CERTOLIZUMAB PEGOL IS ASSOCIATED WITH LONG-TERM IMPROVEMENTS IN PATIENT-REPORTED OUTCOMES IN AXIAL SPONDYLOARTHRITIS PATIENTS, INCLUDING ANKYLOSING SPONDYLITIS AND NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS- 4-YEAR OUTCOMES FROM THE RAPID-AXS ...
Author(s)
Sieper J1, Kivitz A2, van Tubergen A3, Deodhar A4, Harris K5, Nurminen T6, Landewé R7
1Charité – University Medicine Berlin, 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, 7Zuyderland Medical Center, Heerlen, The Netherlands
OBJECTIVES: To investigate whether early improvements in patient-reported outcomes (PROs) observed with certolizumab pegol (CZP) treatment were maintained over 4 years in the RAPID-axSpA trial of axial spondyloarthritis (axSpA) patients, including ankylosing spondylitis (AS) and non-radiographic axSpA (nr-axSpA). METHODS: The RAPID-axSpA trial (NCT01087762) was double-blinded and placebo-controlled to Week (Wk)24, dose-blinded to Wk48, and open-label to Wk204. Patients fulfilled ASAS criteria and had active axSpA. Patients originally randomized to CZP (200mg every 2 wks or 400mg every 4 wks) continued assigned dose in open-label period. Outcomes reported include total back pain, fatigue, BASFI, ASQoL, and Sleep Problems Index II domain of Medical Outcomes Study Sleep Scale (MOS-SPI). PRO data are reported for patients randomized to CZP at Wk0 (combined doses) as mean change from baseline, imputed by last observation carried forward. RESULTS: Of 218 axSpA patients randomized to CZP at Wk0 (121 AS; 97 nr-axSpA), 203 (93%) completed Wk24 and 142 (65%) Wk204. Rapid improvements from baseline to Wk24 were maintained over 4 years (to Wk204) in total back pain (Wk24: -3.2; Wk204: -3.7), fatigue (Wk24: -2.7; Wk204: -3.1), BASFI (Wk24: -2.4; Wk204: -2.7), ASQoL (Wk24: -5.1; Wk204: -5.9), and MOS-SPI (Wk24: -12.8; Wk204: -14.6). Responses were similar in AS and nr-axSpA patients in all PROs assessed, including total back pain (Wk24: -3.2, -3.3; Wk204: -3.6, -3.8), fatigue (Wk24: -2.6, -2.9; Wk204: -3.0, -3.3), BASFI (Wk24: -2.3, -2.4; Wk204: -2.6, -2.7), ASQoL (Wk24: -4.8, -5.5; Wk204: -5.7, -6.3), and MOS-SPI (Wk24: -10.5, -15.7; Wk204: -12.7, -16.9; data shown for AS and nr-axSpA, respectively). Similar outcomes were also seen with both CZP dose regimens. CONCLUSIONS: Early improvements in axSpA patients, observed to Wk24 in all PROs assessed, were subsequently maintained over 4 years of CZP treatment to Wk204. Similar maintained improvements were observed in both the AS and nr-axSpA subpopulations.
Conference/Value in Health Info
2016-10, ISPOR Europe 2016, Vienna, Austria
Value in Health, Vol. 19, No. 7 (November 2016)
Code
PSY114
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Systemic Disorders/Conditions