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SAT0388 Long-Term Efficacy and Tolerability of Golimumab in Active Nonradiographic Axial Spondyloarthritis: Results of The Open-Label Extension of A Randomized, Double-Blind Study
  1. D. van der Heijde1,
  2. M. Dougados2,
  3. W.P. Maksymowych3,
  4. J. Braun4,
  5. G. Bergman5,
  6. S.P. Curtis5,
  7. A. Tzontcheva5,
  8. G. Philip5,
  9. S. Huyck5,
  10. J. Sieper6
  1. 1Leiden University Medical Center, Leiden, Netherlands
  2. 2Paris-Descartes University, Paris, France
  3. 3University of Alberta, Edmonton, Canada
  4. 4Rheumazentrum Ruhrgebiet, Herne, Germany
  5. 5Merck & Co., Inc., Kenilworth, United States
  6. 6University Clinic Benjamin Franklin, Berlin, Germany

Abstract

Background The efficacy and tolerability of golimumab (GLM) for nonradiographic axial spondyloarthritis (nr-axSpA) have been demonstrated in a 16-week randomized, double-blind (DB), placebo (PBO)-controlled, phase 3 study (GO-AHEAD; NCT01453725).1

Objectives We report the long-term results from an open-label extension (OLE) of GO-AHEAD.

Methods Patients (pts) completing the 16-week DB study (GLM or PBO) received open-label GLM 50 mg every 4 weeks (36-week efficacy period; 8-week safety follow-up). Prespecified responder analyses for ASAS20, ASAS40, BASDAI50, and ASAS partial remission (PR) at weeks 16, 20, 24, 32, 40, and 52 used the OLE-treated population (GLM/GLM, n=93; PBO/GLM, n=96). In a post hoc analysis, the DB-treated population was used for GLM/GLM responder analyses (GLM/GLM, n=97). Non-responder imputation was used for missing ASAS20, ASAS40, and ASAS PR values; LOCF imputation was used for missing BASDAI data. The incidence/severity of adverse events (AEs) were recorded. Data were summarized descriptively.

Results In total, 176/189 (93%) pts entering the OLE completed week 60 (GLM/GLM, 85/93 [91%]; PBO/GLM, 89/96 [93%]). In the prespecified analysis, the proportions of ASAS20, ASAS40, BASDAI50, and ASAS PR responders in the OLE were similar to those in the DB phase among pts who continued GLM (GLM/GLM group); consistent results were observed in the GLM/GLM group when using the DB-treated population (Figure A,B). Among pts who switched from PBO in the DB phase to GLM in the OLE (PBO/GLM group), there were higher proportions of responders to GLM in the OLE than responders to PBO in the DB phase (Figure C). There were no notable differences in the number/types of AEs between the GLM/GLM and PBO/GLM groups (Table).

Table 1.

Summary of AEs in the GO-AHEAD OLE

Conclusions In the GO-AHEAD OLE, improvements in disease activity were retained in pts who received GLM and in pts who switched from PBO to GLM. Consistent with results of the GO-AHEAD DB study, treatment with GLM in the OLE was generally well tolerated in pts with nr-axSpA.

  1. Sieper J, et al. Arthritis Rheum. 2015;67(10),2702–2712.

Disclosure of Interest 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, W. Maksymowych Grant/research support from: AbbVie, Janssen, Pfizer, Consultant for: AbbVie, Amgen, UCB, Pfizer, Merck, Janssen, Eli Lilly, Celgene, Synarc, Boehringer, J. Braun Grant/research support from: Abbvie (Abbott), Amgen, Biogen, Boehringer, BMS, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Epirus, Hospira, Janssen, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis and UCB, Consultant for: Abbvie (Abbott), Amgen, Biogen, Boehringer, BMS, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Epirus, Hospira, Janssen, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis and UCB, G. Bergman Shareholder of: Merck & Co., Inc., Kenilworth, NJ, USA, Employee of: Merck & Co., Inc., Kenilworth, NJ, USA, S. Curtis Shareholder of: Merck & Co., Inc., Kenilworth, NJ, USA, Employee of: Merck & Co., Inc., Kenilworth, NJ, USA, A. Tzontcheva Shareholder of: Merck & Co., Inc., Kenilworth, NJ, USA, Employee of: Merck & Co., Inc., Kenilworth, NJ, USA, G. Philip Shareholder of: Merck & Co., Inc., Kenilworth, NJ, USA, Employee of: Merck & Co., Inc., Kenilworth, NJ, USA, S. Huyck Shareholder of: Merck & Co., Inc., Kenilworth, NJ, USA, Employee of: Merck & Co., Inc., Kenilworth, NJ, USA, J. Sieper Consultant for: AbbVie, Eli Lilly, Janssen Biologics, Merck, Novartis, Pfizer, Roche, UCB

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