CERTOLIZUMAB PEGOL IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS, INCLUDING ANKYLOSING SPONDYLITIS AND NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS- 96-WEEK RESULTS OF THE RAPID ...
Author(s)
Sieper J1, Kivitz A2, van Tubergen A3, Deodhar A4, Szegvari B5, Nurminen T6, Landewé R7
1University Hospital Charité, Berlin, Germany, 2Altoona Center for Clinical Research, Duncansville, PA, USA, 3Maastricht University Medical Center, Maastricht, The Netherlands, 4Oregon Health and Science University, Portland, OR, USA, 5UCB Pharma, Brussels, Belgium, 6UCB Pharma, Monheim, Germany, 7Amsterdam and Atrium Medical Center, Heerlen, The Netherlands
OBJECTIVES To report the effect of certolizumab pegol (CZP), a PEGylated Fc-free anti-TNF, on patient-reported outcomes (PROs) in axial spondyloarthritis (axSpA), including ankylosing spondylitis (AS) and non-radiographic axSpA (nr-axSpA), over 96 weeks (wks) of the RAPID-axSpA trial. METHODS The RAPID-axSpA trial (NCT01087762) is double-blind and placebo-controlled to Wk24, dose-blind to Wk48, and open-label to Wk204. Patients fulfilled ASAS criteria and had active axSpA. Patients originally randomized to CZP (200mg Q2W or 400mg Q4W, following 400mg loading dose at Wks 0, 2, 4) continued on their assigned dose in the dose-blind phase and OLE. Here we report PRO data for the CZP-treated randomized set, including mean change from baseline and the proportion of patients achieving a Minimal Clinically Important Difference (MCID). Missing data were imputed by LOCF. Correlations between clinical and patient-reported outcomes were also investigated. RESULTS Of 218 patients randomized to CZP, 203 (93%) completed Wk24, 191 (88%) Wk48, and 174 (80%) Wk96. Rapid improvements from baseline to Wk24 were maintained to Wk96 in all patient subpopulations (overall axSpA, AS, nr-axSpA) in pain (Wk24: -3.2,-3.2,-3.3; Wk96: -3.6,-3.6,-3.7); fatigue (Wk24: -2.7,-2.5,-2.9; Wk96: -2.9,-2.8,-3.1); BASFI (Wk24: -2.4,-2.3,-2.4; Wk96: -2.6,-2.6,-2.6); ASQoL (Wk24: -5.1,-4.8,-5.5; Wk96: -5.7,-5.5,-6.1) and sleep (Wk24: -12.8,-10.5,-15.7; Wk96: -13.9,-11.6,-16.7). CZP-treated patients also maintained improvements in SF-36 components and domains. Sustained improvements in the proportion of patients (overall axSpA, AS, nr-axSpA) achieving MCID (%) were observed in fatigue (Wk24: 78.4,76.0,81.4; Wk96: 67.0,70.2,62.9); BASFI (Wk24: 67.4,68.6,66.0; Wk96: 64.2,68.6,58.8) and ASQoL (Wk24: 69.3,71.1,67.0; Wk96: 65.6,66.9,63.9). Similar outcomes were seen with both dosing regimens. Correlations were observed between improvements in PROs (pain/fatigue/SF-36) and clinical outcomes (ASDAS) (data not shown). CONCLUSIONS Improvements in PROs (including pain, fatigue and ASQoL) were maintained over 96 wks in both the AS and nr-axSpA subpopulations. Sustained improvements in the proportion of patients achieving MCID were also reported.
Conference/Value in Health Info
2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands
Value in Health, Vol. 17, No. 7 (November 2014)
Code
PMS73
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Musculoskeletal Disorders