IMPACT OF CERTOLIZUMAB PEGOL (CZP) ON HEALTH-RELATED QUALITY OF LIFE (HRQOL)- RHEUMATOID ARTHRITIS (RA) PATIENTS APPROACH POPULATION US NORMS IN MENTAL HEALTH AND VITALITY DOMAINS

Author(s)

Strand V1, Fleischmann R2, Kvien TK3, Kavanaugh A4, Smolen J5, Wells AF6, Nikai E7, Coteur G7, Combe B81Stanford University, Portola Valley, CA, USA, 2Univeristy of Texas Southwestern Medical Center, Dallas, TX, USA, 3Diakonhjemmet Hospital, Oslo, Norway, 4University of California, San Diego, LaJolla, CA, USA, 5Medical University of Vienna, Vienna, Austria, 6Rosalind Franklin University of Medicine and Science, Oak Creek, WA, USA, 7UCB, Brussels, Belgium, 8Hopital Lapeyronie, Montpellier, France

OBJECTIVES: CZP 200 or 400mg Q2W + methotrexate (MTX) significantly improved HRQoL in patients with active RA over 1 year. Here we evaluated HRQoL in RA patients following long-term CZP+MTX treatment.   METHODS: Patients who completed 52 weeks treatment in RAPID 1 (completers) were eligible to enter an open-label (OL) study with CZP 400mg Q2W + MTX. HRQoL was assessed using the SF-36 Survey that includes 8 domains (physical functioning [PF], role physical [RP], bodily pain [BP], general health [GH], vitality [VT], social functioning [SF], role emotional [RE] and mental health [MH]) grouped into summary scores: Physical (PCS) and Mental (MCS). MCIDs are 2.5 points for PCS/MCS and 5 for domain scores. Mean changes from baseline in HRQoL were analysed in completers at Week 100; domain scores were compared with US population norms (age/gender matched).   RESULTS: CZP completers reported rapid and marked improvements in HRQoL at Weeks 12 (1st assessment) and 52 that were sustained to 100 weeks. Completers originally receiving CZP 200mg + MTX had mean PCS and MCS improvements of 7.2 and 8.8 points, respectively, at Week 12, 9.1 and 8.2 points at Week 52, and 10.1 and 7.7 points at Week 100; improvements were similar in patients originally receiving CZP 400mg + MTX. Improvements in RE, GH and MH were sustained following long-term OL treatment, and met or exceeded MCID in PF, RP, BP and VT, which had the largest decrements at baseline. After 100 weeks of CZP+MTX, BP, VT, SF and MH scores approached or met normative values.  CONCLUSIONS: CZP+MTX treatment results in rapid and clinically meaningful improvements in PCS, MCS and all SF-36 domains that were sustained over 2 years. BP, VT, SF and MH approached or met age/gender matched US population norms. Comparable benefits were reported in RA patients enrolled in both CZP treatment arms.

Conference/Value in Health Info

2009-10, ISPOR Europe 2009, Paris, France

Value in Health, Vol. 12, No. 7 (October 2009)

Code

PMS84

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Musculoskeletal Disorders

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