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SAT0399 Efficacy of Golimumab for Nonradiographic Axial Spondyloarthritis: Subgroup Analysis by Baseline MRI and C-Reactive Protein Status
  1. J. Sieper1,
  2. D. van der Heijde2,
  3. W.P. Maksymowych3,
  4. J. Braun4,
  5. G. Bergman5,
  6. S.P. Curtis5,
  7. A. Tzontcheva5,
  8. G. Philip5,
  9. S. Huyck5,
  10. M. Dougados6
  1. 1University Clinic Benjamin Franklin, Berlin, Germany
  2. 2Leiden University Medical Center, Leiden, Netherlands
  3. 3University of Alberta, Edmonton, Canada
  4. 4Rheumazentrum Ruhrgebiet, Herne, Germany
  5. 5Merck & Co., Inc., Kenilworth, United States
  6. 6Paris-Descartes University, Paris, France

Abstract

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

Objectives We investigated the effect of GLM in patients (pts) with nr-axSpA based on presence or absence of objective inflammation (ASAS+ MRI sacroiliitis and/or C-reactive protein [CRP] > upper limit of normal [ULN]) at baseline.

Methods Pts with nr-axSpA (ASAS criteria, centrally read SI joint X-rays/MRIs, disease duration ≤5 years, chronic back pain ≥3 years, high disease activity, and inadequate response or intolerance to NSAIDs) were randomized (with ASAS-defined MRI sacroiliitis by single central reader [yes, SI+; no, SI–] and CRP level [≤ULN or >ULN] as stratification factors) to GLM 50 mg SC or PBO Q4W for 16 wks. The primary endpoint was ASAS20 response at wk 16. Estimated between-group differences in ASAS20, ASAS40, BASDAI50, and ASAS partial remission (PR) response at wk 16 for four pt subgroups (MRI SI+ & CRP >ULN; MRI SI– & CRP >ULN; MRI SI+ & CRP ≤ULN; MRI SI– & CRP ≤ULN) were compared by Miettinen-Nurminen methods. No multiplicity control was used.

Results In total, 197 pts were treated (GLM=97; PBO=100). Treatment group differences in ASAS20, ASAS40, BASDAI50, and ASAS PR response were greater in pts with baseline objective inflammation (Table). Results should be interpreted with caution, given the small subgroups and absence of multiplicity control.

Table 1.

Subgroup analysis of response by MRI SI status and CRP level at baseline

Conclusions In the DB phase of GO-AHEAD, nr-axSpA pts with baseline objective inflammation (particularly with CRP >ULN) had greater responses to GLM. No GLM treatment benefit was observed in pts with MRI SI– & CRP ≤ULN.

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

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, 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, M. Dougados Grant/research support from: AbbVie, Lilly, Novartis, Pfizer, Roche, Sanofi, UCB

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