Artikel
Long-Term Tolerability and Efficacy of Golimumab in Active Nonradiographic Axial Spondyloarthritis (nr-axSpA): Results from the Open-Label Extension of a Randomized, Double-Blind Study
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Autoren
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Desiree van der Heijde
- Leiden University Medical Center, Department of Rheumatology, Leiden, The Netherlands
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Maxime Dougados
- Hôpital Cochin, Department of Rheumatology, Paris, France
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Walter Maksymowych
- University of Alberta, Edmonton, Canada
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Joachim Sieper
- Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektologie, Rheumatologie, Berlin
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Gina Bergman
- Merck & Co., Inc., Whitehouse Station, NJ, USA
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Sean Curtis
- Merck & Co., Inc., Whitehouse Station, NJ, USA
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Anjela Tzontcheva
- Merck & Co., Inc., Whitehouse Station, NJ, USA
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Susan Huyck
- Merck & Co., Inc., Whitehouse Station, NJ, USA
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George Philip
- Merck & Co., Inc.,, Whitehouse Station, NJ, USA
| Veröffentlicht: | 29. August 2016 |
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Gliederung
Text
Background: We report the findings from an open-label-extension (OLE) of GO-AHEAD that evaluated the tolerability/efficacy of the long-term-use of golimumab (GLM) in patients with nr-axSpA.
Methods: Patients completing the 16-week GO-AHEAD-study were eligible to receive open-label GLM 50mg every 4 wks during the 44-wk-extension (36-wk-treatment period; 8-wk-safety-follow-up). Safety evaluations included the incidence/severity of AEs. Efficacy evaluations included ASAS20/40, BASDAI50, ASAS partial remission (PR; ≤20mm score in all 4 domains), and ASDAS-C at wks20, 24, 32, 40, and 52. QoL-evaluations included EQ-5D and WPAI at wks 16 and 52. Data were summarized descriptively; all patients were included. Non-responder-imputation was used for missing ASAS20/40, and ASAS PR values. BASDAI required 3 of 5 responses; LOCF-imputation was used for missing values. ASDAS-C was only calculated if all components were available.
Results: Of the 197 patients in GO-AHEAD, 189 entered the OLE (GLM/GLM, 93/97[96%]; PBO/GLM, 96/100[96%]). 174/189(92%) patients completed all visits (GLM/GLM, 85/93[91%]; PBO/GLM, 89/96[93%]). There were no notable differences in the number/types of AEs. For ASAS20/40, BASDAI50, and ASAS PR, the PBO/GLM-group showed notable improvement after switching to GLM, while the proportions of responders in the GLM/GLM-group remained higher. For wk52 vs wk16, mean changes from baseline (BL) in ASDAS-C were similar or better in the GLM/GLM-group (–2.2 vs –1.7) and were improved in the PBO/GLM-group after switching to GLM (–1.7 vs –0.6). At wk52, the mean change from BL in EQ-5D-Health-State-VAS-score was 3.2cm in the GLM/GLM-group and 2.3cm in the PBO/GLM-group, and the mean change from BL in the WPAI was –28.1% in the GLM/GLM-group compared to –22.8%.
Table 1 [Tab. 1], Figure 1 [Fig. 1]
Conclusion: Consistent with results of GO-AHEAD- trial, treatment with GLM in the OLE was generally well tolerated in nr-axSpA-patients. Improvements in disease activity were retained in GLM-patients in the OLE and in PBO-patients who switched to GLM.
