LONG-TERM BENEFITS OF 4-WEEKLY CERTOLIZUMAB PEGOL COMBINATION AND MONOTHERAPY ON HOUSEHOLD PRODUCTIVITY AND SOCIAL PARTICIPATION IN RHEUMATOID ARTHRITIS- 5 YEAR RESULTS FROM AN OPEN LABEL EXTENSION STUDY

Author(s)

Strand V1, Purcaru O2, van Vollenhoven R3, Choy E4, Fleischmann R51Stanford University, Palo Alto, CA, USA, 2UCB Pharma, Brussels, Belgium, 3Karolinska University Hospital, Stockholm, Sweden, 4Cardiff University School of Medicine, Cardiff, United Kingdom, 5Metroplex Clinical Research Center, Dallas, TX, USA

OBJECTIVES: The current analysis evaluates the long-term impacts on household productivity and social participation of CZP 400mg Q4W combination and monotherapy over 5 years. METHODS: In this open-label extension (OLE) (NCT00160693) patients (pts) originally enrolled in FAST4WARD (NCT00548834) or study 014 (NCT00544154) received CZP 400 mg Q4W for 24 wks. Pts who completed or withdrew on/after Wk12 in either study were eligible and were permitted to take DMARDs in OLE. Household productivity and social participation were assessed through the RA-specific Work Productivity Survey (WPS-RA); results are reported up to Wk268 (5.2yrs). The analyzed population consisted of (1) Wk 24 CZP completers from FAST4WARD (N=75) or 014 (N=96) who entered the OLE (all pts group) and (2) FAST4WARD CZP completers who entered OLE and did not receive MTX/DMARDs (N=48) (monotherapy subgroup).  RESULTS: In both populations analyzed, a rapid reduction in the number of days of household work days missed per month was seen from feeder study baseline (BL, 7.4 and 11.1 mean days respectively) over 24wks of the feeder studies to OLE entry (3.5 and 4.1 mean days respectively) and continued to decline over time, up to Week 268 (1.2 and 1.4 mean days respectively). Increased participation in family/social/leisure activities was reported in both populations, with a decrease in the number of days missed per month from feeder study baseline (4.4 and 6.2 mean days, respectively), to entry to OLE, at a mean of 1.3 and 1.1 days respectively for monotherapy pts; improvements continued over the 5 years to 0.4 and 0.2 days on average in the 2 populations respectively. CONCLUSIONS: CZP treatment, in combination with MTX/DMARDs or as monotherapy, rapidly decreased the number of household work or social/family/leisure days missed per month. These improvements were maintained up to 5 years with open-label CZP following 24 wks double-blind CZP therapy.

Conference/Value in Health Info

2012-11, ISPOR Europe 2012, Berlin, Germany

Value in Health, Vol. 15, No. 7 (November 2012)

Code

PMS67

Topic

Economic Evaluation

Topic Subcategory

Work & Home Productivity - Indirect Costs

Disease

Musculoskeletal Disorders

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