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THU0238 A Randomized, Double-Blind, Placebo-Controlled, 16-Week Study of Subcutaneous Golimumab in Patients with Active Nonradiographic Axial Spondyloarthritis
  1. J. Sieper1,
  2. D. van der Heijde2,
  3. M. Dougados3,
  4. W.P. Maksymowych4,
  5. J.A. Boice5,
  6. G. Bergman5,
  7. S. Curtis5,
  8. A. Tzontcheva5,
  9. S. Huyck5,
  10. H.H. Weng5
  1. 1University Clinic Benjamin Franklin, Berlin, Germany
  2. 2Leiden University Medical Center, Leiden, Netherlands
  3. 3Paris-Descartes University, Paris, France
  4. 4University of Alberta, Edmonton, Canada
  5. 5Merck & Co., Inc., Kenilworth, United States

Abstract

Background Axial spondyloarthritis (axSpA), including ankylosing spondylitis (AS) and nonradiographic axial SpA (nr-axSpA), is a chronic inflammatory disease marked by back pain and progressive spinal stiffness.

Objectives To determine whether golimumab (GLM) is superior to placebo (PBO) in patients with 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 [SI] joint X-rays and MRIs, 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/intolerance to NSAIDs). Patients were randomized 1:1 to SC GLM 50 mg or PBO every 4 wks. The primary endpoint was ASAS 20 at wk 16. Treatment group differences for all patients and those with objective signs of inflammation (OSI; baseline inflammation by centrally evaluated SI MRI and/or elevated CRP) were compared by stratified Miettinen–Nurminen method for responder endpoints and Mann–Whitney test for SPARCC MRI SI score.

Results Of 198 patients enrolled, 197 were treated (GLM=97, PBO=100). Mean age was 31 years; 57% were male. At baseline, mean BASDAI was 6.5 cm (SD=1.5); SPARCC MRI SI, 11.3 (SD=14.0); and ASDAS, 3.5 (SD=0.9). The primary endpoint (wk 16 ASAS 20) was achieved by more GLM patients than PBO patients (71.1% vs 40.0%, P <.0001; table). More GLM than PBO patients attained ASAS 40, ASAS partial remission, and BASDAI 50 (table). Mean ASDAS improvements were greater with GLM (−1.7) than PBO (−0.6; P<0.0001). Similar results were obtained in the OSI population for all clinical measures. In the non-OSI population, wk 16 ASAS 20 attainment was comparable between treatments (47.4% GLM vs 50.0% PBO; P=.8711); effects of GLM on other endpoints were small or nonexistent. Mean SPARCC MRI SI score improvements were greater with GLM than PBO for all patients (−5.3 vs −0.9; P<0.0001) and the OSI population (−6.4 vs −1.2, P<0.0001).

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

Conclusions Patients with active nr-axSpA treated with GLM had significantly greater improvements in disease activity and inflammation on MRI than patients treated with PBO. GLM was generally well tolerated.

Disclosure of Interest J. Sieper Consultant for: AbbVie, Eli-Lilly, Janssen Biologics, Merck, Novartis, Pfizer, Roche, UCB, D. van der Heijde Consultant for: AbbVie, Amgen, AstraZeneca, Augurex, BMS, Boehringer Ingelheim, Celgene, Centocor, Chugai, Covagen, Daiichi, Eli-Lilly, Galapagos, GSK, Janssen Biologics, Merck, Novartis, Novo-Nordisk, Otsuka, Pfizer, Roche, Sanofi-Aventis, UCB, Vertex, Employee of: Imaging Rheumatology BV, M. Dougados Grant/research support from: AbbVie, Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, Consultant for: AbbVie, Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, W. Maksymowych Grant/research support from: AbbVie, Janssen, Pfizer, Consultant for: AbbVie, UCB, Pfizer, Merck, Janssen, Eli Lilly, Celgene, Synarc, J. Boice Employee of: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ (former), G. Bergman Employee of: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, S. Curtis Employee of: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, A. Tzontcheva Employee of: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, S. Huyck Employee of: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, H. Weng Employee of: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ (former)

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