Article
Baseline Demographic and Disease Characteristics Associated with Response to Golimumab in Patients with Active Nonradiographic Axial Spondyloarthritis
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Authors
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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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Susan Huyck
- Merck & Co., Inc., Whitehouse Station, NJ, USA
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Anjela Tzontcheva
- Merck & Co., Inc., Whitehouse Station, NJ, USA
| Published: | August 29, 2016 |
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Outline
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Background: The purpose of this study was to explore the response consistency in subgroups of patients with nonradiographic axial spondyloarthritis (nr-axSpA) who received golimumab (GLM) or placebo (PBO) for 16 wks.
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 (SI) joint X-rays and MRIs; disease duration ≤5 years; 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 subcutaneous GLM 50mg or PBO every 4 wks. Estimated between-group treatment differences and 95%-CIs for ASAS20 and ASAS40 responses at wk16 were calculated for prespecified patient subgroups. Treatment and subgroup differences were compared by stratified Miettinen–Nurminen-methods with baseline inflammation by SI joint MRI and screening CRP-level as stratification factors. No multiplicity control was applied.
Results: A total of 197 patients were treated (GLM=97; PBO=100). ASAS20 at wk16 was achieved by 71.1% of GLM-patients and 40.0% of PBO-patients (P <.0001). Although size of response differed somewhat across the subgroups, responses were greater to GLM than PBO in most patient subgroups (P<.05) (Table 1 [Tab. 1]).
Because of the small numbers of patients within subgroups and because subgroups may not represent randomized samples, results should be considered exploratory and interpreted with caution. Treatment group differences appeared to be larger in patients with objective signs of inflammation (MRI SI or CRP>ULN). The results for ASAS40 and ASAS20 were very similar.
Conclusion: Patients with active nr-axSpA who received GLM were more likely to achieve ASAS20 at wk16 than those treated with PBO across a variety of baseline characteristics, including those with baseline objective signs of inflammation (eg, MRI SI or CRP >ULN).
