EARLY AND SUSTAINED REMISSION ASSOCIATED WITH NORMALIZED PHYSICAL FUNCTION AND HEALTH-RELATED QUALITY OF LIFE AND SIGNIFICANTLY IMPROVED PRODUCTIVITY IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS TREATED WITH GOLIMUMAB- TWO YEAR DATA FROM THE ...
Author(s)
Kavanaugh A1, McInnes I2, Krueger GG3, Gladman D4, Beutler A5, Gathany T6, Mudivarthy S7, Mack M7, Tandon N7, Han C6, Mease P81University of California, San Diego, LaJolla, CA, USA, 2University of Glasgow, Glasgow, United Kingdom, 3University of Utah, Sal
OBJECTIVES: Evaluate golimumab’s(GLM) impact on disease remission, physical function, work productivity and healthcare utilization in patients with psoriatic arthritis (PsA) over 2yrs. METHODS: In GO-REVEAL, 405 adults with active PsA were randomized to GLM(50 or 100 mg) q4wks or placebo. At wk16, patients with inadequate response entered early escape. All placebo-treated patients received GLM50mg from wk24. Clinical responses parameters included 20% improvement in American College of Rheumatology (ACR20) criteria, 75% improvement in Psoriasis Area and Severity Index(PASI75); a disease activity score (DAS28) <2.6 defined remission. Patient‑reported outcomes included health assessment questionnaire(HAQ), self-reported productivity and medical visits. Comparisons between GLM and placebo before wk24 employed ANOVA on van der Waerden normal scores (continuous outcomes) or Chi-square test (categorical). RESULTS: Baseline HAQ and PASI scores were 1.02 and 7.8. A greater proportion of GLM- than placebo-treated patients achieved DAS28 remission by wk4(16.3% vs. 3.6%, p<0.001) and wk14 (30.6% vs. 1.9%, p<0.001). Remission rates increased over time, exceeding 50% for GLM-treated patients at wk104. Greater proportions of GLM-treated patients achieved ACR20 and PASI75 responses, normalized HAQ (≤0.5) or health-related quality-of-life (HRQoL), or significantly improved work productivity versus placebo at wk14 (all p<0.01). These improvements were sustained through wks52 and 104. A greater proportion of patients achieving versus not achieving DAS28 remission also achieved normalized physical function or had significantly improved work productivity from baseline at wks52 and 104. Improvements in employability, time lost from work by patients and caregivers and healthcare utilization were observed at wks52 and 104, especially among patients achieving DAS28 remission. The overall GLM safety profile through wk104 was similar to other anti-TNFα agents indicated for PsA. CONCLUSIONS: GLM treatment induced early and sustained remission (DAS28<2.6), resulting in long-term improvements in physical function, QoL, and work productivity and reduced healthcare utilization, in PsA patients.
Conference/Value in Health Info
2011-05, ISPOR 2011, Baltimore, MD, USA
Value in Health, Vol. 14, No. 3 (May 2011)
Code
PMS66
Topic
Health Service Delivery & Process of Care
Topic Subcategory
Health Care Research
Disease
Musculoskeletal Disorders