RAPID IMPROVEMENTS IN PATIENT REPORTED OUTCOMES WITH CERTOLIZUMAB PEGOL IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS, INCLUDING ANKYLOSING SPONDYLITIS AND NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS- 24 WEEK RESULTS OF A PHASE 3 DOUBLE BLIND RANDO ...

Author(s)

Sieper J1;Kivitz A2;van Tubergen A3;Deodhar A4;Coteur G*5;Woltering F6, Landewé R7 1Univ Hospital Charité, Berlin, Germany, 2Altoona Center for Clinical Research, Duncansville, PA, USA, 3Maastricht University Medical Center, Maastricht, Netherlands, 4Oregon Health and Science University, Portland, OR, USA, 5UCB Pharma, Brussels, Belgium, 6UCB Pharma, Monheim, Germany, 7Amsterdam and Atrium Medical Center, Heerlen, Netherlands

OBJECTIVES: RAPID-axSpA (NCT01087762) investigated the impact of certolizumab pegol (CZP) on patient reported outcomes (PRO) in axial spondyloarthritis (axSpA), including ankylosing spondylitis (AS) and non-radiographic axSpA (nr-axSpA, axSpA with no definitive sacroiliitis on X-ray). METHODS: The ongoing 158-week (Wk) RAPID-axSpA trial was double blind and placebo-controlled to Wk24. Recruited patients had adult-onset active axSpA, including AS and nr-axSpA. Patients were randomized 1:1:1 to placebo, or 400mg CZP at Wk0, two and four followed by either 200mg CZP every two weeks (Q2W) or 400mg CZP every four weeks (Q4W). PRO endpoints included, physical function (BASFI), total spinal pain, daily pain diary to Wk4, fatigue (from BASDAI), Ankylosing Spondylitis Quality of Life (AsQoL), Sleep Problems Index II domain of the MOS Sleep scale, and SF-36. Change from baseline in PRO was analyzed in full analysis set with LOCF imputation. RESULTS: A total of 325 patients were randomized. Baseline characteristics were similar between groups. Compared to placebo, improvements at Wk24 in CZP 200mg Q2W and 400mg Q4W treated groups were observed in pain (-1.3 vs. -3.3 and -3.2), fatigue (-0.9 vs. -2.6 and -2.8), BASFI (-0.5 vs. -2.4 and -2.2) and AsQoL (-1.7 vs. -5.1 and -5.1). Improvements were seen from Wk1, and in spinal pain from day 2. CZP-treated patients also had greater improvements in sleep, and SF-36 components and domains. More CZP patients reached population norms for SF-36. CZP impact on pain, fatigue and AsQoL in AS and nr-axSpA patients was similar. Relative to placebo, CZP-treated nr-axSpA patients demonstrated greater improvements in BASFI and sleep compared to AS, and were more likely to reach population norms for SF-36. CONCLUSIONS: Both dosing regimens of CZP rapidly improved all PRO including pain, fatigue, physical function and QoL of axSpA, in both AS and nr-axSpA patients.

Conference/Value in Health Info

2013-05, ISPOR 2013, New Orleans, LA, USA

Value in Health, Vol. 16, No. 3 (May 2013)

Code

PMS50

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Musculoskeletal Disorders

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