Artikel
Quality of Life in Patients with Active Nonradiographic Axial Spondyloarthritis after 16 Weeks of Golimumab Treatment
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Autoren
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Walter Maksymowych
- University of Alberta, Edmonton, Canada
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Maxime Dougados
- Hôpital Cochin, Department of Rheumatology, Paris, France
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Joachim Sieper
- Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektologie, Rheumatologie, Berlin
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Sean Curtis
- Merck & Co., Inc., Whitehouse Station, NJ, USA
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Gina Bergman
- Merck & Co., Inc., Whitehouse Station, NJ, USA
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Susan Huyck
- Merck & Co., Inc., Whitehouse Station, NJ, USA
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Anjela Tzontcheva
- Merck & Co., Inc., Whitehouse Station, NJ, USA
| Veröffentlicht: | 29. August 2016 |
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Gliederung
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Background: The purpose was to determine whether golimumab (GLM) is superior to placebo (PBO) in improving the Quality of Life (QoL) of patients with nonradiographic axial spondyloarthritis (nr-axSpA).
Methods: GO-AHEAD was a double-blind, randomized, PBO-controlled trial of GLM in patients with active nr-axSpA (ASAS-criteria and centrally read sacroiliac joint X-rays and MRI; disease duration ≤5years; chronic back pain; high disease activity [total back pain ≥40mm on a 0–100mm VAS and BASDAI ≥4cm]; and inadequate response/intolerance to NSAIDs). Patients were randomized 1:1 to SC GLM 50mg or PBO every 4 wk. Secondary outcomes related to QoL included the 36-item Short Form Health Survey (SF-36), Ankylosing Spondylitis QoL (ASQoL), EuroQoL 5-Dimension (EQ-5D) Index and Health State (0–10cm VAS), and Work Productivity and Activity Impairment (WPAI) questionnaire scores at wk16. Treatment group differences for all patients and for the objective signs of inflammation (OSI) population (baseline inflammation by centrally evaluated SI MRI and/or elevated CRP) were compared using a constrained longitudinal data-analysis for continuous endpoints and Mann-Whitney test for WPAI scores.
Results: Of 197 treated patients (GLM=97; PBO=100), mean age was 31 years; 57% were male. At wk16, GLM-treated-patients had greater improvements from baseline QoL than PBO-treated-patients measured by ASQoL, EQ-5D, and SF-36 (Table 1 [Tab. 1]). GLM-patients also had greater improvements in percentages of WPAI overall work impairment (–21.1 vs –11.7, P=.0391) and activity impairment (–24.9 vs –8.6, P<.0001); impairment while working and work-time missed were not significantly different. Results for QoL and WPAI measures were similar in the OSI population, except that patients in the GLM-group also had greater improvements in percentage of impairment while working (P=.0194).
Conclusion: GLM-treated-patients with active nr-axSpA had greater improvement in QoL and work-productivity outcomes at wk16 than PBO-treated-patients.
