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43. Kongress der Deutschen Gesellschaft für Rheumatologie, 29. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie, 25. Wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie

02.-05. September 2015, Bremen

A Randomized, Double-blind, Placebo-controlled, 16-Week Study of Subcutaneous Golimumab in Patients With Active Nonradiographic Axial Spondyloarthritis

Meeting Abstract

  • Joachim Sieper - Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektologie, Rheumatologie, Berlin
  • Desiree van der Heijde - Leiden University Medical Center, Department of Rheumatology, Leiden, The Netherlands
  • Maxime Dougados - Hôpital Cochin, Department of Rheumatology, Paris, France
  • Walter Maksymowych - University of Alberta, Edmonton, Canada
  • Judith Boice - Merck & Co., Inc., Whitehouse Station, NJ, USA
  • Gina Bergman - Merck & Co., Inc., Whitehouse Station, NJ, USA
  • Sean Curtis - Merck & Co., Inc., Whitehouse Station, NJ, USA
  • Anjela Tzontcheva - Merck & Co., Inc., Whitehouse Station, NJ, USA
  • Susan Huyck - Merck & Co., Inc., Whitehouse Station, NJ, USA
  • Holly Weng - Merck Sharp & Dohme Corp., Brüssel, Belgium

Deutsche Gesellschaft für Rheumatologie. Deutsche Gesellschaft für Orthopädische Rheumatologie. Gesellschaft für Kinder- und Jugendrheumatologie. 43. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 29. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 25. wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR). Bremen, 02.-05.09.2015. Düsseldorf: German Medical Science GMS Publishing House; 2015. DocSpA.15

doi: 10.3205/15dgrh221, urn:nbn:de:0183-15dgrh2215

Published: September 1, 2015

© 2015 Sieper et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.


Outline

Text

Introduction: AxSpA, including AS and nr-axSpA, is a chronic inflammatory disease marked by back pain and progressive spinal stiffness. The goal of GO-AHEAD was to determine if golimumab (GLM) is superior to placebo (PBO) in nr-axSpA-patients.

Methods: GO-AHEAD (Phase-3b, double-blind, randomized, PBO-controlled trial) evaluated SC GLM50mg vs PBO in patients (18–45 years) with active nr-axSpA (ASAS criteria, centrally-read SI-joint X-rays; disease duration ≤5 years; chronic back pain; high disease activity [total back pain ≥40 mm on a 0–100 mm VAS and BASDAI ≥4 cm]; and inadequate response or intolerance to NSAIDs). Patients were randomized 1:1 to GLM or PBO every 4 weeks. Primary endpoint: ASAS20-attainment at week 16. Key secondary endpoints: ASAS40, ASAS partial remission, BASDAI50, Spondyloarthritis Research Consortium of Canada (SPARCC) MRI sacroiliac (SI) joint score change. ASDAS based on CRP was assessed. Treatment group differences for all patients-as-treated and the target populations (signs of inflammation by MRI or elevated CRP at baseline) were compared (stratified Miettinen and Nurminen method for responder endpoints; Mann-Whitney test for MRI SI joint score).

Results: Of 198 patients, 197 were treated (GLM=97; PBO=100). Mean age: 31 years; 57% male. At baseline, mean BASDAI was 6.5 cm (SD=1.5), SPARCC MRI SI was 11.3 (SD=14.0), and ASDAS was 3.5 (SD=0.9). The primary endpoint was achieved by significantly more GLM-patients (71.1%) than PBO-patients (40.0%). Significantly more GLM-patients also attained ASAS40, ASAS partial remission, and BASDAI50. Mean ASDAS improvements were greater with GLM than PBO (–1.7 vs –0.6; P<.0001). Mean SPARCC MRI SI joint score improvements (baseline to week16) were greater with GLM than PBO (–5.3 vs –0.9; P<.0001); improvements for the target population were –6.4 vs –1.2 (P<.0001).

Table 1 [Tab. 1]

Adverse events (AEs) occurred in 41% of GLM and 47% of PBO-patients. Serious AEs: 1 GLM (female partner reported fetal death) and 2 PBO-patients (cholelithiasis, back pain). There were no serious infections, serious opportunistic infections, active tuberculosis, malignancies, serious systemic hypersensitivity, or deaths.

Conclusion: Active nr-axSpA-patients treated with GLM had significantly greater improvements in disease activity and inflammation on MRI than PBO-patients. GLM was well-tolerated and generally had a favorable benefit-risk profile.