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Rapid and Sustained Improvement in Health-Related Quality of Life and Utility for 72 Weeks in Patients with Ankylosing Spondylitis Receiving Etanercept ANNELIES BOONEN, VAISHALI PATEL, SHANA TRAINA, CHIUN-FANG CHIOU, ANDREAS MAETZEL, and WAYNE TSUJI
ABSTRACT. Methods. Patients completing a 24-week placebo-controlled trial were continued on ETN in a 72-week open-label extension study. Short Form-36 (SF-36), EuroQOL-5D (EQ-5D), and EuroQOL visual analog scale (EQ-VAS) scores were collected at open-label baseline and every 12 weeks thereafter. Mental and physical component scores (MCS and PCS) of the SF-36, EQ-5D and SF-6D utility scores, and quality-adjusted life-years (QALY) were calculated. Results. 257 patients [129 previous placebo (PLA) and 128 ETN recipients] enrolled in this open-label extension study, and 85% completed the 72-week followup. PCS, EQ-5D and SF-6D utilities, and EQ-VAS were significantly lower at open-label baseline in the previous PLA group (PLA/ETN group) than in the previous ETN group (ETN/ETN group; all p < 0.001). At week 12, PCS and MCS, EQ-5D and SF-6D utility scores, and EQ-VAS were similar in the PLA/ETN and ETN/ETN groups. As expected, mean change in EQ-5D in the PLA/ETN group was significantly greater than that for SF-6D (0.18 vs 0.06; p < 0.0001). HRQOL and utility improvements were maintained in both groups for up to 72 weeks. The average 72-week QALY gain per person in the PLA/ETN group was 0.24 and 0.10 for EQ-5D and SF-6D, respectively. Conclusion. Patients continuing ETN therapy sustained HRQOL and utility improvements attained during the original PLA-controlled trial. Patients previously taking PLA showed rapid and sustained improvements in HRQOL and utility and substantial QALY gain with ETN therapy. (J Rheumatol First Release Feb 15 2008) Keyword Indexing Terms:
ANKYLOSING SPONDYLITIS
From the Department of Internal Medicine, Division of Rheumatology, University Hospital Maastricht, Maastricht, The Netherlands; Amgen Inc., Thousand Oaks, California, USA; and Amgen (Europe) GmbH, Zug, Switzerland. Funded by Immunex Corporation, a wholly owned subsidiary of Amgen Inc., and by Wyeth Research. A. Boonen, MD, PhD; Department of Internal Medicine, Division of Rheumatology, University Hospital Maastricht; V. Patel, PharmD; S. Traina, PhD; C-F. Chiou, PhD; W. Tsuji, MD, Amgen Inc.; A. Maetzel, MD, MSc, PhD, Amgen (Europe) GmbH. Address reprints to Dr. A. Boonen, Department of Internal Medicine, Division of Rheumatology, University Hospital Maastricht, PO Box 5800, 6202 AZ Maastricht, The Netherlands. E-mail: aboo@sint.azm.nl Accepted for publication November 8, 2007.
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